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

Not Applicable

Completed

• Conditions: Chronic Pain; Chronic Low Back Pain; Knee Pain Chronic; Compliance, Patient
• Interventions: Other: Number of Exercises; Other: Delivery Type; Other: Type of Instruction; Other: Mobile Reminder

• Registration Number: NCT03470753
• Lead Sponsor: Dan Rhon

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-01-12
• Study First Submitted: 2018-02-07
• Study First Submitted QC: 2018-03-19
• Study First Posted: 2018-03-20
• Primary Completion: 2019-06-30
• Study Completion: 2019-11-30
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-16
• Last Update Posted: 2020-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

1. The primary complaint of low back pain or knee pain and is not actively seeking care for their contralateral knee.
2. The current episode for the injury is 6 weeks or greater
3. A home exercise program is appropriate as part of the management plan for their injury on the first day
4. Between the age of 18 and 65 years.
5. Own and utilize a smart phone
6. Read and speak English well enough to interact with the smart phone-based tool.
7. Able and willing to come in for follow-up at 1-month.

Exclusion Criteria

1. History of prior surgery to the lower extremities or spine
2. Already receiving or have received treatment for this episode of pain within the past 6 months.
3. 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
4. If participating with low back pain, known current pregnancy or history of pregnancy in the last 6 months
5. Exiting military health system in the next 2 months, pending litigation, or pending a medical separation board.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Type of instruction	Number of Exercises	Phase 1: Handout on paper versus handout and visual demonstration/performance.
Exercise Amount	Number of Exercises	Phase 1: 2 or 4 exercises.
Type of instruction	Type of Instruction	Phase 1: Handout on paper versus handout and visual demonstration/performance.
Delivery Type	Delivery Type	Phase 2: Handout vs electronic delivery
Delivery Type	Mobile Reminder	Phase 2: Handout vs electronic delivery
Reminder Type	Delivery Type	Phase 2: Mobile reminders vs no mobile reminders
Reminder Type	Mobile Reminder	Phase 2: Mobile reminders vs no mobile reminders
Exercise Amount	Type of Instruction	Phase 1: 2 or 4 exercises.

Primary Outcome Measures

Name	Time	Method
Performance Assessment Tool	1-month	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
Compliance	1-month	Subjects will be asked to submit self-reported daily compliance logs.

Secondary Outcome Measures

Name	Time	Method
Patient Reported Outcomes Measurement Information Systems (PROMIS) 57 (v2.0)	1-month	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.
Self-perception on Physical Health and Ability to Return to Work or Full Duty	1-month	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.
Patient Acceptable Symptom State (PASS)	1-month	the PASS as a global, dichotomized single-item score indicating if patients are satisfied with the current state of their symptoms.

Trial Locations

Locations (1)

Brooke Army Medical Center; 🇺🇸 San Antonio, Texas, United States