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

NCT00769626 | Terminated Phase 3

• 1 other identifier: DES-529-2008
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 3

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.

Conditions

Back Pain; Low Back Pain

Keywords

Low Back Pain; Clinical Practice Guidelines; Spinal Manipulation; Physical Therapy Techniques

Outcome Measures

Primary Outcomes (1)

• Oswestry Disability Questionnaire Patient Global Rating of Improvement

  6 months

Secondary Outcomes (1)

• Numeric Pain Rating Scale Fear-Avoidance Beliefs Questionnaire Patient Satisfaction Questionnaire European Quality of Life (EuroQOL) Direct medical costs

  6 months

Study Arms (2)

Early Treatment

EXPERIMENTAL

Other: Early Treatment

Usual Care

ACTIVE COMPARATOR

Other: Usual Care

Interventions

Usual Care 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.

Usual Care

Early Treatment 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.

Early Treatment

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Intermountain Health Care, Inc.: lead

Study Sites (3)

Intermountain Healthcare, South Jordan Health Center

South Jordan, Utah, 84095, United States

Location

Intermountain Healthcare Taylorsville Health Center

Taylorsville, Utah, 84118, United States

Location

Intermountain Healthcare West Jordan Health Center

West Jordan, Utah, 84088, United States

Location

MeSH Terms

Conditions

Back Pain; Low Back Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Julie M Fritz, PhD,PT,ATC

  Intermountain Healthcare, The University of Utah

  PRINCIPAL INVESTIGATOR

• Gerard P Brennan, PhD, PT

  Intermountain Health Care, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 8, 2008
• First Posted: October 9, 2008
• Study Start: September 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: May 1, 2010
• Last Updated: July 18, 2011

Record last verified: 2008-10

Locations

US (3)