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NCT06585033: PISCES
Placebo Effect In Spinal Cord Electrical Stimulation for Pain
NA trial testing Spinal cord stimulation in Chronic Postoperative Pain in 50 participants. Currently enrolling.
30 June 2027
Quick facts
| Lead sponsor | Sahlgrenska University Hospital |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 15 November 2024 |
| Primary completion | 30 June 2027 |
| Estimated completion | 30 June 2027 |
| Sites | 4 locations across Sweden, Netherlands, Norway |
Drugs / interventions tested
- Spinal cord stimulation
- Spinal cord stimulation
Conditions studied
- Chronic Postoperative Pain — all drugs for Chronic Postoperative Pain →
Sponsor
Sahlgrenska University Hospital
Who can join
Adults 18 to 70, any sex, with Chronic Postoperative Pain. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Objective: To evaluate if spinal cord stimulation (SCS) performs better than placebo (no stimulation) in the long term to reduce persistent neuropathic leg pain refractory to medication and other conservative treatments in patients who have undergone lumbar spinal surgery. Study design: Multicenter, double blind, randomized, sham-controlled trial. After a positive SCS test trial, participants (18-70 years) will be implanted with a non-rechargeable SCS system providing active, subthreshold stimulation and followed for 12 months in a blinded cross-over design. The primary outcome measure is the difference in change in leg pain intensity scores using the Numeric Rating Scale (NRS) between a 3-month period with optimized subthreshold stimulation, and a 3-month period with no stimulation, as compared to baseline. Quality of life, physical functioning, sleep quality, return to work, and reduction in medication use will also be investigated. Background: Up to 20% of patients who have undergone lumbar spinal surgery experience persistent back/leg pain leading to long-term reduction in functionality and quality of life. SCS is an established and safe, minimally invasive treatment for these patients when no further surgery is indicated and conservative therapies have been found to be ineffective. Placebo-controlled studies, comparing active and sham stimulation, were lacking until recently as traditional SCS relied on the patient feeling the stimulation (paresthesia). Technological progress with development of paresthesia-free stimulation forms now allows for the execution of placebo-controlled studies. A recent trial showing no significant difference in long-term effectiveness between active SCS and sham suffers from significant methodological shortcomings. This necessitates further sham-controlled studies to determine the effectiveness of SCS.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06585033
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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 NCT06585033 (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 Sahlgrenska University Hospital
- Last refreshed: 2 December 2025
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