Effects of Muscle Energy Techniques With and Without Manual Axial Distraction in Post-Mastectomy Patients With Axillary Web Syndrome

NCT ID: NCT07266623

Last Updated: 2025-12-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-13
• Study Completion Date: 2026-05-30

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.

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.

Conditions

Axillary Web Syndrome; Post-mastectomy

Keywords

Axillary web syndrome; Muscle energy techniques; Manual axial distraction; Functional outcomes; Range of motion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group A (Muscle energy technique + Manual axial distraction)

Group Type: EXPERIMENTAL

Muscle energy technique + Manual axial distraction

Intervention Type: OTHER

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 B (Muscle energy technique only)

Group Type: EXPERIMENTAL

Muscle energy technique

Intervention Type: OTHER

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.

Interventions

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

Intervention Type: OTHER

Muscle energy technique

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Lahore University of Biological and Applied Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Muhammad Tariq Shafi

Role: STUDY_CHAIR

Lahore University of Biological and Applied Sciences

Central Contacts

Tayyba Majeed

Role: CONTACT

Phone: +923019491681

Email: tayybamajeed501@gmail.com

Muhammad Tariq Shafi

Role: CONTACT

Phone: +92345190056

Email: muhammadtariq@ubas.edu.pk

References

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.

Reference Type: BACKGROUND

PMID: 25977305 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 37950230 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 37043039 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 40153020 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 37750301 (View on PubMed)

Other Identifiers

UBAS/ERB/FoRS/25/031

Identifier Type: -

Identifier Source: org_study_id