Effects of Visual-Feedback Induced Therapy and Active Release Technique on Shoulder Pain, Lymphedema, and Functional Disability in Post-Mastectomy Patients.

NCT07719725 | Not Yet Recruiting

• 1 other identifier: UBAS/ERB/26/043010
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ost-Mastectomy Shoulder Dysfunction

Outcome Measures

Primary Outcomes (3)

• Pain intensity

  Pain numeric scale: The Numeric Pain Rating Scale is an 11-point scale from 0 to 10 used to measure pain intensity.

  From enrollment to 6 weeks.

• Shoulder pain and disability

  The Shoulder Pain and Disability Index is a 13-item, patient-reported questionnaire. Percentage score (0% to 100%).

  From baseline to 6 weeks.

• Limb volume

  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)

  From baseline to 6 weeks

Study Arms (2)

Active Release Technique

EXPERIMENTAL

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.

Other: Active release technique

Visual-Feedback Induced Therapy

ACTIVE COMPARATOR

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.

Other: Visual-Feedback Induced Therapy

Interventions

Active release technique OTHER

Participants 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.

Active Release Technique

Visual-Feedback Induced Therapy OTHER

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.

Visual-Feedback Induced Therapy

Eligibility Criteria

• Age: 40 Years - 65 Years
• Gender Eligibility Details: Females are eligible for this study as the study is about mastectomy patients.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lahore University of Biological and Applied Sciences: lead

Study Sites (1)

University of biological and applied sciences

Lahore, Punjab Province, 0000, Pakistan

Location

Central Study Contacts

Eisha Fatima

CONTACT

03364824758; eishamughal41822@gmail.com

Eisha Fatima, MSPT-MSK

CONTACT

03364824758; eishamughal41822@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2026
• First Posted: July 22, 2026
• Study Start: July 16, 2026
• Primary Completion: July 30, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

PA (1)