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

NCT06679400 | Completed Results

• 2 other identifiers: HUM00250137U24AT011969
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Myofacial

Keywords

Massage therapy; Ultrasound; History of unilateral breast cancer

Outcome Measures

Primary Outcomes (1)

• Change in Muscle Stiffness of the Pectoralis Major

  This will be assessed by ultrasound shear wave elastography before and after myofascial massage. Reported as the average shear wave velocity value at the most medial inferior site imaged.

  Baseline, post massage (approximately 5 minutes and 60 minutes)

Secondary Outcomes (2)

• Change in Muscle Perfusion of the Pectoralis Major

  Baseline, post massage (approximately 5 minutes and 60 minutes)

• Global Satisfaction Measured by the Patient Global Impression of Change

  Approximately 7 days post-intervention

Study Arms (2)

Massage with Restricted Communication

EXPERIMENTAL

Data was collected before, immediately after (\~5 minutes) and 60 minutes after a myofascial massage with restricted communication with the therapist

Behavioral: Massage

Massage with Full Communication

EXPERIMENTAL

Data was collected before, immediately after (\~5 minutes) and 60 minutes after a myofascial massage with full communication with the therapist

Behavioral: Massage

Interventions

Massage BEHAVIORAL

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.

Massage with Full Communication; Massage with Restricted Communication

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Facial Pain

Interventions

Massage

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Results Point of Contact

• Title: David Lipps
• Organization: University of Michigan

dlipps@umich.edu

7346473131

Study Officials

• David Lipps, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Kinesiology

Model Details: Participants will be randomized 1:1 to receive massage where communication with the massage therapist is permitted or restricted.

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 7, 2024
• Study Start: December 12, 2024
• Primary Completion: September 20, 2025
• Study Completion: September 30, 2025
• Last Updated: June 22, 2026
• Results First Posted: June 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)