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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Myofacial
• Intervention / Treatment: Behavioral: Massage

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 Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Massage with communication level 1; The therapist and the participant will have this level of communication (known as level 1 here). Further details will be explained at the end of the study.	Behavioral: Massage; Participants will have one massage that will last 30 minutes and focus on the chest and shoulder of the side that received the cancer treatment. There will be certain techniques applied during the intervention (per protocol). The timing and order of each element will be varied based on tissue response and patient feedback. All participants will have ultrasounds and complete surveys prior and after the massage.
Experimental: Massage with communication level 2; The therapist and the participant will have this level of communication (known as level 2). Further details will be explained at the end of the study.	Behavioral: Massage; Participants will have one massage that will last 30 minutes and focus on the chest and shoulder of the side that received the cancer treatment. There will be certain techniques applied during the intervention (per protocol). The timing and order of each element will be varied based on tissue response and patient feedback. All participants will have ultrasounds and complete surveys prior and after the massage.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in muscle perfusion of the pectoralis major and upper trapezius	This will be assessed by Doppler imaging and superb microvascular imaging before and after myofascial massage.	Baseline, post massage (approximately 30 minutes and 60 minutes)
Change in muscle stiffness of the pectoralis major compared between groups	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.	Baseline, post massage (approximately 30 minutes and 60 minutes)
Global Satisfaction measured by the Patient Global Impression of Change will be compared between groups at the different communication levels	This is a one question that participants chose from Very much improved (0) - Very much worse (6).	Approximately 60 minutes (during wait period after massage)

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: David Lipps, PhD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2024
• Primary Completion (Actual): September 20, 2025
• Study Completion (Actual): September 30, 2025

Study Registration Dates

• First Submitted: November 5, 2024
• First Submitted That Met QC Criteria: November 5, 2024
• First Posted (Actual): November 7, 2024

Study Record Updates

• Last Update Posted (Estimated): October 10, 2025
• Last Update Submitted That Met QC Criteria: October 8, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Ultrasound; Massage therapy; History of unilateral breast cancer
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Facial Pain; Therapeutics; Complementary Therapies; Physical Therapy Modalities; Rehabilitation; Therapy, Soft Tissue; Musculoskeletal Manipulations; Massage
• Other Study ID Numbers: HUM00250137; U24AT011969 (U.S. NIH Grant/Contract)

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
• product manufactured in and exported from the U.S.: No