Burst Crossover Trial
- Conditions
- Back Pain with RadiationPain, Postoperative
- Interventions
- Procedure: Burst Spinal Cord StimulationProcedure: Sham spinal cord stimulationDevice: SCS implant
- Registration Number
- NCT05372822
- Lead Sponsor
- St. Olavs Hospital
- Brief Summary
Spinal cord stimulation (SCS) is a widely applied therapy to treat chronic neuropathic pain, and one of the most common indications is persisting radicular neuropathic pain following lumbar spine surgery. In traditional SCS therapies, the objective has been to replace the pain sensation with paresthesia. The anticipation is that the electrical current alters pain processing by masking the sensation of pain with a comfortable tingling or paresthesia. Although patients mostly cope with paresthesia, a significant proportion reports that the sensation is unpleasant.
'Burst' SCS utilizes complex programming to deliver high-frequency stimuli. This SCS technique seems to provide paresthesia-free stimulation, resulting in better pain relief of low back and leg pain then traditional tonic stimulation.
The widespread use of SCS has not been backed by solid evidence. The absence of placebo-controlled trials has long been an important point of criticism, but due to the nature of the intervention with sensation of paresthesia, studies with placebo control have so far not been considered possible. When 'burst' SCS is used the stimulation is often unnoticed by the patient, allowing comparison with placebo stimulation.
The aim of this randomized double-blind sham-controlled crossover trial is to evaluate the efficacy of 'burst' spinal cord stimulation for chronic radicular pain following spine surgery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- Have undergone ≥1 back surgeries and developed chronic radicular pain that has remained refractory to non-surgical treatment for ≥6 months
- Minimum pain intensity of 5/10 on the leg pain NRS at baseline
- Successful two-week SCS testing period with tonic stimulation (≥2 points reduction in leg pain NRS from baseline). This means patients will experience paresthesia during the SCS trial period
- Mandatory assessment at the Multidisciplinary outpatient clinic for back-, neck- and shoulder rehabilitation, St. Olavs University Hospital
- Successful two-week SCS testing period with tonic stimulation (≥50% reduction in leg pain NRS from baseline). This means patients will experience paresthesia during the SCS trial period
- Coexisting conditions that would increase procedural risk (e.g., sepsis, coagulopathy)
- History of laminectomy or posterior fusion at the thoracolumbar junction, where percutaneous electrode end tips are routinely placed.
- Abnormal pain behavior and/or unresolved psychiatric illness.
- Unresolved issues of secondary gain or inappropriate medication use.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Burst SCS SCS implant Burst Spinal cord stimulation. SCS system implanted and burst stimulation given Sham SCS Sham spinal cord stimulation Sham spinal cord stimulation. SCS system implanted but no stimulation given. Burst SCS Sham spinal cord stimulation Burst Spinal cord stimulation. SCS system implanted and burst stimulation given Burst SCS Burst Spinal Cord Stimulation Burst Spinal cord stimulation. SCS system implanted and burst stimulation given Sham SCS Burst Spinal Cord Stimulation Sham spinal cord stimulation. SCS system implanted but no stimulation given. Sham SCS SCS implant Sham spinal cord stimulation. SCS system implanted but no stimulation given.
- Primary Outcome Measures
Name Time Method change in disease-specific functional outcome from baseline 12 months measured with version 2.0 of the Oswestry disability index (ODI) that has been translated into Norwegian and tested for psychometric properties. The ODI questionnaire quantifies disability for degenerative conditions of the lumbar spine and covers intensity of pain, ability to lift, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. The index is scored from 0 to 100. Zero means no disability and 100 reflects maximum disability.
- Secondary Outcome Measures
Name Time Method Daily physical activity 12 months measured by use of a body-worn accelerometer (activPALs from PAL Technologies Ltd., Glasgow, United Kingdom) attached by a waterproof tape to the midpoint of the patients' anterior right thigh
Change in generic health-related quality of life measured with the Euro-Qol-5D (5L) 12 months Change in back pain 12 months measured using numerical rating scales (NRS)
change in leg pain 12 months measured using numerical rating scales (NRS)
Six-month follow-up of pain-related disability 18 months Back pain-related disability, leg pain, back pain, and health-related quality of life at 6 months following completion of the final randomization period when patients are unblinded and provided with handheld spinal cord stimulation programmers allowing changes to stimulation settings and switching between burst and tonic stimulation. Measured with version 2.0 of the Oswestry disability index (ODI), leg pain NRS, back pain NRS, Euro-Qol 5D
Trial Locations
- Locations (1)
St Olavs Hospital
🇳🇴Trondheim, Norway