NCT02391350

Management Strategies for Patients With Low Back Pain and Sciatica

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Low Back Pain
• Sciatica
• Physical Therapy

Interventions

Type	Name	Description
BEHAVIORAL	Education and re-assurance	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.
PROCEDURE	Physical Therapy	Physical therapy will consist of repeated exercises, spinal mobilization and mechanical traction in an effort to maximize centralization of symptoms.

Timeline

• Start date: 2015-02-01
• Primary completion: 2019-10-01
• Completion: 2019-10-01
• First posted: 2015-03-18
• Last updated: 2021-01-22
• Results posted: 2020-12-24

Locations

1 site across 1 country: United States