Exercise combined with noninvasive brain stimulation for chronic spinal pain
Patient-centered Management of Chronic Spinal Pain by Addressing the Peripheral and Central Component With Exercise and Non-invasive Neuromodulation: A Randomized Control Trial (RCT)
NA · Fundación Universidad Católica de Valencia San Vicente Mártir · NCT06969456
This project will see if adding a mild form of brain stimulation (tDCS) to motor control exercises helps adults with persistent spinal pain who haven't improved with standard treatments.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Fundación Universidad Católica de Valencia San Vicente Mártir (other) |
| Locations | 1 site (Valencia, Valencia) |
| Trial ID | NCT06969456 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial compares motor control exercise plus transcranial direct current stimulation (tDCS) to motor control exercise with sham stimulation in adults with Persistent Spinal Pain Syndrome Type 2 (PSPS-T2). Participants with neuropathic features and high pain scores will be randomized to receive a course of supervised exercises together with either active tDCS or sham tDCS. Primary outcomes include pain intensity, physical function, and psychological well-being measured during treatment and at follow-up. The trial tests whether combining neuromodulation with a biopsychosocial exercise program produces greater and longer-lasting benefits than exercise alone.
Who should consider this trial
Good fit: Adults (≥18 years) diagnosed with PSPS-T2 who have had at least six months of high-intensity pain (VAS ≥7) with neuropathic features (DN4 ≥4) and who have not improved with standard treatments.
Not a fit: Patients with structural spine deformities, recent or planned abdominal surgeries, pregnancy or lactation, severe fractures or other major pathologies, or significant neurologic/psychiatric disorders are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the approach could reduce pain and disability and improve quality of life without adding invasive procedures or long-term medications.
How similar studies have performed: Noninvasive brain stimulation like tDCS has shown modest benefits in some chronic pain studies, but combining tDCS with targeted motor-control exercise for PSPS-T2 is relatively novel and evidence remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Have a diagnostic of PSPS-T2 * Neuropathic pain (DNA4 ≥ 4) * Patients older than 18 years * ≥ 6 months with pain * VAS score ≥ 7 Exclusion Criteria: * Previous or programmed surgeries in abdominal area * Pregnant or lactating * Severe fractures or pathologies * Spine structural deformity * Neurologic or psychiatric issues
Where this trial is running
Valencia, Valencia
- Catholic Univerity of Valencia — Valencia, Valencia, Spain (RECRUITING)
Study contacts
- Study coordinator: Borja Huertas Ramirez Juan Vicente Mampel, Phd Studente
- Email: borja.huertas@mail.ucv.es
- Phone: +34 684098665
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.
Conditions: Spinal Pain Syndrome, Chronic Pain, Chronic spinal pain, neuromodulation, motor control exercises, biopsychosocial approach, disability, quality of life