Trial Outcomes & Findings for Effects of Myofascial Massage and Patient-therapist Communication Levels on Shoulder Muscle Properties in Breast Cancer Survivors With Myofascial Pain (NCT NCT06679400)
NCT ID: NCT06679400
Last Updated: 2026-06-22
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
21 participants
Primary outcome timeframe
Baseline, post massage (approximately 5 minutes and 60 minutes)
Results posted on
2026-06-22
Participant Flow
Participants were recruited from an online recruitment portal (umhealthresearch.org)
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.
Participant milestones
| Measure |
Massage With Full Communication
Data was collected before, immediately after (\~5 minutes) and 60 minutes after a myofascial massage with full communication with the therapist
|
Massage With Restricted Communication
Data was collected before, immediately after (\~5 minutes) and 60 minutes after a myofascial massage with restricted communication with the therapist
|
|---|---|---|
|
Before
STARTED
|
10
|
11
|
|
Before
COMPLETED
|
10
|
11
|
|
Before
NOT COMPLETED
|
0
|
0
|
|
Immediately After
STARTED
|
10
|
11
|
|
Immediately After
COMPLETED
|
10
|
11
|
|
Immediately After
NOT COMPLETED
|
0
|
0
|
|
60 Minutes After
STARTED
|
10
|
11
|
|
60 Minutes After
COMPLETED
|
10
|
11
|
|
60 Minutes After
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Myofascial Massage and Patient-therapist Communication Levels on Shoulder Muscle Properties in Breast Cancer Survivors With Myofascial Pain
Baseline characteristics by cohort
| Measure |
Massage With Restricted Communication
n=11 Participants
Data was collected before, immediately after (\~5 minutes) and 60 minutes after a myofascial massage with restricted communication with the therapist
|
Massage With Full Communication
n=10 Participants
Data was collected before, immediately after (\~5 minutes) and 60 minutes after a myofascial massage with full communication with the therapist
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.9 yrs
STANDARD_DEVIATION 11.4 • n=20 Participants
|
55.5 yrs
STANDARD_DEVIATION 10.1 • n=20 Participants
|
53.1 yrs
STANDARD_DEVIATION 10.8 • n=40 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=20 Participants
|
10 Participants
n=20 Participants
|
21 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=20 Participants
|
10 Participants
n=20 Participants
|
19 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=20 Participants
|
9 Participants
n=20 Participants
|
19 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
BPI Pain Intensity
|
6.2 units on a scale
STANDARD_DEVIATION 2.5 • n=20 Participants
|
4.9 units on a scale
STANDARD_DEVIATION 2.0 • n=20 Participants
|
5.6 units on a scale
STANDARD_DEVIATION 2.3 • n=40 Participants
|
PRIMARY outcome
Timeframe: Baseline, post massage (approximately 5 minutes and 60 minutes)Population: Rows display data gathered at baseline as well as post massage (approximately 5 minutes and 60 minutes after massage completion)
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.
Outcome measures
| Measure |
Massage With Restricted Communication
n=11 Participants
Data was collected before, immediately after (\~5 minutes) and 60 minutes after a myofascial massage with restricted communication with the therapist
|
Massage With Full Communication
n=10 Participants
Data was collected before, immediately after (\~5 minutes) and 60 minutes after a myofascial massage with full communication with the therapist
|
|---|---|---|
|
Change in Muscle Stiffness of the Pectoralis Major
60 Minutes After
|
5.0 m/s
Standard Deviation 3.5
|
4.4 m/s
Standard Deviation 1.6
|
|
Change in Muscle Stiffness of the Pectoralis Major
Before
|
4.0 m/s
Standard Deviation 1.3
|
4.3 m/s
Standard Deviation 1.5
|
|
Change in Muscle Stiffness of the Pectoralis Major
Immediately After
|
4.3 m/s
Standard Deviation 2.7
|
5.1 m/s
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: Baseline, post massage (approximately 5 minutes and 60 minutes)Population: Rows display data gathered at baseline as well as post massage (approximately 5 minutes and 60 minutes after massage completion)
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.
Outcome measures
| Measure |
Massage With Restricted Communication
n=11 Participants
Data was collected before, immediately after (\~5 minutes) and 60 minutes after a myofascial massage with restricted communication with the therapist
|
Massage With Full Communication
n=10 Participants
Data was collected before, immediately after (\~5 minutes) and 60 minutes after a myofascial massage with full communication with the therapist
|
|---|---|---|
|
Change in Muscle Perfusion of the Pectoralis Major
Before
|
0.8 % of pixels
Standard Deviation 1.1
|
1.5 % of pixels
Standard Deviation 2.5
|
|
Change in Muscle Perfusion of the Pectoralis Major
Immediately After
|
0.5 % of pixels
Standard Deviation 0.5
|
4.3 % of pixels
Standard Deviation 8.7
|
|
Change in Muscle Perfusion of the Pectoralis Major
60 Minutes After
|
0.3 % of pixels
Standard Deviation 0.4
|
8.4 % of pixels
Standard Deviation 12.6
|
SECONDARY outcome
Timeframe: Approximately 7 days post-interventionThis is a one question that participants chose from Very much improved (0) - Very much worse (6).
Outcome measures
| Measure |
Massage With Restricted Communication
n=11 Participants
Data was collected before, immediately after (\~5 minutes) and 60 minutes after a myofascial massage with restricted communication with the therapist
|
Massage With Full Communication
n=10 Participants
Data was collected before, immediately after (\~5 minutes) and 60 minutes after a myofascial massage with full communication with the therapist
|
|---|---|---|
|
Global Satisfaction Measured by the Patient Global Impression of Change
|
2.6 units on a scale
Standard Deviation 1.7
|
2.6 units on a scale
Standard Deviation 0.5
|
Adverse Events
Massage With Full Communication
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Massage With Restricted Communication
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Massage With Full Communication
n=10 participants at risk
Data was collected before, immediately after (\~5 minutes) and 60 minutes after a myofascial massage with full communication with the therapist
|
Massage With Restricted Communication
n=11 participants at risk
Data was collected before, immediately after (\~5 minutes) and 60 minutes after a myofascial massage with restricted communication with the therapist
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Increased pain and soreness at site of massage lasting greater than 48 hours
|
10.0%
1/10 • From enrollment until end of follow-up, up to 30 days
Adverse event screener was provided 7 days after study visit, and if a potential adverse event was reported, follow-up continuted.
|
9.1%
1/11 • From enrollment until end of follow-up, up to 30 days
Adverse event screener was provided 7 days after study visit, and if a potential adverse event was reported, follow-up continuted.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place