Effects of Muscle Energy Techniques With and Without Manual Axial Distraction in Post-Mastectomy Patients With Axillary Web Syndrome (MET MAD PM AWS)

Effects of Muscle Energy Techniques With and Without Manual Axial Distraction on Pain, Range of Motion Anf Functional Outcomes in Post-Mastectomy Patients With Axillary Web Syndrome

This randomized controlled trial aims to evaluate the effects of muscle energy techniques with and without manual axial distraction among post-mastectomy patients with axillary web syndrome. Fifty-eight participants will be randomly allocated into two groups and will receive the interventions for six weeks. It is hypothesized that the group that will receive both the muscle energy technique and manual axial distraction will produce greater improvements compared to the other group that will receive only MET.

Study Overview

Detailed Description

Axillary web syndrome (AWS) is a common post-mastectomy complication characterized by painful, palpable cords that limit shoulder mobility and functional performance. Current rehabilitation approaches emphasize soft-tissue mobilization, stretching, and manual therapy, yet evidence regarding the combined application of muscle energy technique (MET) and manual axial distraction (MAD) remains limited. This randomized controlled trial is designed to compare the effectiveness of MET alone versus MET combined with MAD in improving pain, range of motion (ROM), cord resolution, and functional outcomes in women with AWS. Participants will be randomly assigned to one of two groups using a concealed allocation procedure. All participants will begin each session with a 10-minute heating pad application to promote tissue elasticity, followed by a standardized stretching protocol targeting shoulder flexion and abduction in both supine and sitting positions; each stretch will be repeated five times and held for 30 seconds. The intervention group will receive MET applied to the pectoralis major, supraspinatus, subscapularis, and latissimus dorsi muscles in addition to MAD. MET will be administered using approximately 20% isometric contraction effort without pain, held for 7-10 seconds, followed by therapist-assisted stretching to the new tissue barrier; this cycle will be repeated three times per muscle. Positioning will be adapted for each muscle based on anatomical considerations, such as supine positioning with arm abduction for pectoralis major and subscapularis, or seated positioning for supraspinatus. The MAD technique will be performed using sustained shoulder joint traction for 15-30 seconds combined with firm digital pressure along the fibrous cords until a palpable "snapping" sensation indicates cord release. The comparison group will receive the same stretching and MET protocol without MAD. All interventions will be delivered three times per week for six consecutive weeks, with each session lasting approximately 30-40 minutes and tailored to participant tolerance. Primary outcomes include pain (Numeric Rating Scale), shoulder ROM (goniometry). Secondary outcomes include functional outcome( DASH questionnaire) and cord visibility. Outcome assessments will be conducted at baseline and at six weeks by a blinded assessor. Statistical analysis will include normality testing followed by parametric (paired and independent t-tests, ANOVA) or non-parametric equivalents (Wilcoxon or Mann-Whitney U tests) as appropriate. Effect sizes will be calculated, and significance will be set at p < 0.05. The trial is designed to determine whether adding MAD to MET results in superior improvements in tissue extensibility, pain reduction, ROM enhancement, and functional recovery compared with MET alone, thereby providing evidence-based guidance for rehabilitation of post-mastectomy AWS.

Study Type

Interventional

Enrollment (Estimated)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients diagnosed with AWS following breast cancer surgery
  • Females aged 30 to 60 years old
  • Participants must be within 1 month to 2 years post-surgery
  • Participants having limited shoulder ROM
  • Participants must have completed their post-surgery radiation therapy and chemotherapy minimum of 2-3 weeks

Exclusion Criteria:

  • Any previous history of shoulder pathology
  • Patients with a cervical problem that radiates pain down the shoulder
  • Pregnant females
  • Bilateral mastectomy
  • Ongoing cancer stage
  • Participants with ongoing chemotherapy
  • Frozen shoulder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A (Muscle energy technique + Manual axial distraction)
In the MET+ MAD group, a combination of muscle energy techniques and manual axial distraction will be applied on the affected side. The use of MET will target the pectoralis major, supraspinatus, subscapularis, and latissimus dorsi muscles. The participant will contract the targeted muscle for 10 seconds and then relax it. After that, the therapist will stretch that muscle for 10 to 30 seconds, along with manual axial distraction applied to the affected shoulder. The technique of manual axial distraction will employ firm digital pressure combined with distraction at various points over the fibrous band. The intervention will be given 3 times a week for 6 weeks, intensity will be according to the participants' tolerance. Each session will continue for 30 to 40 minutes
Experimental: Group B (Muscle energy technique only)
Group B will receive only the muscle energy techniques targeting the pectoralis major, supraspinatus, subscapularis, and lattisimus dorsi muscles on the affected side. The participants will contract the target muscle for 10 seconds and then relax it. After that, the therapist will stretch that muscle for 10 to 30 seconds. The intervention will be given three times a week for six weeks, and each session will continue for 30 to 40 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Intensity
Time Frame: Baseline: Before intervention 6 weeks post-intervention
Participants will be asked to rate the pain by using an outcome measure tool, NPRS, a numeric pain rating scale that ranges from 0 to 10. O means no pain, 1-3 means mild pain, 4-6 means moderate pain, 7-10 means severe pain.
Baseline: Before intervention 6 weeks post-intervention
Shoulder Range of Motion
Time Frame: Baseline: Before intervention 6 weeks post-intervention
Shoulder range of motion of the affected side will be measured by using an outcome measure tool, goniometry. Shoulder flexion and abduction ranges will be assessed in the sitting position. Each movement will be performed thrice, and the average values will be analyzed accordingly.
Baseline: Before intervention 6 weeks post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Outcomes
Time Frame: Baseline: Before intervention 6 weeks post-intervention
Functional outcomes of the participants will be measured by using an outcome measure tool, the DASH (Disabilities of the Arm, Shoulder, and Hand) questionnaire. This questionnaire will assess functional measures that have been asked with 30 different questions regarding the disabilities of the arm, shoulder, and hand, and answers will be recorded as no difficulty to mild, moderate, and severe. Each question has a lowest score of 1, which means there is no difficulty in performing a certain task, and a highest score of 5, indicating that the person is unable to perform the task in question. At least 2 questions must be answered to complete the assessment. Scoring is reported between 0 and 100, with higher disability if scores are high.
Baseline: Before intervention 6 weeks post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Study Chair: Muhammad Tariq Shafi, Lahore University of Biological and Applied Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 13, 2025

Primary Completion (Estimated)

May 25, 2026

Study Completion (Estimated)

May 30, 2026

Study Registration Dates

First Submitted

November 24, 2025

First Submitted That Met QC Criteria

November 24, 2025

First Posted (Estimated)

December 5, 2025

Study Record Updates

Last Update Posted (Actual)

December 22, 2025

Last Update Submitted That Met QC Criteria

December 15, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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