Pain, Myofacial
Conditions
Keywords
Massage therapy, Ultrasound, History of unilateral breast cancer
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.
Interventions
BEHAVIORALMassage
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.
Sponsors
University of Michigan
National Center for Complementary and Integrative Health (NCCIH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Participants will be randomized 1:1 to receive massage where communication with the massage therapist is permitted or restricted.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Muscle Stiffness of the Pectoralis Major | Baseline, post massage (approximately 5 minutes and 60 minutes) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Muscle Perfusion of the Pectoralis Major | Baseline, post massage (approximately 5 minutes and 60 minutes) | This will be assessed by color flow Doppler imaging before and after myofascial massage. Reported as color pixel density (% of pixels where flow is detected across a 5-second cine clip) at the most medial inferior site imaged. |
| Global Satisfaction Measured by the Patient Global Impression of Change | Approximately 7 days post-intervention | This is a one question that participants chose from Very much improved (0) - Very much worse (6). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDavid Lipps, PhD
University of Michigan
Participant flow
Recruitment details
Participants were recruited from an online recruitment portal (umhealthresearch.org)
Pre-assignment details
In total, 56 individuals consented to the study. 35 individuals did not pass the screening questionnaire after consent or did not show up to their research appointment and were taken off the study.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 50.9 yrs STANDARD_DEVIATION 11.4 |
| BPI Pain Intensity | 6.2 units on a scale STANDARD_DEVIATION 2.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 10 |
| other Total, other adverse events | 1 / 11 | 1 / 10 |
| serious Total, serious adverse events | 0 / 11 | 0 / 10 |
Outcome results
None listed