Patient-Centered Chronic Spinal Pain Management Using Exercise and Neuromodulation: Study Protocol for a Randomized Controlled Trial.
Borja Huertas-Ramirez, Eloy Jaenada-Carrilero, Mariola Belda-Antoli...
https://pubmed.ncbi.nlm.nih.gov/41373250/Actively Recruiting
Led by Fundación Universidad Católica de Valencia San Vicente Mártir · Updated on 2025-12-08
42
Participants Needed
1
Research Sites
17 weeks
Total Duration
Chronic spinal pain, particularly Persistent Spinal Pain Syndrome Type 2 PSPS-T2, is a complex condition often without clear structural causes and includes symptoms like severe disability and reduced quality of life. This trial evaluates the combination of transcranial direct current stimulation tDCS and motor control exercises versus exercises alone for patients with PSPS-T2 who have not improved with usual treatments. The goal is to improve function, reduce pain, and enhance psychological health through a patient-focused approach. Participants will be randomly assigned to two groups one receiving 20 minutes of tDCS at 1.5 mA targeting the left dorsolateral prefrontal cortex alongside motor control exercises, and a control group receiving only the exercises with a brief sham tDCS to mimic sensations. The exercise program includes core stabilization and strength training with specific breathing techniques and ultrasound feedback for muscle activation. The tDCS uses saline-soaked sponge electrodes placed according to EEG standards, with ramp-up and ramp-down periods to optimize safety and comfort. Throughout the study, participants will be assessed before treatment and at 1, 3, and 6 months after starting. Measurements include the Oswestry Disability Index for function, pain scales, psychological questionnaires, and assessments of neuropathic pain and depression. The trial tracks outcomes related to pain, disability, and mental health, aiming to provide new insights into managing PSPS-T2 with combined neuromodulation and exercise. The total duration includes baseline and multiple follow-up visits to evaluate lasting effects.
CONDITIONS
Managing Chronic Spinal Pain With Exercise and Neuromodulation
B
Borja Huertas Ramirez Juan Vicente Mampel, Phd Studente
J
Juan Vicente Mampel Juan vicente, PHD
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Fundación Universidad Católica de Valencia San Vicente Mártir
Lead Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration not explicitly stated
Participants receive motor control exercises focusing on core stabilization and general strength training, with visual feedback to optimize technique. The experimental group also receives non-invasive brain stimulation (tDCS) targeting the left dorsolateral prefrontal cortex during exercise sessions, while the control group receives a sham stimulation.
Sessions with tDCS or sham and exercise occur regularly; visit frequency not specifically defined
Duration - 6 months after treatment
Participants are assessed on functionality, pain, psychosocial variables, depression, and quality of life at multiple time points after treatment completion to evaluate outcomes.
Visits at 1 month, 3 months, and 6 months post-treatment
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Lead Sponsor