- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07266623
Effects of Muscle Energy Techniques With and Without Manual Axial Distraction in Post-Mastectomy Patients With Axillary Web Syndrome (MET MAD PM AWS)
December 15, 2025 updated by: Lahore University of Biological and Applied Sciences
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
Status
Not yet recruiting
Conditions
Intervention / Treatment
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
- Name: Tayyba Majeed
- Phone Number: +923019491681
- Email: tayybamajeed501@gmail.com
Study Contact Backup
- Name: Muhammad Tariq Shafi
- Phone Number: +92345190056
- Email: muhammadtariq@ubas.edu.pk
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.
General Publications
- Koehler LA, Blaes AH, Haddad TC, Hunter DW, Hirsch AT, Ludewig PM. Movement, Function, Pain, and Postoperative Edema in Axillary Web Syndrome. Phys Ther. 2015 Oct;95(10):1345-53. doi: 10.2522/ptj.20140377. Epub 2015 May 14.
- Meer TA, Noor R, Bashir MS, Ikram M. Comparative effects of lymphatic drainage and soft tissue mobilization on pain threshold, shoulder mobility and quality of life in patients with axillary web syndrome after mastectomy. BMC Womens Health. 2023 Nov 10;23(1):588. doi: 10.1186/s12905-023-02762-w.
- Gonzalez-Rubino JB, Vinolo-Gil MJ, Martin-Valero R. Effectiveness of physical therapy in axillary web syndrome after breast cancer: a systematic review and meta-analysis. Support Care Cancer. 2023 Apr 12;31(5):257. doi: 10.1007/s00520-023-07666-x.
- Gonzalez-Rubino JB, Martin-Valero R, Vinolo-Gil MJ. Physiotherapy protocol to reduce the evolution time of axillary web syndrome in women post-breast cancer surgery: a randomized clinical trial. Support Care Cancer. 2025 Mar 28;33(4):326. doi: 10.1007/s00520-025-09373-1.
- Sandrin F, Nevola Teixeira LF, Garavaglia M, Gandini S, Simoncini MC, Luini A. The efficacy in shoulder range of motion of a snapping manual maneuver added to a standardized exercise protocol in axillary web syndrome: a randomized controlled trial. Acta Oncol. 2023 Aug;62(8):969-976. doi: 10.1080/0284186X.2023.2241995. Epub 2023 Sep 26.
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
Keywords
Other Study ID Numbers
- UBAS/ERB/FoRS/25/031
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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