Spinal Cord Stimulation Combined With Exercise in Persistent Spinal Pain Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-09

Study Completion Date

2026-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Managing Chronic Spinal Pain With Exercise and Neuromodulation

NCT06969456

Spinal Pain Syndrome Chronic Pain (Back / Neck)

RECRUITING NA

Craniosacral Therapy to Treat Chronic Low Back Pain

NCT01822236

Low Back Pain

COMPLETED NA

Transcranial Direct Current Stimulation (tDCS) Combined With Aerobic Exercise in Chronic Nonspecific Low Back Pain (LBP)

NCT05830851

Low Back Pain Chronic Low-back Pain

UNKNOWN NA

Combining Mechanisms for Better Outcomes (COMBO)

NCT03689920

Chronic Pain Back Pain

COMPLETED NA

Effectiveness of Diaphragm Treatment in Reducing Low Back Pain

NCT06069388

Low Back Pain, Mechanical

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Failed Back Surgery Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

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

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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. 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.

Group Type ACTIVE_COMPARATOR

Spinal Cord Stimulation

Intervention Type 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+Exercise

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.

Group Type EXPERIMENTAL

Exercise

Intervention Type 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

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No