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

This study has been terminated.
(Unable to recruit patients)
Sponsor:
Information provided by:
Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier:
NCT00769626
First received: October 8, 2008
Last updated: July 15, 2011
Last verified: October 2008

October 8, 2008
July 15, 2011
September 2008
September 2009   (final data collection date for primary outcome measure)
Oswestry Disability Questionnaire Patient Global Rating of Improvement [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00769626 on ClinicalTrials.gov Archive Site
Numeric Pain Rating Scale Fear-Avoidance Beliefs Questionnaire Patient Satisfaction Questionnaire European Quality of Life (EuroQOL) Direct medical costs [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Standardizing Management of Patients With Low Back Pain in Primary Care and Physical Therapy
Standardizing Management of Patients With Low Back Pain in Primary Care and Physical Therapy: A Randomized Clinical Trial

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Back Pain
  • Low Back Pain
  • 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.
  • 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.
  • Experimental: Early Treatment
    Intervention: Other: Early Treatment
  • Active Comparator: Usual Care
    Intervention: Other: Usual Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
15
May 2010
September 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00769626
DES-529-2008
No
Julie M. Fritz, Clinical Outcomes Research Scientist, Intermountain Healthcare
Intermountain Health Care, Inc.
Not Provided
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.
Intermountain Health Care, Inc.
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP