Abstract
BackgroundAlthough 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/DesignPatients 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.DiscussionRecruitment began in January 2013 and will continue until 2016.Trial registrationClinicaltrials.gov: NCT01697358 (http://www.clinicaltrials.gov)
Highlights
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
Randomized controlled trials (RCTs) have shown spinal cord stimulation (SCS) to be a clinically effective and cost-effective adjunct to medical management [6,7,8] or alternative to a further operation [9,10] in patients with failed back surgery syndrome (FBSS) characterized by leg pain exceeding or equaling axial low back pain
RCT evidence is needed to confirm the efficacy of the use of multicolumn SCS in patients with FBSS characterized by predominant back pain
Summary
Between 5 and 50% of patients suffer from chronic back and/or leg pain, commonly known as failed back surgery syndrome (FBSS) [1,2] and characterized by disabling neuropathic radicular leg pain with or without low back pain, which might have mixed neuropathic and nociceptive pain components [3]. Other outcomes include: Mental Component Summary score on Short-Form 36 [20]; EuroQoL 5D-5 L (EQ-5D5 L) [22]; Pittsburgh Sleep Quality Index [23]; healthcare use related to the pain condition and to its treatment (for example, managing adverse events, interventions, investigations, drugs, length and number of inpatient hospitalizations, and number of emergency room, office, and other healthcare-related visits) [24]; employment status (‘What is your current employment status?’, ‘If out of work: what is the main reason you are out of work?’); patient satisfaction (‘Would you recommend this therapy to patients suffering from pain similar to yours?’, ‘Overall how satisfied or unsatisfied are you with this therapy?’); Patient Global Impression of Change version 2 [25]; programming parameters and paresthesia coverage; and adverse events (adverse events and device deficiencies documentation will include date of adverse event or device deficiency, diagnosis and description of the event, assessment of seriousness of the event, treatment of the event, outcome or resolution and date of the event, and relationship of the event to the device or to OMM – in addition to the standard questionnaire data collection schedule, the EQ-5D-5 L will be collected, when possible, whenever a device-related adverse event occurs that might require a surgical intervention or hospitalization).
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