The purpose of this study is to explore and compare the effectiveness of in-person versus remote physical therapy (PT) for the treatment of musculoskeletal (MSK) pain within the Military Health System (MHS).
This study will explore the effect of remote two-way video conference telehealth physical therapy sessions compared to standard of care in-person physical therapy. Eligible participants will be randomized into one of the 2 treatment arms. Specific aims will compare the effectiveness of physical therapy delivery strategies on the primary outcome of Pain, Enjoyment, and General Activity (PEG-3) Scale, which measures pain interference, and secondary outcomes of PROMIS short forms (mood, physical function, fatigue, sleep disturbance, and prescription medication misuse), patient global impression of change, and pain self-efficacy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
210
Participants assigned to in-person PT will receive individual treatment sessions provided by a licensed, on-site PT. Participants will receive 1-on-1 sessions based on the preference and clinical expertise of the clinician. Participants assigned to in-person physical therapy will receive individual treatment sessions provided by a licensed, on-site physical therapist at the participating military treatment facility. Physical therapists delivering in-person physical therapy will have the option to provide participants a digital home exercise program, however this will not be required. If you choose to download and use either app, you will have to accept the app's terms of service.
Participants assigned to telehealth physical therapy will use two-way video conferencing with a licensed physical therapist via a secure platform approved for patient care. Video conferencing will be accessible via a mobile app or web browser on your home computer. Participants assigned to telehealth physical therapy will be provided a digital home exercise program. The home exercise program is accessible via a mobile app or web browser on your home computer. This is an app that some military clinics already use as standard of care for providing home exercise programs to their patients, so there is a chance you would be receiving your exercises by this method even if you didn't participate in this study.
Tripler Army Medical Center
Tripler AMC, Hawaii, United States
Carl R. Darnall Army Medical Center
Fort Hood, Texas, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, United States
Madigan Army Medical Center
Joint Base Lewis McChord, Washington, United States
Pain, Enjoyment, and General Activity Scale (PEG-3)
The PEG-3 measure includes 3 items evaluating 1) pain severity; and interference of pain with 2) enjoyment and 3) general activity. Item response options range from 0-10. The PEG-3 score is expressed as the mean of all item scores ranging from 0-10.
Time frame: 12 Weeks
PROMIS-29
The PROMIS-29 assesses additional domains relevant to patients with MSK pain including physical function, fatigue, depression, anxiety, pain intensity, ability to participate in social roles, and sleep disturbance. The PROMIS-29 can also be used to calculate a physical and mental health summary score and can be used in cost-effectiveness analyses.
Time frame: 12 Weeks
Pain Self-Efficacy Questionnaire (PSEQ)
Because of its role in patients' capacity of selfmanagement, we will use the 10 item Pain Self-Efficacy Questionnaire (PSEQ) to quantify an individual's confidence in performing activities despite pain.
Time frame: 12 Weeks
Patient Global Assessment of Change (PGIC)
Participants' satisfaction with their intervention will be based on the single-item Patient Global Assessment of Change (PGIC).
Time frame: 12 Weeks
PROMIS Short Form Prescription Pain Medication Misuse
The PROMIS short form 7a assesses the abuse of prescription pain medication. The short form uses fixed items from the PROMIS item bank to provide a T-score with population mean = 50 (sd=10).
Time frame: 26 Weeks
EuroQoL (EQ-5D)
The EQ-5D is a generic quality of life questionnaire that will assess quality of life on a scale that can be referenced to other disease conditions. The EQ-5D covers 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each domain has 3 response categories: level 1, "no problems"; level 2, "some problems"; and level 3, "inability or extreme problems." Responses are combined to give a 5-digit descriptive health state classification (e.g., 11222). The EQ-5D yields a total of 243 possible health states. Valuations for each health state are available. The EQ-5D is commonly used in economic evaluation of interventions and cost-effectiveness analysis.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 12 Weeks