RecruitingNot ApplicableNCT06969456

Managing Chronic Spinal Pain With Exercise and Neuromodulation

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)


Sponsor

Fundación Universidad Católica de Valencia San Vicente Mártir

Enrollment

42 participants

Start Date

Oct 27, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria5

  • Have a diagnostic of PSPS-T2
  • Neuropathic pain (DNA4 ≥ 4)
  • Patients older than 18 years
  • ≥ 6 months with pain
  • VAS score ≥ 7

Exclusion Criteria5

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

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Interventions

PROCEDUREExercise

Structured treatment sessions, each lasting 30 minutes, will be organized into distinct blocks. In the initial phases, participants will engage in exercises emphasizing core stabilization and general strength training, with a particular focus on forced expiration as a technique to ensure the proper activation of the transversus abdominis muscle. This methodology aims to mitigate adverse effects associated with increased intra-abdominal pressure. To optimize the activation of the transversus abdominis, patients will be instructed to perform a forced expiration while concurrently drawing the navel inward and upward toward the spine, maintaining the lumbar spine in a neutral position. During the initial exercises, ultrasound imaging of the transversus abdominis will be employed as visual feedback, enabling patients to observe muscle thickening during forced expiration. This visual feedback enhances the accuracy of muscle activation and exercise technique. Exercises will be progressively s

PROCEDURETDCS

The transcranial direct current stimulation (tDCS) protocol will involve the application of a continuous current for 30 minutes, with an intensity ranging from 1 to 1.5 mA, targeting the left dorsolateral prefrontal cortex (DLPFC) during each session. Two saline-soaked sponge electrodes, each measuring 35 cm², will be employed to ensure adequate skin contact. In accordance with the international 10-20 EEG electrode placement system, the anodal electrode will be positioned at the F3 location, specifically targeting the left DLPFC. The reference electrode will be placed above the left eye to facilitate efficient current flow through the prefrontal region of the brain. To enhance both safety and efficacy, a 30-second ramp-up and ramp-down period will be incorporated at the commencement and conclusion of the stimulation session. This methodology is intended to minimize potential adverse effects and ensure an optimal stimulation experience for participants.

PROCEDUREShamTDCS

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.


Locations(1)

Catholic Univerity of Valencia

Valencia, Valencia, Spain

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NCT06969456


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