Clinical trial NCT00769626: Standardizing Management of Patients With Low Back Pain in Primary Care and Physical Therapy
Official title: Standardizing Management of Patients With Low Back Pain in Primary Care and Physical Therapy: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Back Pain
Low Back Pain
Keywords: Low Back Pain
Clinical Practice Guidelines
Spinal Manipulation
Physical Therapy Techniques
Lead sponsor: Intermountain Health Care, Inc.
Sponsor class: OTHER
First posted: 2008-10-09
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Oswestry Disability Questionnaire Patient Global Rating of Improvement
timeFrame: 6 months
Secondary outcomes:
measure: Numeric Pain Rating Scale Fear-Avoidance Beliefs Questionnaire Patient Satisfaction Questionnaire European Quality of Life (EuroQOL) Direct medical costs
timeFrame: 6 months
Other outcomes:
Locations:
city: South Jordan
country: United States
facility: Intermountain Healthcare, South Jordan Health Center
state: Utah
city: Taylorsville
country: United States
facility: Intermountain Healthcare Taylorsville Health Center
state: Utah
city: West Jordan
country: United States
facility: Intermountain Healthcare West Jordan Health Center
state: Utah
Study officials:
affiliation: Intermountain Healthcare, The University of Utah
name: Julie M Fritz, PhD,PT,ATC
role: PRINCIPAL_INVESTIGATOR
affiliation: Intermountain Health Care, Inc.
name: Gerard P Brennan, PhD, PT
role: STUDY_DIRECTOR
References: