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References

References to studies included in this review

Meglio 1989 {published data only}

Meglio M, Cioni B, Rossi GF. Spinal cord stimulation in management of chronic pain. A 9‐year experience. Journal of Neurosurgery 1989;70(4):519‐24.

Shimoji 1993 {published data only}

Shimoji K, Hokari T, Kano T, Tomita M, Kimura R, Watanabe S, et al. Management of intractable pain with percutaneous epidural spinal cord stimulation: differences in pain‐relieving effects among diseases and sites of pain. Anesthesia and Analgesia 1993;77(1):110‐6.

Yakovlev 2010 {published data only}

Yakovlev AE, Resch BE, Karasev SA. Treatment of cancer‐related chest wall pain using spinal cord stimulation. American Journal of Hospice and Palliative Medicine 2010;27(8):552‐6.

Yakovlev 2011 {published data only}

Yakovlev AE, Resch BE. Spinal cord stimulation for cancer‐related low back pain. American Journal of Hospice and Palliative Medicine 2011;29(2):93‐7.

References to studies excluded from this review

Cata 2004 {published data only}

Cata JP, Cordella JV, Burton AW, Hassenbusch SJ, Weng HR, Dougherty PM. Spinal cord stimulation relieves chemotherapy‐induced pain: a clinical case report. Journal of Pain Symptom Management 2004;27(1):72‐8.

Clavo 2004 {published data only}

Clavo B, Robaina F, Catalá L, Pérez JL, Lloret M, Caramés MA, et al. Effect of cervical spinal cord stimulation on regional blood flow and oxygenation in advanced head and neck tumours. Annals of Oncology 2004;15(5):802‐7.

Clavo 2009 {published data only}

Clavo B, Robaina F, Montz R, Carames MA, Lloret M, Ponce P, et al. Modification of glucose metabolism in radiation‐induced brain injury areas using cervical spinal cord stimulation. Acta Neurochirurgica 2009;151(11):1419‐25.

Eisenberg 2002 {published data only}

Eisenberg E, Brecker C. Lumbar spinal cord stimulation for cervical‐originated central pain: a case report. Pain 2002;100(3):299‐301.

Hamid 2007 {published data only}

Hamid B, Haider N. Spinal cord stimulator relieves neuropathic pain in a patient with radiation‐induced transverse myelitis. Pain Practice 2007;7(4):345‐7.

Lee 2006 {published data only}

Lee AW, Pilitsis JG. Spinal cord stimulation: indications and outcomes. Neurosurgical Focus 2006;21(6):E3.

Lee 2009 {published data only}

Lee MG, Choi SS, Lee MK, Kong MH, Lee IO, Oh HR. Thoracic spinal cord stimulation for neuropathic pain after spinal meningioma removal: a case report. Clinical Journal of Pain 2009;25(2):167‐9.

Nouri 2011 {published data only}

Nouri KH, Brish EL. Spinal cord stimulation for testicular pain. Pain Medicine 2011;12(9):1435‐8.

Rainov 2007 {published data only}

Rainov NG, Heidecke V. Hardware failures in spinal cord stimulation (SCS) for chronic benign pain of spinal origin. Acta Neurochirurgica Supplement 2007;97(Pt 1):101‐4.

Robaina 2007 {published data only}

Robaina F, Clavo B. The role of spinal cord stimulation in the management of patients with brain tumors. Acta Neurochirurgica Supplement 2007;97(Pt 1):445‐53.

Ting 2007 {published data only}

Ting JC, Fukshansky M, Burton AW. Treatment of refractory ischaemic pain from chemotherapy‐induced Raynaud's syndrome with spinal cord stimulation. Pain Practice 2007;7(2):143‐6.

Tsubota 2009 {published data only}

Tsubota S, Higaki N, Nagaro T. A case of neuropathic cancer pain in the lower extremities successfully treated with spinal cord stimulation. Masui 2009;58(11):1460‐1.

Yakovlev 2008 {published data only}

Yakovlev AE, Ellia Y. Spinal cord stimulation as a treatment option for intractable neuropathic cancer pain. Clinical Medicine & Research 2008;6(3‐4):103‐6.

Yakovlev 2009 {published data only}

Yakovlev AE, Resch BE. Treatment of intractable abdominal pain patient with Bannayan‐Riley‐Ruvalcaba syndrome using spinal cord stimulation. WMJ: official publication of the State Medical Society of Wisconsin 2009;108(6):323‐6.

Additional references

Boswell 2010

Boswell MV, Trescot AM, Datta S, Schultz DM, Hansen HC, Abdi S, et al. Interventional techniques: evidence‐based practice guidelines in the management of chronic spinal pain. Pain Physician 2007;10(1):7‐111.

Christo 2008

Christo PJ, Mazloomdoost D. Cancer pain and analgesia. Annals of the New York Academy of Sciences. 2008.

Costantini 2005

Costantini A. Spinal cord stimulation. Minerva Anestesiology 2005;71(7‐8):471‐4.

Flagg 2012

Flagg A, McGreevy K, Williams K. Spinal cord stimulation in the treatment of cancer‐related pain: "back to the origins". Current Pain and Headache Reports 2012;16(4):343‐9. [PUBMED: 22610506]

Frey 2009

Frey ME, Manchikanti L, Benyamin RM, Schultz DM, Smith HS, Cohen SP. Spinal cord stimulation for patients with failed back surgery syndrome: a systematic review. Pain Physician 2009;12(2):379‐97.

Grabow 2003

Grabow TS, Tella PK, Raja SN. Spinal cord stimulation for complex regional pain syndrome: an evidence‐based medicine review of the literature. Clinical Journal of Pain 2003;19(6):371‐83.

Herr 2004

Herr K, Titler MG, Schilling ML, Marsh JL, Xie XJ, Ardery G, et al. Evidence‐based assessment of acute pain in older adults: current nursing practices and perceived barriers. Clinical Journal of Pain 2004;20(5):331‐40.

Hurlow 2012

Hurlow A, Bennett MI, Robb KA, Johnson MI, Simpson KH, Oxberry SG. Transcutaneous electric nerve stimulation (TENS) for cancer pain in adults. Cochrane Database of Systematic Reviews 2012, Issue 3. [DOI: 10.1002/14651858.CD006276.pub3]

IASP 2008

International Association for the Study of Pain (IASP). Opioid‐induced hyperalgesia. Pain Clinical Updates of International Association for the Study of Pain. 2008; Vol. XVI, issue 2:1‐4.

Isagulian 2008

Isagulian ED, Shabalov VA. Neuromodulation‐‐controlled analgesia. Criteria for long efficiency. Journal of Neurosurgical Problems 2008;2:18‐26.

Kemler 2010

Kemler MA, Raphael JH, Bentley A, Taylor RS. The cost‐effectiveness of spinal cord stimulation for complex regional pain syndrome. Value In Health 2010;13(6):735‐42.

Klomp 2009

Klomp HM, Steyerberg EW, Habbema JD, Van Urk H, ESES study group. What is the evidence on efficacy of spinal cord stimulation in (subgroups of) patients with critical limb ischemia. Annals of Vascular Surgery 2009;23(3):355‐63.

Mailis 2004

Mailis‐Gagnon A, Furlan AD, Sandoval JA, Taylor RS. Spinal cord stimulation for chronic pain. Cochrane Database of Systematic Reviews 2004, Issue 3. [DOI: 10.1002/14651858.CD003783.pub2]

Michael 2009

Michael EF, Laxmaiah M, Ramsin MB, David MS, Howard SS, Steven PC. Spinal cord stimulation for patients with failed back surgery syndrome: A systematic review. Pain Physician 2009;12:379‐97.

Miguel 2000

Miguel R. Interventional treatment of cancer pain: the fourth step in the World Health Organization analgesic ladder?. Cancer Control 2000;7(2):149‐56.

Miles 1974

Miles J, Lipton S, Hayward M, Bowsher D, Mumford J, Molony V. Pain relief by implanted electrical stimulators. Lancet 1974;1(7861):777‐9.

Moher 2001

Moher D, Schulz KF, Altman DG. The CONSORT Statement: revised recommendations for improving the quality of reports of parallel‐group randomised trials. Lancet 2001;357:1191‐4.

North 2008

North RB, Shipley J, Taylor RS. Generating evidence on spinal cord stimulation for failed back surgery syndrome: not yet fully charged. Clinical Journal of Pain 2009;24(9):757‐8.

Reeves 2011

Reeves BC, Deeks JJ, Higgins JPT, Wells GA. Chapter 13: Including non‐randomised studies. In: Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions;Version 5.1.0. The Cochrane Collaboration, 2011.

Review Manager 2011 [Computer program]

The Nordic Cochrane Centre, The Cochrane Collaboration. Review Manager (RevMan). Version 5.0. Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2008.

Ro 2005

Ro LS, Chang KH. Neuropathic pain: mechanisms and treatments. Chang Gung Medical Journal 2005;28(9):597‐605.

Running 2011

Running A, Turnbeaugh E. Oncology pain and complementary therapy. Clinical Journal of Oncology Nursing 2011;15(4):374‐9.

Schmidt 2010

Schmidt BL, Hamamoto DT, Simone DA, Wilcox GL. Mechanism of cancer pain. Molecular Interventions 2010;10(3):164‐78.

Schug 1990

Schug SA, Zech D, Dorr U. Cancer pain management according to WHO analgesic guidelines. Journal of Pain and Symptom Management 1990;5:27‐32.

Simpson 2009

Simpson EL, Duenas A, Holmes MW, Papaioannou D, Chilcott J. Spinal cord stimulation for chronic pain of neuropathic or ischaemic origin: systematic review and economic Evaluation. Health Technology Assessment 2009;13:number 17.

Slavik 2004

Slavik E, Ivanović S. Cancer pain (neurosurgical management). Acta Chirurgica Lugoslavica 2004;51(4):15‐23.

Stephen 2005

Stephen M, Martin K. Wall and Melzack's Textbook of Pain. Churchill Livingstone, 2005.

Stojanovic 2002

Stojanovic MP, Abdi S. Spinal cord stimulation. Pain Physician 2002 July;5(3):341.

Sweet 1974

Sweer WH, Wespic JG. Stimulation of the posterior columns of the spinal cord for pain control: indications, technique, and results. Clinical Neurosurgery 1974;21:278‐310.

Taylor 2006

Taylor RS, Van Buyten JP, Buchser E. Spinal cord stimulation for complex regional pain syndrome: a systematic review of the clinical and cost‐effectiveness literature and assessment of prognostic factors. European Journal of Pain 2006;10(2):91‐101.

Taylor 2009

Taylor RS, De Vries J, Buchser E, Dejongste MJ. Spinal cord stimulation in the treatment of refractory angina: systematic review and meta‐analysis of randomised controlled trials. Biomedcentral Cardiovascular Disorders 2009;7:9‐13.

Ubbink 2005

Ubbink DT, Vermeulen H. Spinal cord stimulation for non‐reconstructable chronic critical leg ischaemia. Cochrane Database of Systematic Reviews 2005, Issue 3. [DOI: 10.1002/14651858.CD004001.pub2]

Vandenbroucke 2007

Vandenbroucke JP, von Elm E, Altman DG, Gøtzsche PC, Mulrow CD, Pocock SJ, et al. Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): explanation and elaboration.. PLoS Medicine 2007;4:e297.

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Jump to:

Meglio 1989

Methods

Part of a retrospective study to analyse 109 patients with chronic pain who underwent spinal cord stimulation, clinical efficacy was analysed in relation to the aetiology of pain.

Participants

From 1978‐1986,109 participants were enrolled, 11 patients with cancer pain; 40 with vasculopathic pain, 19 with lower back pain; 15 with paraplegic pain; 9 with deafferentation pain,10 with post‐herpetic pain.

Interventions

Percutaneous placement of the stimulator electrodes or positioned through a small laminectomy after a test period of 5 to 60 days, two kinds of stimulators were used: the first was a radiofrequency system; the second was programmable stimulators, which were programmed with a pulse width of 210 microseconds and a rate of 85 Hz,64 seconds on,1 to 4 minutes off, amplitude was at will to produce comfortable paraesthesia.

Outcomes

Reduction of visual analogue scale as percentage of analgesia (0% denotes no effect,100% denotes complete pain relief, a reduction of more than 50% of original pain was considered as responder); adverse events.

Notes

None

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

High risk

No information was provided.

Allocation concealment (selection bias)

High risk

No information was provided.

Blinding of participants and personnel (performance bias)
All outcomes

High risk

No information was provided.

Blinding of outcome assessment (detection bias)
All outcomes

High risk

No information was provided.

Incomplete outcome data (attrition bias)
All outcomes

High risk

No information was provided.

Selective reporting (reporting bias)

High risk

No information was provided.

Other bias

High risk

No information was provided.

Shimoji 1993

Methods

A survey of clinical results of using percutaneous epidural low‐frequency spinal cord stimulation for chronic pain.

Participants

Between 1970‐1991, 454 patients with chronic pain received percutaneous epidural low‐frequency spinal cord stimulation, 52 with carcinoma/sarcoma; 126 with post‐herpetic neuralgia; 189 with causalgia; 12 with spinal trauma; 9 with SMON; 3 with tabes dorsalis; 8 with phantom pain; 14 with TAO/ASO; 9 with thalamic syndrome; 32 with other pain.

Interventions

All patients received implantation of electrodes at sites of pain which connected to a stimulator that delivered saw‐wave pulses (0.5ms in duration and 0.5‐50 Hz in frequency). The frequency of stimulation was adjustable by the patient at between 1.6 and 8.0 Hz, the intensity being 0.5‐5.0 V. The mode of stimulation was continuous in nine patients with cancer or occasional (3‐12/day for 20‐30 min) in 445 patients, depending on patients' complaints.

Outcomes

Degree of pain relief as visual analogue scale, 50% of reduction was considered as pain relief; adverse events.

Notes

None

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

High risk

No information was provided.

Allocation concealment (selection bias)

High risk

No information was provided.

Blinding of participants and personnel (performance bias)
All outcomes

High risk

No information was provided.

Blinding of outcome assessment (detection bias)
All outcomes

High risk

No information was provided.

Incomplete outcome data (attrition bias)
All outcomes

High risk

No information was provided.

Selective reporting (reporting bias)

High risk

No information was provided.

Other bias

High risk

No information was provided.

Yakovlev 2010

Methods

To retrospectively analyse the pain relief outcome of spinal cord stimulation in patients with cancer‐related chest wall pain.

Participants

From 2005‐2008,14 patients diagnosed with lung cancer underwent thoracotomy or lung resection and postoperative radiation therapy, and complained of intractable chronic chest pain.

Interventions

14 patients received percutaneous implantation of permanent leads and stimulators at T3,T4,T5 after a successful trial of at least 2 days; stimulators were programmed with a pulse width of 400 to 450 microseconds and a rate of 50‐60 Hz,amplitude ranged from 1.5‐2.3 volts.

Outcomes

Rate of opioid use before and after treatment; pre procedure, 1 month post implant and 12 months post implant visual analogue scale; complication.

Notes

None

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

High risk

No information of randomisation was provided.

Allocation concealment (selection bias)

High risk

No information of allocation concealment was provided.

Blinding of participants and personnel (performance bias)
All outcomes

High risk

No information of blinding was provided.

Blinding of outcome assessment (detection bias)
All outcomes

High risk

No information of blinding of outcome assessment was provided.

Incomplete outcome data (attrition bias)
All outcomes

High risk

No information of patient dropout was provided.

Selective reporting (reporting bias)

High risk

No information was provided.

Yakovlev 2011

Methods

To retrospectively analyse the pain relief of spinal cord stimulation for intractable cancer‐related lower back pain.

Participants

Between 2005‐2009,15 patients underwent surgical resections and radiation therapy because of metastatic disease related to colon, anal cancer, angiosarcoma of the sacrum, complained of intractable chronic low back pain.

Interventions

15 patients received percutaneous implantation of permanent leads and stimulators at T11‐12,T12/L1 after successful trial at least 2 days,stimulators were programmed with a pulse width of 390 to 480 microseconds and a rate of 40‐60 Hz,amplitude ranged from 1.4‐5.2 volts.

Outcomes

Rate of opioid use before and after treatment; pre procedure ,1 month post implant and 12 months post implant visual analogue scale; complications.

Notes

None

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

High risk

No information was provided.

Allocation concealment (selection bias)

High risk

No information was provided.

Blinding of participants and personnel (performance bias)
All outcomes

High risk

No information was provided.

Blinding of outcome assessment (detection bias)
All outcomes

High risk

No information was provided.

Incomplete outcome data (attrition bias)
All outcomes

High risk

No information was provided.

Selective reporting (reporting bias)

High risk

No information was provided.

Other bias

High risk

No information was provided.

ASO: arteriosclerosis obliterans
SMON: subacute myelo‐optico‐neuropathy
TAO: thromboangiitis obliterans

Characteristics of excluded studies [ordered by study ID]

Jump to:

Study

Reason for exclusion

Cata 2004

Individual case report

Clavo 2004

Outcomes not related to the topic of systemic review

Clavo 2009

Outcomes not related to the topic of systemic review

Eisenberg 2002

Individual case report

Hamid 2007

Individual case report.

Lee 2006

Review article of SCS.

Lee 2009

Individual case report.

Nouri 2011

Individual case report.

Rainov 2007

Outcomes not related to the topic of review.

Robaina 2007

Individual case report.

Ting 2007

Individual case report.

Tsubota 2009

Individual case report.

Yakovlev 2008

Case report including only 2 patients.

Yakovlev 2009

Individual case report.

SCS: spinal cord stimulation

Data and analyses

Open in table viewer
Comparison 1. Pain Intensity after SCS implantation

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Pain intensity‐‐‐Visual Analogue Scale Show forest plot

2

58

Mean Difference (IV, Random, 95% CI)

4.38 [3.93, 4.83]

Analysis 1.1

Comparison 1 Pain Intensity after SCS implantation, Outcome 1 Pain intensity‐‐‐Visual Analogue Scale.

Comparison 1 Pain Intensity after SCS implantation, Outcome 1 Pain intensity‐‐‐Visual Analogue Scale.

Open in table viewer
Comparison 2. Pain intensity‐‐‐1 month after SCS versus 12 months after SCS

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Pain Intensity‐‐‐Visual Analogue Scale Show forest plot

2

58

Mean Difference (IV, Fixed, 95% CI)

0.91 [0.50, 1.32]

Analysis 2.1

Comparison 2 Pain intensity‐‐‐1 month after SCS versus 12 months after SCS, Outcome 1 Pain Intensity‐‐‐Visual Analogue Scale.

Comparison 2 Pain intensity‐‐‐1 month after SCS versus 12 months after SCS, Outcome 1 Pain Intensity‐‐‐Visual Analogue Scale.

Study flow diagram.
Figures and Tables -
Figure 1

Study flow diagram.

Comparison 1 Pain Intensity after SCS implantation, Outcome 1 Pain intensity‐‐‐Visual Analogue Scale.
Figures and Tables -
Analysis 1.1

Comparison 1 Pain Intensity after SCS implantation, Outcome 1 Pain intensity‐‐‐Visual Analogue Scale.

Comparison 2 Pain intensity‐‐‐1 month after SCS versus 12 months after SCS, Outcome 1 Pain Intensity‐‐‐Visual Analogue Scale.
Figures and Tables -
Analysis 2.1

Comparison 2 Pain intensity‐‐‐1 month after SCS versus 12 months after SCS, Outcome 1 Pain Intensity‐‐‐Visual Analogue Scale.

Table 1. STROBE checklist

Structure

Item

Recommendation

Title and abstract

1

Indicate the study’s design with a commonly used term in the title or the abstract; provide in the abstract an informative and balanced summary of what was done
and what was found.

Introduction

Background/rationale

2

Explain the scientific background and rationale for the investigation being reported.

Objectives

3

State specific objectives, including any prespecified hypotheses.

Methods

Study design

4

Present key elements of study design early in the paper.

Setting

5

Describe the setting, locations, and relevant dates, including periods of recruitment, exposure, follow‐up, and data collection.

Participants

6

Give the eligibility criteria, and the sources and methods of selection of participants.

Variables

7

Clearly define all outcomes, exposures, predictors, potential confounders, and effect modifiers. Give diagnostic criteria, if applicable.

Data sources/
measurement

8

For each variable of interest, give sources of data and details of methods of assessment (measurement). Describe comparability of assessment methods if there
is more than one group.

Bias

9

Describe any efforts to address potential sources of bias.

Study size

10

Explain how the study size was arrived at.

Quantitative variables

11

Explain how quantitative variables were handled in the analyses. If applicable, describe which groupings were chosen and why.

Statistical methods

12

(a) Describe all statistical methods, including those used to control for confounding.
(b) Describe any methods used to examine subgroups and interactions.
(c) Explain how missing data were addressed.

(d) If applicable, describe analytical methods taking account of sampling strategy.

Results

Participants

13

(a) Report numbers of individuals at each stage of study—e.g. numbers potentially eligible, examined for eligibility, confirmed eligible, included in the study, completing follow‐up, and
analysed.
(b) Give reasons for non‐participation at each stage.
Participants
(c) Consider use of a flow diagram.

Descriptive
data

14

(a) Give characteristics of study participants (e.g. demographic, clinical, social) and information on exposures and potential confounders.
(b) Indicate number of participants with missing data for each variable of interest.

Outcome data

15

Report numbers of outcome events or summary measures.

Main results

16

If relevant, consider translating estimates of relative risk into absolute risk for a meaningful time period.

Other analyses

17

Report other analyses done—e.g. analyses of subgroups and interactions, and sensitivity analyses.

Discussion

Key results

18

Summarise key results with reference to study objectives.

Limitations

19

Discuss limitations of the study, taking into account sources of potential bias or imprecision.
Discuss both direction and magnitude of any potential bias.

Interpretation

20

Give a cautious overall interpretation of results considering objectives, limitations, multiplicity of analyses, results from similar studies, and other relevant evidence.

Generalisability

21

Discuss the generalisability (external validity) of the study results.

Other information

Funding

22

Give the source of funding and the role of the funders for the present study and, if applicable, for the original study on which the present article is based

Figures and Tables -
Table 1. STROBE checklist
Table 2. Result of STOBE Checklist

Item No.

Meglio 1989

Shimoji 1993

Yakovlev 2010

Yakovlev 2011

1

Y

Y

Y

Y

2

N

Y

Y

Y

3

N

Y

Y

Y

4

N

N

N

N

5

N

N

Y

Y

6

N

N

N

N

7

N

N

N

N

8

N

N

N

Y

9

N

N

N

N

10

N

N

N

N

11

Y

Y

Y

Y

12

N

N

N

N

13

N

N

N

N

14

N

N

N

N

15

Y

Y

Y

Y

16

N

N

N

N

17

N

N

N

N

18

Y

Y

Y

Y

19

N

N

N

N

20

Y

Y

Y

Y

21

Y

Y

Y

Y

22

N

N

Y

Y

Y:Yes; N:No; U:Unlear

Figures and Tables -
Table 2. Result of STOBE Checklist
Comparison 1. Pain Intensity after SCS implantation

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Pain intensity‐‐‐Visual Analogue Scale Show forest plot

2

58

Mean Difference (IV, Random, 95% CI)

4.38 [3.93, 4.83]

Figures and Tables -
Comparison 1. Pain Intensity after SCS implantation
Comparison 2. Pain intensity‐‐‐1 month after SCS versus 12 months after SCS

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Pain Intensity‐‐‐Visual Analogue Scale Show forest plot

2

58

Mean Difference (IV, Fixed, 95% CI)

0.91 [0.50, 1.32]

Figures and Tables -
Comparison 2. Pain intensity‐‐‐1 month after SCS versus 12 months after SCS