Pain, ChronicMAPAPNCT07056335
Physical Activity and Percussive Massage Therapy for Reducing Pain in Older Women
A study testing Self-monitoring, Physical activity and percussive massage therapy education and Percussive massage therapy in people with Pain, Chronic, run by University of Michigan at 1 site in United States.
Trial summary
Over 60% of women aged 65 and older suffer from pain, yet this group is underrepresented in research. Physical activity and percussive massage therapy may help manage pain, but both require consistent engagement, making long-term participation challenging for most people. Read more about this study
- Who is it for?
- Ages 65 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Chronic
- What is being tested?
- Self-monitoring, Physical activity and percussive massage therapy education and Percussive massage therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2025to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years and older
- Women only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Older aged female (65 years of age or older)
- Self-report pain as a barrier to PA
- Self-report not engaging in regular aerobic physical activity
- Express an interest in increasing PA levels.
- Proficient in English
- Own an IOS or Android smartphone with regular internet access
Show all 10Show fewer
- Check emails at least daily
- Capable of providing informed consent
- Willing to use a massage gun for 3 months
- Live in continental US
Who cannot join
- Planned surgery that limits mobility in the next 2 months.
- Concurrently participating in other pain management or physical activity programs
- Cancer-related pain
- Neurological disorder that affects cognition
- Mobility impairments that prevent unassisted walking.
- Receiving active medical treatment that would impair protocol compliance
Trial locations and contacts
1 site in 1 country.
About this study
Over 60% of women aged 65 and older suffer from pain, yet this group is underrepresented in research. Physical activity and percussive massage therapy may help manage pain, but both require consistent engagement, making long-term participation challenging for most people. Self-monitoring could improve adherence to these pain management efforts, but the optimal strategies for self-monitoring remain unknown.
This is a a 2x2 factorial randomized controlled trial in older women (N = 108) to determine which behavior(s) should be self-monitored to (1) promote engagement in physical activity and percussive massage therapy and (2) reduce pain. This study design will allow examination on effects of self-monitoring across different behaviors to identify the most effective strategies for improving pain management adherence and reducing pain.
Read the detailed description
Pain is a common and disabling condition, affecting 1.5 billion people worldwide. Chronic pain is especially prevalent in women and older adults; over 63% of women aged 65+ report chronic pain. Yet this population has been understudied. Two evidence-based strategies hold promise for managing pain in older women: physical activity (PA) and percussive massage therapy (PMT).
PA is widely recommended for pain relief and improving functioning in older adults. However, pain is a commonly-cited barrier to PA. PMT through a massage gun offers promise for both acute pain management and reducing pain as a barrier to physical activity. PMT may be useful, however, few studies have examined the effectiveness of PMT for pain relief in older women, either alone or in combination with physical activity. PA and PMT also share a common challenges as pain management strategies - both require consistent engagement, yet long-term participation is challenging for most people.
Self-monitoring, the practice of recalling and recording a desired behavior regularly, is a widely adopted, evidence-based technique that supports behavior change. Conceptually, self-monitoring of PA and PMT should increase engagement in those behaviors and reduce pain. Yet, self-monitoring can be burdensome and difficult to maintain. Previous research found that engagement in self-monitoring within the first month may have long-lasting effects, but individuals typically disengage during early weeks. Therefore, limiting the scope of self-monitoring burden is important for long-term adherence. This research will answer the question, "Should a daily self-monitoring intervention focus on PA, PMT or both to promote engagement in those behaviors and reduce pain intensity and interference in older women?" There are two specific aims of this study:
Aim 1 (Behavior Change). To determine which behavior(s) should be self-monitored in an intervention to promote engagement in PA and PMT.
Aim 2 (Pain). To determine which behavior(s) should be self-monitored in an intervention to reduce pain intensity and interference.
- Conditions
- Pain, Chronic
- Being tested
- Self-monitoring, Physical activity and percussive massage therapy education, Percussive massage therapy
- Keywords
- behavior change
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-monitoringBehavioural
Self-monitoring as a behavior change technique to support pain self-care behaviors
Physical activity and percussive massage therapy educationBehavioural
Participants will receive education on why physical activity and massage are important for pain self-care. They will also receive daily physical activity and massage goals.
Percussive massage therapyDevice
Also called Massage gun
Participants will receive a massage gun to support daily pain self-care.
| Study group | Role | What they receive |
|---|---|---|
| Physical Activity Self-monitoring | Experimental | Participants will receive a Theragun® device and education about the benefits of PA and PMT for older adults.
Participants will receive daily email for physical activity self-monitoring. Receives: Behavioral: Self-monitoring; Behavioral: Physical activity and percussive massage therapy education; Device: Percussive massage therapy |
| Percussive Massage Therapy Self-monitoring | Experimental | Participants will receive a Theragun® device and education about the benefits of PA and PMT for older adults.
Participants will receive daily email for massage gun usage self-monitoring. Receives: Behavioral: Self-monitoring; Behavioral: Physical activity and percussive massage therapy education; Device: Percussive massage therapy |
| Physical activity and Percussive Massage Therapy Self-monitoring | Experimental | Participants will receive a Theragun® device and education about the benefits of PA and PMT for older adults.
Participants will receive daily email for physical activity and massage gun usage self-monitoring. Receives: Behavioral: Self-monitoring; Behavioral: Physical activity and percussive massage therapy education; Device: Percussive massage therapy |
| No self-monitoring | Active comparator | Participants will receive a Theragun® device and education about the benefits of PA and PMT for older adults. Receives: Behavioral: Physical activity and percussive massage therapy education; Device: Percussive massage therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported pain intensity and interference
Self-reported pain will be assessed using Brief Pain Inventory. The Brief Pain Inventory is a self-report measure that assesses both pain severity and the degree to which pain interferes with daily functioning. Scores are reported on a numeric rating scale ranging from 0 to 10, with higher scores indicating worse outcomes. Specifically, 0 represents "no pain" or "no interference," while 10 represents "pain as bad as you can imagine" or "complete interference." The Brief Pain Inventory yields two main scores: a Pain Severity score, calculated as the mean of four items assessing worst, least, average, and current pain; and a Pain Interference score, calculated as the mean of seven items assessing interference with general activity, mood, walking ability, work, relationships, sleep, and enjoyment of life.
Measured: Baseline, 1 month, 2 month
Secondary outcomes (1)
Average Daily Step Counts
Average daily step counts recorded by Actigraph accelerometer over a 7-day monitoring period
Measured: Baseline, 1 month, 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start15 Jan 2025
- Primary completion14 Oct 2025
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, ChronicStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- This is a 2 (self-monitoring PA: daily prompts vs none) x 2 (self-monitoring PMT: daily prompts vs none) factorial experiment with random assignment. All participants will receive a Theragun® device and education about the benefits of PA and PMT for older adults. Participants will then be randomly assigned to one of four experimental groups.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shiyu Li, University of Michigan
- Investigators
- Shiyu Li, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07056335
- Sponsor's protocol ID
- HUM00262006
- Acronym
- MAPAP
- Status last verified
- Nov 2025
- First submitted
- 13 Jun 2025
- Last updated
- 10 Nov 2025
- Results posted
- No
- 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 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity and Percussive Massage Therapy for Reducing Pain in Older Women
- ClinicalTrials.gov ID
- NCT07056335
- Acronym / sponsor ID
- MAPAP / HUM00262006
- Conditions
- Pain, Chronic
- Keywords
- behavior change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 14 Oct 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 9 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Over 60% of women aged 65 and older suffer from pain, yet this group is underrepresented in research. Physical activity and percussive massage therapy may help manage pain, but both require consistent engagement, making long-term participation challenging for most people. Self-monitoring could improve adherence to these pain management efforts, but the optimal strategies for self-monitoring remain unknown.
This is a a 2x2 factorial randomized controlled trial in older women (N = 108) to determine which behavior(s) should be self-monitored to (1) promote engagement in physical activity and percussive massage therapy and (2) reduce pain. This study design will allow examination on effects of self-monitoring across different behaviors to identify the most effective strategies for improving pain management adherence and reducing pain.
Detailed description
Pain is a common and disabling condition, affecting 1.5 billion people worldwide. Chronic pain is especially prevalent in women and older adults; over 63% of women aged 65+ report chronic pain. Yet this population has been understudied. Two evidence-based strategies hold promise for managing pain in older women: physical activity (PA) and percussive massage therapy (PMT).
PA is widely recommended for pain relief and improving functioning in older adults. However, pain is a commonly-cited barrier to PA. PMT through a massage gun offers promise for both acute pain management and reducing pain as a barrier to physical activity. PMT may be useful, however, few studies have examined the effectiveness of PMT for pain relief in older women, either alone or in combination with physical activity. PA and PMT also share a common challenges as pain management strategies - both require consistent engagement, yet long-term participation is challenging for most people.
Self-monitoring, the practice of recalling and recording a desired behavior regularly, is a widely adopted, evidence-based technique that supports behavior change. Conceptually, self-monitoring of PA and PMT should increase engagement in those behaviors and reduce pain. Yet, self-monitoring can be burdensome and difficult to maintain. Previous research found that engagement in self-monitoring within the first month may have long-lasting effects, but individuals typically disengage during early weeks. Therefore, limiting the scope of self-monitoring burden is important for long-term adherence. This research will answer the question, "Should a daily self-monitoring intervention focus on PA, PMT or both to promote engagement in those behaviors and reduce pain intensity and interference in older women?" There are two specific aims of this study:
Aim 1 (Behavior Change). To determine which behavior(s) should be self-monitored in an intervention to promote engagement in PA and PMT.
Aim 2 (Pain). To determine which behavior(s) should be self-monitored in an intervention to reduce pain intensity and interference.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- This is a 2 (self-monitoring PA: daily prompts vs none) x 2 (self-monitoring PMT: daily prompts vs none) factorial experiment with random assignment. All participants will receive a Theragun® device and education about the benefits of PA and PMT for older adults. Participants will then be randomly assigned to one of four experimental groups.
| Arm | Type | Receives |
|---|---|---|
| Physical Activity Self-monitoring | Experimental | Behavioral: Self-monitoring, Behavioral: Physical activity and percussive massage therapy education, Device: Percussive massage therapyParticipants will receive a Theragun® device and education about the benefits of PA and PMT for older adults. Participants will receive daily email for physical activity self-monitoring. |
| Percussive Massage Therapy Self-monitoring | Experimental | Behavioral: Self-monitoring, Behavioral: Physical activity and percussive massage therapy education, Device: Percussive massage therapyParticipants will receive a Theragun® device and education about the benefits of PA and PMT for older adults. Participants will receive daily email for massage gun usage self-monitoring. |
| Physical activity and Percussive Massage Therapy Self-monitoring | Experimental | Behavioral: Self-monitoring, Behavioral: Physical activity and percussive massage therapy education, Device: Percussive massage therapyParticipants will receive a Theragun® device and education about the benefits of PA and PMT for older adults. Participants will receive daily email for physical activity and massage gun usage self-monitoring. |
| No self-monitoring | Active comparator | Behavioral: Physical activity and percussive massage therapy education, Device: Percussive massage therapyParticipants will receive a Theragun® device and education about the benefits of PA and PMT for older adults. |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- Older aged female (65 years of age or older)
- Self-report pain as a barrier to PA
- Self-report not engaging in regular aerobic physical activity
- Express an interest in increasing PA levels.
- Proficient in English
Key exclusion criteria (6 listed)
- Planned surgery that limits mobility in the next 2 months.
- Concurrently participating in other pain management or physical activity programs
- Cancer-related pain
- Neurological disorder that affects cognition
- Mobility impairments that prevent unassisted walking.
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 |
|---|---|---|
| Self-monitoringSelf-monitoring as a behavior change technique to support pain self-care behaviors | Behavioural | Percussive Massage Therapy Self-monitoring, Physical Activity Self-monitoring, Physical activity and Percussive Massage Therapy Self-monitoring |
| Physical activity and percussive massage therapy educationParticipants will receive education on why physical activity and massage are important for pain self-care. They will also receive daily physical activity and massage goals. | Behavioural | No self-monitoring, Percussive Massage Therapy Self-monitoring, Physical Activity Self-monitoring, Physical activity and Percussive Massage Therapy Self-monitoring |
| Percussive massage therapyAlso: Massage gunParticipants will receive a massage gun to support daily pain self-care. | Device | No self-monitoring, Percussive Massage Therapy Self-monitoring, Physical Activity Self-monitoring, Physical activity and Percussive Massage Therapy Self-monitoring |
Primary outcome
Self-reported pain intensity and interference
Time frame: Baseline, 1 month, 2 month
Self-reported pain will be assessed using Brief Pain Inventory. The Brief Pain Inventory is a self-report measure that assesses both pain severity and the degree to which pain interferes with daily functioning. Scores are reported on a numeric rating scale ranging from 0 to 10, with higher scores indicating worse outcomes. Specifically, 0 represents "no pain" or "no interference," while 10 represents "pain as bad as you can imagine" or "complete interference." The Brief Pain Inventory yields two main scores: a Pain Severity score, calculated as the mean of four items assessing worst, least, average, and current pain; and a Pain Interference score, calculated as the mean of seven items assessing interference with general activity, mood, walking ability, work, relationships, sleep, and enjoyment of life.
1 secondary outcome
Average Daily Step Counts
Time frame: Baseline, 1 month, 2 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Pain, Chronic
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
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.
Shiyu Li, 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 Self-monitoring, Physical activity and percussive massage therapy education and Percussive massage therapy in people with Pain, Chronic, 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 10 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 10 Nov 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Self-reported pain intensity and interference (time frame: Baseline, 1 month, 2 month). 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 10 Nov 2025.