Managing Chronic Spinal Pain With Exercise and Neuromodulation

NCT ID: NCT06969456

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-27
• Study Completion Date: 2027-01-01

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.

Detailed Description

Chronic spinal pain, characterized by persistent discomfort, frequently lacks discernible structural abnormalities and represents a complex, multifactorial condition. This disorder, manifested by symptoms such as lumbar pain, severe disability, diminished quality of life, and elevated unemployment rates, poses a substantial challenge for treatment. Therapeutic strategies encompass surgical intervention, pharmacological treatments, and conservative methods emphasizing exercise and behavioral therapies. However, the heterogeneous nature of these patients complicates both diagnosis and the assessment of clinical outcomes. Among the diagnostic terms for chronic spinal pain, Persistent Spinal Pain Syndrome (PSPS), particularly PSPS-T2, has garnered attention due to its high prevalence and recurrence in clinical pain management. The complexity of PSPS necessitates a multidisciplinary approach, with a recent shift towards patient-centered care, which has proven effective in reducing both direct and indirect costs associated with these patients. PSPS-T2 has the potential to affect a significant portion of the population, influenced by biological, psychological, and social components. The condition's neuroplasticity involves both peripheral and central mechanisms, which alter the central nervous system's state, contributing to the persistence of pain. Recent advancements in neuromodulatory strategies, such as non-invasive brain stimulation (NIBS), have shown promise in treating spinal pain, particularly in cases associated with neuropathic pain and comorbidities like depression. Additionally, motor control exercises and spinal stabilization have demonstrated efficacy in reducing pain and disability, supporting self-management and improving biopsychosocial beliefs. Combining exercise with NIBS may enhance outcomes, offering an alternative for patients resistant to conventional treatments. This study aims to evaluate the effects of combining neuromodulation (tDCS) with motor control exercises in PSPS-T2 patients. Specifically, we hypothesize that this combined intervention will lead to improvements in functionality, pain reduction, and psychological outcomes, benefiting patients who have not responded to other treatments. A randomized controlled trial (RCT) will be conducted with two groups: an experimental group receiving both tDCS and exercise, and a control group receiving only exercise. The primary objective is to assess baseline characteristics and the effects of the intervention on functionality, pain, psychosocial variables, depression, and quality of life. Secondary objectives include identifying clinical profiles and evaluating the impact of gender, age, and BMI on treatment outcomes. This study is expected to provide valuable insights into the efficacy of combined neuromodulation and exercise for managing PSPS-T2, with potential applications in clinical practice.

Conditions

Spinal Pain Syndrome; Chronic Pain (Back / Neck)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: 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

TDCS

Intervention Type: 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 + 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 .

Group Type: PLACEBO_COMPARATOR

Exercise

Intervention Type: 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

ShamTDCS

Intervention Type: 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.

Interventions

Exercise

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

Intervention Type: PROCEDURE

TDCS

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundación Universidad Católica de Valencia San Vicente Mártir

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Catholic Univerity of Valencia

Valencia, Valencia, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Borja Huertas Ramirez Juan Vicente Mampel, Phd Studente

Role: CONTACT

borja.huertas@mail.ucv.es

+34 684098665

Juan Vicente Mampel Juan vicente, PHD

Role: CONTACT

juan.vicente@ucv.es

+34 674177877

Facility Contacts

Borja Huertas Ramirez, PhD Student

Role: primary

juan.vicente@ucv.es

+34 684098665

Juan V-M Vicente Mampel, PhD

Role: backup

juan.vicente@ucv.es

+34 674177877

References

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.

Reference Type: BACKGROUND

PMID: 29879788 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33400434 (View on PubMed)

Other Identifiers

UCV/2024-2025/031

Identifier Type: -

Identifier Source: org_study_id