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

NCT ID: NCT06679400

Last Updated: 2025-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-12

Study Completion Date

2025-09-30

Brief Summary

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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

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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.

Conditions

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Pain, Myofacial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomized 1:1 to receive massage where communication with the massage therapist is permitted or restricted.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Massage

Intervention Type 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 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.

Group Type EXPERIMENTAL

Massage

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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David B Lipps, PhD

Associate Professor of Kinesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Lipps, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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U24AT011969

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00250137

Identifier Type: -

Identifier Source: org_study_id

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