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Spinal manipulation for acute low‐back pain

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Appendices

Appendix 1. CENTRAL Search Strategy

  1. #1        MeSH descriptor Back explode all trees

  2. #2        MeSH descriptor Buttocks, this term only

  3. #3        MeSH descriptor Leg, this term only

  4. #4        MeSH descriptor Back Pain explode tree 1

  5. #5        MeSH descriptor Back Injuries explode all trees

  6. #6        MeSH descriptor Low Back Pain, this term only

  7. #7        MeSH descriptor Sciatica, this term only

  8. #8        (low next back next pain)

  9. #9        (lbp)

  10. #10      (#1 OR #2 OR #3 OR #4 OR #5 OR #6 OR #7 OR #8 OR #9)

  11. #11      MeSH descriptor Musculoskeletal Manipulations explode all trees

  12. #12      MeSH descriptor Chiropractic explode all trees

  13. #13      manip*

  14. #14      MeSH descriptor Osteopathic Medicine explode all trees

  15. #15      osteopath*

  16. #16      chiropract*

  17. #17      (#11 OR #12 OR #13 OR #14 OR #15 OR #16)

  18. #18      (#17 AND #10

  19. #19      (#18)

Appendix 2. MEDLINE Search Strategy

  1. Clinical Trial.pt.

  2. randomized.ab,ti.

  3. placebo.ab,ti.

  4. dt.fs.

  5. randomly.ab,ti.

  6. trial.ab,ti.

  7. groups.ab,ti.

  8. or/1‐7

  9. Animals/

  10. Humans/

  11. 9 not (9 and 10)

  12. 8 not 11

  13. dorsalgia.ti,ab.

  14. exp Back Pain/

  15. backache.ti,ab.

  16. (lumbar adj pain).ti,ab.

  17. coccyx.ti,ab.

  18. coccydynia.ti,ab.

  19. sciatica.ti,ab.

  20. sciatica/

  21. spondylosis.ti,ab.

  22. lumbago.ti,ab.

  23. exp low back pain/

  24. or/13‐23

  25. exp Manipulation, Chiropractic/

  26. exp Manipulation, Orthopedic/

  27. exp Manipulation, Osteopathic/

  28. exp Manipulation, Spinal/

  29. exp Musculoskeletal Manipulations/

  30. exp Chiropractic/

  31. manipulation.mp.

  32. manipulate.mp.

  33. exp Orthopedics/

  34. exp Osteopathic Medicine/

  35. or/25‐34

  36. 12 and 24 and 35

  37. limit 36 to yr="2007 ‐ 2008"

Appendix 3. EMBASE Search Strategy

Yields 123 for 2007‐8

  1. Clinical Article/

  2. exp Clinical Study/

  3. Clinical Trial/

  4. Controlled Study/

  5. Randomized Controlled Trial/

  6. Major Clinical Study/

  7. Double Blind Procedure/

  8. Multicenter Study/

  9. Single Blind Procedure/

  10. Phase 3 Clinical Trial/

  11. Phase 4 Clinical Trial/

  12. crossover procedure/

  13. placebo/

  14. or/1‐13

  15. allocat$.mp.

  16. assign$.mp.

  17. blind$.mp.

  18. (clinic$ adj25 (study or trial)).mp.

  19. compar$.mp.

  20. control$.mp.

  21. cross?over.mp.

  22. factorial$.mp.

  23. follow?up.mp.

  24. placebo$.mp.

  25. prospectiv$.mp.

  26. random$.mp.

  27. ((singl$ or doubl$ or trebl$ or tripl$) adj25 (blind$ or mask$)).mp.

  28. trial.mp.

  29. (versus or vs).mp.

  30. or/15‐29

  31. 14 and 30

  32. human/

  33. Nonhuman/

  34. exp ANIMAL/

  35. Animal Experiment/

  36. 33 or 34 or 35

  37. 32 not 36

  38. 31 not 36

  39. 37 and 38

  40. 38 or 39

  41. dorsalgia.mp.

  42. back pain.mp.

  43. exp BACKACHE/

  44. (lumbar adj pain).mp.

  45. coccyx.mp.

  46. coccydynia.mp.

  47. sciatica.mp.

  48. exp ISCHIALGIA/

  49. spondylosis.mp.

  50. lumbago.mp.

  51. exp Low back pain/

  52. or/41‐51

  53. exp CHIROPRACTIC/

  54. exp Orthopedic Manipulation/

  55. exp Manipulative Medicine/

  56. exp Osteopathic Medicine/

  57. manipulation.mp.

  58. manipulate.mp.

  59. exp Orthopedics/

  60. osteopathy.mp.

  61. or/53‐60

  62. 40 and 52 and 61

  63. limit 62 to yr="2007 ‐ 2008"

Appendix 4. CINAHL Search Strategy

  1. Randomized Controlled Trials.mp.

  2. clinical trial.pt.

  3. exp Clinical Trials/

  4. (clin$ adj25 trial$).tw.

  5. ((singl$ or doubl$ or trebl$ or tripl$) adj25 (blind$ or mask$)).tw.

  6. exp PLACEBOS/

  7. placebo$.tw.

  8. random$.tw.

  9. exp Study Design/

  10. (latin adj square).tw.

  11. exp Comparative Studies/

  12. exp Evaluation Research/

  13. Follow‐Up Studies.mp.

  14. exp Prospective Studies/

  15. (control$ or prospectiv$ or volunteer$).tw.

  16. Animals/

  17. or/1‐15

  18. 17 not 16

  19. dorsalgia.ti,ab.

  20. exp Back Pain/

  21. backache.ti,ab.

  22. (lumbar adj pain).ti,ab.

  23. coccyx.ti,ab.

  24. coccydynia.ti,ab.

  25. sciatica.ti,ab.

  26. exp SCIATICA/

  27. spondylosis.ti,ab.

  28. lumbago.ti,ab.

  29. exp low back pain/

  30. or/19‐29

  31. exp CHIROPRACTIC/

  32. exp MANIPULATION, CHIROPRACTIC/

  33. exp MANIPULATION, ORTHOPEDIC/

  34. exp MANIPULATION, OSTEOPATHIC/

  35. manipulation.mp.

  36. manipulate.mp.

  37. exp Manual Therapy/

  38. exp ORTHOPEDICS/

  39. exp OSTEOPATHY/

  40. or/31‐39

  41. 18 and 30 and 40

  42. limit 41 to yr="2007 ‐ 2008"

  43. from 42 keep 1‐44

Appendix 5. Criteria for risk of bias assessment for RCTs

1. Was the method of randomization adequate? This item was scored "yes" if a random (unpredictable) assignment sequence was used. Examples of adequate methods are coin toss (for studies with two groups), rolling a dice (for studies with two or more groups), drawing of balls of different colours, drawing of ballots with the study group labels from a dark bag, computer‐generated random sequence, pre‐ordered sealed envelops, sequentially‐ordered vials, telephone call to a central office, and pre‐ordered list of treatment assignments. Examples of inadequate methods are alternation, birth date, social security or insurance number, date in which subjects are invited to participate in the study and hospital registration number.

2. Was the treatment allocation concealed? This item was scored "yes" if the assignment was generated by an independent person not responsible for determining the eligibility of the patients. This means that the person had no information about the persons included in the trial and had no influence on the assignment sequence or on the decision about eligibility of the patient.

Was knowledge of the allocated interventions adequately prevented during the study?
3. Was the patient blinded to the intervention?
This item was scored “yes” if the index and control group(s) were indistinguishable for the patients or if the success of blinding was tested among the patients and it was successful. 

4. Was the care provider blinded to the intervention? This item was scored “yes” if the index and control groups were indistinguishable for the care providers or if the success of blinding was tested among the care providers and it was successful. Comment: This item was always "no" for spinal manipulative therapy given that it is impossible to blind the clinician (unlike, for example, medication). 

5. Was the outcome assessor blinded to the intervention for the primary outcomes? This item was scored  “yes” if the success of blinding was tested among the outcome assessors and it was successful. For patient‐reported outcomes, in which the patient is the outcome assessor (e.g., pain, disability, recovery), blinding was considered adequate if participants were also blinded to treatment allocation. This is independent of whether the outcomes were recorded by an independent assessor blinded to allocation during a clinic visit or outcomes that were assessed via a questionnaire mailed to the patient. Studies limited to physiological outcomes were scored as a "no" as these were not considered relevant outcomes.

Were incomplete outcome data adequately addressed?
6. Was the drop‐out rate described and acceptable?
This item was scored "yes" if the number of participants who were included in the study but did not complete the observation period or were not included in the analysis were described and reasons given, or in absence of this information, the percentage of withdrawals and drop‐outs did not exceed 20% for the short‐term follow‐up (3 months or less) and 30% for long‐term follow‐up (9 months or more) and was therefore, not likely to lead to substantial bias.

7. Were all randomized participants analysed in the group to which they were allocated? This item was scored "yes" if all randomized patients were analysed in the group to which they were allocated for the primary outcomes and follow‐up measurements, regardless of non‐compliance and co‐interventions. This excludes missing values, meaning imputation (by whatever means) was not required.   

8. Are reports of the study free of suggestion of selective outcome reporting? This item was scored "yes" if all the results from all pre‐specified outcomes were adequately reported. This determination was made by comparing the protocol (if available) with the full‐report/publication or in the absence of the protocol, articles were assessed as "yes" if all three primary outcomes (i.e. pain, back‐pain specific functional status/disability, and recovery) were reported.

Other sources of potential bias:
9.  Were the groups similar at baseline regarding the most important prognostic indicators?
This item was scored “yes” if the groups were similar at baseline regarding the main demographic factors (e.g. age, gender), duration and severity of complaints and value of the main outcome measure(s).

10. Were co‐interventions avoided or similar? This item was scored “yes” if there were no co‐interventions or they were similar between the index and control group(s).

11. Was the compliance acceptable in all groups? This item was scored "yes" if the compliance with the intervention was considered acceptable based upon the reported intensity, duration, number and frequency of sessions for both the index and control group(s). For example, spinal manipulative therapy is usually administered over several sessions; therefore, it was necessary to assess how many sessions had been prescribed for the patients a priori and whether they attended (most) of these sessions.

12. Was the timing of the outcome assessment similar in all groups? This item was scored "yes" if the timing of the outcome assessment(s) were identical for all groups and for all important outcome measures.