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

• 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.

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.

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.

• 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.
• 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).

• 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.
  Intervention: Procedure: Usual Care
• 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.
  Intervention: Procedure: Early Physical Therapy

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)