Comparative Effectiveness of Early Physical Therapy Versus Usual Care for Low Back Pain (COMPETE)

This study is currently recruiting participants.
Verified September 2013 by Madigan Army Medical Center
Sponsor:
Collaborator:
U.S. Army Medical Research and Materiel Command
Information provided by (Responsible Party):
Madigan Army Medical Center
ClinicalTrials.gov Identifier:
NCT01556581
First received: March 14, 2012
Last updated: September 23, 2013
Last verified: September 2013
  Purpose

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. 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.


Condition Intervention
Low Back Pain
Procedure: Usual Care
Procedure: Early Physical Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Madigan Army Medical Center:

Primary Outcome Measures:
  • Modified Oswestry Disability Index [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Numeric Pain Rating Scale [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    The GROC 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.


Estimated Enrollment: 220
Study Start Date: September 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Usual Care
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
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
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
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).

Detailed Description:

The specific aims of this study are the following:

  1. 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.
  2. 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.
  3. Evaluate the importance of psychosocial factors on outcomes within both groups of treatment.
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria -

  • 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

Exclusion Criteria:

  • 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01556581

Contacts
Contact: Daniel Rhon, PT, DPT, DSc 2539680780 daniel.rhon@us.army.mil

Locations
United States, Washington
Madigan Army Medical Center Recruiting
Tacoma, Washington, United States, 98431
Sponsors and Collaborators
Madigan Army Medical Center
U.S. Army Medical Research and Materiel Command
Investigators
Study Chair: Julie Fritz, PT, PhD University of Utah