Burst Spinal Cord Stimulation for Neuropathic Pain.
CompletedNot applicableNCT03733886
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
This study will evaluate the effect of Burst spinal cord stimulation (SCS) in the treatment of painful radiculopathy in lower extremity(ies) with or without lower back pain. It is a multicenter double-blinded "n-of-1" RCT with repeated two-week periods of Burst SCS or sham in randomised order.
Study details
- Official title
- A Randomised Sham-controlled Double-blinded Study of Burst Spinal Cord Stimulation for Chronic Peripheral Neuropathic Pain.
- Conditions
- Peripheral Neuropathic Pain
- Radiculopathy
- Lower Back Pain
- Interventions
- Device: Burst SCS (Abbott Proclaim IPG and single lead Abbott Octrode at level Th9/10)
- Sponsor
- Oslo University Hospital
- Collaborators
- Uppsala University Hospital
- Start date
- 2019-09-09
- Primary completion
- 2023-06-22
- Sex
- All
- Age range
- from 18 Years to 80 Years
- Results posted
- No results posted in this snapshot
- Countries
- Norway, Sweden
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * History, symptoms and clinical findings consistent with painful radiculopathy in lower extremity(ies) ("probable" or "definite") for at least 3 months, with or without lower back pain. The pain in the extremity(ies) must dominate. * Understand Norwegian or Swedish language (written and spoken). * Usual pain intensity ≥ 3.5 / 10 (NRS 0-10) Exclusion Criteria: Absolute * Opioid dose \> 100 mg morphine equivalents / day * Ongoing litigation * Mental / psychiatric disorder that may affect treatment * Chronic generalized pain * Pregnancy * Hypersensitivity to local anesthetics * Serious or unclear medical condition such as angina pectoris, severe vascular disorder, infection, malignancy disease, bleeding disorders * Laminectomy in or above level for planned epidural access * Spine surgery the last 3 months Relative * Ongoing medication that affects coagulation or platelet function
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03733886