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Completed

NCT Number: NCT01726803

Comparative Effectiveness of Acute Low Back Pain Management

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.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Intermountain Health Care, Salt Lake City, Utah, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Early Physical Therapy with Usual Care

Other

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.

Usual Care

Other

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.

Primary outcomes

  1. Oswestry Disability Index

    Time frame: 3 months

    10-item Oswestry Disability Index assessing low back pain-related disability. Scores range from 0-100 with higher numbers indicating greater disability.

Secondary outcomes

  1. Numeric Pain Rating

    Time frame: 3 months

    0-10 numeric rating of low back pain intensity, score range from 0-10 with higher numbers indicating greater pain intensity.

  2. EQ-5D

    Time frame: 3 months

    European Quality of Life Measure, assesses general quality of life. Scores are expressed on a scale from 0 - 1.0 with higher scores representing greater quality of life.

  3. Fear-Avoidance Beliefs Questionnaire (Work Subscale)

    Time frame: 3 months

    Measures fear-avoidance beliefs related to work. Scores range from 0-42 with higher numbers representing greater levels of fear avoidance beliefs about work.

  4. Patient Global Rating of Improvement (Percentage of Participants Reporting Successful Outcome)

    Time frame: 3 months

    15-point patient global rating scale. Patient is asked to rate current condition relative to condition at the beginning of treatment on a scale ranging from "A Very Great Deal Worse" to "A Very Great Deal Better". Higher numbers indicate greater self-rating. Those rating at least 12 are considered successful as a dichotomous outcome.

  5. Health Care Utilization (MRI)

    Time frame: 12 months

    Utilization of healthcare for low back pain (MRI utilization)

  6. Pain Catastrophizing

    Time frame: 3 months

    13-item Pain Catastrophizing Scale assessing the extent of catastrophizing thinking is response to pain. Each item is scored 1-4 for a total score of 13-52. Higher numbers indicate greater levels of catastrophizing.

  7. Lost Work Time

    Time frame: 12 months

    Missed work due to LBP

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • Intermountain Health Care, Inc.

Registry information

Official study title

Comparative Effectiveness of Management Strategies for Acute Low Back Pain

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Nov 15, 2012
Registry last updated
Oct 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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