Chronic PainNCT03470753
Impact of Home Exercise Delivery on Compliance & Outcomes for Musculoskeletal Pain
A study testing Number of Exercises, Type of Instruction and Delivery Type in people with Chronic Pain and Compliance, Patient, run by Dan Rhon at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Pain, Compliance, Patient, Chronic Low Back Pain
- What is being tested?
- Number of Exercises, Type of Instruction and Delivery Type
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jan 2018to 30 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brooke Army Medical Center
San Antonio, Texas, 78219
About this study
Official title: The Impact of Home Exercise Program Delivery Type on Exercise Compliance and Clinical 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.
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.
- Being tested
- Number of Exercises, Type of Instruction, Delivery Type, Mobile Reminder
- Medical subject headings
- Chronic Pain, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Number of ExercisesOther
Subjects will receive either 2 or 4 exercises to evaluate the short-term recall and performance.
Type of InstructionOther
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 TypeOther
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 ReminderOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Amount | Active comparator | Phase 1: 2 or 4 exercises. Receives: Other: Number of Exercises; Other: Type of Instruction |
| Type of instruction | Active comparator | Phase 1: Handout on paper versus handout and visual demonstration/performance. Receives: Other: Number of Exercises; Other: Type of Instruction |
| Delivery Type | Active comparator | Phase 2: Handout vs electronic delivery Receives: Other: Delivery Type; Other: Mobile Reminder |
| Reminder Type | Experimental | Phase 2: Mobile reminders vs no mobile reminders Receives: Other: Delivery Type; Other: Mobile Reminder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1-month
Compliance
Subjects will be asked to submit self-reported daily compliance logs.
Measured: 1-month
Secondary outcomes (3)
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.
Measured: 1-month
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.
Measured: 1-month
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.
Measured: 1-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2018
- Study start12 Jan 2018
- Primary completion30 Jun 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dan Rhon
- Sponsor type
- US federal agency
- Responsible party
- Sponsor-investigator, Dan Rhon, Brooke Army Medical Center
- Investigators
- Daniel Rhon, DSc, Principal investigator, Brooke Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03470753
- Sponsor's protocol ID
- C.2017.093d
- Status last verified
- Jan 2020
- First submitted
- 7 Feb 2018
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 20091582Bollen 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 24972606Chou 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.
PubMed 17909210Hayden 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 15867410Jack 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 20163979Holcomb 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
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Home Exercise Program Delivery Type on Exercise Compliance and Clinical Outcomes for Musculoskeletal Pain
- ClinicalTrials.gov ID
- NCT03470753
- Acronym / sponsor ID
- C.2017.093d
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Dan RhonUS federal agency
- Study start
- 12 Jan 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 20 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Exercise Amount | Active comparator | Other: Number of Exercises, Other: Type of InstructionPhase 1: 2 or 4 exercises. |
| Type of instruction | Active comparator | Other: Number of Exercises, Other: Type of InstructionPhase 1: Handout on paper versus handout and visual demonstration/performance. |
| Delivery Type | Active comparator | Other: Delivery Type, Other: Mobile ReminderPhase 2: Handout vs electronic delivery |
| Reminder Type | Experimental | Other: Delivery Type, Other: Mobile ReminderPhase 2: Mobile reminders vs no mobile reminders |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Number of ExercisesSubjects will receive either 2 or 4 exercises to evaluate the short-term recall and performance. | Other | Exercise Amount, Type of instruction |
| Type of InstructionThe 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. | Other | Exercise Amount, Type of instruction |
| Delivery TypeIn phase 2 subjects will be provided 4 exercises using only a handout vs delivered to them electronically with the addition of a video. | Other | Delivery Type, Reminder Type |
| Mobile ReminderA 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. | Other | Delivery Type, Reminder Type |
Primary outcome
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
Compliance
Time frame: 1-month
Subjects will be asked to submit self-reported daily compliance logs.
3 secondary outcomes
Patient Reported Outcomes Measurement Information Systems (PROMIS) 57 (v2.0)
Time frame: 1-month
Patient Acceptable Symptom State (PASS)
Time frame: 1-month
Self-perception on Physical Health and Ability to Return to Work or Full Duty
Time frame: 1-month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Background: PubMed 20091582Jordan 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.
- Background: PubMed 24972606Bollen 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.
- Background: PubMed 17909210Chou 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.
- Background: PubMed 15867410Hayden 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.
- Background: PubMed 20163979Jack 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.
- Background: PubMed 25934517Holcomb 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Rhon, DSc principal investigator
Brooke Army Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Number of Exercises, Type of Instruction and Delivery Type in people with Chronic Pain and Compliance, Patient, run by Dan Rhon at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance Assessment Tool (time frame: 1-month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03470753, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.