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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03470753
• Other study ID #: C.2017.093d
• Status: Completed
• Phase: N/A
• Start date: January 12, 2018
• Est. completion date: November 30, 2019

Study information

• Verified date: January 2020
• Source: Brooke Army Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: November 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Other:
• Number of Exercises
Subjects will receive either 2 or 4 exercises to evaluate the short-term recall and performance.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Brooke Army Medical Center	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Dan Rhon

Country where clinical trial is conducted

United States, 

References & Publications (6)

Bollen JC, Dean SG, Siegert RJ, Howe TE, Goodwin VA. A systematic review of measures of self-reported adherence to unsupervised home-based rehabilitation exercise programmes, and their psychometric properties. BMJ Open. 2014 Jun 27;4(6):e005044. doi: 10.1136/bmjopen-2014-005044. Review. — View Citation

Chou R, Huffman LH; American Pain Society; American College of Physicians. Nonpharmacologic therapies for acute and chronic low back pain: a review of the evidence for an American Pain Society/American College of Physicians clinical practice guideline. Ann Intern Med. 2007 Oct 2;147(7):492-504. Review. Erratum in: Ann Intern Med. 2008 Feb 5;148(3):247-8. — View Citation

Hayden JA, van Tulder MW, Tomlinson G. Systematic review: strategies for using exercise therapy to improve outcomes in chronic low back pain. Ann Intern Med. 2005 May 3;142(9):776-85. Review. — View Citation

Holcomb LS. A Taxonomic Integrative Review of Short Message Service (SMS) Methodology: A Framework for Improved Diabetic Outcomes. J Diabetes Sci Technol. 2015 Apr 30;9(6):1321-6. doi: 10.1177/1932296815585132. Review. — View Citation

Jack K, McLean SM, Moffett JK, Gardiner E. Barriers to treatment adherence in physiotherapy outpatient clinics: a systematic review. Man Ther. 2010 Jun;15(3):220-8. doi: 10.1016/j.math.2009.12.004. Epub 2010 Feb 16. Review. — View Citation

Jordan JL, Holden MA, Mason EE, Foster NE. Interventions to improve adherence to exercise for chronic musculoskeletal pain in adults. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD005956. doi: 10.1002/14651858.CD005956.pub2. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Compliance	Subjects will be asked to submit self-reported daily compliance logs.	1-month
Secondary	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
Secondary	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
Secondary	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