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

NCT07056335 | Completed

• 1 other identifier: HUM00262006
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Pain, Chronic

Keywords

behavior change

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 1 month, 2 month

Secondary Outcomes (1)

• Average Daily Step Counts

  Baseline, 1 month, 2 month

Other Outcomes (1)

• Self-monitoring engagement

  Daily over the first month

Study Arms (4)

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.

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.

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.

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.

Behavioral: Physical activity and percussive massage therapy education; Device: Percussive massage therapy

Interventions

Self-monitoring BEHAVIORAL

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

Percussive Massage Therapy Self-monitoring; Physical Activity Self-monitoring; Physical activity and Percussive Massage Therapy Self-monitoring

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.

No self-monitoring; Percussive Massage Therapy Self-monitoring; Physical Activity Self-monitoring; Physical activity and Percussive Massage Therapy Self-monitoring

Percussive massage therapy DEVICE

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

Also known as: Massage gun

No self-monitoring; Percussive Massage Therapy Self-monitoring; Physical Activity Self-monitoring; Physical activity and Percussive Massage Therapy Self-monitoring

Eligibility Criteria

• Age: 65 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Blood Glucose Self-Monitoring; Exercise

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Self-Testing; Self Care; Therapeutics; Investigative Techniques; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Shiyu Li, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigator and outcome assessor will not know which group the participants are assigned to. Instead, the assigned group is be as numbers.
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Research Fellow, Motivation Lab School of Kinesiology

Model Details: 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.

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: July 9, 2025
• Study Start: January 15, 2025
• Primary Completion: October 14, 2025
• Study Completion: November 1, 2025
• Last Updated: November 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)