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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-12

Study Completion Date

2019-11-30

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.

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Exercise Amount

Phase 1: 2 or 4 exercises.

Group Type ACTIVE_COMPARATOR

Number of Exercises

Intervention Type OTHER

Subjects will receive either 2 or 4 exercises to evaluate the short-term recall and performance.

Type of Instruction

Intervention Type OTHER

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.

Type of instruction

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

Group Type ACTIVE_COMPARATOR

Number of Exercises

Intervention Type OTHER

Subjects will receive either 2 or 4 exercises to evaluate the short-term recall and performance.

Type of Instruction

Intervention Type OTHER

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.

Delivery Type

Phase 2: Handout vs electronic delivery

Group Type ACTIVE_COMPARATOR

Delivery Type

Intervention Type OTHER

In phase 2 subjects will be provided 4 exercises using only a handout vs delivered to them electronically with the addition of a video.

Mobile Reminder

Intervention Type OTHER

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.

Reminder Type

Phase 2: Mobile reminders vs no mobile reminders

Group Type EXPERIMENTAL

Delivery Type

Intervention Type OTHER

In phase 2 subjects will be provided 4 exercises using only a handout vs delivered to them electronically with the addition of a video.

Mobile Reminder

Intervention Type OTHER

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.

Interventions

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Number of Exercises

Subjects will receive either 2 or 4 exercises to evaluate the short-term recall and performance.

Intervention Type OTHER

Type of Instruction

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.

Intervention Type OTHER

Delivery Type

In phase 2 subjects will be provided 4 exercises using only a handout vs delivered to them electronically with the addition of a video.

Intervention Type OTHER

Mobile Reminder

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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No