Efficacy of Mirror Therapy for Complex Regional Pain Syndrome in Post-Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in pain intensity (Visual Analog Scale - VAS)
研究概览
简要总结
The goal of this clinical study is to evaluate the effectiveness of mirror therapy in treating complex regional pain syndrome (CRPS) in patients after stroke using clinical assessments, electrophysiological evaluations, and ultrasonographic measurements by comparing pre- and post-treatment outcomes.
The main questions it aims to answer are:
Does mirror therapy lead to improvements in clinical outcomes in post-stroke patients with CRPS when assessed before and after treatment? Does mirror therapy reduce pain, improve motor function, and enhance functional independence based on clinical assessments? Does mirror therapy reduce swelling (edema) in the affected limb as measured by ultrasonographic evaluations? Does mirror therapy lead to changes in sympathetic nervous system function as assessed by electrophysiological evaluations?
Researchers will compare mirror therapy to sham mirror therapy (a similar procedure without therapeutic effect) to determine its effectiveness.
Participants will:
Be randomly assigned to either a mirror therapy group or a control group Receive conventional rehabilitation therapy and contrast bath treatment for 4 weeks Receive either mirror therapy or sham mirror therapy for 20 minutes daily Be evaluated before and after treatment using clinical scales, electrophysiological tests, and ultrasonographic measurements.
详细描述
Complex regional pain syndrome (CRPS) is a challenging complication following stroke, characterized by pain, edema, autonomic dysfunction, and impaired motor function. It significantly affects rehabilitation outcomes and quality of life. Despite various treatment approaches, optimal management remains difficult. Mirror therapy has emerged as a non-invasive rehabilitation technique that provides visual feedback and may influence cortical reorganization and pain modulation. Additionally, it may have effects on autonomic function, particularly the sympathetic nervous system.
This prospective, randomized, single-blind study was conducted in the inpatient Physical Medicine and Rehabilitation clinic of Başakşehir Çam and Sakura City Hospital between October 2022 and October 2023. Patients with post-stroke CRPS who met the inclusion criteria were enrolled and randomly assigned to either a mirror therapy group or a control group. Both groups received a standardized conventional rehabilitation program and contrast bath therapy. The intervention group additionally received mirror therapy, while the control group received sham mirror therapy.
The aim of the study was to evaluate the clinical effectiveness of mirror therapy in post-stroke CRPS through a multidimensional approach. Clinical status, functional outcomes, electrophysiological parameters related to sympathetic nervous system function, and ultrasonographic measurements of soft tissue changes were assessed before and after the intervention period.
This study provides comprehensive evaluation of mirror therapy effects by combining clinical assessments with objective electrophysiological and imaging-based measurements. The findings are expected to contribute to the understanding of the role of mirror therapy in the management of CRPS after stroke and to support its use as an accessible and complementary rehabilitation approach.
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, 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
- •Patients with a first-ever ischemic or hemorrhagic stroke
- •Time since stroke onset of ≤ 12 months
- •Diagnosed with Complex Regional Pain Syndrome (CRPS) Type 1 according to the Budapest criteria
- •In the dystrophic stage (Stage 2) of CRPS
- •Mini-Mental State Examination (MMSE) score > 24
- •Brunnstrom upper extremity-hand stage between 1 and 4
- •Age between 18 and 65 years
排除标准
- •Unstable medical condition
- •Presence of neglect
- •Severe aphasia preventing completion of assessment scales
- •Presence of a concomitant lower motor neuron lesion
- •History of fracture, surgery, or amputation in the affected limb
- •Presence of implanted electronic devices (e.g., cardiac pacemaker)
- •Local infection at the application site
- •Use of oral steroids or pregabalin/gabapentin within the last 3 months
- •History of intra-articular injection, botulinum toxin injection, or suprascapular nerve block within the last 3 months
研究组 & 干预措施
Mirror Therapy Group
Participants in this arm received conventional rehabilitation therapy and contrast bath therapy for 4 weeks in addition to mirror therapy for 20 minutes daily
干预措施: Mirror Therapy (Behavioral)
Sham Mirror Therapy Group
Participants in this arm received conventional rehabilitation therapy and contrast bath therapy for 4 weeks in addition to sham mirror therapy for 20 minutes daily
干预措施: Sham Mirror Therapy (Behavioral)
结局指标
主要结局
Change in pain intensity (Visual Analog Scale - VAS)
时间窗: Baseline and after 4 weeks
Pain intensity will be assessed using the Visual Analog Scale (VAS) before and after the 4-week treatment period.
次要结局
- Change in motor recovery (Brunnstrom Staging)(Baseline and after 4 weeks)
- Change in upper extremity motor function (Fugl-Meyer Assessment)(Baseline and after 4 weeks)
- Change in spasticity (Modified Ashworth Scale, MAS)(Baseline and after 4 weeks)
- Change in functional independence (Functional Independence Measure, FIM)(Baseline and after 4 weeks)
- Change in neuropathic pain (DN4)(Baseline and after 4 weeks)
- Change in neuropathic pain (LANSS)(Baseline and after 4 weeks)
- Change in sympathetic nervous system function (sympathetic skin response)(Baseline and after 4 weeks)
- Change in cutaneous silent period (CSP)(Baseline and after 4 weeks)
- Change in subcutaneous tissue thickness (ultrasonography)(Baseline and after 4 weeks)
研究者
Beyza Ozturk
Physical Medicine and Rehabilitation Resident
Başakşehir Çam & Sakura City Hospital