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

NCT00769626 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2011-07-18

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Intermountain Health Care, Inc.

    lead OTHER

Principal Investigators

  • Julie M Fritz, PhD,PT,ATC · Intermountain Healthcare, The University of Utah

  • Gerard P Brennan, PhD, PT · Intermountain Health Care, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2009-09-30
Completion
2010-05-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00769626 on ClinicalTrials.gov