跳至主要内容
临床试验/NCT06969456
NCT06969456招募中不适用

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)

Fundación Universidad Católica de Valencia San Vicente Mártir1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2025年10月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
42
试验地点
1
主要终点
The Oswestry Disability Index (ODI)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

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

研究组 & 干预措施

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.

干预措施: Exercise (Procedure)

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.

干预措施: TDCS (Procedure)

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 .

干预措施: Exercise (Procedure)

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 .

干预措施: ShamTDCS (Procedure)

结局指标

主要结局

The Oswestry Disability Index (ODI)

时间窗: Pre-treatment, 1-month follow-up, 3-month follow-up, 6-month follow-up

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.

次要结局

  • 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)
  • Beck Depression Inventory(Pre-treatment, 1-month follow-up, 3-month follow-up, 6-month follow-up)
  • The Chronic Pain Self-Efficacy Questionnaire by Martín-Aragón(Pre-treatment, 1-month follow-up, 3-month follow-up, 6-month follow-up)

研究者

发起方
Fundación Universidad Católica de Valencia San Vicente Mártir
申办方类型
Other
责任方
Sponsor

研究点 (1)

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