Standardizing Management of Patients With Low Back Pain in Primary Care and Physical Therapy

NCT ID: NCT00769626

Last Updated: 2011-07-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2010-05-31

Brief Summary

The purpose of this study is to compare the clinical outcomes and costs associated with two different management strategies for patients with acute low back pain who consult their primary care physician. The investigators hypothesize that management using a brief, standardized physical therapy intervention will result in better outcomes than management based on current practice guideline recommendations of watchful waiting for the first 4 weeks following consultation.

Detailed Description

The Institute of Medicine recognizes low back pain (LBP) as a top 15 priority condition, calling for health care organizations to develop new, evidence-based management strategies. Most patients with acute LBP are managed in primary care. Primary care management is characterized by high variability in decision-making, including referral to specialties such as physical therapy. In the face of this variability it is not surprising that the outcomes of management for patients with acute LBP are also inconsistent, with a considerable proportion going on to persistent or recurrent symptoms. Costs associated with patients who fail to recover quickly or completely can be substantial.

Many patients with acute LBP are referred from primary care to physical therapy. Physical therapy management of patients with acute LBP is also highly variable in terms of the interventions used and the outcomes achieved. More effective and standardized management for patients with acute LBP could impact progression of the condition before the concerns associated with chronic pain become evident, and are therefore central to reducing costs and improving outcomes.

Numerous practice guidelines have been developed to attempt to reduce variability and improve outcomes for patients with acute LBP managed in primary care. Current guidelines provide little direction for determining the optimal type of patient and timing for referral to physical therapy, other than a broad recommendation to delay referral for at least a few weeks. Within physical therapy there is an absence of validated decision-support tools to reduce inappropriate variation in care and improve outcomes. The Investigators have developed and validated a clinical decision rule identifying a subgroup of patients with LBP likely to experience rapid and sustained improvement with a brief, standardized physical therapy intervention delivered early in the course of care, suggesting it may be more cost-effective to manage this subgroup with early referral to physical therapy. The impact of integrating this rule into routine clinical care has not been assessed.

We will conduct a randomized clinical trial examining outcomes and costs associated with integrating the decision rule into primary care management of patients with LBP. Patients with LBP who fit the decision rule criteria will be randomized into one of two groups; one managed with usual care based on current practice guidelines; the other managed based on the decision rule with early, standardized physical therapy. Patients will be followed for 6 months. Outcomes will include measures of disability, pain, satisfaction, and costs.

Conditions

Back Pain; Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Early Treatment

Group Type: EXPERIMENTAL

Early Treatment

Intervention Type: OTHER

Patients in the early treatment group will receive the usual care intervention (advice and education, and medication consistent with current evidence-based guidelines). Patients will also be referred to physical therapy for 4 sessions over a 3-week period. A standardized protocol will be used in physical therapy including spinal manipulation and trunk strengthening exercises. Patients will be instructed to return to the primary care provider if they are not satisfied with their progress after completion of the 4 sessions.

Usual Care

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: OTHER

Patients in the usual care group will receive advice and education to remain active and anticipate a favorable prognosis. Patients will also receive medication from the primary care provider consistent with current evidence-based guidelines(acetaminophen or non-steroidal anti-inflammatories). Consistent with current practice guidelines, patients will be instructed to return to the primary care provider if they are not satisfied with their progress after 4 weeks.

Interventions

Usual Care

Patients in the usual care group will receive advice and education to remain active and anticipate a favorable prognosis. Patients will also receive medication from the primary care provider consistent with current evidence-based guidelines(acetaminophen or non-steroidal anti-inflammatories). Consistent with current practice guidelines, patients will be instructed to return to the primary care provider if they are not satisfied with their progress after 4 weeks.

Intervention Type: OTHER

Early Treatment

Patients in the early treatment group will receive the usual care intervention (advice and education, and medication consistent with current evidence-based guidelines). Patients will also be referred to physical therapy for 4 sessions over a 3-week period. A standardized protocol will be used in physical therapy including spinal manipulation and trunk strengthening exercises. Patients will be instructed to return to the primary care provider if they are not satisfied with their progress after completion of the 4 sessions.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Symptoms of pain and/or numbness between the 12th rib and buttocks with or without symptoms into one or both legs, which, in the opinion of the primary care provider, originate from the lumbar region.
• Age 18 - 60 years
• Oswestry disability score > 20%
• Both of the clinical decision rule criteria: Duration of current symptoms < 16 days, and patient report of no symptoms (pain, numbness, etc.) distal to the knee since onset.

Exclusion Criteria

• Prior surgery to the lumbosacral spine
• Current pregnancy
• Neurogenic LBP defined as the presence of either: a positive straight leg raise test (symptom reproduction at <450) or reflex, sensory, or strength consistent with lumbar nerve root compression
• Judgment of the primary care provider of "red flags" of a potentially serious condition including cauda equina syndrome, major or rapidly progressing neurological deficit, fracture, cancer, or infection

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Intermountain Health Care, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Intermountain Healthcare

Principal Investigators

Julie M Fritz, PhD,PT,ATC

Role: PRINCIPAL_INVESTIGATOR

Intermountain Healthcare, The University of Utah

Gerard P Brennan, PhD, PT

Role: STUDY_DIRECTOR

Intermountain Health Care, Inc.

Locations

Intermountain Healthcare, South Jordan Health Center

South Jordan, Utah, United States

Intermountain Healthcare Taylorsville Health Center

Taylorsville, Utah, United States

Intermountain Healthcare West Jordan Health Center

West Jordan, Utah, United States

Countries

United States

Other Identifiers

DES-529-2008

Identifier Type: -

Identifier Source: org_study_id