Skip to main content
OpenTrials
Completed

NCT Number: NCT03470753

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Pain Behavior Chronic Low Back Pain Compliance, Patient Health Behavior Knee Pain Chronic Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Compliance Signs and Symptoms Treatment Adherence and Compliance

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brooke Army Medical Center

San Antonio, Texas, 78219, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Number of Exercises

Other

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

Type of Instruction

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

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

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.

Primary outcomes

  1. Performance Assessment Tool

    Time frame: 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

  2. Compliance

    Time frame: 1-month

    Subjects will be asked to submit self-reported daily compliance logs.

Secondary outcomes

  1. Patient Reported Outcomes Measurement Information Systems (PROMIS) 57 (v2.0)

    Time frame: 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.

  2. Patient Acceptable Symptom State (PASS)

    Time frame: 1-month

    the PASS as a global, dichotomized single-item score indicating if patients are satisfied with the current state of their symptoms.

  3. Self-perception on Physical Health and Ability to Return to Work or Full Duty

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Dan Rhon

Fed

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 20, 2018
Registry last updated
Jan 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.