Managing Chronic Spinal Pain With Exercise and Neuromodulation

Официальное название

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)

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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 abdo
• Процедура 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, spe
• Процедура 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.

Первичные конечные точки

• The Oswestry Disability Index (ODI) [Срок оценки: Pre-treatment, 1-month follow-up, 3-month follow-up, 6-month follow-up]

Вторичные конечные точки (7)

• Tampa Scale 11 (TSK-11) [Срок оценки: Pre-treatment, 1-month follow-up, 3-month follow-up, 6-month follow-up]
• Catastrophizing [Срок оценки: Pre-treatment, 1-month follow-up, 3-month follow-up, 6-month follow-up]
• SF-12 [Срок оценки: Pre-treatment, 1-month follow-up, 3-month follow-up, 6-month follow-up]
• Visual Analogue Scale (VAS) [Срок оценки: Pre-treatment, 1-month follow-up, 3-month follow-up, 6-month follow-up]
• DN4 Questionnaire [Срок оценки: Pre-treatment, 1-month follow-up, 3-month follow-up, 6-month follow-up]
• Beck Depression Inventory [Срок оценки: Pre-treatment, 1-month follow-up, 3-month follow-up, 6-month follow-up]
• The Chronic Pain Self-Efficacy Questionnaire by Martín-Aragón [Срок оценки: Pre-treatment, 1-month follow-up, 3-month follow-up, 6-month follow-up]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Catholic Univerity of Valencia — Valencia

Публикации

• 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
• 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
• 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

Идентификаторы

NCT: NCT06969456 · UCV/2024-2025/031

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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