Spinal Cord Stimulation Combined With Exercise in Persistent Spinal Pain Syndrome

Failed Back Surgery Syndrome Clinical Trial

Official title:

Spinal Cord Stimulation Combined With Exercise in Patients Diagnosed With Persistent Spinal Pain Syndrome. A Randomized Control Trial (RCT)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06272539
• Other study ID #: 2023 101435
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: January 1, 2026

Study information

• Verified date: February 2024
• Source: Fundación Universidad Católica de Valencia San Vicente Mártir
• Contact: Juan Vicente Mampel, PhD
• Phone: 674177877
• Email: juan.vicente[@]ucv.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Failed Back Surgery Syndrome
• Syndrome

Intervention

Procedure:
• Exercise
The exercise 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.
• Spinal Cord Stimulation
Spinal cord stimulation (SCS) involves an implantable pulse generator with the potential for enhanced therapeutic success through stimulation algorithms and parameters (28). Spinal cord stimulation (SCS) targeting distal areas, such as the dorsal root ganglion, may offer greater anatomical specificity in therapy

Locations

Country	Name	City	State
Spain	Juan Vicente-Mampel	Torrent	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
Fundación Universidad Católica de Valencia San Vicente Mártir	Instituto de Investigación Biomédica de Salamanca

Country where clinical trial is conducted

Spain, 

References & Publications (5)

Baber Z, Erdek MA. Failed back surgery syndrome: current perspectives. J Pain Res. 2016 Nov 7;9:979-987. doi: 10.2147/JPR.S92776. eCollection 2016. — View Citation

Cho JH, Lee JH, Song KS, Hong JY. Neuropathic Pain after Spinal Surgery. Asian Spine J. 2017 Aug;11(4):642-652. doi: 10.4184/asj.2017.11.4.642. Epub 2017 Aug 7. — View Citation

Christelis N, Simpson B, Russo M, Stanton-Hicks M, Barolat G, Thomson S, Schug S, Baron R, Buchser E, Carr DB, Deer TR, Dones I, Eldabe S, Gallagher R, Huygen F, Kloth D, Levy R, North R, Perruchoud C, Petersen E, Rigoard P, Slavin K, Turk D, Wetzel T, Loeser J. Persistent Spinal Pain Syndrome: A Proposal for Failed Back Surgery Syndrome and ICD-11. Pain Med. 2021 Apr 20;22(4):807-818. doi: 10.1093/pm/pnab015. — View Citation

Nijs J, Meeus M, Cagnie B, Roussel NA, Dolphens M, Van Oosterwijck J, Danneels L. A modern neuroscience approach to chronic spinal pain: combining pain neuroscience education with cognition-targeted motor control training. Phys Ther. 2014 May;94(5):730-8. doi: 10.2522/ptj.20130258. Epub 2014 Jan 30. — View Citation

Othman R, Dassanayake S, Jayakaran P, Tumilty S, Swain N, Mani R. Relationships Between Psychological, Social, Physical Activity, and Sleep Measures and Somatosensory Function in Individuals With Spinal Pain: A Systematic Review and Meta-analysis. Clin J Pain. 2020 Feb;36(2):124-134. doi: 10.1097/AJP.0000000000000775. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disability (Oswestry Disability Index)	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	at baseline, Post3weeks, Post2months, Post6months
Primary	Perception Pain (Visual analogue scale)	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	at baseline, Post3weeks, Post2months, Post6months
Secondary	Quality of life (Short Form 36 Health Survey, SF36)	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.	at baseline, Post3weeks, Post2months, Post6months
Secondary	Patient's satisfaction	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.	at baseline, Post3weeks, Post2months, Post6months
Secondary	Strength (Sorensen Test)	Sorensen test it measures the amount of strength and resistance of the back extensors	at baseline, Post3weeks, Post2months, Post6months
Secondary	Fear of Movement (Tampa Scale of Kinesiophobia, TSK)	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.	at baseline, Post3weeks, Post2months, Post6months
Secondary	Individual's belief in their own ability to successfully execute tasks (Self-efficacy Scale)	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.	at baseline, Post3weeks, Post2months, Post6months
Secondary	Catastrophic thinking (Pain Catastrophizing Scale)	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	at baseline, Post3weeks, Post2months, Post6months