NCT06272539 Spinal Cord Stimulation Combined With Exercise in Persistent Spinal Pain Syndrome
| NCT ID | NCT06272539 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fundación Universidad Católica de Valencia San Vicente Mártir |
| Condition | Failed Back Surgery Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2024-04-09 |
| Primary Completion | 2026-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 36 participants in total. It began in 2024-04-09 with a primary completion date of 2026-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Introduction. At the neurophysiological level, it is possible to observe an increase in the central processing of pain in patients diagnosed with persistent Spinal Pain Syndrome (PSPS-T1/2), potentially stemming from dysfunctions in the endogenous facilitation and inhibition of pain. Administration of high doses of spinal cord stimulation to individuals with PSPS-T1/2 may induce supraspinal descending activation. Similarly, exercise is recognized as a fundamental aspect of spinal pain management. Studies have demonstrated its impact on neurophysiological factors, including the release of spinal and supraspinal beta-endorphins, which activate μ-opioid receptors. Therefore, the purpose of this study will be to examine the effect of SCS in combination with lumbo-pelvic stability core training on perceived low back pain, quality of life and disability in failed back surgery syndrome (FBSS) patients. Methods/Materials. A double-blind randomized clinical trial (RCT) has been designed. All participants will be randomized from a pre-set sequence. The intervention design has been elaborated from the CONSORT guidelines. This study protocol has been approved by the Ethics Committee in research of Salamanca Health Area (protocol number PI 2023 101435 in (24/01/2024) in accordance with the ethical guidelines of the Helsinki declaration. Sample size was calculated using G Power® Sample size software (University of Düsseldorf). The calculation was based on a moderate effect size of 0.4 (partial η2 = 0.40, α = .05, power = 0.90), resulting in a total of 28 patients. Assuming a 30% dropout rate, 36 participants will be recruited in total. Two sessions per week will be scheduled for 8 weeks with a total of 16 sessions. Each work session will have a duration of 60 minutes. The exercise will be adapted according to the phases based on the results already published, limiting in each phase the degrees of flexion and extension of the spine in order to avoid the risk of electrode migration. Primary outcomes will be functionality, satisfaction, strength, psychosocial variables, quality of life and pain perception.
Eligibility 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.
Contact & Investigator
Francisco J Sanchez Montero
PRINCIPAL INVESTIGATOR
Complejo Asistencial Universitario de Salamanca. Unidad del Dolor
Frequently Asked Questions
Who can join the NCT06272539 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Failed Back Surgery Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06272539 currently recruiting?
Yes, NCT06272539 is actively recruiting participants. Contact the research team at juan.vicente@ucv.es for enrollment information.
Where is the NCT06272539 trial being conducted?
This trial is being conducted at Torrent, Spain.
Who is sponsoring the NCT06272539 clinical trial?
NCT06272539 is sponsored by Fundación Universidad Católica de Valencia San Vicente Mártir. The principal investigator is Francisco J Sanchez Montero at Complejo Asistencial Universitario de Salamanca. Unidad del Dolor. The trial plans to enroll 36 participants.