Clinical trial NCT06679400: Effects of Myofascial Massage and Patient-therapist Communication Levels on Shoulder Muscle Properties in Breast Cancer Survivors With Myofascial Pain
Official title: Effects of Myofascial Massage and Patient-therapist Communication Levels on Shoulder Muscle Properties in Breast Cancer Survivors With Myofascial Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain, Myofacial
Keywords: Massage therapy
Ultrasound
History of unilateral breast cancer
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2024-11-07
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized 1:1 to receive massage where communication with the massage therapist is permitted or restricted.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in muscle stiffness of the pectoralis major
timeFrame: Baseline, post massage (approximately 30 minutes and 60 minutes)
Secondary outcomes:
measure: Change in muscle perfusion of the pectoralis major and upper trapezius
timeFrame: Baseline, post massage (approximately 30 minutes and 60 minutes)
measure: Change in muscle stiffness of the pectoralis major compared between groups
timeFrame: Baseline, post massage (approximately 30 minutes and 60 minutes)
measure: Global Satisfaction measured by the Patient Global Impression of Change will be compared between groups at the different communication levels
timeFrame: Approximately 60 minutes (during wait period after massage)
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: David Lipps, PhD
role: PRINCIPAL_INVESTIGATOR
References: