Spinal Cord Stimulation Combined With Exercise in Persistent Spinal Pain Syndrome

Not Applicable

Recruiting

• Conditions: Failed Back Surgery Syndrome

• Registration Number: NCT06272539
• Lead Sponsor: Fundación Universidad Católica de Valencia San Vicente Mártir

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-15
• Study First Submitted QC: 2024-02-21
• Study First Posted: 2024-02-22
• Study Start: 2024-04-09
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-26
• Last Update Posted: 2024-08-28
• Primary Completion: 2026-01-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Perception Pain (Visual analogue scale)	at baseline, Post3weeks, Post2months, Post6months	This scale is an efficient tool to quantify in a subjective and selective way this range in which 0 is considered a total absence of pain and 10 the worst pain imaginable
Disability (Oswestry Disability Index)	at baseline, Post3weeks, Post2months, Post6months	The Oswestry Disability Index (ODI) is the most used and validated assessment test for lumbar pain. Is a self-assessment test divided in ten sections designed to assess the limitations in daily life

Secondary Outcome Measures

Name	Time	Method
Fear of Movement (Tampa Scale of Kinesiophobia, TSK)	at baseline, Post3weeks, Post2months, Post6months	The Tampa Scale of Kinesiophobia (TSK) was used to measure fear of movement or reinjury. Scores on the TSK are calculated by summing responses to individual items, with higher scores indicating greater levels of kinesiophobia. The scale has been validated and widely used in research and clinical settings to assess and monitor fear of movement in individuals with chronic pain conditions, musculoskeletal injuries, and other conditions where fear of movement may impact rehabilitation or daily functioning.
Individual's belief in their own ability to successfully execute tasks (Self-efficacy Scale)	at baseline, Post3weeks, Post2months, Post6months	The Self-Efficacy Scale is a tool used to measure an individual's belief in their own ability to successfully execute tasks and achieve goals in specific situations.; The scale typically consists of items that assess an individual's perceived self-efficacy in various domains or activities, such as academic performance, athletic ability, social interactions, or coping with challenges. Respondents rate their confidence levels on a Likert scale, indicating the extent to which they believe they can successfully perform tasks or overcome obstacles.; Scores on the Self-Efficacy Scale are calculated by summing responses to individual items, with higher scores indicating greater perceived self-efficacy in the specified domains.
Quality of life (Short Form 36 Health Survey, SF36)	at baseline, Post3weeks, Post2months, Post6months	The measures the quality of life and comprises several dimensions: (a) physical functioning, (b) role physical, (c) role emotional, (d) social functioning, (e) bodily pain and (f) vitality. Scores for each component summary are calculated based on responses to the twelve items, with higher scores indicating better health-related quality of life.
Strength (Sorensen Test)	at baseline, Post3weeks, Post2months, Post6months	Sorensen test it measures the amount of strength and resistance of the back extensors
Catastrophic thinking (Pain Catastrophizing Scale)	at baseline, Post3weeks, Post2months, Post6months	The Pain Catastrophizing Scale (PCS), a self-administered questionnaire (13 items on a Likert-type scale from 0 to 4) was used in this study to assess the level of catastrophizing in the presence of pain
Patient's satisfaction	at baseline, Post3weeks, Post2months, Post6months	There are already published studies about diagnosed patients that evaluate their satisfaction using a numeric scale of 11 (-5 to 5) (37,38). High scores show the patient's satisfaction with the treatment.

Trial Locations

Locations (1)

Juan Vicente-Mampel; 🇪🇸 Torrent, Valencia, Spain