nctId: NCT06272539 id: 2023 101435 briefTitle: Spinal Cord Stimulation Combined With Exercise in Persistent Spinal Pain Syndrome overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-01-01 date: 2026-01-01 date: 2024-02-22 date: 2024-02-28 name: Fundación Universidad Católica de Valencia San Vicente Mártir class: OTHER name: Instituto de Investigación Biomédica de Salamanca briefSummary: 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. conditions: Failed Back Surgery Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: By doing so, we will aim to eliminate or reduce potential biases due to the order of patients and any transference effects that might occur if one profile clinical patients will influence the performance in several evaluations. Specifically, each patient will complete a sequence of allocation in the order of A, B, B, A, where 'A' represents SCS treatment isolated and 'B' denotes combined treatment. Subsequently, the average of the two 'A' conditions was calculated, and the same process was applied for the 'B' conditions whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 36 type: ESTIMATED name: Exercise name: Spinal Cord Stimulation measure: Disability (Oswestry Disability Index) measure: Perception Pain (Visual analogue scale) measure: Quality of life (Short Form 36 Health Survey, SF36) measure: Patient's satisfaction measure: Strength (Sorensen Test) measure: Fear of Movement (Tampa Scale of Kinesiophobia, TSK) measure: Individual's belief in their own ability to successfully execute tasks (Self-efficacy Scale) measure: Catastrophic thinking (Pain Catastrophizing Scale) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Juan Vicente-Mampel city: Torrent state: Valencia zip: 46900 country: Spain lat: 39.43705 lon: -0.46546 hasResults: False