Combining spinal cord stimulation with exercise for chronic back pain relief
Spinal Cord Stimulation Combined With Exercise in Patients Diagnosed With Persistent Spinal Pain Syndrome. A Randomized Control Trial (RCT)
This study is testing whether combining spinal cord stimulation with core exercise can help people with chronic back pain feel better and improve their daily lives.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Fundación Universidad Católica de Valencia San Vicente Mártir Academic / other |
| Locations | 1 site (Torrent, Valencia) |
| Trial ID | NCT06272539 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of spinal cord stimulation (SCS) combined with lumbo-pelvic stability core training on patients suffering from Failed Back Surgery Syndrome (FBSS) and persistent spinal pain syndrome. The study aims to assess improvements in perceived low back pain, quality of life, and disability among participants. Utilizing a double-blind randomized clinical trial design, the research will involve patients who have experienced significant pain for at least six months and meet specific eligibility criteria. The approach focuses on both neurophysiological mechanisms and the benefits of exercise in pain management.
Who should consider this trial
Good fit: Ideal candidates for this study are Spanish-speaking adults over 18 years old with persistent spinal pain and a Visual Analogue Scale score greater than 7.
Not a fit: Patients with prior abdominal surgeries, severe fractures, or significant neurological or psychiatric issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel and effective treatment option for patients with chronic back pain who have not responded to previous interventions.
How similar studies have performed: Other studies have shown promising results with spinal cord stimulation and exercise in managing chronic pain, indicating that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Have a diagnostic of PSPS-T1/2 with leg pain and back pain, * Patients older than 18 years * 6 months with pain * Visual Analogue Scale score \>7 * Spanish native language Exclusion Criteria: * Previous surgeries in abdominal area * Pregnant or lactating * Severe fractures or pathologies * Spine structural deformity * Neurologic or psychiatric issues.
Where this trial is running
Torrent, Valencia
- Juan Vicente-Mampel — Torrent, Valencia, Spain (Recruiting)
Study contacts
- Principal investigator: Francisco J Sanchez Montero — Complejo Asistencial Universitario de Salamanca. Unidad del Dolor
- Study coordinator: Juan Vicente Mampel, PhD
- Email: juan.vicente@ucv.es
- Phone: 674177877
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.