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

Primary Purpose

Chronic Pain, Compliance, Patient, Chronic Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Number of Exercises
Type of Instruction
Delivery Type
Mobile Reminder
Sponsored by
Dan Rhon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Brooke Army Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Experimental

Arm Label

Exercise Amount

Type of instruction

Delivery Type

Reminder Type

Arm Description

Phase 1: 2 or 4 exercises.

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

Phase 2: Handout vs electronic delivery

Phase 2: Mobile reminders vs no mobile reminders

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
February 7, 2018
Last Updated
January 16, 2020
Sponsor
Dan Rhon
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1. Study Identification

Unique Protocol Identification Number
NCT03470753
Brief Title
Impact of Home Exercise Delivery on Compliance & Outcomes for Musculoskeletal Pain
Official Title
The Impact of Home Exercise Program Delivery Type on Exercise Compliance and Clinical Outcomes for Musculoskeletal Pain
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
January 12, 2018 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
November 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dan Rhon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Compliance, Patient, Chronic Low Back Pain, Knee Pain Chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise Amount
Arm Type
Active Comparator
Arm Description
Phase 1: 2 or 4 exercises.
Arm Title
Type of instruction
Arm Type
Active Comparator
Arm Description
Phase 1: Handout on paper versus handout and visual demonstration/performance.
Arm Title
Delivery Type
Arm Type
Active Comparator
Arm Description
Phase 2: Handout vs electronic delivery
Arm Title
Reminder Type
Arm Type
Experimental
Arm Description
Phase 2: Mobile reminders vs no mobile reminders
Intervention Type
Other
Intervention Name(s)
Number of Exercises
Intervention Description
Subjects will receive either 2 or 4 exercises to evaluate the short-term recall and performance.
Intervention Type
Other
Intervention Name(s)
Type of Instruction
Intervention Description
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
Intervention Name(s)
Delivery Type
Intervention Description
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
Intervention Name(s)
Mobile Reminder
Intervention Description
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 Outcome Measure Information:
Title
Performance Assessment Tool
Description
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
Time Frame
1-month
Title
Compliance
Description
Subjects will be asked to submit self-reported daily compliance logs.
Time Frame
1-month
Secondary Outcome Measure Information:
Title
Patient Reported Outcomes Measurement Information Systems (PROMIS) 57 (v2.0)
Description
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.
Time Frame
1-month
Title
Patient Acceptable Symptom State (PASS)
Description
the PASS as a global, dichotomized single-item score indicating if patients are satisfied with the current state of their symptoms.
Time Frame
1-month
Title
Self-perception on Physical Health and Ability to Return to Work or Full Duty
Description
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.
Time Frame
1-month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Rhon, DSc
Organizational Affiliation
Brooke Army Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brooke Army Medical Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78219
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20091582
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;2010(1):CD005956. doi: 10.1002/14651858.CD005956.pub2.
Results Reference
background
PubMed Identifier
24972606
Citation
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.
Results Reference
background
PubMed Identifier
17909210
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. doi: 10.7326/0003-4819-147-7-200710020-00007. Erratum In: Ann Intern Med. 2008 Feb 5;148(3):247-8.
Results Reference
background
PubMed Identifier
15867410
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. doi: 10.7326/0003-4819-142-9-200505030-00014.
Results Reference
background
PubMed Identifier
20163979
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.
Results Reference
background
PubMed Identifier
25934517
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.
Results Reference
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Impact of Home Exercise Delivery on Compliance & Outcomes for Musculoskeletal Pain

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