Combining Non-invasive Brain Stimulation and Physiotherapy to Improve the Management of Chronic Low Back Pain in Veterans
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Physical functioning (ODI)
研究概览
简要总结
Chronic low back pain (CLBP) is a major health challenge in Canada, leading to substantial disability and socioeconomic burden, particularly among Veterans. In military Veterans, LBP is the most common chronic pain condition. Conventional interventions have limited effectiveness. The refractoriness to interventions suggests that specific CLBP mechanisms may be missed by current treatments, prompting a shift towards psychologically informed approaches which aim to address emotional and cognitive factors alongside biomedical aspects. The integration of these concepts into physiotherapy is called psychologically informed physiotherapy (PiP). Despite promising results of PiP from randomized controlled trials, residual pain and disability often persist in Veterans. Non-invasive brain stimulation, such as repetitive transcranial magnetic stimulation (rTMS), may enhance the effectiveness of PiP by modulating cognition, emotion, and pain. This proposal seeks to determine whether non-invasive brain stimulation can enhance the effects of PiP.
详细描述
The study will compare the effects of (1) combining rTMS with PiP, (2) PiP alone (+sham rTMS), and (3) usual physiotherapy (UP) on physical functioning in Veterans suffering from CLBP and comorbid psychological factors associated with back pain. Participants will undergo an 8-week intervention program. Validated questionnaires will be used to measure outcomes at baseline, 2-, 8-, and 26-week follow-ups. The main objective is to determine if the combination of PiP and rTMS is superior to PiP and UP alone to improve physical functioning in Veterans suffering from CLBP and comorbid psychological factors.
The secondary objectives are to compare the effectiveness of these interventions on secondary outcomes, that are, pain intensity, quality of life, movement pain-related fear, pain catastrophizing, self-efficacy, depression symptoms, medication use and post-traumatic stress disorder symptoms.
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
- Double (Participant, Care Provider)
盲法说明
The masking depends on the intervention:
For rTMS, participants, treating physiotherapists and the statistician will be blinded to the group allocation. It is not possible to blind the rTMS technician because they need to choose the right TMS coil and muscle twitches in the face is elicited by the active rTMS.
For physiotherapy, it is only possible to blind the statistician.
Although the outcomes assessors are not blinded per se, the use of REDcap limits the possibility of bias related to outcomes assessor.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults between 18 and 65 years old
- •Military Veterans with non-specific chronic low back pain (> 3 months, > 50% of the days in the last 6 months)
- •High level of psychosocial factors, scoring ≥4 on the Start Back Screening Tool
- •Functional limitations, scoring ≥ 15% on the Oswestry Disability Index (ODI)
排除标准
- •Non-musculoskeletal conditions causing low back pain (e.g., neoplasia, fracture)
- •Diagnosis of drug or alcohol abuse
- •Change of drug dosage in the last month for the treatment of pain or mental health
- •Presenting with any specific rTMS-related exclusion criteria such as previous seizure/convulsion, cochlear implant, and pregnancy
研究组 & 干预措施
Usual physiotherapy
Participants will attend 6 sessions within 8 weeks (1session /week for 4 weeks, 1 session every 2 weeks between weeks 5-8). Each physiotherapy will last 30-45 min.
干预措施: Usual physiotherapy (Other)
Active rTMS + PiP
For weeks 1 and 2, participants will attend 5 brain stimulation sessions. During the first phase, the session will last 30-40 min (10-20 min of installation + 20 minutes of stimulation).
In the second phase (weeks 3-8), brain stimulation and physiotherapy will be delivered in 2 separate sessions during the same week for 6 weeks. Each brain stimulation session will last 30-40 min and each physiotherapy session will last 30-45 min. Overall, participants will receive 11 sessions of rTMS only and 6 PiP sessions.
干预措施: Active rTMS (Device)
Active rTMS + PiP
For weeks 1 and 2, participants will attend 5 brain stimulation sessions. During the first phase, the session will last 30-40 min (10-20 min of installation + 20 minutes of stimulation).
In the second phase (weeks 3-8), brain stimulation and physiotherapy will be delivered in 2 separate sessions during the same week for 6 weeks. Each brain stimulation session will last 30-40 min and each physiotherapy session will last 30-45 min. Overall, participants will receive 11 sessions of rTMS only and 6 PiP sessions.
干预措施: Psychologically-informed physiotherapy (PiP) (Other)
Sham rTMS + PiP
For weeks 1 and 2, participants will attend 5 sham brain stimulation sessions. During the first phase, the session will last 30-40 min (10-20 min of installation + 20 minutes of stimulation). In the second phase (weeks 3-8), brain stimulation and physiotherapy session will be delivered in 2 separate sessions during the same week for 6 weeks. Each sham brain stimulation session will last 30-40 min and each physiotherapy will last 30-45 min. Overall, participants will receive 11 sessions of sham rTMS only and 6 PiP sessions.
干预措施: Sham rTMS (Device)
Sham rTMS + PiP
For weeks 1 and 2, participants will attend 5 sham brain stimulation sessions. During the first phase, the session will last 30-40 min (10-20 min of installation + 20 minutes of stimulation). In the second phase (weeks 3-8), brain stimulation and physiotherapy session will be delivered in 2 separate sessions during the same week for 6 weeks. Each sham brain stimulation session will last 30-40 min and each physiotherapy will last 30-45 min. Overall, participants will receive 11 sessions of sham rTMS only and 6 PiP sessions.
干预措施: Psychologically-informed physiotherapy (PiP) (Other)
结局指标
主要结局
Physical functioning (ODI)
时间窗: Baseline, weeks 2, 8 and 26.
The Oswestry Disability Index (ODI) is a self-completed questionnaire on estimated disability including 10 questions rated on a 6-item scale, from 0 (no disability) to 5 points (maximal disability). The total score ranges from 0 (no disability) to 100% (maximal disability).
次要结局
- Pain intensity (NPRS)(Baseline, weeks 2, 8 and 26.)
- Quality of life (EQ-5D-5L)(Baseline, weeks 2, 8 and 26.)
- Depression symptoms (PHQ)(Baseline, weeks 2, 8 and 26.)
- Pain catastrophizing (PCS)(Baseline, weeks 2, 8 and 26.)
- Fear of movement (TSK-13)(Baseline, weeks 2, 8 and 26)
- Self-efficacy (PSEQ-10)(Baseline, weeks 2, 8 and 26.)
- Post-traumatic stress disorder (PCL-5)(Baseline, weeks 2, 8 and 26.)
- Medication use(Baseline, weeks 2, 8 and 26.)
- Global rating of change (GRC)(Weeks 2, 8 and 26)
- Patient Acceptable Symptom State (PASS)(Baseline, weeks 2, 8 and 26.)
研究者
Hugo Massé-Alarie
Associate Professor
Laval University