Clinical trial NCT06969456: Managing Chronic Spinal Pain With Exercise and Neuromodulation
Official title: 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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Spinal Pain Syndrome
Chronic Pain (Back / Neck)
Keywords: Chronic spinal pain
neuromodulation
motor control exercises
biopsychosocial approach
disability
quality of life
Lead sponsor: Fundación Universidad Católica de Valencia San Vicente Mártir
Sponsor class: OTHER
First posted: 2025-05-13
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The Oswestry Disability Index (ODI)
timeFrame: Pre-treatment, 1-month follow-up, 3-month follow-up, 6-month follow-up
Secondary outcomes:
measure: Tampa Scale 11 (TSK-11)
timeFrame: Pre-treatment, 1-month follow-up, 3-month follow-up, 6-month follow-up
measure: Catastrophizing
timeFrame: Pre-treatment, 1-month follow-up, 3-month follow-up, 6-month follow-up
measure: SF-12
timeFrame: Pre-treatment, 1-month follow-up, 3-month follow-up, 6-month follow-up
measure: Visual Analogue Scale (VAS)
timeFrame: Pre-treatment, 1-month follow-up, 3-month follow-up, 6-month follow-up
measure: DN4 Questionnaire
timeFrame: Pre-treatment, 1-month follow-up, 3-month follow-up, 6-month follow-up
measure: Beck Depression Inventory
timeFrame: Pre-treatment, 1-month follow-up, 3-month follow-up, 6-month follow-up
measure: The Chronic Pain Self-Efficacy Questionnaire by Martín-Aragón
timeFrame: Pre-treatment, 1-month follow-up, 3-month follow-up, 6-month follow-up
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.