Assessing the effectiveness and cost effectiveness of subcutaneous nerve stimulation in patients with predominant back pain due to failed back surgery syndrome (SubQStim study): Study protocol for a multicenter randomized controlled trial

Trials

Volumn 14, Issue 1, 2013, Pages

  Eldabe, Sam ^a   Kern, Michael ^b   Peul, Wilco ^c   Green, Colin ^d   Winterfeldt, Kristi ^e   Taylor, Rod S ^d  

^a JAMES COOK UNIVERSITY HOSPITAL   (United Kingdom)

^b ELISABETHINEN HOSPITAL   (Austria)

^c LEIDEN UNIVERSITY MEDICAL CENTER   (Netherlands)

^d UNIVERSITY OF EXETER MEDICAL SCHOOL   (United Kingdom)

^e MEDTRONIC INC   (United States)

Author keywords

Chronic Back Pain; Failed Back Surgery Syndrome; Peripheral Nerve Stimulation; Randomized Controlled Trial; Subcutaneous Stimulation

Indexed keywords

ANTICONVULSIVE AGENT; ANTIDEPRESSANT AGENT; NONSTEROID ANTIINFLAMMATORY AGENT; OPIATE;

ANALGESIA; ARTICLE; BACKACHE; CONTROLLED STUDY; COST EFFECTIVENESS ANALYSIS; FAILED BACK SURGERY SYNDROME; FOLLOW UP; HEALTH CARE UTILIZATION; HUMAN; LEG PAIN; MAJOR CLINICAL STUDY; MULTICENTER STUDY; NERVE STIMULATION; OUTCOME ASSESSMENT; PAIN ASSESSMENT; PATIENT SATISFACTION; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; SUBCUTANEOUS NERVE STIMULATION; WELLBEING;

ANALGESICS; AUSTRALIA; BACK PAIN; CLINICAL PROTOCOLS; COST-BENEFIT ANALYSIS; DISABILITY EVALUATION; EUROPE; HEALTH CARE COSTS; HUMANS; ORTHOPEDIC PROCEDURES; PAIN MEASUREMENT; PAIN, INTRACTABLE; PAIN, POSTOPERATIVE; PATIENT SATISFACTION; PREDICTIVE VALUE OF TESTS; QUALITY OF LIFE; QUESTIONNAIRES; RESEARCH DESIGN; SPINE; TIME FACTORS; TRANSCUTANEOUS ELECTRIC NERVE STIMULATION; TREATMENT FAILURE;

EID: 84879236950     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-14-189     Document Type: Article

References (40)

1. Waddell G. The Back Pain Revolution 1998, London, UK: Churchill Livingstone.
2. Manca A, Eldabe S, Buchser E, Kumar K, Taylor RS. Relationship between health-related quality of life, pain, and functional disability in neuropathic pain: patients with failed back surgery syndrome. Value Health 2010, 13:95-102. 10.1111/j.1524-4733.2009.00588.x, 19695004.
3. Doth A, Hansson PS, Jensen MP, Taylor RS. The burden of neuropathic pain: a systematic review and meta-analysis of health utilities. Pain 2010, 149:338-344. 10.1016/j.pain.2010.02.034, 20227832.
4. Maniadakis N, Gray A. The economic burden of back pain in the UK. Pain 2000, 84:95-103. 10.1016/S0304-3959(99)00187-6, 10601677.
5. North R, Shipley J, Prager J, Barolat G, Barulich M, Bedder M, Calodney A, Daniels A, Deer T, DeLeon O, Drees S, Fautdch M, Fehrenbach W, Hernandez J, Kloth D, Krames ES, Lubenow T, North R, Osenbach R, Panchal SJ, Sitzman T, Staats P, Tremmel J, Wetzel T, American Academy of Pain Medicine Practice parameters for the use of spinal cord stimulation in the treatment of chronic neuropathic pain. Pain Med 2007, 8(Suppl 4):S200-S275. American Academy of Pain Medicine.
6. Oakley JC. Spinal cord stimulation in axial low back pain: solving the dilemma. Pain Med 2006, 7:C58-C63.
7. Kumar K, Taylor RS, Jacques L, Eldabe S, Meglio M, Molet J, Thomson S, O'Callaghan J, Eisenberg E, Milbouw G, Buchser E, Fortini G, Richardson J, North RB. Spinal cord stimulation versus conventional medical management for neuropathic pain: a multicentre randomised controlled trial in patients with failed back surgery syndrome. Pain 2007, 132:179-188. 10.1016/j.pain.2007.07.028, 17845835.
8. North RB, Kidd DH, Olin J, Sieracki JM, Farrokhi F, Petrucci L, Cutchis PN. Spinal cord stimulation for axial low back pain: a prospective, controlled trial comparing dual with single percutaneous electrodes. Spine 2005, 30:1412-1418. 10.1097/01.brs.0000166502.05449.a8, 15959371.
9. Stanton-Hicks M, Panourias IG, Sakasb D, Slavinc KV. The future of peripheral nerve stimulation. Prog Neurol Surg 2011, 24:210-217.
10. Wall PD, Sweet WH. Temporary ablation of pain in man. Science 1967, 155:108-109. 10.1126/science.155.3758.108, 6015561.
11. Levy RM. Differentiating the leaves from the branches in the tree of neuromodulation: the state of peripheral nerve field stimulation. Neuromodulation 2011, 14:201-205. 10.1111/j.1525-1403.2011.00359.x, 21992239.
12. Campbell JN, Long DM. Peripheral nerve stimulation in the treatment of intractable pain. J Neurosurg 1976, 45:692-699. 10.3171/jns.1976.45.6.0692, 1086348.
13. Paicius RM, Bernstein CA, Lempert-Cohen C. Peripheral nerve field stimulation for the treatment of low back pain: preliminary results of long-term follow-up: a case series. Neuromodulation 2007, 10:279-290. 10.1111/j.1525-1403.2007.00116.x, 22150840.
14. Sator-Katzenschlager S, Fiala K, Kress HG, Kofler A, Neuhold J, Kloimstein H, Ilias W, Mozes-Balla EM, Pinter M, Loining N, Fuchs W, Heinze G, Likar R. Subcutaneous target stimulation (STS) in chronic noncancer pain: a nationwide retrospective study. Pain Pract 2010, 10:279-286. 10.1111/j.1533-2500.2009.00351.x, 20230450.
15. Verrills P, Mitchell B, Vivian D, Sinclair C. Peripheral nerve stimulation: a treatment for chronic low back pain and failed back surgery syndrome?. Neuromodulation 2009, 12:68-75. 10.1111/j.1525-1403.2009.00191.x, 22151226.
16. Falco FJ, Berger J, Vrable A, Onyewu O, Zhu J. Cross-talk: a new method for peripheral nerve stimulation. Pain Physician 2009, 12:965-983.
17. Burgher AH, Huntoon MA, Turley TW, Doust MW, Stearns LJ. Subcutaneous peripheral nerve stimulation with inter-lead stimulation for axial neck and low back pain: case series and review of the literature. Neuromodulation 2012, 15:100-106. 10.1111/j.1525-1403.2011.00388.x, 21854499.
18. Verrills P, Vivian D, Mitchell B, Barnard A. Peripheral nerve field stimulation for chronic pain: 100 cases and review of the literature. Pain Med 2011, 12:1395-1405. 10.1111/j.1526-4637.2011.01201.x, 21812906.
19. Verrills P, Mitchell B, Vivian D, Sinclair C. Peripheral nerve field stimulation: is age an indicator of outcome?. Neuromodulation 2009, 12:60-67. 10.1111/j.1525-1403.2009.00190.x, 22151225.
20. Yakovlev AE, Resch BE, Yakovleva VE. Peripheral nerve field stimulation in the treatment of postlaminectomy syndrome after multilevel spinal surgeries. Neuromodulation 2011, 14:534-538. 10.1111/j.1525-1403.2011.00387.x, 21854498.
21. Dworkin RH, Turk DC, Wyrwich KW, Beaton D, Cleeland CS, Farrar JT, Haythornthwaite JA, Jensen MP, Kerns RD, Ader DN, Brandenburg N, Burke LB, Cella D, Chandler J, Cowan P, Dimitrova R, Dionne R, Hertz S, Jadad AR, Katz NP, Kehlet H, Kramer LD, Manning DC, McCormick C, McDermott MP, McQuay HJ, Patel S, Porter L, Quessy S, Rappaport BA, et al. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain 2008, 9:105-121. 10.1016/j.jpain.2007.09.005, 18055266.
22. Taylor RS, Buscher E, Van Buyten J-P. Spinal cord stimulation for chronic back and leg pain and failed back surgery syndrome: a systematic review and analysis of prognostic factors. Spine 2005, 30:152-160.
23. North R, Shipley J, Prager J, Barolat G, Barulich M, Bedder M, Calodney A, Daniels A, Deer T, DeLeon O, Drees S, Fautdch M, Fehrenbach W, Hernandez J, Kloth D, Krames ES, Lubenow T, North R, Osenbach R, Panchal SJ, Sitzman T, Staats P, Tremmel J, Wetzel T. Practice parameters for the use of spinal cord stimulation in the treatment of chronic neuropathic pain. Pain Med 2007, 8(Suppl 4):S200-S275.
24. Fairbank J, Pynsent P. The Oswestry disability index. Spine 2000, 25:2940-2953. 10.1097/00007632-200011150-00017, 11074683.
25. McHorney CA, Ware JE, Raczek AE. The MOS 36-item Short-Form Health Survey (SF-36): II. Psychometric and clinical tests of validity in measuring physical and mental health constructs. Med Care 1993, 31:247-263. 10.1097/00005650-199303000-00006, 8450681.
26. Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res 2011, 20:1727-1736. 10.1007/s11136-011-9903-x, 3220807, 21479777.
27. Hurst H, Bolton J. Assessing the clinical significance of change scores recorded on subjective outcome measures. J Manipulative Physiol Ther 2004, 27:26-35. 10.1016/j.jmpt.2003.11.003, 14739871.
28. Manca A, Kumar K, Taylor RS, Jacques L, Eldabe S, Meglio M, Molet J, Thomson S, O'Callaghan J, Eisenberg E, Milbouw G, Buchser E, Fortini G, Richardson J, Taylor RJ, Goeree R, Sculpher MJ. Quality of life, resource consumption and costs of spinal cord simulation versus conventional medical management in neuropathic pain patients with failed back surgery syndrome (PROCESS trial). Eur J Pain 2008, 12:1047-1058. 10.1016/j.ejpain.2008.01.014, 18359255.
29. Bouhassira D, Attal N, Alchaar H, Boureau F, Brochet B, Bruxelle J, Cunin G, Fermanian J, Ginies P, Grun-Overdyking A, Jafari-Schluep H, Lantéri-Minet M, Laurent B, Mick G, Serrie A, Valade D, Vicaut E. Comparison of pain syndromes associated with nervous or somatic lesions and development of a new neuropathic pain diagnostic questionnaire (DN4). Pain 2005, 114:29-36. 10.1016/j.pain.2004.12.010, 15733628.
30. Zigmond A, Snaith R. The hospital anxiety and depression scale. Acta Psych Scand 1983, 67:361-370.
31. Bender R, Lange S. Adjusting for multiple testing - when and how?. J Clin Epidemiol 2001, 54:344-349.
32. Schulz K, Altman DG, Moher D, CONSORT Group CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Ann Intern Med 2010, 152:1-6. 10.7326/0003-4819-152-1-201001050-00179, 19949136, CONSORT Group.
33. White IR, Horton NJ, Carpenter J, Pocock SJ. Strategy for intention to treat analysis in randomised trials with missing outcome data. BMJ 2011, 342:d40. 10.1136/bmj.d40, 3230114, 21300711.
34. Bang H, Robins J. Doubly robust estimation in missing data and causal inference models. Biometrics 2005, 61:962-972. 10.1111/j.1541-0420.2005.00377.x, 16401269.
35. Brazier J, Ratcliffe J, Salomon JA, Tsuchiya A. Measuring and Valuing Health Benefits for Economic Evaluation 2007, Oxford, UK: Oxford University Press.
36. Hoch JS, Briggs AH, Willan AR. Something old, something new, something borrowed something blue: a framework for the marriage of health econometrics and cost-effectiveness analysis. Health Econ 2002, 11:415-430. 10.1002/hec.678, 12112491.
37. Van Hout BA, Al MJ, Gordon GS, Ruten FFH. Costs, effects and C/E-ratios alongside a clinical-trial. Health Econ 1994, 3:309-319. 10.1002/hec.4730030505, 7827647.
38. National Institute for Health and Clinical Excellence (NICE) Spinal Cord Stimulation for Chronic Pain of Neuropathic or Ischaemic Origin 2008, London, UK: National Institute for Health and Clinical Excellence, National Institute for Health and Clinical Excellence (NICE).
39. 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 Technol Assess 2009, 13:1-154.
40. Taylor RS, Ryan J, O'Donnell R, Eldabe S, Kumar K, North RB. The cost-effectiveness of spinal cord stimulation in the treatment of failed back surgery syndrome. Clin J Pain 2010, 26:463-469. 10.1097/AJP.0b013e3181daccec, 20551721.