Comparative Effectiveness of Acute Low Back Pain Management

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by University of Utah
Sponsor:
Collaborator:
Intermountain Health Care, Inc.
Information provided by (Responsible Party):
University of Utah
ClinicalTrials.gov Identifier:
NCT01726803
First received: November 8, 2012
Last updated: November 9, 2012
Last verified: November 2012
  Purpose

Current practice guidelines for patients with acute low back pain (LBP) recommend a stepped care approach with initial treatment of education and advice to remain active. Referral to physical therapy is considered only when patients fail to recover after a few weeks. Recent research has led to the identification a subgroup of patients likely to experience rapid, pronounced, and sustained decreases in disability and pain with a brief manipulation and exercise intervention, suggesting it may be more cost-effective to manage this sub-group with early referral to physical therapy instead of the usual care approach. The integration of this evidence into routine practice has not been evaluated. We will assess the outcomes of integrating this evidence into the management of patients with low back pain. The study is a randomized trial, comparing management with early manipulation with the current care process model. Patients fitting the inclusion criteria will be randomized into one of two groups. One group will be managed with the current care process model. The other group will be managed consistent with the decision rule recommending early referral for a brief manipulation and exercise intervention during the first 4 weeks. Patients will be followed over 1 year. Outcomes will include measures of disability, pain, satisfaction, and direct medical costs. The study will examine the costs and effectiveness of integrating the alternative care model into practice.


Condition Intervention
Low Back Pain
Other: Early Physical Therapy
Other: Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparative Effectiveness of Management Strategies for Acute Low Back Pain

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Oswestry Disability Index [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    10-item Oswestry Disability Index


Secondary Outcome Measures:
  • Numeric Pain Rating [ Time Frame: Baseline. 4 weeks, 3 months, 12 months ] [ Designated as safety issue: No ]
    0-10 numeric rating of low back pain intensity

  • EQ-5D [ Time Frame: Baseline. 4 weeks, 3 months, 12 months ] [ Designated as safety issue: No ]
    European Quality of Life Measure

  • Fear-Avoidance Beliefs Questionnaire [ Time Frame: Baseline. 4 weeks, 3 months, 12 months ] [ Designated as safety issue: No ]
  • Patient Global Rating of Improvement [ Time Frame: 4 weeks, 3 months, 12 months ] [ Designated as safety issue: No ]
    15-point patient global rating scale

  • Health care utilization [ Time Frame: 4 weeks, 3 months, 12 months ] [ Designated as safety issue: No ]
    Utilization of healthcare for low back pain

  • Pain Catastrophizing [ Time Frame: Baseline. 4 weeks, 3 months, 12 months ] [ Designated as safety issue: No ]
    13-item Pain Catastrophizing Scale

  • Lost work time [ Time Frame: 4 weeks, 3 months, 12 months ] [ Designated as safety issue: No ]
    Number of hours of lost work productivity


Estimated Enrollment: 220
Study Start Date: April 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Usual Care
Usual care arm will receive management as recommended by practice guidelines and directed by the primary care provider. The recommended stepped care approach is used with initial management of advice and education only and no referral to physical therapy during the initial 4 weeks.
Other: Early Physical Therapy
The early physical therapy arm includes 4 total sessions. The first 2 sessions include use of thrust spinal manipulation with exercises for range of motion and strengthening of the spine. The final 2 sessions include the exercise component only.
Other: Usual Care
The usual care intervention includes advice and education to remain active and provision of the Back Book highlighting these recommendations. Pharmaceuticals may be prescribed at the discretion of the primary care provider. Follow-up visits to primary care provided are recommended for all patients dissatisfied with their progress.
Experimental: Early Physical Therapy
The Early Physical Therapy arm will receive the same advice and education intervention received by the usual care group and will be referred to receive 4 sessions of physical therapy during the first 4 weeks. The physical therapy protocol involves spinal manipulation and exercise.
Other: Usual Care
The usual care intervention includes advice and education to remain active and provision of the Back Book highlighting these recommendations. Pharmaceuticals may be prescribed at the discretion of the primary care provider. Follow-up visits to primary care provided are recommended for all patients dissatisfied with their progress.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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, are originating from tissues of the lumbar region.
  • Age 18 - 60 years
  • Oswestry disability score > 20%
  • Both of the following clinical decision rule criteria: a)Duration of current symptoms < 16 days; and b)Patient report of no symptoms (pain, numbness, etc.) distal to the knee in past 72 hours.

Exclusion Criteria:

  • Prior surgery to the lumbosacral spine
  • Any treatment for low back pain in past 6 months
  • Current pregnancy
  • Currently receiving treatment for LBP from another healthcare provider (e.g., chiropractic, massage therapy, injections, etc.)
  • Presence of neurogenic LBP defined as the presence of either of the following:

    a) Positive ipsilateral or contralateral straight leg raise (reproduction of symptoms at <45 degrees); or b)Reflex, sensory, or strength deficits in a pattern 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, infection or systemic disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01726803

Contacts
Contact: Jake Magel, PT, DSc 801-581-6861 jake.magel@hsc.utah.edu
Contact: Julie M Fritz, PT, PhD 801-581-6861 julie.fritz@hsc.utah.edu

Locations
United States, Utah
The University of Utah Healthcare System Recruiting
Salt Lake City, Utah, United States, 84108
Contact: Jake Magel, PT, DSc    801-581-6861    jake.magel@hsc.utah.edu   
Principal Investigator: Julie M Fritz, PT, PhD         
Intermountain Health Care Recruiting
Salt Lake City, Utah, United States, 84106
Contact: Jake Magel, PT, DSc    801-581-8681    Jake.Magel@imail.org   
Principal Investigator: Julie M Fritz, PT, PhD         
Sponsors and Collaborators
University of Utah
Intermountain Health Care, Inc.
Investigators
Principal Investigator: Julie M Fritz, PT, PhD University of Utah and Intermountain Healthcare
  More Information

No publications provided

Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT01726803     History of Changes
Other Study ID Numbers: 1R18HS018672
Study First Received: November 8, 2012
Last Updated: November 9, 2012
Health Authority: United States: Agency for Healthcare Research and Quality

Keywords provided by University of Utah:
Low Back Pain
Primary Care
Physical Therapy

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 20, 2014