NCT07266623

Brief Summary

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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Dec 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress87%
Dec 2025May 2026

First Submitted

Initial submission to the registry

November 24, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 5, 2025

Completed
8 days until next milestone

Study Start

First participant enrolled

December 13, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2026

Expected
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2026

Last Updated

December 22, 2025

Status Verified

December 1, 2025

Enrollment Period

5 months

First QC Date

November 24, 2025

Last Update Submit

December 15, 2025

Conditions

Keywords

Axillary web syndromeMuscle energy techniquesManual axial distractionFunctional outcomesRange of motion

Outcome Measures

Primary Outcomes (2)

  • Pain Intensity

    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

    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 Outcomes (1)

  • Functional Outcomes

    Baseline: Before intervention 6 weeks post-intervention

Study Arms (2)

Group A (Muscle energy technique + Manual axial distraction)

EXPERIMENTAL
Other: Muscle energy technique + Manual axial distraction

Group B (Muscle energy technique only)

EXPERIMENTAL
Other: Muscle energy technique

Interventions

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

Group A (Muscle energy technique + Manual axial distraction)

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.

Group B (Muscle energy technique only)

Eligibility Criteria

Age30 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemales
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 25977305BACKGROUND
  • 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.

    PMID: 37950230BACKGROUND
  • 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.

    PMID: 37043039BACKGROUND
  • 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.

    PMID: 40153020BACKGROUND
  • 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.

    PMID: 37750301BACKGROUND

Study Officials

  • Muhammad Tariq Shafi

    Lahore University of Biological and Applied Sciences

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Due to the nature of the intervention, the blinding of participants and therapists was not feasible. To overcome the assessment bias, the outcome assessor remained blinded to group allocations, maintaining single blinded study design
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2025

First Posted

December 5, 2025

Study Start

December 13, 2025

Primary Completion (Estimated)

May 25, 2026

Study Completion (Estimated)

May 30, 2026

Last Updated

December 22, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share