Last reviewed · How we verify
NCT05372822
Burst Crossover Trial
NA trial testing Burst Spinal Cord Stimulation in Back Pain with Radiation in 50 participants. Currently enrolling.
15 August 2025
Quick facts
| Lead sponsor | St. Olavs Hospital |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 1 May 2021 |
| Primary completion | 15 August 2025 |
| Estimated completion | 15 August 2025 |
| Sites | 1 location across Norway |
Drugs / interventions tested
- Burst Spinal Cord Stimulation
- Sham spinal cord stimulation
- SCS implant
Conditions studied
- Back Pain with Radiation — all drugs for Back Pain with Radiation →
- Pain, Postoperative — all drugs for Pain, Postoperative →
Sponsor
St. Olavs Hospital
Who can join
18 and older, any sex, with Back Pain with Radiation or Pain, Postoperative. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05372822
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Burst Spinal Cord Stimulation
Trials testing the same drug.
- NCT03546738 — Spinal Cord Burst Stimulation for Chronic Radicular Pain Following Lumbar Spine Surgery · NA · completed
Other St. Olavs Hospital trials
Trials by the same sponsor.
- NCT07331766 — Collaboratory Treatment Pathway for Chronic Pain Patients. · NA · enrolling by invitation
- NCT07305025 — Pelvic Pain Electro-Acupuncture · NA · not yet recruiting
- NCT07245264 — Adjuvant Tranexamic Acid (TXA) Versus Surgery Alone for Adult Patients With Chronic Subdural Hematoma (CSDH) · Phase 2, PHASE3 · recruiting
- NCT07180433 — Piloting 18F-FAPI PET/MRI for Applications in Breast Cancer · NA · not yet recruiting
- NCT06854861 — Premixed Glucagon/Insulin Solution for Faster Insulin Absorption in Type 1 Diabetes · Phase 1, PHASE2 · suspended
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05372822 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by St. Olavs Hospital
- Last refreshed: 24 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05372822.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing