Methods

'following ethical approval and through a randomised controlled clinical trial, 120 pregnant women with LBP were recruited into experimental and control groups.'

Conducted in Iran; no funding source stated.

Participants

Inclusion criteria:                                                                                                       

Gestational age: 17 to 22 weeks.

History of at least 12 weeks back pain during pregnancy.

Exclusion criteria:

Contraindications of physical activity according to ACOG committee guidelines.

History of exercise before pregnancy.

History of spinal surgery, spinal tumours, hip fracture, vertebral malformations, osteoporosis, and multiple sclerosis.

Interventions

Experiment group: N = 60

• Illustrated booklet on the exercises and ergonomic principles.

• 5 educational workshops, 20 min each, on the abdominal and back muscles, strengthening and stretching exercises; led by an expert midwife and a physiotherapist.

• Follow‐up telephone calls to assure the sustainability of intervention.

Control  group: N = 60

No intervention.

Outcomes

Pain (VAS) and disability (Oswestry disability questionnaire) were measured in both groups. But in the results, only the baseline and the difference from baseline, with no report of SD, was reported in each study group.

The comparison of all changes between 2 study groups were statistically significant with P < 0.0001.

Low‐back pain

X

Pelvic pain

Low‐back pain and pelvic pain

Notes

Change score from immediately after treatment was subtracted from the baseline pain score for an 'immediately after treatment' VAS score; reported lost to follow‐up was assumed to have happened during treatment; RevMan calculator was used to calculate SD to allow results to be included in meta‐analysis for 'any exercise vs usual prenatal care', analysis 1.1

‐ translated from Arabic by single Iranian researcher.

Funding = no information provided.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Block randomisation with matching (stratification?) for age, gestational age, and BMI.

Allocation concealment (selection bias)

Unclear risk

Not mentioned in paper.

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Patients were not blinded. Nothing mentioned about blinding of providers.

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Nothing mentioned about blinding of outcome assessors.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

120 patients were enrolled (60 in each group). 3 patients in intervention group, 5 in control group missed. In all cases the researchers lost track of the patients due to the change in living location.

Selective reporting (reporting bias)

Unclear risk

The outcomes were also measured at 6^th month and 1 year after delivery. But only the results for immediately after treatment, and 3 months after delivery were reported.

Pain (VAS) and disability (Oswestry disability questionnaire) were measured in both groups. But in the results, only the baseline and the difference from baseline, with no report of SD, was reported in each study group.

The comparison of all changes between 2 study groups were statistically significant with P < 0.0001.

Other bias

Low risk

Nothing noted in the paper.

Methods

• 'randomised masked prospective experimental clinical trial.'

• 106 consecutive women referred for management of symphysis pubic problems were asked to participate.

• Those who met the inclusion criteria were assesses by 1 of 4 therapists who were identically trained; 36 withdrew prior to randomisation because they did not meet the inclusion criteria.

• To see a small to medium effect size (0.35) on a modified RMDQ, with power set at 0.8 and alpha at 0.05, 30 participants were needed per group.

• Number randomised = 90; number analysed = 87.

Participants

Inclusion criteria:                                                                                                         

Pregnant women referred to the National Women’s Hospital, Auckland, New Zealand physical therapy outpatient department for treatment.

Have pain (insidious onset) and tenderness on palpation in the symphysis pubis, with or without radiation to the groin.

Have a positive ASLR test result. A positive test result required the participant to experience pain or difficulty with this movement. (See study’s Appendix 1 for more description).

Exclusion criteria:

Medical conditions preventing the use of pelvic support belts. For example, some types of placenta previa.

Posterior (sacroiliac joint or lumbar spine) pain that was considered by the woman to be worse than the symphysis pubis pain.

Interventions

Experiment group:

1. Exercise plus non‐rigid support belt: N = 29.

• Participants received same information and exercises as the control group.

• Received a non‐rigid neoprene support belt (Smiley Belt).

• Received a logbook for recording number of hours the belt was worn and number of times exercises done.

2. Exercise plus rigid support belt: N = 28.

• Participants received same information and exercises as the control group.

• Received a rigid belt (Lifecare Pubic Belt).

• Received a logbook for recording number of hours the belt was worn and number of times exercises done.

Control group: Exercise only: N = 30.

Participants received an exercise booklet with 5 exercises aimed to increase the stability of the pelvic bones. A trained physical therapist demonstrated the exercises and checked that they were being performed correctly.

Exercise needed to be completed 3 times daily for 1 week. Participants were given logbook to record the frequency they exercised.

Participants also received verbal and written education about the anatomy and pathology of symphysis pubis dysfunction and self‐help management. (See study’s Appendix 2 and 3 for specific exercises and self‐help management techniques.)

Outcomes

Average and worst pain in last week ‐ VAS (0‐100); days off work; modified Roland Morris Disability Questionnaire; Patient Specific Functional Scale; measured at baseline, after treatment.

Low‐back pain

Pelvic pain

X

Low‐back pain and pelvic pain

Notes

There were no significant differences between the groups in adherence to their exercise program or belt wearing. The adherence rate is acceptable (average for all participants: Exercises = 16.5/21 times, Number of hours belt worn/week = 44.2).

Funding = Maurice and Phyllis Paykel Trust for a Research Scholarship.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: 'Randomization process involved the use of a table of 3 randomly permuted blocks'.

Allocation concealment (selection bias)

Unclear risk

Not specifically mentioned: patients assigned to groups by independent person (not connected to study) but unclear how this was actually done.

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Patients not blinded; therapists providing exercise therapy were unaware of the intervention groups to which participants were assigned. However, unclear as to who distributed the belts.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Authors did not specify who collected the outcomes (outcomes were self‐report measures).

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No withdrawals in the control group.

1 woman in the non‐rigid support belt group delivered her baby before the post‐intervention assessment.

2 women in the rigid support belt group delivered their babies before their post‐intervention assessment.

1 woman refused to be in the study as she was 'not prepared to be in the exercise‐only group'.

No exclusions mentioned.

Selective reporting (reporting bias)

Low risk

Study reported all outcomes it said it would report in methods.

Other bias

Low risk

Groups similar at baseline; adherence similar between groups; outcomes taken at same time for each group, co‐interventions likely to be similar.

Methods

Observer‐blinded randomised controlled trial.

Participants

257 women were randomised.

Inclusion criteria:

Healthy Norwegian speaking women between 18 to 40 years from 2 Maternity Care Units (within the Norwegian Public Health System).

Exclusion criteria:

1. Pregnant women carrying twins.

2. Inflammatory rheumatic disorders.

3. Risk factors for miscarriage.

Interventions

Intervention group (N = 129/106 analysed):

• Participants, referred to 1 of 2 specially trained physical therapists, will receive tailored supervised group exercise once a week, along with advice to do daily home exercise.

• Specific attention to body awareness and ergonomic advice in real‐life situations; the main focus of the intervention being the specific training of the transversely oriented abdominal muscles with co‐activation of the lumbar multifidus at the lumbosacral region, and stretching the hip abductors.

• Intervention will take place for a maximum of 16 weeks, between 20‐36 weeks' gestation, with no follow‐up after 36 weeks' gestation.

Control group (N = 128/107 analysed):

Usual prenatal care.

Outcomes

Primary outcome:

The proportion of women experiencing pain in the pelvic girdle or lumbar spine.

Secondary outcomes:

1. Functional status measured with the modified Roland Morris Disability Questionnaire (0‐24).

2. Low‐back and lumbo‐pelvic pain measured using the VAS scale (0‐10).

3. Health related quality of life measured with the SF‐8 Health Survey.

All outcomes measured at 24, 28, 32, and 36 weeks' gestation.

Low‐back pain

Pelvic pain

Low‐back pain and pelvic pain

X

Notes

Funding/sponsor: Norwegian Fund for Postgraduate Training in Physiotherapy (Norway)

Lead author contacted to clarify the number analysed in intervention group; she confirmed that it should be 106, not 103 as stated in the Figure and tables.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

'randomisation procedure was computer generated by the statistician not involved in data collection.'

Allocation concealment (selection bias)

Low risk

'group allocation was concealed in consecutively numbered, sealed, opaque envelopes.'

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Participants not blinded.

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Outcomes were self‐reported, therefore not blinded; however the midwives who distributed the questionnaires to the women were not aware of their group allocation.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Treatment group lost 22/129 (17.8%) and the control group lost 21/128 (16.4%) by the end of follow‐up at 36 weeks' gestation.

Selective reporting (reporting bias)

Low risk

Results provided for all the outcomes outlined in the trial registration (ISRCTN95014448).

Other bias

Low risk

Groups were similar at baseline except that the training group had significantly higher BMI; almost twice as many women in the training group had experienced moderate to severe PGP in a previous pregnancy but this was adjusted for in the outcome analyses; adherence to exercises did not seem to vary between groups, nor did consultation with healthcare providers.

Methods

• N = 40 pregnant women 'from the same demographic area' in Sweden; N = 20 in each group (group 1 and 2).

• After diagnosis with pelvic and LBP, women were referred to the acupuncturist at the hospital 'where randomisation was carried out; women were phoned to give them the dates for their acupuncture; baseline data were collected when they came for treatment'.

Participants

Inclusion: healthy pregnant women with low‐back and pelvic pain diagnosed using posterior pain provocation test.

Exclusion: treatment with cortisone, anticoagulants or immunosuppressive drugs, heart disease, diabetes, pacemakers, epilepsy, hepatitis, HIV or AIDS, acute infection, psychiatric disease, haematological disorders, renal disease, premature contractions, needle phobia.

Interventions

Both groups received the same treatment; 8 acupuncture treatments over a 6 week period (2 treatments per week in the first 2 weeks and once per week thereafter) with first treatment lasting 20 minutes and number of needles limited to 5, and remainder 30 minutes with maximum 10 needles.

Group 1 (mean age 28.6 yrs) started treatment at 20 weeks' gestation and

Group 2 (mean age 27.9 yrs) at 26 weeks' gestation.

No control group ‐ acupuncture intervention was started either at 20 (group 1) or 26 weeks (group 2) gestation.

Outcomes

Short Form Health survey questionnaire (SF‐36), Short Form Magill Pain Questionnaire (MPQ), Pain‐o‐meter, Foetal sound measured at baseline, at 4th and 8th treatment sessions, at same times for each group; qualitative data collected via telephone interviews 2‐3 months after delivery.

Both groups had similar experience of acupuncture (from qualitative interviews). Small number of study participants acknowledged by authors. Non compliance in both groups reported.

Low‐back pain

Pelvic pain

Low‐back pain and pelvic pain

X

Notes

Funding = Council of Research and Development (FoU‐centrum), Landstinget Kronoberg, Sweden.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Insufficient information given about sequence generation; in the discussion it states that 'the women were chosen randomly'.

Allocation concealment (selection bias)

Low risk

Telephone allocation.

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

'both groups had similar experience with acupuncture when asked at end of treatment'; unclear if acupuncturists were informed of gestation, or if they were able to determine by observation, however, the difference was only 20 to 26 weeks, therefore likely not a big issue.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Insufficient information provided on who collected the self‐report outcomes.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Both groups had 4 drop‐outs with reasons given ‐ did not appear to be related to intervention.

Selective reporting (reporting bias)

Low risk

Qualitative data supports quantitative data ‐ however the telephone interviews were completed by the study author.

Other bias

Low risk

Co‐interventions and adherence similar across groups, timing of outcome assessment same across groups, mean pain intensity was significantly lower in group 1 than group 2 at baseline.

Methods

386 women consecutively selected by doctors and midwives and randomised to 3 groups by distribution of pre‐sealed opaque envelopes, with group assignment by computer‐generated random table to determine the allocation sequence before the study.
Participants and caregiver not blinded; assessor blinded.
Acupuncture group: randomised = 125; analysed = 110 (88%) (10 declined treatment, 1 declined visit, 5 had early delivery).
Stabilising exercises group: randomised = 131; analysed = 112 (85.5%) (9 declined treatment, 1 moved from area, 4 had early delivery, 5 declined visit).
Standard treatment group (control); randomised = 130; analysed = 108 (83.0%) (15 declined treatment, 3 had early delivery, 3 declined visit, 1 moved from area).

Intention to treat: those who finished the trial were analysed in the group to which they had been assigned.

Participants

Location: East Hospital, Sahlgrenska Academy and 27 maternity care centres in the hospital's reference area in Gothenburg, Sweden; 2000‐2002.
Inclusion criteria: healthy women at 12 to 31 weeks' gestation, fluent in Swedish, singleton fetuses, had defined pregnancy‐related pelvic girdle pain.
Exclusion criteria: those with other pain conditions, systemic disorders, contraindications to treatment.

Interventions

Experiment group 1 ‐ acupuncture.
General information about the condition, anatomy of the back and pelvis, advice about activities of daily living, given a pelvic belt and a home exercise program by physiotherapist + acupuncture treatment given twice a week over 6 weeks using 10 local acupuncture points in sensitive spots + 7 extra‐segmental points ‐ needles inserted to evoke De Qi ‐ left in situ for 30 minutes, stimulated every 10 minutes ‐ given by 2 experienced medical acupuncturists.

Experiment group 2 ‐ stabilising exercises.
General information about the condition, anatomy of the back and pelvis, advice about activities of daily living, given a pelvic belt and a home exercise program by physiotherapist + individual stabilising exercises (modified for pregnancy) for a total of 6 hours over 6 weeks ‐ given by 2 experienced physiotherapists.

Control group: standard treatment.
General information about the condition, anatomy of the back and pelvis, advice about activities of daily living, given a pelvic belt and a home exercise program by physiotherapist ‐ given by 3 experienced physiotherapists.

Outcomes

Measured at 1 week post‐treatment: self‐report pain each a.m. ‐ 100 mm VAS; examiner assessment of recovery from symptoms ‐ positive pain drawing; examiner assessment of recovery from symptoms ‐ posterior pelvic pain provocation test; examiner assessment of recovery from symptoms ‐ pain when turning in bed.

Adverse events: none reported for any of the 3 groups.

Low‐back pain

Pelvic pain

X

Low‐back pain and pelvic pain

Notes

Funding = The Vardal Foundation, the Dagmar Foundation, the Trygg‐Hansa Insurance Company, the Sahlgrenska University Foundation.

14 March 2012 ‐ email & LinkedIn message sent to Dr Elden to clarify number of participants in Table 3; response received ‐ clarified that there were 130 in the standard group and 131 in the exercise group; other data are correct.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer‐generated random table to determine the allocation sequence before the study.

Allocation concealment (selection bias)

Low risk

Pre‐sealed opaque envelopes.

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Participants and providers were not blinded.

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

'Results coded and entered by personnel from independent institution; Statistician blinded to group and treatment.'

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Standard treatment group; randomised = 130; analysed = 108 [83.0%] (lost to follow‐up: declined treatment N = 15, early delivery N = 3, declined visit N = 3, moved from area N = 1).

Acupuncture group: randomised = 125; analysed = 110 [88%] (lost to follow‐up: declined treatment N = 10, declined visit N = 1, early delivery N = 5).

Stabilising exercises: randomised = 131; analysed = 112 [85.5%] (lost to follow‐up: declined treatment N = 9, moved from area N = 1, early delivery N = 4, declined visit N = 5).

ITT: analysed participants measured one week post‐treatment against those randomised.

Selective reporting (reporting bias)

Low risk

Data presented for a priori determined outcomes.

Other bias

Low risk

Table 3 seems to have the number of women reversed between 'Standard' and 'Exercise' groups. Author clarified this to be so.

Methods

• 'randomised double‐blinded controlled trial.'

• Women recruited between June 2006 and May 2007 from 25 units within the Västra Götaland region, Sweden.

• N = 115 randomised; N = 58 to standard treatment plus acupuncture; N = 57 to standard treatment plus non‐penetrating acupuncture.

Participants

Inclusion criteria:                                                                                                    

Pregnant women.
Clinical diagnosis of pelvic girdle pain (according to Ostgaards criteria).
Experienced evening pain of more than 50‐mm on a 100‐mm VAS during baseline week.
Acupuncture‐naive.
Singleton fetuses at 12 to 29 completed gestational weeks.
Must speak Swedish fluently.

Exclusion criteria:

Women with other pain conditions, history of orthopaedic disease or surgery in the spine or pelvic girdle, systemic disorders, coagulation disturbances or increased risk of infection.

Interventions

Experiment group: standard treatment + penetrating acupuncture

Standard treatment: general information about condition and anatomy of back and pelvis and a pelvic belt, gave advice and home programme exercised designed to increase strength in the abdominal and gluteal muscles. Information was supplemented by a leaflet. Also instructed to avoid other treatments during intervention period.

Penetrating acupuncture: see study methods for exact acupuncture points used. Sterilised disposable needles were used and inserted intramuscularly to depth of 15‐50mm. Needles were left in situ for 30 minutes and manually stimulated every 10 minutes.

Control  group: Standard treatment + non‐penetrating acupuncture

Standard treatment: identical to experimental group

Non‐penetrating acupuncture: used a validated sham acupuncture device (which looks like real acupuncture needles but the tip of needle is blunted). The shaft of the sham needle did not penetrate the skin, it collapsed into the handle and creates an illusion of insertion. Needles were left in situ for 30 minutes and manually stimulated every 10 minutes.

Outcomes

EQ‐5d questionnaire and EQ‐5d VAS; VAS ‐ Pain (0‐100) in the morning & evening; Oswestry Disability Index (back specific function); frequency of sick leave; Disability Rating Index (DRI) measured at baseline, after treatment and 1 week follow‐up.

Adverse events: transient, tingling, needle pain, slight bleeding, fainting, sleepiness.

Low‐back pain

Pelvic pain

X

Low‐back pain and pelvic pain

Notes

Pain severity diagnosed with ASLR test and posterior pain provocation test. N = 165 women assessed for eligibility (N = 50 did not meet inclusion criteria). All women acupuncture naive & singleton fetus. No serious adverse events reported. Same contact time, manual contact during search and stimulation of needles, interaction between patient and therapist in both groups. Drop‐outs reported with reasons.

Funding = grants from the Foundation of the Health and Medical care committee of the Region of Västra Götaland (Sweden), grants from the Swedish Medical Reserach Council and Swedish government grants to researchers in the public health service.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: 'Computer‐generated random table was used'.

Allocation concealment (selection bias)

Low risk

Statistician who was not involved in the study administered pre‐coded numbered identical opaque envelopes to assign participants to the intervention groups.

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

Participants: low risk ‐ only LI4 (on hand) not blinded

'Women were blinded to whether they were receiving sham or active treatment.'
Therapist remained neutral for both groups.
Women were treated in a prone position (i.e. unable to see the needles except ones on hand).
Sham needle collapses into a handle to create illusion of insertion.
Reported that most participants believed they received the penetrating acupuncture.

Providers: high risk

Not blinded.
Same therapist administered sham and active treatments.

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Assessors: low risk

Blinded to treatment allocation, doctors handling decisions about sick‐listing were also blinded.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Dropouts: 2 in treatment and 5 in control dropped intervention because it 'violated protocol'.

At follow‐up: 3 drop‐outs in treatment group due to early birth and declined visit, 2 in control group due to declined visit.

Low drop‐out rate, and similar reasons between the groups.
No exclusions mentioned.
Numbers add up.
For missing data and those who withdrew, ITT analysis applied to outcome data using last recorded data.

Low risk: attrition and drop‐outs reported and reasons, numbers at each stage add up, ITT ‐ last value carried forward.

Selective reporting (reporting bias)

Low risk

Study reported all outcomes it said it would report in methods. All outcome data are found in tables.

Other bias

Low risk

Randomisation procedure successful (however more in control group on sick leave?).

Methods

266 randomised: those who could not exercise were excluded from the exercise group, but it's unclear why 54 people dropped out of exercise group and none out of control.
Excluded before randomisation = 14 with UTI, threatened abortion, lack of time, leaving 266 to be randomised.
Randomised to exercise group = 161, 54 who could not participate in exercises = 107.
Randomised to control group = 105.
Participants and caregiver not blinded; assessor‐blinded.
Analysis of pain and flexibility measures were conducted on those who completed the intervention in the group to which they had been randomised.

Participants

280 women invited to participate from those registered at Hazrat Zaynab Hospital prenatal clinic in Tehran, Iran (no details about how they were selected from the 2358 who had registered at the clinic during the study period).
Inclusion criteria: primigravida, 20 to 28 years old, 17 to 22 weeks' gestation, housewives, high school graduates.
Exclusion criteria: women with contraindications to aerobic exercise during pregnancy according to ACOG guidelines, history of exercise before pregnancy, history of orthopaedic disease or surgery, those who missed 3 exercise sessions.

Baseline characteristics.
2 groups similar in age, weight, height, BMI.
Exercise group = 73 women (68%) had LBP during pregnancy.
Control group = 78 women (70.5%) had LBP during pregnancy.

Interventions

Experiment group.
Exercises recommended by Tarbiat Modares Faculty of Sport and tested for pregnant women by physiotherapists, to strengthen abdominal muscles, hamstring muscles and increase traction of iliopsoas and para vertebral muscles.
15 movements in 60 minutes: 5 minutes of slow walking, 5 minutes of extension movements, 10 minutes of general warming up, 15 minutes anaerobic exercise, 20 minutes of specific exercise, 5 minutes return to the 1st position ‐ offered to exercise 3 times a week ‐ supervised by midwife ‐ intensity of exercises controlled by maternal pulse rate ‐ stopped if > 140/minute.

Control group: no treatment.

Outcomes

Adverse events: none reported.

No scales/units given for outcomes measured, but 1 may assume they are reporting the group mean, measured on the KEBEK questionnaire (range 0 to 100, higher = worse pain); change scores do not appear to be included, the degree of lordosis and degree of flexibility of the spine.

Low‐back pain

X

Pelvic pain

Low‐back pain and pelvic pain

Notes

All numbers do not add up; there are contradictions in text; we tried unsuccessfully to clarify data with lead author during the 2007 update.

Funding: not stated.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

‘prospective randomised study’ but method of randomisation not described.

Allocation concealment (selection bias)

Low risk

Sealed envelopes. 

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Participants and providers were not blinded.

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Report states that the outcome assessor was blinded.

Incomplete outcome data (attrition bias)
All outcomes

High risk

Difficult to assess since numbers do not add up; appears that 14 withdrew prior to randomisation; about 20% withdrew/dropped out after randomisation; it appears that 54 dropped out of the intervention group and none out of the control group.

Selective reporting (reporting bias)

High risk

Results are difficult to interpret and appear to be reversed.

Other bias

Low risk

Nothing more to add.

Methods

Potential women were identified through obstetric records and approached, in person or by phone, to determine if they met the inclusion criteria.

41 women were invited to attend; 4 declined, 3 did not attend the first follow‐up.

34 women randomised to either Global Postural Re‐education (GPR) treatment or usual prenatal care.

Participants

Women selected from those receiving prenatal care in 3 health centres and those who attended lectures in preparation for birth at a private hospital in Campinas, Brazil.

Both groups of women were similar in most of the characteristics studied on admission to the study: in the GPR group 10 women came from a private hospital and 7 from a health (publish) centres, in the control group there were 6 women coming from the private hospital and 11 health (public) centres.

Inclusion criteria: LBP, nulliparity, low‐risk singleton pregnancy, gestational age between 20 to 25 weeks, aged 18 to 40 years, absence of obstetric or medical illness, absence of pre‐existing spinal pathologies. Differentiation made between LBP and posterior pelvic pain at baseline physiotherapy assessment.

Interventions

Global Postural Re‐education (GPR) treatment (n = 17)

Weekly 40‐minute sessions for 8 weeks.

Stretching of the muscles of the posterior chain ‐ angle closure coxo‐femoral and abduction of the upper limbs & closing angle coxo‐femoral with adduction of the upper limbs.

Control group (n = 17)

Regular prenatal care.

Outcomes

GPR group

Intensity of LBP, measured with VAS (0‐10) at baseline, before/after each treatment session.

Back‐related function, measured with the RMDQ at baseline, before/after each session.

Control group

Intensity of LBP and back‐related function were measured at baseline, at 4 and 8 weeks of the study.

Use of pain medication collected for both study groups.

Low‐back pain

x

Pelvic pain

Low‐back pain and pelvic pain

Notes

Used Google Translate to translate from Portuguese; verified by single Portuguese researcher.

Paper stated that there was no external funding.

Data needed for the meta‐analyses appeared to be incorrectly reported in the paper and were re‐analysed.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

'randomisation was performed by using a list of random numbers generated by computer.'

Allocation concealment (selection bias)

Unclear risk

No mention in translated version of allocation concealment.

Blinding of participants and personnel (performance bias)
All outcomes

High risk

'these professionals had lagged randomisation, so did not know to which group each woman was allocated' ... however, those who provided the exercise therapy and those who received it would have known to which group they were allocated.

Blinding of outcome assessment (detection bias)
All outcomes

High risk

'at the end of the participation on each woman in the study, they conducted a professional full re‐evaluation of LBP' ... however, the women were the ones who reported their symptoms via the VAS and RMDQ.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

3 participants are reported as lost to follow‐up; there is no real clarification of their initial group ‐ it could be control group, but the 17 in each group do not seem to take any losses into consideration.

Selective reporting (reporting bias)

Low risk

Data provided for baseline and after intervention outcome measures for pain and disability.

Other bias

High risk

Not similar at baseline for education or age (intervention group was better educated and older), but similar in other prognostic factors; women in control group used more pain medication (87% versus 12% in intervention group); no information provided on compliance, co‐interventions or use of pain medication; the control group was only measured twice after baseline, the intervention group was measured 8 times, but all within the same time‐frame.

Methods

Prospective randomised controlled trial ‐ 169 pregnant women.

Study tested the hypothesis the hypothesis that a multi‐modal approach of manual therapy, exercise and education for LBP/PP in pregnancy is superior to standard obstetric care for the reduction of pain, impairment and disability.

Enrollment to the study between 24 and 28 weeks' gestation with follow‐up at 33 weeks' gestation and 3 months postpartum.

Participants

Pregnant women with LBP/PP at enrolment (24 to 28 weeks' gestation). No other criteria provided.

Interventions

Experimental group (n = 87): multi‐modal musculoskeletal and obstetric management (MOM) ‐ standard obstetric care PLUS a chiropractic specialist provided manual therapy, stabilisation exercises and patient education ‐ no details on number of treatments.

Control group (n = 82): Standard Obstetric Care (STOB).

Outcomes

Pain intensity (NRS), Disability (Quebec Disability Questionnaire ‐ QDQ), Personal Pain History (PPH), SLR, P4.

Low‐back pain

Pelvic pain

Low‐back pain and pelvic pain

X

Notes

This was a poster presentation at the 32nd Annual Meeting for the Society for Maternal‐Fetal Medicine with only the abstract published in a supplement of the journal, so further biases are difficult to assess; there was no reference to other publications on this trial and none were identified by a Google and MEDLINE search on 16 Aug 2012.

August 27, 2012: email sent to Dr Gross requesting data, via Saint Louis University School of Medicine, Division of Maternal‐Fetal Medicine general email since unable to find individual email; as of November 2nd, 2012 there has been no response.

Assume study conducted in US, since all PIs list American university affiliations

Grant number: R18HP07640.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

No information provided on method of generating allocation sequence apart from 'randomised' stated in the title and study design section.

Allocation concealment (selection bias)

Unclear risk

Details not provided.

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Insufficient detail provided ‐ Chiropractic specialist performing baseline evaluation and follow‐up exams 'single masked'.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Insufficient detail provided ‐ Chiropractic specialist performing baseline evaluation and follow‐up exams 'single masked'.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Insufficient detail provided ‐ only number in each arm of trial provided in results section.

Selective reporting (reporting bias)

Unclear risk

Limited data provided; e.g. results section states that there was a significant reduction in NRS, QDQ, PPH and SLR scores in the experimental group at 33 weeks' gestation whilst the control group only showed an improvement in QDQ, however on both occasions only P values given (P < 0.05).

Other bias

Unclear risk

Groups were demographically similar and baseline evaluation showed no differences in pain, disability or physical assessments between groups however no data provided pre versus post intervention.

Methods

N = 115 women randomised (N = 55 to Bellybra and N = 60 to Tubigrip).

Participants

Inclusion criteria:                                                                                                         

Women between 20 and 36 weeks pregnancy with lumbar back or posterior pelvic pain.

Exclusion criteria:

Women with high back pain or symphysiolysis but with no concomitant lumbar back or posterior pelvic pain.
Complicated pregnancy.
Non‐English speaking.

Interventions

Experiment group: BellyBra

A nylon/spandex undergarment worn like a vest, has a 1‐way stretch panel across the thoracolumbar back that is designed to provide support and assisted by the involvement of shoulder straps, to improve posture. A wide elastic band sits below the abdomen supporting the uterus and lifting weight off the pelvis.
Worn for 3 weeks, did not specify how often to be worn.

Control  group: Tubigrip                                                                        

More generic form of support. Worn as a double layer and extends from the mid‐thoracic spine to the sacral spine and pelvis.
Worn for 3 weeks, did not specify how often to be worn.

Outcomes

VAS (0‐10 cm), physical activity including work, satisfaction with life survey (SWLS), use of analgesic medication, usefulness of garment at baseline, completion of 3‐week intervention, 'on a return visit to the antenatal clinic' ‐ ? timing.

Low‐back pain

X

Pelvic pain

Low‐back pain and pelvic pain

Notes

Although the primary aim was to assess the severity of LBP and posterior pelvic pain, the pelvic pain was primarily due to pain in the sacroiliac joint.

Australia

Funding = no funding or support was provided for any of the authors; Furtile Mind Pty Ltd (retailers for maternity and postpartum clothes, supplies) provided the BellyBras used in the trial.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: 'Participants were randomised...by means of computer‐generated numbered, sealed, opaque envelopes'.

Allocation concealment (selection bias)

Low risk

Opaque sealed envelopes used.

Blinding of participants and personnel (performance bias)
All outcomes

High risk

No blinding of participants, providers mentioned.

Blinding of outcome assessment (detection bias)
All outcomes

High risk

No blinding of assessors mentioned.

Incomplete outcome data (attrition bias)
All outcomes

High risk

9 participants (16%) in intervention group were lost at follow‐up (2 delivered within study period, 7 failed to attend appointment and could not be contacted).

12 participants in control group (20%) were lost at follow‐up (3 delivered within study period, 9 failed to attend their follow‐up appointment and could not be contacted).

No exclusions mentioned; 14% were lost to follow‐up with no reason.

Selective reporting (reporting bias)

Low risk

Study reported all outcomes it said it would report in methods.

Other bias

High risk

11 women (23.9%) in intervention group and 23 women (47.9%) in control group reported the use of other treatments for their back pain during the study period, including the use of analgesic medication, physiotherapy, acupuncture, massage, etc. (co‐interventions make it difficult to attribute change to the intervention).

Most noticeably, 3 in the intervention and 14 in the control group used analgesic medication during the study period.

44 (95.7%) women in intervention group stated that they wore the garment at least once a week compared with 33 (68.8%) in the control group.

High risk ‐ co‐interventions and compliance different.

Methods

30 women 'randomly assigned' to study group (N = 15) or control group (N = 15).

Participants

Inclusion: women between 20 and 30 years, back pain, nulliparous, 16 weeks' gestation, no regular exercise prior to entering study.

Exclusion: pelvic pain, any systemic disorder or drug use, previous trauma, surgery, damage to spine or lower limbs, any pregnancy complications, ≥ 3 missed treatments.

Interventions

Exercise group = 1 hour introduction session with 7 exercises and relaxation movements taught. Each exercise session lasted 30 minutes x 3 / week x 8 weeks. Exercise included warm up (4.5 minutes) walking, stretching (spine extensors, hamstrings, thigh adductors, lumbar paravertebral muscles), strengthening (thigh extensors and abdominal obliques) x 21 minutes, relaxation x 4.5 minutes.

Control = routine prenatal care ‐ did not perform any of the study exercises.

Outcomes

Roland Morris Disability Questionnaire; lumbar lordosis using flexible ruler and formula measured at baseline, after 1 and 2 months.

Low‐back pain

X

Pelvic pain

Low‐back pain and pelvic pain

Notes

This was part of the journal's 'brief communication' section only, so further biases are difficult to assess; there was no reference to other publications on this trial and none were identified during a Google search 13 March 2012.

14 March 2012 ‐ email & Linked‐In message sent to lead author, requesting more information => as of November 2nd, 2012, no response.

Assume the study was carried out in Iran, since all authors were affiliated with Iranian universities.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

'randomly assigned' ‐ details not provided.

Allocation concealment (selection bias)

Unclear risk

Details not provided.

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Details not provided.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Details not provided.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Details not provided, but number randomised are included in the results table.

Selective reporting (reporting bias)

High risk

Limited data provided; e.g. states that RMDQ was used, but no values given; pain outcome measure not identified, while pain results provided.

Other bias

Unclear risk

This was part of the journal's 'brief communication' section only, so further biases are difficult to assess; there was no reference to other publications on this trial and none were identified during a Google search 13 March 2012.

Methods

Preventive randomised controlled trial.
329 women invited to participate, 258 were randomised 'using sealed envelopes'. Enrolment was done in segments of time, since only 60 women could participate in the pool program at the same time.

Participants

Women registering at 1 of 6 maternity clinics run by Falun County Health Care Board in Sweden and had their ultrasound between gestational age 15 to 18 weeks.
329 women invited to study, from 967 who registered. 60 invitees declined because they could not participate in water gymnastics.
258 randomised to 2 groups of 129 each.

Inclusion criteria
Gestational age less than 19 weeks; fluent in Swedish; expectations of a normal pregnancy.

Exclusion criteria
Women with epilepsy, a previous preterm birth before week 32, younger than 18 years, women already participating in a water gymnastics program.

Drop‐outs due to inability to participate in water gymnastics, recurrent UTIs, shift work, baby‐sitting problems, miscarriage, intrauterine death, lack of time, invited to participate after date of closure.

Interventions

Intervention group:
20 1‐hour weekly water gymnastics classes involving exercise (tested for pregnant women) and relaxation in water (32 to 34 degrees).
First 10 sessions with exercises suitable for early pregnancy; last 10 sessions with exercises suitable for later pregnancy.
Hour session divided into 30 minutes exercise + 30 minutes relaxation.

Control group: no treatment.

Outcomes

Back pain ‐ VAS; number of days taken as sick leave because of back pain in pregnancy.

Adverse effects: no excess risk for pregnancy associated with water gymnastics observed: no differences with gyn/UTI infections, maternal weight gain, gestational age at delivery, weight/height of neonate, delivery characteristics.

Low‐back pain

X

Pelvic pain

Low‐back pain and pelvic pain

Notes

Funding: Dalarna Research Institute; Local Insurance Office.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

'Preventive randomised controlled trial' randomised 'using sealed envelopes' ‐ actual method of randomisation not described, but it was conducted 'by a mid‐wife when the women had their ultrasound.'

Allocation concealment (selection bias)

Low risk

Adequate ‐ sealed envelopes.

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Participants and caregiver not blinded.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Assessor blinding unclear.

Incomplete outcome data (attrition bias)
All outcomes

High risk

Participants who completed the study were analysed in the groups to which they were randomised; less than 5% reported as lost to follow‐up; numbers do not always add up ‐ query if N for outcomes are based on those who answered specific questions on follow‐up?.

Selective reporting (reporting bias)

High risk

Not enough data were given to allow use of the VAS; pain data provided in graphs from which one cannot extract exact values. Difficult to follow the path of recruitment, drop‐outs since numbers given in text do not add up.

Other bias

Low risk

Nothing noted.

Methods

Randomised controlled trial ‐ 50 women.

Participants

South African women of 20 to 40 years between 16 and 24 weeks' gestation; LBP/PP (with or without radiation to the knee) that had started during current pregnancy (72% of sample had LBP).

Interventions

Exercise group (N = 26/24 analysed): 1 formal exercise class lasting 30‐45 minutes with warm‐up and cool down periods incorporated. Handout illustrating and explaining the exercise program which consisted of postural, transversus abdominis and pelvic floor exercises to train correct isolation and isometric contraction. Exercises then individually progressed to increase level of difficulty and facilitate co‐contraction of transversus abdominis and pelvic floor muscles with gluteals, quadriceps and other muscle groups. Follow‐up class every second week for 10 weeks. Women also asked to complete a daily home exercise programme and record their goals in their training diary. Verbal information on basic back care and posture during pregnancy and an information pamphlet.

Control group (N = 24/22 analysed): verbal information on basic back care and posture during pregnancy and an information pamphlet as for exercise group but no specific instructions given to participants regarding whether to perform any exercise.

Outcomes

Pain intensity (NRS 0‐10); functional ability (Likert modified Roland Morris Disability Questionnaire (RMDQ).

Low‐back pain

Pelvic pain

Low‐back pain and pelvic pain

X

Notes

Neurological exam was completed at assessment along with erector spinae palpation, sacroiliac palpation, P4 test and passive SLR however, apart from erector spinae palpation eliciting LBP symptoms, the positive yield of these tests for subtyping of symptoms was low.

Funding not reported.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer‐generated random numbers in balanced blocks of 20.

Allocation concealment (selection bias)

Low risk

Sealed numbered opaque envelopes.

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Unblinded.

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Unblinded.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

ITT analysis completed; less than 10% of sample lost to follow‐up.

Selective reporting (reporting bias)

Low risk

Outcomes reported as specified.

Other bias

Low risk

Groups similar at baseline regarding most important prognostic indicators; outcomes assessed at same time for both groups; compliance reported in detail.

Methods

100 women, enrolled and randomised to 1 of 2 groups. The code for group allocation was obtained in advance by throwing dice in pairs of 10, and enclosed in advance in an envelope, marked with the order number of inclusion and opened consecutively by midwife on inclusion to the study.
Participants and caregiver not blinded; assessor blinded.
Those who finished the trial were analysed in the assigned groups.
Lost to follow‐up: 1 ward closed to recruitment after 12 months because women no longer wished to be included in the study.
Acupuncture group = randomised 50, analysed 37; (lost 6 due to clinic closure, 3 delivered, 2 did not like acupuncture, 1 did not complete assessment correctly, 1 lost due to vacation of midwife).
Control group = randomised 50, analysed 35 (lost 6 due to clinic closure, 5 did not complete forms correctly, 3 insisted on acupuncture, 1 was admitted to hospital for pain management and rest).

Study in Sweden.
No mention of funding.
Length of study or follow‐up not given.

Participants

Inclusion criteria: 3rd trimester of pregnancy, presented at the maternity ward centres in southern Sweden, complaining of pelvic girdle or LBP.
Exclusion criteria: those participating in study for less than 3 weeks.

Baseline.
2 groups did not differ significantly in age (30 ± 5.0 years); gestational week at first visit (30 ± 4.2 weeks); employed (75%); had acupuncture before (20%); negative attitude to acupuncture (20%).
Pain in sacroiliac region or over symphysis with no motor or sensory disturbances: A = 78%; C = 80%.
Duration of pain: A = 8.8 ± 5.6 weeks; C = 6.0 ± 3.8 weeks (P < 0.001).
Duration of pain in past 24 hours: A = 9.8 ± 7.1 hours; C = 9.2 ± 7.4 hours.
Number of participants on analgesics: A = 1; C = 0.

Interventions

Experiment group.
Acupuncture given according to written instructions and periosteal stimulation.
Started with LR3 and GV20 points + local tender points, added BL60, SI3 and 1 of lumbar and sacral bladder points (BL22‐26) if needed; stimulated to De Qi, needles left in place for increasing length of time.
Time: patient received acupuncture twice a week during first 2 weeks; after this, they only received it once a week (note ‐ no total duration of treatment time given).

Control group: no treatment.

Outcomes

Pain increased, pain unchanged, pain decreased, no pain during last 3 weeks of pregnancy, pain on activity decreased, Visits to maternity centres, number of participants who used analgesics, number of participants who used TENS, number of participants who used sacroiliac belt, number of participants who used physiotherapy, baby's birthweight, baby's Apgar at 1/5/10 minutes.

Adverse effects: reported by 38% of acupuncture group ‐ local pain (6); heat or sweating (5); local haematoma (2); tiredness (2); nausea (2); weakness (1).

Low‐back pain

Pelvic pain

Low‐back pain and pelvic pain

X

Notes

No mention of funding.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

‘code for group obtained in advance by throwing dice in pairs of 10.’

Allocation concealment (selection bias)

Low risk

'Predetermined code enclosed in advance in envelop, marked with the order number of inclusion and opened consecutively by midwife on inclusion.'

Blinding of participants and personnel (performance bias)
All outcomes

High risk

No explicit mention in the report, but it seems unlikely that either the women, midwives or acupuncturists were unaware of inclusion into the acupuncture or control group.

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

'two blinded investigators independently assessed the development of the patients' individual VAS scoring over time with a kappa coefficient of 0.68% (95% CI 0.54 to 0.83)'.

Incomplete outcome data (attrition bias)
All outcomes

High risk

Over 20% lost to follow‐up in each group.

1 ward closed to recruitment after 12 months because women no longer wished to be included in the study => excluded 12 participants who had been enrolled by this clinic, leaving 44 in each group.

Acupuncture group ‐ lost 3 because they delivered, 2 did not like acupuncture, 1 did not complete assessment correctly, 1 lost due to vacation of midwife (7) ‐ analysed 37/50.

Control group ‐ lost 5 ‐ did not complete forms correctly, 3 insisted on acupuncture, 1 was admitted to hospital for pain management and rest (9) ‐ analysed 35/50.

Selective reporting (reporting bias)

High risk

Data provided on outcomes listed in methods section but at times they are difficult to follow and not presented in a fashion that allow analyses.

Other bias

High risk

Variety of other treatments used by the women to relieve symptoms (analgesics, TENS, pelvic belt, physio); length of study unclear.

Methods

N = 146 randomised (group 1: N = 49; group 2: N = 48; group 3; N = 49). Participants stratified by age and gravida.

Participants

Inclusion: obstetric patients with back pain up to 30 weeks' gestation; exclusion: intent to deliver outside study site, high‐risk pregnancy, including gestational diabetes, pre‐eclampsia, placenta previa, abruptio placenta.

Interventions

Group 1: usual obstetric care plus osteopathic manipulative treatment (OMT).

Group 2: usual obstetric care plus sham ultrasound (Sham US).

Group 3 (controls): usual obstetric care. 7 treatments each lasting 30 minutes at 30, 32, 34, 36, 37, 38, 39 weeks' gestation.

OMT = included any of the following modalities: soft tissue, myofascial release, muscle energy, range of motion mobilisations used in a systematic manner by all providers*.

Sham US = using a non‐functional ultrasound therapy unit that provided both visible and auditory cues provided by a normal ultrasound unit.

Usual obstetric care during pregnancy ‐ no study treatments provided (7 visits in total: at 30, 32, 34, 36, 37, 38, 39 weeks' gestation).

Outcomes

VAS (0‐10cm) ‐ average back pain experienced; Roland Morris Disability Questionnaire (back‐specific function) measured at baseline and after 7th (last) treatment session; at same times for each group.

Low‐back pain

X

Pelvic pain

Low‐back pain and pelvic pain

Notes

*Treatment providers met regularly to ensure consistency in duration, type, anatomic location and manner of OMT provided. OMT and Sham US provided by same physicians with same amount of attention given to both groups. 2 from each treatment group missed more than 50% of treatments. Compliance best in control group.

Funding = grants from the Osteopathic Heritage Foundation and the National Center for Complementary and Alternative Medicine at the National Institutes of Health.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Patients randomly assigned and stratified by age and gestation, but no other information given about the sequence generation.

Allocation concealment (selection bias)

Unclear risk

Insufficient information given.

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Not possible to blind patients or care providers.

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Outcome measures were by self‐report, but high risk because patients not blinded.

Incomplete outcome data (attrition bias)
All outcomes

High risk

ITT analysis = 144 participants; last observation carried forward, attrition and exclusions reported (23 (16%) withdrew before visit 7; 60 (42%) withdrew due to delivery) ... but query the reliability of imputing over 1/2 of the data (actual data for 146 ‐ 83 = 63).

Selective reporting (reporting bias)

Low risk

Several approaches used to decrease risk of bias from last observation carried forward method.

Other bias

Low risk

Similar compliance in treatment groups, baseline measurements similar, co‐interventions controlled, outcomes taken at same time points.

Methods

• Prospective randomised controlled single‐blind study.

• Women recruited from 2 different maternity healthcare departments and randomised to superficial or deep acupuncture.

• 106 women examined; 70 women randomised; 23 dropped out; analyses conducted on 47 who completed the study.

Participants

Inclusion criteria:                                                                                                         

Gestational age: 22 to 36 weeks.
Duration of pain: ≥ 2 weeks.
Pain intensity last week, rated on VAS, 0‐100: ≥ 60.
Increased pelvic pain in walking, turning from 1 side to the other in bed, or rising from sitting to standing.
Physical examination confirming provoked pelvic pain:

(i) In 1 of 3 tests: posterior pelvic pain provocation test (P4), standing on 1 leg, Patrick’s Fabere test;

(ii) In palpating tissue over: the sacroiliac joints, the symphysis pubis, or mm. Gluteus maximus/medius.

Exclusion criteria:

Earlier experience of acupuncture treatment.
Fear of needles.
Urogenital infections.
Symptoms of lingering pelvic pain due to earlier pregnancy.

Interventions

Experiment group: Deep stimulation acupuncture (N = 25)

10 acupuncture treatments of 30 minutes each, given twice weekly for 5 weeks by a registered physiotherapist. See study for exact location of acupuncture points used.
Longer and thicker needles were inserted intramuscularly. Needles were stimulated 5 times during the treatment sessions by manually twirling the needles 180° back and forth until patient reported sensations ofde qi.

Control  group:  Superficial stimulation acupuncture (N = 22)

10 acupuncture treatments of 30 minutes each, given twice weekly for 5 weeks by a registered physiotherapist. See study for exact location of acupuncture points used.
Shorter and thinner needles were inserted subcutaneously and left in place until end of treatment. To mimic the procedure of deep stimulation, therapist sat down by patient 4 additional times during treatment without manipulating the needles.

Outcomes

VAS pain (at rest and during 3 daily activities); Nottingham Health Profile

measured 5 days prior to and 5 days after treatment; at same time for both groups.

Low‐back pain

Pelvic pain

X

Low‐back pain and pelvic pain

Notes

Funding = research grants from Praktikertjänst AB and the National Security in Sweden.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

'women ... were randomised ...' but randomisation procedure not described

Unclear risk ‐ as above, randomisation procedure not explained.

Allocation concealment (selection bias)

Low risk

Quote: 'Sealed envelopes with labels for determination of treatment were used in randomisation provided by a statistician not involved in the study'.

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

Both groups given acupuncture so could not tell difference as patients were acupuncture naive; care providers knew whether they gave superficial or deep acupuncture but acted the same towards the patient regardless.

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Self‐reported outcomes collected from patients who were unaware of their treatment group.

Incomplete outcome data (attrition bias)
All outcomes

High risk

Dropout rate: 23 participants out of 70 (13 in Superficial group, 10 in Deep group)

Reasons for drop‐outs listed; reasons similar for both groups.

It does not seem that the grouping affected the drop‐out reasons, and although almost 1/3 dropped out from each group, the over‐riding reason was non‐compliance with completing pain diaries.

No excluded data mentioned ‐ and it appears that analyses only done on complete data sets.

Selective reporting (reporting bias)

Low risk

Study reported all outcomes it said it would report in methods.

Other bias

Low risk

No other

Women all acupuncture naive. Groups similar at baseline.

Methods

The physiotherapist conducting the research randomised the women into 2 groups by means of a 'raffle' or 'lottery'.
Exercise group = 33; control group = 36.

There appeared to be no drop‐outs and although analysis is unclear, there appears to be no contamination of groups in analysis; outcomes for control group not reported.

Participants

Inclusion criteria: women with lumbar or pelvic pain, gestational age greater than 12 weeks, live in city of Paulinia, Brazil.
Exclusion criteria: twin pregnancy, neurological symptoms in the lower limbs, restrictions for exercise, those already engaged in a physiotherapy program to ease symptoms.

Interventions

Experiment group: exercises in groups for 'global activity and stretching'.

Control group: routine medical recommendations.

Outcomes

Proportion of women with improvement, VAS after 8 weeks.

Adverse events: not reported.

Low‐back pain

Pelvic pain

Low‐back pain and pelvic pain

X

Notes

Funding: not reported

translated from Portugese by single Portuguese researcher

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Used a 'Raffle' or 'lottery'.

Allocation concealment (selection bias)

High risk

Physiotherapist who was doing the research allocated to groups.

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Description of blinding for participants, caregiver not provided.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Description of blinding for assessors not provided.

Incomplete outcome data (attrition bias)
All outcomes

High risk

Outcome table appears to indicate no drop‐outs; report appears to indicate that there is no contamination between groups, but none of this is clearly described.

Selective reporting (reporting bias)

High risk

Results are incomplete (only intervention group's improvement reported, no data for control group).

Other bias

High risk

Other treatments not described; baseline data were not comparable: Exercise group = 48% greater than 5 on VAS 0‐10; Usual care group = 61% greater than 5 on VAS 0‐10.

Methods

• Pregnant women were recruited between October 1998 to May 2000.

• 1533 women in and around Trondheim, Norway were invited to join => 301 were randomised.

• Primary outcome was prevention and treatment of urinary incontinence; secondary outcome was prevention and treatment of pelvic and LBP.

Participants

Inclusion criteria:                                                                                                          

Nulliparous.
≥ 18 years old.

Singleton live fetus at a routine ultrasound scan at 18 weeks of pregnancy.

Exclusion criteria:

Pregnancy complications.
High risk of preterm labour.
Pain during PFM contractions.
Ongoing urinary tract infection or diseases that could interfere with participation.
Living too far from Trondheim to be able to attend weekly training groups.

Interventions

Experiment group: Exercise training group

Training with a physical therapist in groups of 10 to 15 women for 60 minutes once per week for 12 weeks, where training focused on PFM and other exercises.
Women were encouraged to perform 8 to 12 intensive PFM contractions twice per day at home. Motivation was strongly emphasised.
Each training sessions consisted of: 15 to 20 minutes aerobic activity, 30 to 35 minutes of exercises, 5 to 10 minutes of light stretching, body awareness, and breathing and relaxation exercises.
Women were given general advice related to ergonomics and daily life activities in pregnancy.

Control  group:

Women received customary information given by their midwife or general practitioner. They were not discouraged from exercising on their own.

Outcomes

Self‐reported pain in the low‐back area lasting for ≥ 1 week; pain drawing, off sick due to low‐back/pelvic pain (yes/no); Disability Rating index; pelvic floor muscle strength measured at baseline (20 weeks' gestation); 36 weeks' gestation, 3 months' postpartum.

Low‐back pain

Pelvic pain

Low‐back pain and pelvic pain

X

Notes

Adherence to training protocol was registered based on the women’s personal training diary (must do 2 sets of 8 to 12 contractions of PFM per day) and reports from the physical therapists that led the group training (participation in ?6 group training sessions).
120 of the 148 women (81%) in training group followed the training protocol

Funding = Norwegian Fund for Postgraduate Training in Physiotherapy and the Norwegian Women's Public Health Association.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: 'Randomization was done in blocks of 32 with the use of opaque sealed envelopes', did not specify method used to select the blocks, but likely OK, given the fact that they used other safeguards.

Allocation concealment (selection bias)

Low risk

Opaque sealed envelopes used.

Quote: 'A secretary with no other involvement in the trial prepared the envelopes. Each woman opened 1 of the envelopes herself and was enrolled by the secretary in the secretary's office.'

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Participants and care providers were aware of treatments (exercise vs usual care).

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Quote: 'The principal investigator was not involved in the training of the women and was blinded to group allocation while making the assessments and plotting the data'. However, the outcomes were self‐report and the women were not blinded to their treatment; unclear if those who received usual care were aware of other options.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

7 participants in control and 5 in training group withdrew after the first assessment

Reasons for withdrawal were diseases connected to pregnancy (n = 6) or personal reasons (n = 6).

It does not seem that the grouping affected the drop‐out reasons.

No excluded data mentioned.

Selective reporting (reporting bias)

Low risk

Study reported all outcomes it said it would report in methods.

Other bias

Unclear risk

Unclear risk: Influence of co‐interventions, adherence not reported in results.

Methods

• 'Randomised controlled clinical trial in the classic 'waiting list' design.

• Carried out by 2 osteopaths in their offices in Űberlingen and Műlheim, Germany.

• Women recruited from 'a number of midwives and gynaecologists'.

Participants

• 60 pregnant women with pelvic and/or low‐back pain that had lasted at least a week and was at least VAS > 3.

• Average age 30 years, mean gestation 25 weeks.

Interventions

Intervention group: received 4 osteopathic treatments in weekly intervals.

Waiting list comparison group, after 5 weeks on the waiting list they received osteopathic treatment that was reported as 'having no relevance for the study'.

Outcomes

Pain, measured with VAS; interference with ADL, measured with Quebec Back Pain Disability Scale at baseline and end of first 5 weeks (end of treatment for intervention group).

Low‐back pain

Pelvic pain

Low‐back pain and pelvic pain

X

Notes

Information taken from an abstract of an unpublished thesis that is available in German, for a cost, from Akademie füf Osteopathie (AFO), Deutschland (funds not available to obtain full manuscript).

Funding not reported.

Abstract initially translated from German by single German‐speaking researcher, then English abstract found on‐line.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

'Randomised controlled clinical trial' ‐ methodology not reported in abstract.

Allocation concealment (selection bias)

Unclear risk

Waiting list comparison group, after 5 weeks waiting list they get a treatment that is reported as having no relevance for the study.

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

No mention of blinding in abstract.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No mention of blinding in abstract.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

3 patients in the control group dropped out; no information provided on exclusions or analyses.

Selective reporting (reporting bias)

Low risk

Data provided for pain and Quebec Back Pain Disability Scale.

Other bias

Unclear risk

Difficult to assess since we were unable to access the full thesis.

Methods

Pilot randomised controlled trial ‐ 57 participants randomised. All participants screened initially by phone and all treatments described prior to randomisation. No limit on what stage in pregnancy women could enter the trial. Before randomisation all participants identified their treatment preference.

Participants

Inclusion criteria: healthy pregnant women with singleton fetus and LBP of unknown origin that began during pregnancy and was reproduced by manual palpation.

Exclusion criteria: women with health conditions that contra‐indicated exercise (including heart disease, hypertension, BMI > 40, diabetes, incompetent cervix, ruptured membranes, decreased fetal movement) or manipulation (including unrelenting night pain, loss of bladder or bowel control, progressive neurological deficit, cancer, spinal fracture, unexplained weight loss, unrelenting fever).

Women who smoked, consumed alcohol, were taking anti‐depressants or had Roland Morris Disability Questionnaire score above 20 or below 4. Women planning to move during pregnancy, not willing to comply with study procedures and unable to read and write English.

Interventions

Exercise group (control; N = 22): exercise booklet provided with specific exercises and recommendations for postural and movement patterns to alleviate LBP, and advice on when to stop exercising. Individualised stretching and strengthening exercises were prescribed, demonstrated and practiced at each study visit. Exercisies took approximately 15 minutes to perform and participants were asked to exercise 5 x/week.

Spinal manipulative therapy (N = 15): high velocity, low amplitude thrust applied to isolated joint to move it just past physiological end range in side‐lying position. Direction, velocity and amplitude determined by the clinician from palpation findings.

Neuro emotional technique (NET; N = 20): Chiropractic mind‐body technique using relaxed breathing and visualisation techniques with elements of traditional Chinese medicine (such as association of emotions with certain organs or meridians) and chiropractic medicine (adjustment of spinal levels innervating specific organs. The NET standard protocol was followed (Pablis et al., 2008).

Maximum number of treatments per participant = 8 with very few in any group reaching this amount. Co‐interventions controlled.

Outcomes

Pain intensity (NRS 0‐10), RMDQ (back‐specific function), sick leave due to pregnancy related LBP (assessed but not listed as 1 of the outcomes).

Low‐back pain

X

Pelvic pain

Low‐back pain and pelvic pain

Notes

138 participants screened; sick leave not listed in methods as 1 of the outcomes but reported in Table 2; higher drop‐out from exercise group however adherence to exercise did not affect outcomes.

Funding provided by The One Foundation, the research division of the NeuroEmotional Technique; 'The One Foundation did not contribute to the study in any other way'.

Conducted at Oregon Health & Science University, USA.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

The method used to generate the allocation sequence was not described ‐ 'before being randomised, participants identified their treatment preference ... she would open the consecutive envelope in her preference strata in the presence of the researcher ... women were randomly allocated into 1 of three treatment groups'.

Allocation concealment (selection bias)

Low risk

'the randomisation schedule was completed prior to initiating the study and was concealed from all study staff by using consecutively numbered, sealed, opaque envelopes for each strata of preference group.'

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Participants and practitioners were not blinded to treatment group after randomisation.

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Participants were outcome assessors.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

ITT analysis performed. Missing data ‐ last observation carried forward. Minor inaccuracies noted in number excluded prior to randomisation, and between text and Figure 1 in drop‐outs from exercise group (N = 1).

Selective reporting (reporting bias)

Low risk

Last observation carried forward may limit data but carried out to replicate methods used in an earlier trial by Licciardone and colleagues (2010). Sensitivity analysis completed providing similar results to primary outcome analysis.

Other bias

High risk

Participants randomised according to their treatment preference, entered the study at different gestational points, groups were not similar at baseline for all prognostic factors, and were paid to participate (USD$20 per visit).

Methods

100 women invited and divided into 2 groups; 10 withdrawn from exercise group prior to intervention => 90 analysed.

Participants

Inclusion criteria:                                                                                                          

Pregnant women in the second half of pregnancy referred to prenatal clinics of Qom province, Iran.
Participants were in 20 to 22 weeks of gestation.

Exclusion criteria:

Inability to perform exercises; excluded after missing 3 sessions.

Interventions

Experiment group: Exercise program = 40

Program consisted of 15 minute warm up and cool down plus 30 minute cycling in the range of 55% to 65% of the maximal heart rate with respect to the age. Exercises were prescribed by a physical training specialist. The exercise sessions were 3 times a week for 8 weeks.

Control group: = 50

The study did not specify what the control group was.

Outcomes

Pain, measured with Quebec questionnaire, measured at baseline and 8 weeks after start of program; demographic data collected at baseline; P value < 0.05 considered to be statistically significant.

Low‐back pain

X

Pelvic pain

Low‐back pain and pelvic pain

Notes

Email to the corresponding author for clarification failed to elicit a response.

Funding = grant from Sports Medicine Research Center and Vice Chancellor for Research at Tehran University of Medical Sciences.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

No description of sequence generation were described except 'the total numbers of 100 invited were divided into two exercise and control groups'.

'Randomised' was only mentioned in the abstract.

Unclear risk: randomisation procedure not described.

Allocation concealment (selection bias)

Unclear risk

Not mentioned.

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Not mentioned, but assume not.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not mentioned.

Incomplete outcome data (attrition bias)
All outcomes

High risk

Quote: 'every woman missing three session of exercise was excluded from the study' ‐ but unclear how many this affected.

Drop‐outs/withdrawals from study not mentioned, however, 10 women who were randomised did not proceed to the intervention because they were unable to participate in the exercises.

Did not specify how they dealt with the missing/excluded data.

Selective reporting (reporting bias)

Low risk

Study reported all outcomes it said it would report in methods.

Other bias

Unclear risk

Unclear risk: compliance not reported, nor co‐interventions.

Methods

2‐armed, 2 centre randomised controlled trial ‐ 855 women randomised.

Participants

Inclusion criteria: aged 18 years or more, singleton live fetus and within 30 minute drive of hospital and able to attend weekly training.

Exclusion criteria: high‐risk pregnancy or diseases that could interfere with participation in exercise.

Interventions

Exercise group (N = 429/396 analysed): 60‐minute exercise sessions 1x/week for 12 weeks between 20 to 36 weeks' gestation led by a physiotherapist in groups of 8 to 15 participants. Each session consisted of moderate intensity (13‐14 on Borg scale) aerobic activity, strength training and balance exercises. 45 minute home exercise session 2 x/week consisting of 30 minutes of aerobic activity and 15 minutes of strengthening and balance exercises. Adherence monitored throughout.

Control group (N = 426/365 analysed): standard antenatal care; not discouraged from exercising

Both groups given written information on pelvic floor exercises, diet and pregnancy related lumbo‐pelvic pain.

Outcomes

Lumbopelvic pain ‐ VAS (0‐100) ‐ morning and evening, sick leave due to lumbo‐pelvic pain, Disability Rating Index (DRI), Fear avoidance Beliefs Questionnaire.

Low‐back pain

Pelvic pain

Low‐back pain and pelvic pain

X

Notes

Additional outcomes related to a related study: gestational diabetes, glucose metabolism.

Approximately 60% of women who enrolled reported lumbo‐pelvic pain at time of inclusion.

Funding sources: Norwegian University of Sciences and Technology, Norweigian Fund for Postgraduate Training in Physiotherapy, Liason Committee for Central Norway Regional Health Authority.

30 October 2012 ‐ email sent to lead author to clarify correct number analysed in the intervention group ‐ 396 or 397; author confirmed that there were 396 women in the intervention group

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computerised randomisation.

Allocation concealment (selection bias)

Low risk

'concealed randomisation' by a web‐based computerised procedure; ... personnel had no influence over randomisation.'

Blinding of participants and personnel (performance bias)
All outcomes

High risk

While personnel had no influence over the process of randomisation, the physiotherapists who delivered the programmes were aware of the end results ... i.e. they were providing the participants with the intervention.

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Outcomes were self‐reported symptoms, therefore the women were the outcome assessors and they knew whether they were receiving exercise therapy or not.

Incomplete outcome data (attrition bias)
All outcomes

High risk

Exercise group = 8% drop‐out/loss to follow‐up; control group = 14% drop‐out/loss to follow‐up with a large proportion of these giving no reason and not included in the analysis.

Selective reporting (reporting bias)

Low risk

All outcomes reported as specified in methods.

Other bias

Low risk

Groups similar at baseline even when not including those lost to follow‐up. Co‐interventions avoided or similar between groups and compliance with exercise assessed against specified level of 3 x/week. Timing of outcome assessment same for both groups.

Methods

74 women were allocated to experimental or control groups by using a 'random sampling technique' (no description).
Exercise group: randomised = 37; analysed = 32 (76.2%).
Control group: randomised = 37; analysed = 35 (83.3%).
Lost to follow‐up: toxemia (3), would not deliver at hospital (3), preterm labour due to oligohydramnios (1), group membership not noted, nor the reasons for the other losses.

Participants

Inclusion criteria: primigravida, healthy ‐ no underlying disease, 20 to 35 years old, 26 to 30 weeks' gestation, at least 140 cm tall, BMI before becoming pregnant less than 25 kg/m², non‐smoker, no previous severe back and pelvic pain, no contraindication for exercise during pregnancy, did not exercise regularly (< 1/week), attending prenatal clinic and intend to deliver at King Chulalongkorn Memorial Hospital, Bangkok, fluent in Thai, willing to participate in study regimen.

Exclusion criteria:
Underlying disease that would effect exercise, pregnancy and labour, e.g. heart disease, diabetes mellitus, thyrotoxicosis, hypertension, infection, unable to follow exercise program 5 days/week for 8 weeks, weight gain more than 25 kg or less than 10 kg, do not intend to deliver at King Chulalongkorn Memorial Hospital.

Women were similar at baseline for all factors except job activities: exercise group sat more often at work (N/S); control group stood more often at work and income: exercise group were in higher paid jobs than the control (P = 0.008).

Interventions

Experiment group.
Sitting pelvic tilt exercise: week 1 = do 4 cycles (hold position for 5 seconds then relax for 5 seconds) of exercises each morning and evening; increase by 2 cycles/session in weeks 2 to 4, until you are doing 10 cycles/session, then continue at this level for the next 4 weeks.
Exercises should be done twice a day, 5 days/week (twice under supervision of exercise instructor at the hospital; 3 times unsupervised at home) for a total of 8 weeks.
Record kept of exercises done; instructor checked agility and overall fitness when at clinic.

Control group: no treatment (nothing noted in article).

Outcomes

Pain improved, pain worsened, pain measured with VAS, gestational age at birth, baby's Apgar score at 1 minute, baby's Apgar score at 5 minutes.

Adverse events: 'no negative effects on mother or fetus; no preterm labour; no premature rupture of membranes'.

Low‐back pain

X

Pelvic pain

Low‐back pain and pelvic pain

Notes

Numbers are not consistently reported throughout the article; total number of participants seems to range from 73 to 84, with most mention of 74 randomised, which is the number we used. Data needed for the meta‐analyses appeared to be incorrectly reported in the paper and were re‐analysed.

Funding: not mentioned.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

‘random sampling technique’ but not described; in discussion section, the authors state 'the inclusion and exclusion criteria were used to match these two groups as closely as possible and scrutinize the variables that may contribute to the impact of physical conditioning or pregnancy outcomes'... which doesn't sound like 'randomisation'...

Allocation concealment (selection bias)

Unclear risk

Unclear ‐ 'allocated to experimental or control groups'.

Blinding of participants and personnel (performance bias)
All outcomes

High risk

No blinding of participants or providers.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Unclear about outcome assessors.

Incomplete outcome data (attrition bias)
All outcomes

High risk

17% loss of participants from control group; 24% loss of participants from intervention group; details for withdrawals not clearly described. Analysis on 67 completers only.

Selective reporting (reporting bias)

Low risk

Reported on LBP for mothers, 1‐minute and 5‐minute Apgar scores and birthweight of babies.

Other bias

Unclear risk

Exercise diary kept and checked by exercise instructor; co‐interventions not described.

Methods

Cross‐over trial: order of use of pillows being 'randomly assigned' ‐‐ further details on randomisation not given.
109 women recruited; 92 women finished the 2‐week observational period.
Analysis unclear (cross‐over study) ‐ analysed results of everyone who had one intervention against the results of those who received the 2nd intervention.

Participants

Inclusion criteria.
36 weeks' gestation, attending an antenatal clinic in Brisbane, Australia.
Low‐risk pregnancy.

Drop‐outs related to delivery, failure to present to clinic for assignment of 2nd pillow, failure to return completed questionnaires.

Interventions

Provision of 2 different types of pillow to support the pregnant abdomen when lying in a lateral position. The pillows were taken home and used for 1 week each, consecutively. The Ozzlo pillow was a locally designed, curved, sloping, soft cushion conforming to the shape of the abdomen; the control pillow was a standard hospital pillow.

Outcomes

Numbers of women reporting moderate improvement in backache or better. Numbers of women reporting relief of insomnia.

No adverse effected noted.

Low‐back pain

X

Pelvic pain

Low‐back pain and pelvic pain

Notes

There was no comparison with no treatment. We contacted the authors in 1999 and the Ozzlo pillow seems no longer to be made.

Funding source not noted.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Cross‐over trial: order of use of pillows being 'randomly assigned' ‐‐ further details on randomisation not given.

Allocation concealment (selection bias)

Unclear risk

Unclear.

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Participants and personnel did not seem to be blinded.

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Outcome assessors did not appear to be blinded.

Incomplete outcome data (attrition bias)
All outcomes

High risk

84% of women completed study; women acted as their own control but there was no 'wash‐out period' provided between pillows.

Selective reporting (reporting bias)

High risk

Data were measured for all women when they used 1 pillow and all women when they used the second one, rather than providing data at the end of the first phase of the trials, before the cross‐over.

Other bias

Unclear risk

Daily worksheets describing sleep patterns, pain, etc handed in end of each week; co‐interventions not mentioned.

Methods

• Randomised controlled trial, conducted at Yale‐New Haven Hospital, USA.

• Women recruited by prenatal healthcare providers in the area; women called the hotline and spoke with the research assistant.

159R/152A

Participants

Inclusion: pregnant women between 25‐38 weeks' gestation) with LBP and/or posterior PP.

Exclusion: associated nerve root syndrome, neurologic deficit, fever, abdominal pain, other systematic manifestations, active uterine contractions.

N = 159 randomised. AA = 58; Sham AA = 54; WL = 47.

All patients acupuncture naive. Drop‐outs and exclusions reported with reasons.

Interventions

Group 1: auricular (ear) acupuncture x 7 days plus self‐care (AA). N = 58. Used specific acupuncture points (kidney, analgesia, shenmen).

Group 2: sham auricular (ear) acupuncture x 7 days plus self‐care (Sham AA). N = 54. used non‐specific points (shoulder, wrist, extra auricular point).

Group 3: self‐care only waiting list control (WL). N = 47.

Self care only. No acupuncture treatment received. Women just given advice.

NB: All women given advice to rest if desired, take 650 mg acetaminophen every 6 hours if needed, use hot/cold compress as desired.

Outcomes

VAS ‐ Pain (0‐100 mm); Disability Rating Index (DRI) ‐ functional status; State Trait Anxiety Index (STAI), measured at baseline, after 7 days of continuous AA or Sham AA and at 1 week post treatment (for both groups).

Days off work not included in outcomes.

Low‐back pain

Pelvic pain

Low‐back pain and pelvic pain

X

Notes

Funding = national Center for the Complementary and Alternative Medicine Grant.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

'randomly assigned to one of the three treatment groups based on a computer generated randomisation sheet.'

Allocation concealment (selection bias)

Unclear risk

No information provided on allocation concealment.

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

Women had no previous experience with acupuncture and were asked to complete a credibility questionnaire after the removal of the needles.

While not blinded, acupuncturist was skilled and trained and followed a strict script during treatment to avoid any nuances being picked up by the participants.

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Assessors and statisticians were blinded; women who gave self‐reports were also blinded.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Attrition and exclusions reported, numbers add up in the analysis, authors indicate how they managed missing values in their analysis.

Selective reporting (reporting bias)

Low risk

Study reported all outcomes as indicated in the methods section.

Other bias

Low risk

Similar co‐interventions; groups similar at baseline, timing of outcome assessment same across groups and compliance acceptable across groups.

Methods

Randomised controlled trial ‐ 60 women.

Participants

Swedish women with pelvic or back pain arising before 32 weeks' gestation.

Interventions

Acupuncture.
3 times/week for 2 weeks, then 2 times/week for 2 weeks = total 10; each session = 30 minutes.
2 to 10 needles used, started with fossa triangularis points in ear adding body points, local points as needed; needles were gently tapped or rotated 15 minutes after insertion until De Qi reached.

Physiotherapy.
1 to 2 times/week within 6 to 8 weeks = total 10 physiotherapy group sessions; 50 minutes each.
Individualised treatment based on assessment + trochanter‐belt for pelvic support, warmth, massage, soft‐tissue mobilisation if needed.
All were offered water gymnastics according to a defined program.

Outcomes

VAS (pain), disability rating indices and rating of overall effect all assessed by the women in the trial.

Adverse effects: no serious adverse effects reported, but 2 women reported small subcutaneous hematomas in the ear from acupuncture.

Low‐back pain

Pelvic pain

Low‐back pain and pelvic pain

X

Notes

There was no comparison with no treatment.

The pain and disability scales were not used in this review because of insufficient data.

Study funded by the Council of Research and Development of Vrinnevi Hospital, Norrkoping, Sweden.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

60 women who accepted invitation to join study 'drew a closed envelope from a box to randomise to either the acupuncture or physiotherapy group', but method of randomisation not described.

Allocation concealment (selection bias)

Low risk

'drew a closed envelope from a box.'

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Participants and caregiver not blinded.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Aassessor blinding unclear.

Incomplete outcome data (attrition bias)
All outcomes

High risk

Analysed those who completed the intervention in the group to which they had been randomised.

2 of 30 women were not analysed in the acupuncture group since they had both inadvertently received both acupuncture and physiotherapy.
12 of 30 women in the physiotherapy group dropped out: preterm contractions (3), delivered during study (1), pre‐eclampsia (1), no pain‐diary notes (1), failed to attend (3), inconvenient treatment hours (3).

Selective reporting (reporting bias)

High risk

Data for pain and disability outcomes not provided with sufficient detail to include in analyses.

Other bias

High risk

Statistically significant difference in the distribution of type of pain at baseline, women pursued different co‐treatments to relieve symptoms.