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

Official title

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

Overview

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.

Interventions

• Other 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 di
• 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.

Primary outcome measures

• Pain Intensity [Time frame: Baseline: Before intervention 6 weeks post-intervention]
• Shoulder Range of Motion [Time frame: Baseline: Before intervention 6 weeks post-intervention]

Secondary outcome measures (1)

• Functional Outcomes [Time frame: Baseline: Before intervention 6 weeks post-intervention]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

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. PMID 25977305
• 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 37950230
• 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 37043039
• 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 40153020
• 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 37750301

Identifiers

NCT: NCT07266623 · UBAS/ERB/FoRS/25/031

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗