Comparative Effectiveness of Early Physical Therapy Versus Usual Care for Low Back Pain (COMPETE)
|ClinicalTrials.gov Identifier: NCT01556581|
Recruitment Status : Completed
First Posted : March 16, 2012
Last Update Posted : September 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Low Back Pain||Procedure: Usual Care (UC) Procedure: Early Physical Therapy (PT)||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||119 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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.|
|Actual Study Start Date :||February 2012|
|Actual Primary Completion Date :||July 27, 2016|
|Actual Study Completion Date :||December 2016|
Active Comparator: 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.
Procedure: 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.
Active Comparator: 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.
Procedure: 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).
- Modified Oswestry Disability Index [ Time Frame: 12 months ]The Oswestry Disability Questionnaire (OSW) is a 10-item condition-specific measure of functional status for patients with LBP. We will use 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.
- Numeric Pain Rating Scale (NPRS) [ Time Frame: 12 months ]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.
- Fear Avoidance Belief Questionnaire (FABQ) [ Time Frame: 12 Months ]The Fear Avoidance Beliefs Questionnaire will be used to measure patients' beliefs about how physical activity and work may affect their LBP and perceived risk for re-injury. The FABQ contains two subscales; a 7-item work subscale (FABQW), and 4-item physical activity subscale (FABQPA). Test-retest reliability of the FABQ subscales is high, and validity is supported by associations with disability and work loss in patients with acute and chronic LBP. Heightened fear-avoidance beliefs have been shown to be a risk factor for the development of chronic LBP following an acute episode.
- Pain Catastrophizing Scale (PCS) [ Time Frame: 12 months ]The PCS is a 13-item patient-report scale developed to measure the extent to which people catastrophize in response to pain. Each item is scored from 0 ('not at all') to 4 ('all the time'). The PCS is reported as a total score, with higher scores indicating greater catastrophizing, and is composed of three sub-scales: Rumination, Magnification, and Helplessness. The PCS has been shown to have high levels of internal consistency and construct validity.
- Global Rating of Change (GRC) [ Time Frame: 12 Months ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01556581
|United States, Washington|
|Madigan Army Medical Center|
|Tacoma, Washington, United States, 98431|
|Study Chair:||Julie Fritz, PT, PhD||University of Utah|