Standardizing Management of Patients With Low Back Pain in Primary Care and Physical Therapy
|ClinicalTrials.gov Identifier: NCT00769626|
Recruitment Status : Terminated (Unable to recruit patients)
First Posted : October 9, 2008
Last Update Posted : July 18, 2011
|Condition or disease||Intervention/treatment||Phase|
|Back Pain Low Back Pain||Other: Usual Care Other: Early Treatment||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Standardizing Management of Patients With Low Back Pain in Primary Care and Physical Therapy: A Randomized Clinical Trial|
|Study Start Date :||September 2008|
|Actual Primary Completion Date :||September 2009|
|Actual Study Completion Date :||May 2010|
|Experimental: Early Treatment||
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.
|Active Comparator: Usual Care||
Other: 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.
- Oswestry Disability Questionnaire Patient Global Rating of Improvement [ Time Frame: 6 months ]
- Numeric Pain Rating Scale Fear-Avoidance Beliefs Questionnaire Patient Satisfaction Questionnaire European Quality of Life (EuroQOL) Direct medical costs [ Time Frame: 6 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00769626
|United States, Utah|
|Intermountain Healthcare, South Jordan Health Center|
|South Jordan, Utah, United States, 84095|
|Intermountain Healthcare Taylorsville Health Center|
|Taylorsville, Utah, United States, 84118|
|Intermountain Healthcare West Jordan Health Center|
|West Jordan, Utah, United States, 84088|
|Principal Investigator:||Julie M Fritz, PhD,PT,ATC||Intermountain Healthcare, The University of Utah|
|Study Director:||Gerard P Brennan, PhD, PT||Intermountain Health Care, Inc.|