Effects of Myofascial Massage and Patient-therapist Communication Levels on Shoulder Muscle Properties in Breast Cancer Survivors with Myofascial Pain

Not Applicable

Recruiting

• Conditions: Pain, Myofacial

• Registration Number: NCT06679400
• Lead Sponsor: University of Michigan

Brief Summary

The objective of the proposed study is to assess how myofascial massage alters stiffness and microvascular perfusion of shoulder muscles and how these changes are influenced by patient-therapist interactions.

The primary hypothesis is that stiffness of shoulder muscles will be decreased, and microvascular perfusion will be increased after a 30-minute myofascial massage, and that the addition of patient-therapist communication levels will result in greater changes with certain levels.

Detailed Description

Please note that there are certain details left off of this registration in order to collect information regarding certain aspects of the trial. These details (approved by the IRB) will be updated at the end of the trial.

Study Timeline

• Study First Submitted: 2024-11-05
• Study First Submitted QC: 2024-11-05
• Study First Posted: 2024-11-07
• Study Start: 2024-12-12
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-05
• Last Update Posted: 2025-03-10
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

• Previous unilateral breast cancer diagnosis
• Treatment for primary breast cancer was completed 3 months to 2 years prior to enrollment (defined as completion of all treatments except oral maintenance therapies)
• Myofascial pain in upper quadrant of the chest
• Ability to understand and willingness to sign a written informed consent.

Exclusion Criteria

• Chronic neuromuscular or orthopedic injury currently affecting upper extremity function that is unrelated to their cancer diagnosis
• Currently undergoing physical therapy, occupational therapy or other treatment for side effects related to their cancer diagnosis or other injury to the upper extremity
• History of fibromyalgia
• Broken or bruised skin in the chest/shoulder area
• Diagnosed with metastatic breast cancer
• Currently receiving treatment for other forms of cancer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in muscle stiffness of the pectoralis major	Baseline, post massage (approximately 30 minutes and 60 minutes)	This will be assessed by ultrasound shear wave elastography before and after myofascial massage.

Secondary Outcome Measures

Name	Time	Method
Change in muscle perfusion of the pectoralis major and upper trapezius	Baseline, post massage (approximately 30 minutes and 60 minutes)	This will be assessed by Doppler imaging and superb microvascular imaging before and after myofascial massage.
Change in muscle stiffness of the pectoralis major compared between groups	Baseline, post massage (approximately 30 minutes and 60 minutes)	This will be assessed by ultrasound shear wave elastography and compared between patients randomized to a group with restricted or unrestricted communication with the massage therapist.
Global Satisfaction measured by the Patient Global Impression of Change will be compared between groups at the different communication levels	Approximately 60 minutes (during wait period after massage)	This is a one question that participants chose from Very much improved (0) - Very much worse (6).

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States