Managing Chronic Spinal Pain With Exercise and Neuromodulation

NCT06969456 | Recruiting DMC

• 1 other identifier: UCV/2024-2025/031
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spinal Pain Syndrome; Chronic Pain (Back / Neck)

Keywords

Chronic spinal pain; neuromodulation; motor control exercises; biopsychosocial approach; disability; quality of life

Outcome Measures

Primary Outcomes (1)

• The Oswestry Disability Index (ODI)

  The Oswestry Disability Index (ODI) is the most widely used and validated assessment tool for low back pain. It is a self-administered questionnaire divided into ten sections designed to evaluate limitations in activities of daily living. Each section is scored on a scale from 0 to 5, with 5 indicating the highest level of disability. The total index score is calculated by dividing the sum of the section scores by the maximum possible score and multiplying by 100, yielding a percentage. The ODI has been validated in Spanish, demonstrating high sensitivity and specificity for functional assessment.

  Pre-treatment, 1-month follow-up, 3-month follow-up, 6-month follow-up

Secondary Outcomes (7)

• Tampa Scale 11 (TSK-11)

  Pre-treatment, 1-month follow-up, 3-month follow-up, 6-month follow-up

• Catastrophizing

  Pre-treatment, 1-month follow-up, 3-month follow-up, 6-month follow-up

• SF-12

  Pre-treatment, 1-month follow-up, 3-month follow-up, 6-month follow-up

• Visual Analogue Scale (VAS)

  Pre-treatment, 1-month follow-up, 3-month follow-up, 6-month follow-up

• DN4 Questionnaire

  Pre-treatment, 1-month follow-up, 3-month follow-up, 6-month follow-up

Study Arms (2)

Exercise + TDCS

EXPERIMENTAL

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.

Procedure: Exercise; Procedure: TDCS

Exercise + ShamTDCS

PLACEBO COMPARATOR

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 .

Procedure: Exercise; Procedure: ShamTDCS

Interventions

Exercise PROCEDURE

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

Exercise + ShamTDCS; Exercise + TDCS

TDCS PROCEDURE

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.

Exercise + TDCS

ShamTDCS PROCEDURE

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.

Exercise + ShamTDCS

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fundación Universidad Católica de Valencia San Vicente Mártir: lead

Study Sites (1)

Catholic Univerity of Valencia

Valencia, Valencia, 46001, Spain

RECRUITING

Related Publications (3)

• Sebaaly A, Lahoud MJ, Rizkallah M, Kreichati G, Kharrat K. Etiology, Evaluation, and Treatment of Failed Back Surgery Syndrome. Asian Spine J. 2018 Jun;12(3):574-585. doi: 10.4184/asj.2018.12.3.574. Epub 2018 Jun 4.

  PMID: 29879788 BACKGROUND

• Bursali C, Ozkan FU, Kaysin MY, Dortcan N, Aktas I, Kulcu DG. Effectiveness of Repetitive Transcranial Magnetic Stimulation in Patients With Failed Back Surgery Syndrome: A Double-Blind Randomized Placebo-Controlled Study. Pain Physician. 2021 Jan;24(1):E23-E30.

  PMID: 33400434 BACKGROUND

• Huertas-Ramirez B, Jaenada-Carrilero E, Belda-Antoli M, Leal-Garcia J, Alonso-Martin M, Mahiques-Sanchis A, Benlloch-Garcia A, Falaguera-Vera F, Vicente-Mampel J. Patient-Centered Chronic Spinal Pain Management Using Exercise and Neuromodulation: Study Protocol for a Randomized Controlled Trial. Healthcare (Basel). 2025 Nov 24;13(23):3032. doi: 10.3390/healthcare13233032.

  PMID: 41373250 DERIVED

MeSH Terms

Conditions

Chronic Pain

Interventions

Exercise; Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Central Study Contacts

Borja Huertas Ramirez Juan Vicente Mampel, Phd Studente

CONTACT

+34 684098665; borja.huertas@mail.ucv.es

Juan Vicente Mampel Juan vicente, PHD

CONTACT

+34 674177877; juan.vicente@ucv.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The guidelines and treatment protocols will be overseen by the principal investigator and a team of specialist physiotherapists, each with over 10 years of experience in the management of neuromodulation and exercise therapy for chronic lumbar pain. Stratified randomization will be implemented to ensure that the compared groups are balanced with respect to the level of neuropathic pain. Prior to the randomization process, the baseline level of neuropathic pain shall be identified. Two strata of participants will be established within their own group. Subgroup 1 will include those participants who are on the DN4 scale of a value of 4,5,6 or 7. In subgroup 2 will be patients who are on the DN4 scale of a value of 8,9 or 10.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: May 13, 2025
• Study Start: October 27, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: December 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)