Patient-centered Management of Chronic Spinal Pain by Addressing the Peripheral and Central Component With Exercise and Non-invasive Neuromodulation: A Randomized Control Trial (RCT)

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Chronic spinal pain is a multifaceted condition frequently characterized by an absence of discernible structural causes, manifesting in symptoms such as significant disability and diminished quality of life. Persistent Spinal Pain Syndrome Type 2 (PSPS-T2) represents a common variant, implicating both peripheral and central nervous system mechanisms. This study investigates the synergistic effects of transcranial direct current stimulation (tDCS) in conjunction with motor control exercises on PSPS-T2 patients who have not responded to conventional treatments. A randomized controlled trial (RCT) will be conducted to compare an experimental group (tDCS + exercise) with a control group (exercise only), with the objective of enhancing functionality, alleviating pain levels, and improving psychological well-being. The findings may contribute to the development of more effective, patient-centered treatment strategies.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Have a diagnostic of PSPS-T2

• Neuropathic pain (DNA4 ≥ 4)

• Patients older than 18 years

• ≥ 6 months with pain

• VAS score ≥ 7

Locations
Other Locations
Spain
Catholic Univerity of Valencia
RECRUITING
Valencia
Contact Information
Primary
Borja Huertas Ramirez Juan Vicente Mampel, Phd Studente
borja.huertas@mail.ucv.es
+34 684098665
Backup
Juan Vicente Mampel Juan vicente, PHD
juan.vicente@ucv.es
+34 674177877
Time Frame
Start Date: 2025-10-27
Estimated Completion Date: 2027-01-01
Participants
Target number of participants: 42
Treatments
Experimental: Exercise + TDCS
The transcranial direct current stimulation (tDCS) group will undergo 20 minutes of continuous stimulation at an intensity of 1.5 mA over the left dorsolateral prefrontal cortex (DLPFC) during each session. Two saline-soaked sponge electrodes, each measuring 35 cm², will be utilized. In accordance with the international 10-20 EEG electrode placement system, the anodal electrode will be positioned over F3 to specifically target the left DLPFC. The reference electrode will be placed over the left eye to ensure that the current traverses the prefrontal area. A 30-second ramp-up period will be implemented at the commencement of the tDCS stimulation, followed by a 30-second ramp-down period at its conclusion.
Placebo_comparator: Exercise + ShamTDCS
The device will be configured to produce an upward gradient for 30 seconds, identical to that used in the experimental group, followed by a downward gradient for another 30 seconds. Consequently, the control group will feel a similar tingling on their scalp as the experimental group. This stimulation will occur for a total of 60 seconds, which is insufficient to induce changes in cortical excitability. Studies have demonstrated that this approach effectively ensures patient blinding .
Related Therapeutic Areas
Sponsors
Leads: Fundación Universidad Católica de Valencia San Vicente Mártir

This content was sourced from clinicaltrials.gov