Management Strategies for Patients With Low Back Pain and Sciatica
Condition: Low Back Pain; Sciatica; Physical Therapy
MeSH terms: Sciatica; Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Low back pain and sciatica is a common condition resulting in high costs and disability for
      society and affected individuals. Presently there is a lack of evidence for what treatments
      may help this condition early in the course of care. Improved early management could reduce
      risks for persistent disability and high costs. The goal of this project is to examine the
      clinical outcomes and costs associated with adding a physical therapy program to early
      management of patients with low back pain and sciatica within primary care.
    

Detailed description: 
      Low back pain (LBP) is a common and costly condition. When accompanied by sciatica, risks for
      persistent disability and future invasive treatments increase. Most patients with LBP and
      sciatica enter the healthcare system in primary care. Optimal primary care management is
      currently unclear and little data are available to assist clinicians and inform patients of
      the likely effects of common options. Practice guidelines agree that imaging, spinal
      injections and surgeries should be reserved for patients whose symptoms do not diminish
      within 4-8 weeks, yet utilization rates for these procedures are increasing rapidly, partly
      due to the uncertainty of what options may be offered to patients for initial treatment.
      Physical therapy is considered an option in the initial management period, but is used
      inconsistently. It is currently unclear what can be expected from early physical therapy for
      patients with LBP and sciatica, and what if any long-term effect it may have on clinical
      outcomes or future healthcare utilization. The investigators research team has conducted a
      series of clinical trials to clarify the evidence for the most effective physical therapy
      procedures for patients with LBP and sciatica, and is now in a position to evaluate if the
      use of early, evidence-based physical therapy can reduce the risk of future disability,
      healthcare utilization and costs. The proposed study is a randomized trial comparing the
      effectiveness of usual, guideline-based initial management of newly consulting patients with
      LBP with sciatica with or without the addition of early physical therapy. Specific aims are
      to compare the clinical effectiveness, costs (direct and indirect), and cost-effectiveness of
      the addition of physical therapy. All patients will be managed with advice, education and
      medication. One group will also receive 6-8 sessions of physical therapy Outcomes will
      include measures of disability, pain, psychological distress, healthcare, utilization, and
      costs over 1 year. This study will permit an examination of the effectiveness and costs
      associated with the use of early physical therapy within primary care for patients with acute
      LBP and sciatica. The results of this study will provide needed information to assist
      clinicians and inform patients of their options for initial management of this common
      condition.
    

Intervention name(s): Education and re-assurance; Physical Therapy
Intervention type(s): Behavioral; Procedure
Intervention description(s): Patients are provided the Back Book and the contents are reviewed emphasizing the favorable natural history of back pain and sciatica and the importance of remaining active.; Physical therapy will consist of repeated exercises, spinal mobilization and mechanical traction in an effort to maximize centralization of symptoms.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment