Low Back PainCOMPETENCT01556581
Comparative Effectiveness of Early Physical Therapy Versus Usual Care for Low Back Pain
A study testing Early Physical Therapy (PT) in people with Low Back Pain, run by Madigan Army Medical Center at 1 site in United States.
Trial summary
The primary purpose of this study is to compare the effectiveness of two management strategies for patients with a recent onset of low back pain (LBP). One is based on usual care and the other is based on early access to physical therapy following a pragmatic treatment-based classification approach. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Early Physical Therapy (PT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to 1 Oct 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Military personnel on active duty and eligible for healthcare at a military treatment facility
- A primary complaint of low back pain defined as symptoms of pain and/or numbness between the 12th rib and buttocks with or without symptoms into the leg(s), which, in the opinion of the provider, are originating from tissues of the lumbar region.
- Duration of current episode of low back pain < 90 days
- Age 18 - 60 years (or emancipated minors on active duty)
- Available for the following 4 weeks to complete a regimen of treatment
Who cannot join
- Oswestry Disability Index < 20%
- History of receiving any medical care for this episode of low back pain within the last 3 months
- Prior surgery to the thoraco-lumbar spine or pelvis
- This episode of back pain is due to a traumatic fracture
- Pending a medical or physical evaluation board or discharge process, pending any litigation related to the condition, or planning on getting out of the military within the next 9 months.
- Any "red flags" that would indicate a potentially serious condition or other significant disease process. These could include but not limited to cauda equina syndrome, large or rapidly progressing neurological deficit, fracture, cancer, ankylosing spondylitis, or other systemic disease.
- Current episode occurred because of a motor vehicle accident
- Currently pregnant (or history of pregnancy in the previous 6 months)
Trial locations and contacts
1 site in 1 country.
United States1 site
Madigan Army Medical Center
Tacoma, Washington, 98431
About this study
Official title: Effectiveness and Subsequent Healthcare Use Associated With Early Physical Therapy Access Compared With a Stepped Usual Care Approach for Treatment of Low Back Pain.
The primary purpose of this study is to compare the effectiveness of two management strategies for patients with a recent onset of low back pain (LBP). One is based on usual care and the other is based on early access to physical therapy following a pragmatic treatment-based classification approach. The secondary purposes are to compare the subsequent healthcare utilization associated with two management strategies as well as to evaluate the importance of psychosocial factors on outcomes within both groups of treatment. The overall hypothesis guiding the study is that the additional initial treatment expense incurred by early implementation will result in superior short-term clinical effectiveness, and will be more cost-effective in the long-term due to reduced healthcare utilization. We will also explore the importance of psychosocial factors on outcomes within both treatment groups, which may provide insights for further improving treatment strategies.
Read the detailed description
The specific aims of this study are the following:
- Compare the effectiveness of two primary care management strategies for patients with a recent onset of combat-related LBP. We hypothesize early physical therapy access for these Soldiers will result in greater improvements in function and quality of life over 1 year as compared to a stepped care strategy.
- Compare the subsequent healthcare utilization associated with two management strategies for patients with a recent onset combat-related LBP. We hypothesize early physical therapy access will result in decreased healthcare utilization over 1 year as compared to a stepped care strategy.
- Evaluate the importance of psychosocial factors on outcomes within both groups of treatment.
- Conditions
- Low Back Pain
- Being tested
- Usual Care (UC), Early Physical Therapy (PT)
- Keywords
- back pain, primary care, physical therapy
- Medical subject headings
- Low Back Pain, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual Care (UC)Procedure or surgery
Initial management for all patients will include an activity-limiting profile for up to 30 days and a 10-day supply of medications if needed (NSAIDs and muscle relaxers). All patients will then receive advice and education about the favorable natural history of LBP and the advantages of remaining as active as possible. All patients will be recommended to follow-up with their primary care provider using normal procedures if they are not satisfied with their progress.
Early Physical Therapy (PT)Procedure or surgery
Patients in the early PT group will receive the same treatment as the usual care group, but will then be referred to physical therapy within 3 days. The physical therapy treatment will be based on the Treatment Based Classification system (an approach that places patients into either an extension-oriented, core strength/stabilization, or a spinal manipulation treatment group based on signs and symptoms).
| Study group | Role | What they receive |
|---|---|---|
| Usual Care (UC) | Active comparator | The usual care (UC) group will be managed with stepped care approach, receiving a screening exam, advice, education, activity limitation profile and medications if needed, but no early physical therapy. Receives: Procedure: Usual Care (UC) |
| Early Physical Therapy (PT) | Active comparator | All subjects in this group will get usual care approach in addition to immediately receiving eight sessions of physical therapy based on a pragmatic treatment based classification system for treating low back pain. Receives: Procedure: Early Physical Therapy (PT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Oswestry Disability Index
The Modified Oswestry Disability Questionnaire (OSW) is a 10-item condition-specific measure of functional status (pain and disability) for patients with low back pain (LBP). Each question has 6 possible answers (0 = worse, 5 = best). The raw score is doubled to provide a percent score from 0 to 100%; with 0 equaling no disability and 100% equalling the worst possible outcome. It measures pain-related disability. We used the modified version that replaces the sex life item with an employment/ homemaking item due to poor compliance with the former. The OSW is widely used in research on non-operative management of patients with LBP, with high levels of test-retest reliability among stable patients (ICC = 0.90), good construct validity, and responsiveness to change for patients with acute LBP. It has a minimum clinically important difference of 6 points.
Measured: 12 months
Secondary outcomes (2)
Numeric Pain Rating Scale (NPRS)
A 0-10 numeric pain rating scale ('0' indicating no pain, and '10' worst imaginable pain) will be used to assess LBP intensity. Numeric pain scales are known to have excellent test-retest reliability. Previous research has found the NPRS to be responsive to change, with a minimum clinically important difference of two points among patients with acute LBP receiving physical therapy.
Measured: 12 months
Global Rating of Change (GRC) of +3 or More (Minimum Clinically Important Change)
The GRC is a 15-point scale that asks the patient to rate the degree of change in his or her condition from the beginning of treatment to the present. The mid-point of the scale is no change (0). Ratings from -1 to -7 represent varying degrees of a worsening of the patient's condition, while rating from +1 to +7 represent varying degrees of improvement. A score of 3 or higher is considered clinically meaningful change.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completion27 Jul 2016
- Study completion1 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Low Back 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Madigan Army Medical Center
- Sponsor type
- US federal agency
- Collaborators
- U.S. Army Medical Research and Development Command, William Beaumont Army Medical Center
- Responsible party
- Sponsor
- Investigators
- Julie Fritz, PT, PhD, Study chair, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01556581
- Sponsor's protocol ID
- 211107
- Acronym
- COMPETE
- Status last verified
- Jun 2020
- First submitted
- 14 Mar 2012
- Last updated
- 14 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Any data sharing must go through a Data Sharing Agreement through the Defense Health Agency
Publications
Fritz JM, Childs JD, Wainner RS, Flynn TW. Primary care referral of patients with low back pain to physical therapy: impact on future health care utilization and costs. Spine (Phila Pa 1976). 2012 Dec 1;37(25):2114-21. doi: 10.1097/BRS.0b013e31825d32f5.
PubMed 22614792Fritz JM, Brennan GP, Hunter SJ, Magel JS. Initial management decisions after a new consultation for low back pain: implications of the usage of physical therapy for subsequent health care costs and utilization. Arch Phys Med Rehabil. 2013 May;94(5):808-16. doi: 10.1016/j.apmr.2013.01.008. Epub 2013 Jan 18.
PubMed 23337426Fritz JM, Cleland JA, Speckman M, Brennan GP, Hunter SJ. Physical therapy for acute low back pain: associations with subsequent healthcare costs. Spine (Phila Pa 1976). 2008 Jul 15;33(16):1800-5. doi: 10.1097/BRS.0b013e31817bd853.
PubMed 18628714Rhon DI, Miller RB, Fritz JM. Effectiveness and Downstream Healthcare Utilization for Patients That Received Early Physical Therapy Versus Usual Care for Low Back Pain: A Randomized Clinical Trial. Spine (Phila Pa 1976). 2018 Oct 1;43(19):1313-1321. doi: 10.1097/BRS.0000000000002619.
PubMed 29489568Rhon D, Fritz J. COMParative Early Treatment Effectiveness between physical therapy and usual care for low back pain (COMPETE): study protocol for a randomized controlled trial. Trials. 2015 Sep 23;16:423. doi: 10.1186/s13063-015-0959-8.
PubMed 26399603
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Subsequent Healthcare Use Associated With Early Physical Therapy Access Compared With a Stepped Usual Care Approach for Treatment of Low Back Pain.
- ClinicalTrials.gov ID
- NCT01556581
- Acronym / sponsor ID
- COMPETE / 211107
- Conditions
- Low Back Pain
- Keywords
- back pain, primary care, physical therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Madigan Army Medical CenterUS federal agency
- Collaborators
- U.S. Army Medical Research and Development Command, William Beaumont Army Medical Center
- Study start
- Feb 2012 (actual)
- Primary completion
- 27 Jul 2016 (actual)
- Study completion
- 1 Oct 2017 (actual)
- First posted
- 16 Mar 2012 (estimated)
- Results
- Posted 14 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to compare the effectiveness of two management strategies for patients with a recent onset of low back pain (LBP). One is based on usual care and the other is based on early access to physical therapy following a pragmatic treatment-based classification approach. The secondary purposes are to compare the subsequent healthcare utilization associated with two management strategies as well as to evaluate the importance of psychosocial factors on outcomes within both groups of treatment. The overall hypothesis guiding the study is that the additional initial treatment expense incurred by early implementation will result in superior short-term clinical effectiveness, and will be more cost-effective in the long-term due to reduced healthcare utilization. We will also explore the importance of psychosocial factors on outcomes within both treatment groups, which may provide insights for further improving treatment strategies.
Detailed description
The specific aims of this study are the following:
- Compare the effectiveness of two primary care management strategies for patients with a recent onset of combat-related LBP. We hypothesize early physical therapy access for these Soldiers will result in greater improvements in function and quality of life over 1 year as compared to a stepped care strategy.
- Compare the subsequent healthcare utilization associated with two management strategies for patients with a recent onset combat-related LBP. We hypothesize early physical therapy access will result in decreased healthcare utilization over 1 year as compared to a stepped care strategy.
- Evaluate the importance of psychosocial factors on outcomes within both groups of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care (UC) | Active comparator | Procedure: Usual Care (UC)The usual care (UC) group will be managed with stepped care approach, receiving a screening exam, advice, education, activity limitation profile and medications if needed, but no early physical therapy. |
| Early Physical Therapy (PT) | Active comparator | Procedure: Early Physical Therapy (PT)All subjects in this group will get usual care approach in addition to immediately receiving eight sessions of physical therapy based on a pragmatic treatment based classification system for treating low back pain. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Military personnel on active duty and eligible for healthcare at a military treatment facility
- A primary complaint of low back pain defined as symptoms of pain and/or numbness between the 12th rib and buttocks with or without symptoms into the leg(s), which, in the opinion of the provider, are originating from tissues of the lumbar region.
- Duration of current episode of low back pain < 90 days
- Age 18 - 60 years (or emancipated minors on active duty)
- Available for the following 4 weeks to complete a regimen of treatment
Key exclusion criteria (8 listed)
- Oswestry Disability Index < 20%
- History of receiving any medical care for this episode of low back pain within the last 3 months
- Prior surgery to the thoraco-lumbar spine or pelvis
- This episode of back pain is due to a traumatic fracture
- Pending a medical or physical evaluation board or discharge process, pending any litigation related to the condition, or planning on getting out of the military within the next 9 months.
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 |
|---|---|---|
| Usual Care (UC)Initial management for all patients will include an activity-limiting profile for up to 30 days and a 10-day supply of medications if needed (NSAIDs and muscle relaxers). All patients will then receive advice and education about the favorable natural history of LBP and the advantages of remaining as active as possible. All patients will be recommended to follow-up with their primary care provider using normal procedures if they are not satisfied with their progress. | Procedure or surgery | Usual Care (UC) |
| Early Physical Therapy (PT)Patients in the early PT group will receive the same treatment as the usual care group, but will then be referred to physical therapy within 3 days. The physical therapy treatment will be based on the Treatment Based Classification system (an approach that places patients into either an extension-oriented, core strength/stabilization, or a spinal manipulation treatment group based on signs and symptoms). | Procedure or surgery | Early Physical Therapy (PT) |
Primary outcome
Modified Oswestry Disability Index
Time frame: 12 months
The Modified Oswestry Disability Questionnaire (OSW) is a 10-item condition-specific measure of functional status (pain and disability) for patients with low back pain (LBP). Each question has 6 possible answers (0 = worse, 5 = best). The raw score is doubled to provide a percent score from 0 to 100%; with 0 equaling no disability and 100% equalling the worst possible outcome. It measures pain-related disability. We used the modified version that replaces the sex life item with an employment/ homemaking item due to poor compliance with the former. The OSW is widely used in research on non-operative management of patients with LBP, with high levels of test-retest reliability among stable patients (ICC = 0.90), good construct validity, and responsiveness to change for patients with acute LBP. It has a minimum clinically important difference of 6 points.
2 secondary outcomes
Numeric Pain Rating Scale (NPRS)
Time frame: 12 months
Global Rating of Change (GRC) of +3 or More (Minimum Clinically Important Change)
Time frame: 12 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22614792Fritz JM, Childs JD, Wainner RS, Flynn TW. Primary care referral of patients with low back pain to physical therapy: impact on future health care utilization and costs. Spine (Phila Pa 1976). 2012 Dec 1;37(25):2114-21. doi: 10.1097/BRS.0b013e31825d32f5.
- Background: PubMed 23337426Fritz JM, Brennan GP, Hunter SJ, Magel JS. Initial management decisions after a new consultation for low back pain: implications of the usage of physical therapy for subsequent health care costs and utilization. Arch Phys Med Rehabil. 2013 May;94(5):808-16. doi: 10.1016/j.apmr.2013.01.008. Epub 2013 Jan 18.
- Background: PubMed 18628714Fritz JM, Cleland JA, Speckman M, Brennan GP, Hunter SJ. Physical therapy for acute low back pain: associations with subsequent healthcare costs. Spine (Phila Pa 1976). 2008 Jul 15;33(16):1800-5. doi: 10.1097/BRS.0b013e31817bd853.
- Derived from this study: PubMed 29489568Rhon DI, Miller RB, Fritz JM. Effectiveness and Downstream Healthcare Utilization for Patients That Received Early Physical Therapy Versus Usual Care for Low Back Pain: A Randomized Clinical Trial. Spine (Phila Pa 1976). 2018 Oct 1;43(19):1313-1321. doi: 10.1097/BRS.0000000000002619.
- Derived from this study: PubMed 26399603Rhon D, Fritz J. COMParative Early Treatment Effectiveness between physical therapy and usual care for low back pain (COMPETE): study protocol for a randomized controlled trial. Trials. 2015 Sep 23;16:423. doi: 10.1186/s13063-015-0959-8.
- Individual participant dataSharing planned: Yes. Any data sharing must go through a Data Sharing Agreement through the Defense Health Agency
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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.
Julie Fritz, PT, PhD study chair
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Physical Therapy (PT) in people with Low Back Pain, run by Madigan Army Medical Center 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 5 inclusion and 8 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 14 Jul 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?
Yes. Results are posted in the registry (first posted 14 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Modified Oswestry Disability Index (time frame: 12 months). 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 NCT01556581, which also lists 5 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 14 Jul 2020.