Pain, MyofacialNCT06679400
Effects of Myofascial Massage and Patient-therapist Communication Levels on Shoulder Muscle Properties in Breast Cancer Survivors With Myofascial Pain
A study testing Massage in people with Pain, Myofacial, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pain, Myofacial
- What is being tested?
- Massage
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2024to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Pain, Myofacial
- Being tested
- Massage
- Keywords
- Massage therapy, Ultrasound, History of unilateral breast cancer
- Medical subject headings
- Facial Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MassageBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Massage with Restricted Communication | Experimental | Data was collected before, immediately after (~5 minutes) and 60 minutes after a myofascial massage with restricted communication with the therapist Receives: Behavioral: Massage |
| Massage with Full Communication | Experimental | Data was collected before, immediately after (~5 minutes) and 60 minutes after a myofascial massage with full communication with the therapist Receives: Behavioral: Massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Muscle Stiffness of the Pectoralis Major
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.
Measured: Baseline, post massage (approximately 5 minutes and 60 minutes)
Secondary outcomes (2)
Change in Muscle Perfusion of the Pectoralis Major
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.
Measured: Baseline, post massage (approximately 5 minutes and 60 minutes)
Global Satisfaction Measured by the Patient Global Impression of Change
This is a one question that participants chose from Very much improved (0) - Very much worse (6).
Measured: Approximately 7 days post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start12 Dec 2024
- Primary completion20 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pain, MyofacialStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized 1:1 to receive massage where communication with the massage therapist is permitted or restricted.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, David B Lipps, PhD, University of Michigan
- Investigators
- David Lipps, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06679400
- Sponsor's protocol ID
- HUM00250137
- Other IDs
- U24AT011969
- Status last verified
- Jun 2026
- First submitted
- 5 Nov 2024
- Last updated
- 22 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Myofascial Massage and Patient-therapist Communication Levels on Shoulder Muscle Properties in Breast Cancer Survivors With Myofascial Pain
- ClinicalTrials.gov ID
- NCT06679400
- Acronym / sponsor ID
- HUM00250137
- Conditions
- Pain, Myofacial
- Keywords
- Massage therapy, Ultrasound, History of unilateral breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 12 Dec 2024 (actual)
- Primary completion
- 20 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 7 Nov 2024 (actual)
- Results
- Posted 22 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized 1:1 to receive massage where communication with the massage therapist is permitted or restricted.
| Arm | Type | Receives |
|---|---|---|
| Massage with Restricted Communication | Experimental | Behavioral: MassageData was collected before, immediately after (~5 minutes) and 60 minutes after a myofascial massage with restricted communication with the therapist |
| Massage with Full Communication | Experimental | Behavioral: MassageData was collected before, immediately after (~5 minutes) and 60 minutes after a myofascial massage with full communication with the therapist |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MassageParticipants 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. | Behavioural | Massage with Full Communication, Massage with Restricted Communication |
Primary outcome
Change in Muscle Stiffness of the Pectoralis Major
Time frame: 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.
2 secondary outcomes
Change in Muscle Perfusion of the Pectoralis Major
Time frame: Baseline, post massage (approximately 5 minutes and 60 minutes)
Global Satisfaction Measured by the Patient Global Impression of Change
Time frame: Approximately 7 days post-intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Lipps, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Massage in people with Pain, Myofacial, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Muscle Stiffness of the Pectoralis Major (time frame: Baseline, post massage (approximately 5 minutes and 60 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.