Spinal Cord Stimulation Combined With Exercise in Persistent Spinal Pain Syndrome

NCT06272539 | Recruiting

• 1 other identifier: 2023 101435
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Failed Back Surgery Syndrome

Keywords

Spinal Cord Stimulation; Exercise

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (6)

• Quality of life (Short Form 36 Health Survey, SF36)

  at baseline, Post3weeks, Post2months, Post6months

• Patient's satisfaction

  at baseline, Post3weeks, Post2months, Post6months

• Strength (Sorensen Test)

  at baseline, Post3weeks, Post2months, Post6months

• Fear of Movement (Tampa Scale of Kinesiophobia, TSK)

  at baseline, Post3weeks, Post2months, Post6months

• Individual's belief in their own ability to successfully execute tasks (Self-efficacy Scale)

  at baseline, Post3weeks, Post2months, Post6months

Study Arms (2)

Spinal Cord Stimulation

ACTIVE COMPARATOR

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. Subthreshold stimulation, utilizing high-frequency or burst energy delivery, has the potential to eliminate noxious and off-target paresthesiae. Recent studies have demonstrated that subthreshold stimulation at high frequencies and/or utilizing different stimulation paradigms can provide equal or even superior pain relief compared to standard SCS (29). The procedure entails the placement of two octapolar electrodes inserted through the epidural space, positioned beneath the dorsal area posterior to the spinal cord's posterior horn.

Procedure: Spinal Cord Stimulation

Spinal Cord Stimulation+Exercise

EXPERIMENTAL

The experimental group will perform a Lumbo-pelvic core stability training program combined with motor control exercises through specific therapeutic exercises of the lumbopelvic centre combined with neurostimulation treatment. The exercise will be adapted according to the phases based on the results already published, the following intervention plan has been designed. Additionally, in each of the phases, the exercises were designed, limiting the degree of flexion/extension and lumbar traction of the exercises. Two weekly sessions will be scheduled during 8 weeks with a total of 24 sessions, each one of 60 minutes of duration. A certified physiotherapist in exercised with at least 10 years of clinical practice has applied treatment.

Procedure: Exercise; Procedure: Spinal Cord Stimulation

Interventions

Exercise PROCEDURE

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+Exercise

Spinal Cord Stimulation PROCEDURE

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

Spinal Cord Stimulation; Spinal Cord Stimulation+Exercise

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have a diagnostic of PSPS-T1/2 with leg pain and back pain,
• Patients older than 18 years
• months with pain
• Visual Analogue Scale score \>7
• Spanish native language

You may not qualify if:

• Previous surgeries in abdominal area
• Pregnant or lactating
• Severe fractures or pathologies
• Spine structural deformity
• Neurologic or psychiatric issues.

Sponsors & Collaborators

• Fundación Universidad Católica de Valencia San Vicente Mártir: lead
• Instituto de Investigación Biomédica de Salamanca: collaborator

Study Sites (1)

Juan Vicente-Mampel

Torrent, Valencia, 46900, Spain

RECRUITING

Related Publications (5)

• 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.

  PMID: 31764166 BACKGROUND

• 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.

  PMID: 27853391 BACKGROUND

• 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.

  PMID: 33779730 BACKGROUND

• 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.

  PMID: 24481595 BACKGROUND

• 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.

  PMID: 28874984 BACKGROUND

MeSH Terms

Conditions

Failed Back Surgery Syndrome; Motor Activity

Interventions

Exercise; Spinal Cord Stimulation

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Francisco J Sanchez Montero

  Complejo Asistencial Universitario de Salamanca. Unidad del Dolor

  PRINCIPAL INVESTIGATOR

• Juan Vicente-Mampel

  Catholic University of Valencia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan Vicente Mampel, PhD

CONTACT

674177877; juan.vicente@ucv.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: February 22, 2024
• Study Start: April 9, 2024
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)