ClinicalTrials.gg
CompletedNCT03470753Updated Jan 18, 2020

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

An interventional study of Number of Exercises and Type of Instruction in Chronic Pain, Compliance, Patient and Chronic Low Back Pain, sponsored by Dan Rhon. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-01-18.

Sponsored by Dan Rhon · Not applicable, Interventional, and Treatment

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Phase
Not applicable
Study type
Interventional
Enrollment
116
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 1,283 studies in Chronic Pain with a site in United States — 258 open to participants now, 349 under way, 7 of them phase 3. Chronic Pain · United States.

Enrollment
336th of 1,092
116 · median 60
Started
2018
with 90 others
No phase
803 of 1,283
169 open now
Registered
440th of 1,283
by date

Among the 1,283 studies in Chronic Pain with a site in United States, this one is the 336th largest by enrollment of the 1,092 interventional ones that give a count, is one of 91 that started in 2018, is one of 803 with no phase, and was the 440th registered.

Chronic Pain

3,227 studies on the registry are indexed under Chronic Pain; 728 are open to participants now.

Browse Chronic Pain studies →

Open to participants now

258 of the 1,283 studies in Chronic Pain with a site in United States are open now. Recruiting first, the newest first:

253 more — sign in →

All 258 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 486 Chronic Pain studies recruiting now, 239 (49%) set no upper age limit and 173 (36%) stop at 75 or younger; 43 take children under 18; 64 take healthy volunteers.

This study: 18 Years to 65 Years · all sexes · no healthy volunteers.

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02

Study 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.

Read the 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.

03

Conditions studied

  • Chronic Pain
  • Compliance, Patient
  • Chronic Low Back Pain
  • Knee Pain Chronic
04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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, , 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
116 participants (actual)

Study arms

  • Active comparator
    Exercise Amount

    Phase 1: 2 or 4 exercises.

    Other: Number of Exercises · Other: Type of Instruction

  • Active comparator
    Type of instruction

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

    Other: Number of Exercises · Other: Type of Instruction

  • Active comparator
    Delivery Type

    Phase 2: Handout vs electronic delivery

    Other: Delivery Type · Other: Mobile Reminder

  • Experimental
    Reminder Type

    Phase 2: Mobile reminders vs no mobile reminders

    Other: Delivery Type · Other: Mobile Reminder

Interventions

  • OtherNumber of Exercises

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

  • OtherType 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.

  • OtherDelivery 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.

  • OtherMobile 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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 1-month

  2. Compliance

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

    Time frame: 1-month

Secondary outcomes

  1. 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.

    Time frame: 1-month

  2. 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.

    Time frame: 1-month

  3. 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.

    Time frame: 1-month

07

Study locations

1 site
  • Brooke Army Medical Center
    San Antonio, Texas 78219, United States
08

References and documents

Publications

  • 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. PubMed 20091582 ↗
  • 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. PubMed 24972606 ↗
  • 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 05;148(3):247-8. doi: 10.7326/0003-4819-148-3-200802050-00020. PubMed 17909210 ↗
  • 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. PubMed 15867410 ↗
  • 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. PubMed 20163979 ↗
  • 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. PubMed 25934517 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2018 to primary completion in Jun 2019, 17 months.

Of 1,295 non-industry interventional studies with no phase under Chronic Pain, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 39. This study's 17 months is below that.

Counting every sponsor, half of 1,378 studies reached it within 20 months; a quarter within 9 and three quarters within 38.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 7, 2018
First posted
Mar 20, 2018
StartActual
Jan 12, 2018
Primary completionActual
Jun 30, 2019
CompletionActual
Nov 30, 2019
Last update
Jan 18, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 18, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03470753
Lead sponsor
Dan Rhon
Responsible party
Dan Rhon (Researcher, Brooke Army Medical Center) — Sponsor-investigator
First posted
Mar 20, 2018
Start date
Jan 12, 2018
Primary completion
Jun 30, 2019
Completion
Nov 30, 2019
Last update
Jan 18, 2020

Study contacts

Daniel Rhon, DSc
principal investigator · Brooke Army Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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