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

Dan Rhon

Status: Completed

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

Treatments: Other: Delivery Type; Other: Mobile Reminder; Other: Number of Exercises; Other: Type of Instruction

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT03470753

C.2017.093d

Details and patient eligibility

About

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.

Full 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.

Enrollment: 116 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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116 participants in 4 patient groups

Exercise Amount

Active Comparator group

Description:

Phase 1: 2 or 4 exercises.

Treatment:

Other: Type of Instruction

Other: Number of Exercises

Type of instruction

Active Comparator group

Description:

Phase 1: Handout on paper versus handout and visual demonstration/performance.

Treatment:

Other: Type of Instruction

Other: Number of Exercises

Delivery Type

Active Comparator group

Description:

Phase 2: Handout vs electronic delivery

Treatment:

Other: Delivery Type

Other: Mobile Reminder

Reminder Type

Experimental group

Description:

Phase 2: Mobile reminders vs no mobile reminders

Treatment:

Other: Delivery Type

Other: Mobile Reminder