University of biological and applied sciences
Lahore, Punjab Province, 0000, Pakistan
Not Yet Recruiting
NCT Number: NCT07719725
Effects of Visual-Feedback Induced Therapy and Active Release Technique on Shoulder Pain, Lymphedema, and Functional Disability in Post-Mastectomy Patients.
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.
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Conditions
Age range
40 year–65 year
Sex eligibility
Male
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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 .
Exclusion criteria
- 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.
Treatment and study plan
Active Release Technique
OtherParticipants in the experiment group 1 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.
Visual-Feedback Induced Therapy
OtherParticipants 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.
Primary outcomes
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Pain intensity
Time frame: 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.
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Shoulder pain and disability
Time frame: From baseline to 6 weeks.
The Shoulder Pain and Disability Index is a 13-item, patient-reported questionnaire. Percentage score (0% to 100%).
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Limb volume
Time frame: 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)
Study contacts
Contact information is provided by the study sponsor or research team.
Eisha Fatima
CONTACT
Eisha Fatima, MSPT-MSK
CONTACT
Sponsors and collaborators
Lead sponsor
Lahore University of Biological and Applied Sciences
Other
Registry information
Important dates
- Study start
- 2026
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Jul 22, 2026
- Registry last updated
- Jul 22, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.