Spinal Cord Stimulation Combined With Exercise in Persistent Spinal Pain Syndrome

Fundación Universidad Católica de Valencia San Vicente Mártir

Status: Enrolling

Conditions: Failed Back Surgery Syndrome

Treatments: Procedure: Exercise; Procedure: Spinal Cord Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06272539

2023 101435

Details and patient eligibility

About

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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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36 participants in 2 patient groups

Spinal Cord Stimulation

Active Comparator group

Description:

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.

Treatment:

Procedure: Spinal Cord Stimulation

Spinal Cord Stimulation+Exercise

Experimental group

Description:

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.

Treatment:

Procedure: Spinal Cord Stimulation

Procedure: Exercise