protocolSection identificationModule nctId: NCT06272539, orgStudyIdInfo id: 2023 101435, briefTitle: Spinal Cord Stimulation Combined With Exercise in Persistent Spinal Pain Syndrome, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-01-01, completionDateStruct date: 2026-01-01, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Fundación Universidad Católica de Valencia San Vicente Mártir, class: OTHER, collaborators name: Instituto de Investigación Biomédica de Salamanca, descriptionModule 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., conditionsModule conditions: Failed Back Surgery Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo 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, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: Exercise, interventions name: Spinal Cord Stimulation, outcomesModule primaryOutcomes measure: Disability (Oswestry Disability Index), primaryOutcomes measure: Perception Pain (Visual analogue scale), secondaryOutcomes measure: Quality of life (Short Form 36 Health Survey, SF36), secondaryOutcomes measure: Patient's satisfaction, secondaryOutcomes measure: Strength (Sorensen Test), secondaryOutcomes measure: Fear of Movement (Tampa Scale of Kinesiophobia, TSK), secondaryOutcomes measure: Individual's belief in their own ability to successfully execute tasks (Self-efficacy Scale), secondaryOutcomes measure: Catastrophic thinking (Pain Catastrophizing Scale), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Juan Vicente-Mampel, city: Torrent, state: Valencia, zip: 46900, country: Spain, geoPoint lat: 39.43705, lon: -0.46546, hasResults: False