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| ID | Type | Description | Link |
|---|---|---|---|
| U24AT011969 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Massage | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, post massage (approximately 5 minutes and 60 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, post massage (approximately 5 minutes and 60 minutes) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Lipps, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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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.
Participants were recruited from an online recruitment portal (umhealthresearch.org)
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Before |
| |||||||||||||
| Immediately After |
| |||||||||||||
| 60 Minutes After |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Massage With Full Communication |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Rows display data gathered at baseline as well as post massage (approximately 5 minutes and 60 minutes after massage completion) | Posted | Mean | Standard Deviation | m/s | Baseline, post massage (approximately 5 minutes and 60 minutes) |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increased pain and soreness at site of massage lasting greater than 48 hours | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Lipps | University of Michigan | 7346473131 | dlipps@umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 10, 2024 | Oct 8, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 25, 2025 | Oct 8, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D005157 | Facial Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008405 | Massage |
| ID | Term |
|---|---|
| D064746 | Therapy, Soft Tissue |
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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Participants will be randomized 1:1 to receive massage where communication with the massage therapist is permitted or restricted.
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|
| 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). | Approximately 7 days post-intervention |
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| NOT COMPLETED |
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Data was collected before, immediately after (~5 minutes) and 60 minutes after a myofascial massage with full communication with the therapist
| BG002 | Total | Total of all reporting groups |
| yrs |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| BPI Pain Intensity | Brief Pain Intensity - Worst pain in past 24 hours. Patients rate their pain intensity on average over the past 24 hours on a 0-10 numeric scale (where 0 is "no pain" and 10 is "pain as bad as you can imagine"). | Mean | Standard Deviation | units on a scale |
|
Data was collected before, immediately after (~5 minutes) and 60 minutes after a myofascial massage with full communication with the therapist |
|
|
| Secondary | 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. | Rows display data gathered at baseline as well as post massage (approximately 5 minutes and 60 minutes after massage completion) | Posted | Mean | Standard Deviation | % of pixels | Baseline, post massage (approximately 5 minutes and 60 minutes) |
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | units on a scale | Approximately 7 days post-intervention |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 1 |
| 11 |
| EG001 | 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 | 0 | 10 | 0 | 10 | 1 | 10 |
|
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| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| 60 Minutes After |
|