Spinal cord stimulation for predominant low back pain in failed back surgery syndrome: study protocol for an international multicenter randomized controlled trial (PROMISE study)

Trials

Krishna Kumar⁵  Jane Shipley³  Carine Van den Abeele¹  Ye Tan⁶  Christine Greening⁶  Lieven Annemans²  Rod S Taylor⁴  Richard B North³  Mehul J Desai⁷  Philippe Rigoard⁸ 

[1] Department of Clinical Research, Medtronic International Trading Sàrl, Route du Molliau 31, Case Postale 1131, Tolochenaz, Switzerland;Ghent University, Department of Public Health, De Pintelaan 185, Ghent 9000, Belgium;The Neuromodulaton Foundation, Inc., 10807 Falls Road, #379, Brooklandville, MD 21022, USA;Institute of Health Research, Exeter Medical School, University of Exeter, Veysey Building, Salmon Pool Lane, Exeter EX2 4SG, UK;Department of Neurosurgery, Regina General Hospital, University of Saskatchewan, Regina, SK, Canada;Department of Clinical Research, Medtronic, Inc., Rice Creek East, 7000 Central Avenue NE, Minneapolis, MN 55432-3568, USA;Metro Orthopedics & Sports Therapy, 8401 Colesville Road #50, Silver Spring, MD 20910, USA;Department of Neurosurgery, Poitiers University Hospital, Poitiers, France

关键词: Randomized controlled trial;    Spinal cord stimulation;    Failed back surgery syndrome;    Neuropathic pain;    Low back pain;   

Others  :  807932
DOI  :  10.1186/1745-6215-14-376

 received in 2013-06-29, accepted in 2013-10-23,  发布年份 2013

【 摘 要 】

Background

Although results of case series support the use of spinal cord stimulation in failed back surgery syndrome patients with predominant low back pain, no confirmatory randomized controlled trial has been undertaken in this patient group to date. PROMISE is a multicenter, prospective, randomized, open-label, parallel-group study designed to compare the clinical effectiveness of spinal cord stimulation plus optimal medical management with optimal medical management alone in patients with failed back surgery syndrome and predominant low back pain.

Method/Design

Patients will be recruited in approximately 30 centers across Canada, Europe, and the United States. Eligible patients with low back pain exceeding leg pain and an average Numeric Pain Rating Scale score ≥5 for low back pain will be randomized 1:1 to spinal cord stimulation plus optimal medical management or to optimal medical management alone. The investigators will tailor individual optimal medical management treatment plans to their patients. Excluded from study treatments are intrathecal drug delivery, peripheral nerve stimulation, back surgery related to the original back pain complaint, and experimental therapies. Patients randomized to the spinal cord stimulation group will undergo trial stimulation, and if they achieve adequate low back pain relief a neurostimulation system using the Specify® 5-6-5 multi-column lead (Medtronic Inc., Minneapolis, MN, USA) will be implanted to capture low back pain preferentially in these patients. Outcome assessment will occur at baseline (pre-randomization) and at 1, 3, 6, 9, 12, 18, and 24 months post randomization. After the 6-month visit, patients can change treatment to that received by the other randomized group. The primary outcome is the proportion of patients with ≥50% reduction in low back pain at the 6-month visit. Additional outcomes include changes in low back and leg pain, functional disability, health-related quality of life, return to work, healthcare utilization including medication usage, and patient satisfaction. Data on adverse events will be collected. The primary analysis will follow the intention-to-treat principle. Healthcare use data will be used to assess costs and long-term cost-effectiveness.

Discussion

Recruitment began in January 2013 and will continue until 2016.

Trial registration

Clinicaltrials.gov: NCT01697358 (http://www.clinicaltrials.gov webcite)

【 授权许可】

   
2013 Rigoard et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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