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

NCT06679400 | Completed

• 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.

  Baseline, post massage (approximately 30 minutes and 60 minutes)

Secondary Outcomes (3)

• Change in muscle perfusion of the pectoralis major and upper trapezius

  Baseline, post massage (approximately 30 minutes and 60 minutes)

• Change in muscle stiffness of the pectoralis major compared between groups

  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

  Approximately 60 minutes (during wait period after massage)

Study Arms (2)

Massage with communication level 1

EXPERIMENTAL

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

Massage with communication level 2

EXPERIMENTAL

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

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 communication level 1; Massage with communication level 2

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

Study Officials

• David Lipps, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

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: October 10, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)