Impact of Home Exercise Delivery on Compliance & Outcomes for Musculoskeletal Pain

Study Overview
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Brief Summary
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Patients seeking care for chronic low back or knee pain will be recruited for enrollment, and randomized within two phases (retention and compliance). Patients will consent to a 2-step study design, with independent randomization for each. The initial step will assess retention based on 4 different exercise prescription strategies. This will be assessed short-term, and then the 2nd step will consist of a second independent randomization to receive different reminder strategies to determine their influence on exercise compliance at home.

Detailed Description
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Patients seeking care for their chronic low back or knee pain will be recruited to participate in a trial investigating the value of different exercise and education prescription strategies as well as strategies to determine the influence of various exercise reminder strategies. On day 1 of enrollment, patients will be randomized and instructed in two different types and amounts of exercises, as well as two types of delivery strategies. The ability to recall and perform these exercises will be assessed 20 minutes after completion of the instructional period (retention). In phase 2, patients will be randomized to receive different reminder strategies (none, email, text, and/or video) and their compliance assessed over a 1 month period (compliance). Self-reported compliance over the first month, and health care utilization outcomes will be analyzed for the 1 year following completion of the 1 month period, in all groups.

Official Title
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The Impact of Home Exercise Program Delivery Type on Exercise Compliance and Clinical Outcomes for Musculoskeletal Pain

Conditions
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Chronic Pain, Compliance, Patient, Chronic Low Back Pain, Knee Pain Chronic

Intervention / Treatment
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* Other: Number of Exercises
* Other: Type of Instruction
* Other: Delivery Type
* Other: Mobile Reminder


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The primary complaint of low back pain or knee pain and is not actively seeking care for their contralateral knee. The current episode for the injury is 6 weeks or greater A home exercise program is appropriate as part of the management plan for their injury on the first day Between the age of 18 and 65 years. Own and utilize a smart phone Read and speak English well enough to interact with the smart phone-based tool. Able and willing to come in for follow-up at 1-month. Exclusion Criteria: History of prior surgery to the lower extremities or spine Already receiving or have received treatment for this episode of pain within the past 6 months. Medical red flags of a potentially serious condition including cauda equina syndrome, major or rapidly progressing neurological deficit, fracture, malignancy, joint infection, or systemic disease If participating with low back pain, known current pregnancy or history of pregnancy in the last 6 months Exiting military health system in the next 2 months, pending litigation, or pending a medical separation board.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Exercise Amount<br>Phase 1: 2 or 4 exercises. | Other: Number of Exercises<br>* Subjects will receive either 2 or 4 exercises to evaluate the short-term recall and performance.<br>Other: Type of Instruction<br>* The type of instruction in phase 1 will be compared: Instruction by providing a handout only vs being instructed by a provider and practiced by the patient with provider feedback.<br>|
| Active Comparator: Type of instruction<br>Phase 1: Handout on paper versus handout and visual demonstration/performance. | Other: Number of Exercises<br>* Subjects will receive either 2 or 4 exercises to evaluate the short-term recall and performance.<br>Other: Type of Instruction<br>* The type of instruction in phase 1 will be compared: Instruction by providing a handout only vs being instructed by a provider and practiced by the patient with provider feedback.<br>|
| Active Comparator: Delivery Type<br>Phase 2: Handout vs electronic delivery | Other: Delivery Type<br>* In phase 2 subjects will be provided 4 exercises using only a handout vs delivered to them electronically with the addition of a video.<br>Other: Mobile Reminder<br>* A text-message based mobile reminder tool will be utilized to engage with subjects via texting on a daily basis to provide reminders and encouragement to perform their home exercises.<br>|
| Experimental: Reminder Type<br>Phase 2: Mobile reminders vs no mobile reminders | Other: Delivery Type<br>* In phase 2 subjects will be provided 4 exercises using only a handout vs delivered to them electronically with the addition of a video.<br>Other: Mobile Reminder<br>* A text-message based mobile reminder tool will be utilized to engage with subjects via texting on a daily basis to provide reminders and encouragement to perform their home exercises.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance Assessment Tool | A locally developed tool designed to meet the needs of assessing both exercise retention and compliance. It will capture the subject's ability to recall the name of an exercise, the prescribed sets and repetitions, and the ability to perform an exercise using a 4-point ordinal scale | 1-month | 
| Compliance | Subjects will be asked to submit self-reported daily compliance logs. | 1-month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Reported Outcomes Measurement Information Systems (PROMIS) 57 (v2.0) | The PROMIS 57-item short form efficiently assesses several outcomes important to patients with chronic low back and knee pain including pain intensity and interference, sleep disturbance, anxiety, depression, fatigue, and social role participation using items developed with rigorous methodology and patient input. | 1-month | 
| Patient Acceptable Symptom State (PASS) | the PASS as a global, dichotomized single-item score indicating if patients are satisfied with the current state of their symptoms. | 1-month | 
| Self-perception on Physical Health and Ability to Return to Work or Full Duty | This survey consists of a total of 9 questions, 5 of them modified from the Short Form-36. It asks questions related to the subject's perception of their physical health. The first 5 questions are related to the subject's perception of ability to return to work or full duty, the need for additional healthcare for their current condition, and function at the level that they feel is expected of them. The final 4 questions ask about their perception of general physical health. | 1-month |