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Physical Activity and Percussive Massage Therapy for Reducing Pain in Older Women

NCT ID: NCT07056335

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-15

Study Completion Date

2025-11-01

Brief Summary

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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

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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

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Pain, Chronic

Keywords

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behavior change

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
Investigator and outcome assessor will not know which group the participants are assigned to. Instead, the assigned group is be as numbers.

Study Groups

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Physical Activity Self-monitoring

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.

Group Type EXPERIMENTAL

Self-monitoring

Intervention Type BEHAVIORAL

Self-monitoring as a behavior change technique to support pain self-care behaviors

Physical activity and percussive massage therapy education

Intervention Type BEHAVIORAL

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 therapy

Intervention Type DEVICE

Participants will receive a massage gun to support daily pain self-care.

Percussive Massage Therapy Self-monitoring

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.

Group Type EXPERIMENTAL

Self-monitoring

Intervention Type BEHAVIORAL

Self-monitoring as a behavior change technique to support pain self-care behaviors

Physical activity and percussive massage therapy education

Intervention Type BEHAVIORAL

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 therapy

Intervention Type DEVICE

Participants will receive a massage gun to support daily pain self-care.

Physical activity and Percussive Massage Therapy Self-monitoring

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.

Group Type EXPERIMENTAL

Self-monitoring

Intervention Type BEHAVIORAL

Self-monitoring as a behavior change technique to support pain self-care behaviors

Physical activity and percussive massage therapy education

Intervention Type BEHAVIORAL

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 therapy

Intervention Type DEVICE

Participants will receive a massage gun to support daily pain self-care.

No self-monitoring

Participants will receive a Theragun® device and education about the benefits of PA and PMT for older adults.

Group Type ACTIVE_COMPARATOR

Physical activity and percussive massage therapy education

Intervention Type BEHAVIORAL

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 therapy

Intervention Type DEVICE

Participants will receive a massage gun to support daily pain self-care.

Interventions

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Self-monitoring

Self-monitoring as a behavior change technique to support pain self-care behaviors

Intervention Type BEHAVIORAL

Physical activity and percussive massage therapy education

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.

Intervention Type BEHAVIORAL

Percussive massage therapy

Participants will receive a massage gun to support daily pain self-care.

Intervention Type DEVICE

Other Intervention Names

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Massage gun

Eligibility Criteria

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Inclusion Criteria

1. Older aged female (65 years of age or older)
2. Self-report pain as a barrier to PA
3. Self-report not engaging in regular aerobic physical activity
4. Express an interest in increasing PA levels.
5. Proficient in English
6. Own an IOS or Android smartphone with regular internet access
7. Check emails at least daily
8. Capable of providing informed consent
9. Willing to use a massage gun for 3 months
10. Live in continental US

Exclusion Criteria

1. Planned surgery that limits mobility in the next 2 months.
2. Concurrently participating in other pain management or physical activity programs
3. Cancer-related pain
4. Neurological disorder that affects cognition
5. Mobility impairments that prevent unassisted walking.
6. Receiving active medical treatment that would impair protocol compliance
Minimum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Shiyu Li

Postdoctoral Research Fellow, Motivation Lab School of Kinesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shiyu Li, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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HUM00262006

Identifier Type: -

Identifier Source: org_study_id