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Completed

NCT Number: NCT07056335

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

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.

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Key information

Age range

65 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Check emails at least daily
  • Capable of providing informed consent
  • Willing to use a massage gun for 3 months
  • Live in continental US

Exclusion criteria

  • 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

Treatment and study plan

Self-monitoring

Behavioral

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

Physical activity and percussive massage therapy education

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

Device

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

Other names: Massage gun

Primary outcomes

  1. 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.

Secondary outcomes

  1. Average Daily Step Counts

    Time frame: Baseline, 1 month, 2 month

    Average daily step counts recorded by Actigraph accelerometer over a 7-day monitoring period

Other outcomes

  1. Self-monitoring engagement

    Time frame: Daily over the first month

    Self-monitoring engagement will be assessed as a daily binary outcome (yes/no) over the first month of the study. Participants will receive daily email surveys prompting them to log the duration of time spent in each physical activity intensity level and/or the duration of self-massage for five targeted muscle groups (calves, glutes, hamstrings, quadriceps, and lower back). The unit of measure will be the percentage of days on which participants completed the self-monitoring prompt, as indicated by a "yes" response to the daily survey.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Acronym: MAPAP

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 9, 2025
Registry last updated
Nov 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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