Effectiveness of Transcranial Direct Current Stimulation (tDCS) in Musculoskeletal Rehabilitation.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Composite Pain Rating
研究概览
简要总结
Reducing pain and recovery of strength and function are major challenges in physical therapy. Transcranial direct current stimulation (tDCS) is a novel intervention that has gained popularity in the rehabilitation of athletic injuries, pain management, and sports performance. Acute application of tDCS has been shown to modulate the perception of effort and fatigue, enhance motor learning, improve endurance performance, and improve muscular power and strength. tDCS has also been shown to reduce pain in patients with chronic pain conditions. Using a double-blind, randomized clinical trial design, we aim to evaluate the effectiveness of tDCS plus standard rehabilitation compared to rehabilitation alone on pain, balance and proprioception, functional performance, and strength following acute ankle inversion sprain. We hypothesize that the group using tDCS will demonstrate superior outcomes in all variables of interest.
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, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Within 2-weeks s/p acute grade 1 or 2 ankle inversion sprain
排除标准
- •Self-Reported Pregnancy
- •Being treated for and on medication for a mental health diagnosis
- •Concussion or non-lateral ankle sprain lower extremity injuries within the past 6 months
- •Open wound or dermatologic lesion on the head or region of application
- •Active implantable medical devices such as cochlear implants or cardiac pacemakers, or with metal implants in the head (excluding standard orthodontic braces, fillings, etc.).
- •Epilepsy or history of seizures
- •Participants who are not fluent in English
研究组 & 干预措施
Transcranial Direct Current Stimulation plus Physical Therapy
Participants in the experimental group will receive the current standard of care in ankle inversion sprain rehabilitation plus a 20-minute application of tDCS during each treatment session via the Halo Sport (Halo Neuroscience, San Francisco, CA) headset. The rehabilitation program will be standardized among all patients and will consist of therapeutic exercises, manual physical therapy, and other modalities. Rehabilitation sessions will be performed 2x weekly and sessions will last approximately 45 to 60 minutes.
干预措施: Transcranial Direct Current Stimulation (Other)
Transcranial Direct Current Stimulation plus Physical Therapy
Participants in the experimental group will receive the current standard of care in ankle inversion sprain rehabilitation plus a 20-minute application of tDCS during each treatment session via the Halo Sport (Halo Neuroscience, San Francisco, CA) headset. The rehabilitation program will be standardized among all patients and will consist of therapeutic exercises, manual physical therapy, and other modalities. Rehabilitation sessions will be performed 2x weekly and sessions will last approximately 45 to 60 minutes.
干预措施: Physical Therapy (Other)
Sham Transcranial Direct Current Stimulation plus Physical Therapy
Participants in the sham control group will receive the current standard of care in ankle inversion sprain rehabilitation plus a 20-minute sham tDCS treatment, where the patient is wearing the tDCS headset, but stimulation is only applied for 30 seconds of the 20-minute period. The rehabilitation program will be standardized among all patients and will consist of therapeutic exercises, manual physical therapy, and other modalities. Rehabilitation sessions will be performed 2x weekly and sessions will last approximately 45 to 60 minutes.
干预措施: Sham Transcranial Direct Current Stimulation (Other)
Sham Transcranial Direct Current Stimulation plus Physical Therapy
Participants in the sham control group will receive the current standard of care in ankle inversion sprain rehabilitation plus a 20-minute sham tDCS treatment, where the patient is wearing the tDCS headset, but stimulation is only applied for 30 seconds of the 20-minute period. The rehabilitation program will be standardized among all patients and will consist of therapeutic exercises, manual physical therapy, and other modalities. Rehabilitation sessions will be performed 2x weekly and sessions will last approximately 45 to 60 minutes.
干预措施: Physical Therapy (Other)
结局指标
主要结局
Composite Pain Rating
时间窗: Change from Baseline to 8-weeks
Numerical Pain Rating Scale assessment of Current, Best 24-hour, Worst 24-hour Pain
Composite Pain Rating
时间窗: Change from Baseline to 4-weeks
Numerical Pain Rating Scale assessment of Current, Best 24-hour, Worst 24-hour Pain
次要结局
- Self-Reported Function(Change from Baseline to 8-weeks)
- Muscle Power(Change from Baseline to 8-weeks)
- Dynamic balance(Change from Baseline to 8-weeks)
- Proprioception(Change from Baseline to 8-weeks)
- Muscle Strength(Change from Baseline to 8-weeks)
- Self-Reported Function(Change from Baseline to 4-weeks)
- Muscle Strength(Change from Baseline to 4-weeks)
- Proprioception(Change from Baseline to 4-weeks)
- Dynamic balance(Change from Baseline to 4-weeks)
- Muscle Power(Change from Baseline to 4-weeks)