Musculoskeletal Pain
Conditions
Keywords
musculoskeletal pain, tele-health, stepped care, physical thrapy access, cost-effective care
Brief summary
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).
Detailed description
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.
Interventions
OTHERIn-person physical therapy (PT)
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.
OTHERTelehealth physical therapy (TH-PT)
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.
Sponsors
Brooke Army Medical Center
Tripler Army Medical Center
Madigan Army Medical Center
C.R.Darnall Army Medical Center
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Clinicians and patients cannot be blinded to randomized group assignment. Treatment assignments will be blinded for investigators, assessors, and the lead study statistician. Outcomes assessments will be blinded for investigators, interventionists, and the lead study statistician. Study participants will be blinded to all adherence and fidelity assessments.
Intervention model description
Parallel arm randomized clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Ages 18-64 * TRICARE Beneficiary (active duty, retiree, dependent) * Health care visit for their MSK condition in the past 6 weeks * Diagnosed with an MSK condition that has persisted for at least 2 weeks * Has a computer (either smartphone, tablet or laptop), with video and audio capabilities for telehealth, including access to internet * Able to speak and read English well enough to provide informed consent, follow study instructions and independently answer the questionnaires * Available to attend treatment sessions over the next 2 months
Exclusion criteria
* Surgery for any MSK condition in the past 6 months * Currently known to be pregnant * Medical contraindication to exercise * Currently receiving or scheduled to receive invasive or other nonpharmacologic interventions for any MSK condition (e.g., chiropractic, injections, etc.) with the exception of a physical therapy referral, an issued profile or duty restriction, or other related patient education * Anyone separating from the military within 9 months (other than normal military retirement), pending a medical or physical evaluation board, discharge from the military for medical reasons, or pending or undergoing any litigation for an injury * Signs of serious or systemic pathology that could be responsible for the musculoskeletal pain (i.e. ankylosing spondylitis, rheumatoid arthritis, gout, lupus, vertebral osteomyelitis, or psoriatic arthritis), currently receiving treatment for cancer other than skin cancer or acute fracture (in the last 3 months) of the musculoskeletal region.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain, Enjoyment, and General Activity Scale (PEG-3) | 12 Weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PROMIS-29 | 12 Weeks | 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. |
| Pain Self-Efficacy Questionnaire (PSEQ) | 12 Weeks | 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. |
| Patient Global Assessment of Change (PGIC) | 12 Weeks | Participants' satisfaction with their intervention will be based on the single-item Patient Global Assessment of Change (PGIC). |
| PROMIS Short Form Prescription Pain Medication Misuse | 26 Weeks | 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). |
| EuroQoL (EQ-5D) | 12 Weeks | 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. |
Countries
United States
Contacts
CONTACTTina Greenlee, PhD
CONTACTCedar Sexton
Outcome results
None listed