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临床试验/NCT07332884
NCT07332884已完成不适用

Comparison of Mirror Therapy and Routine Physical Therapy for the Management of Pain, Spasticity, and Strength in Patients With Complex Regional Pain Syndrome (CRPS): A Randomized Clinical Trial

University of Lahore1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2024年11月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
52
试验地点
1
主要终点
Pain management

研究概览

简要总结

Complex Regional Pain Syndrome (CRPS) is a chronic pain condition characterized by persistent pain, sensory disturbances, motor dysfunction, and functional impairment, often following trauma or surgery. Conventional physical therapy is commonly used in the management of CRPS; however, treatment outcomes are often variable and incomplete. Mirror therapy is a non-invasive rehabilitation technique that uses visual feedback to influence cortical reorganization and may help reduce pain and improve motor function in patients with CRPS.

The purpose of this study is to compare the effectiveness of mirror therapy with routine physical therapy in patients diagnosed with Complex Regional Pain Syndrome. Eligible participants will be allocated into two groups. One group will receive mirror therapy in addition to standard rehabilitation exercises, while the control group will receive routine physical therapy alone. Both interventions will be delivered over a defined treatment period under supervised conditions.

Primary outcomes will include changes in pain intensity, while secondary outcomes will assess functional ability, range of motion, and overall limb use. Outcomes will be measured at baseline and after completion of the intervention period. This study aims to determine whether mirror therapy provides additional benefits over routine physical therapy in reducing pain and improving functional outcomes in patients with Complex Regional Pain Syndrome.

详细描述

Complex Regional Pain Syndrome (CRPS) is a disabling chronic pain condition that may develop after injury, surgery, or immobilization and is associated with disproportionate pain, sensory abnormalities, motor dysfunction, and reduced use of the affected limb. These impairments significantly affect daily activities and quality of life. Although routine physical therapy remains a cornerstone of CRPS management, optimal rehabilitation strategies continue to be explored.

Mirror therapy is a neurorehabilitation technique that provides visual feedback of the unaffected limb to create the illusion of normal movement in the affected limb. This approach is believed to modulate central nervous system processing, reduce maladaptive cortical reorganization, and improve motor control. Previous studies have suggested potential benefits of mirror therapy in chronic pain conditions; however, evidence comparing mirror therapy with routine physical therapy in CRPS remains limited.

This study is designed to evaluate and compare the effects of mirror therapy and routine physical therapy on pain and functional outcomes in patients diagnosed with Complex Regional Pain Syndrome. Participants will be assigned to one of two intervention groups. The experimental group will receive mirror therapy sessions alongside conventional rehabilitation exercises, while the control group will receive routine physical therapy based on standard clinical practice. Interventions will be administered by qualified physical therapists according to a predefined treatment protocol.

Outcome assessments will be conducted at baseline and at the end of the intervention period using standardized and validated measures. The study will assess changes in pain intensity, functional performance, and limb use to determine the comparative effectiveness of mirror therapy versus routine physical therapy. Findings from this study may contribute to evidence-based rehabilitation strategies for patients with Complex Regional Pain Syndrome.

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
Single (Outcomes Assessor)

盲法说明

Masking in a clinical trial refers to the process of concealing certain information from participants, investigators, or other involved parties to prevent bias in the study's outcomes. In addition to the primary parties listed (such as participants, investigators, or outcome assessors), other parties who may be masked can include data analysts, laboratory personnel, or pharmacists responsible for preparing interventions. This ensures that those involved in handling, analyzing, or interpreting study data remain unaware of group assignments, maintaining the integrity and objectivity of the trial results.

入排标准

年龄范围
40 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 40-65 years
  • Both genders
  • Hemiplegic patients with subacute stage
  • Patients who developed CRPS of the hand due to stroke
  • Patients with a diagnosis of CRPS 1

排除标准

  • Cognitive disorders and perceptual disorders
  • Comorbid conditions (e.g., decompensated heart failure, chronic renal insufficiency
  • Hand arthritis
  • Arterial/venous injuries and/ or undergoing arterial revascularization

结局指标

主要结局

Pain management

时间窗: Duration of intervention: 4 weeks Frequency: 30 minutes per session, 5 sessions per week Pain assessments will be conducted at baseline (pre-intervention), weekly during the intervention, and at the end of 4 weeks to evaluate changes in pain intensity

Participants in both arms will receive interventions aimed at reducing pain associated with Complex Regional Pain Syndrome. For the Mirror Therapy Group, pain reduction is targeted through visual-motor feedback, which can help retrain the brain and reduce pain perception. For the Routine Physical Therapy Group, pain is managed through exercises, stretching, and functional activities that improve mobility, reduce stiffness, and decrease pain intensity.

Hand Grip

时间窗: • Baseline assessment: Before the start of the intervention • Interim assessments: Weekly during the 4-week intervention period • Final assessment: At the end of 4 weeks

Hand grip strength will be measured using a dynamometer to assess the functional strength of the affected limb in patients with Complex Regional Pain Syndrome. Participants will be instructed to squeeze the dynamometer maximally for a few seconds, and the best of three trials will be recorded for accuracy. This measurement evaluates improvements in motor function and muscle strength as a result of the intervention.

spasticity

时间窗: Baseline: Before the start of the intervention • Interim assessments: Weekly during the 4-week intervention period • Final assessment: At the end of 4 weeks

Spasticity of the affected limb will be assessed using the Modified Ashworth Scale (MAS), which grades muscle tone from 0 (no increase in tone) to 4 (rigid in flexion or extension). The assessment evaluates resistance to passive movement, helping to determine changes in muscle stiffness and motor control resulting from the intervention.

次要结局

未报告次要终点

研究者

发起方
University of Lahore
申办方类型
Other
责任方
Sponsor

研究点 (1)

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