Effects of Visual-Feedback Induced Therapy and Active Release Technique on Shoulder Pain, Lymphedema, and Functional Disability in Post-Mastectomy Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Pain intensity
研究概览
简要总结
This randomized controlled trial aims to compare the effects of visual-feedback induced therapy and Active Release Technique on shoulder pain, lymphedema, and functional disability in post-mastectomy patients. Participants will be randomly assigned to receive either conventional physiotherapy combined with Active Release Technique or conventional physiotherapy combined with visual-feedback therapy. Outcomes will be measured at baseline and after 6 weeks of intervention.
详细描述
Post-mastectomy patients frequently experience shoulder pain, restricted mobility, and lymphedema, leading to functional disability and reduced quality of life. Conventional physiotherapy provides partial relief; however, innovative approaches such as visual-feedback therapy (mirror therapy) and Active Release Technique may offer improved outcomes. This study evaluates and compares the effectiveness of these interventions in improving pain, limb swelling, and upper-limb function. The findings may help identify optimal rehabilitation strategies for breast cancer survivors.
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)
入排标准
- 年龄范围
- 40 Years 至 65 Years(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Female patients aged 40-65 years.
- •History of unilateral mastectomy performed at least 2 months prior.
- •Persistent shoulder pain (Numeric Pain Rating Scale 4-7).
- •Reduced shoulder range of motion or functional limitation affecting daily activities.
- •Mild to moderate lymphedema of the affected upper limb .
排除标准
- •History of neurological disorders affecting motor function (e.g., stroke, MS).
- •Previous shoulder surgery unrelated to mastectomy.
- •Active infection or open wounds in the affected limb.
- •Already developed frozen shoulder in diabetic patient.
- •Severe lymphedema requires intensive medical management.
- •Cognitive impairment prevents participation in therapy.
研究组 & 干预措施
Visual-Feedback Induced Therapy
Participants in the experimental group 2 will receive the same conventional physiotherapy as the experimental group 1, plus Visual-Feedback Induced Therapy (VFIT) for 40-60 minutes per session, three times per week, for 6 weeks. VFIT uses mirror during shoulder and upper-limb exercises, allowing patients to observe the unaffected limb performing movements while performing symmetrical movements with the affected limb. Exercises focus on shoulder flexion, abduction, rotation, and functional reaching tasks, aiming to correct abnormal movement patterns, reduce compensatory strategies, and enhance central motor control.
干预措施: Visual-Feedback Induced Therapy (Other)
Active Release Technique
Participants will receive a combination of conventional physiotherapy and Active Release Technique (ART) for 40-60 minutes per session, three times per week, over 6 consecutive weeks. The conventional physiotherapy includes hot pack therapy for 15 minutes to reduce pain and improve tissue extensibility, followed by 25-30 minutes of exercise therapy. Exercises target shoulder range of motion (flexion, abduction, external rotation), strengthening of rotator cuff and scapular stabilizers, stretching of pectoralis major and minor, deltoid, biceps, and upper trapezius, and functional tasks such as reaching, lifting, and daily activity simulations. Exercises start with three repetitions and stretches held for 10-15 seconds, with weekly progression based on patient tolerance.
干预措施: Active release technique (Other)
结局指标
主要结局
Pain intensity
时间窗: From enrollment to 6 weeks.
Pain numeric scale: The Numeric Pain Rating Scale is an 11-point scale from 0 to 10 used to measure pain intensity.
Shoulder pain and disability
时间窗: From baseline to 6 weeks.
The Shoulder Pain and Disability Index is a 13-item, patient-reported questionnaire. Percentage score (0% to 100%).
Limb volume
时间窗: From baseline to 6 weeks
Lymphedema measuring tape: A lymphedema measuring tape is a used to measuring circumference of shoulder. Minimum: Grade 1 (Mild - less than 20% volume increase in the limb)Maximum: Grade 4 (Gigantic - massive deformity exceeding 50% to 100% volume increase)
次要结局
未报告次要终点
