Comparative Effectiveness of Acute Low Back Pain Management

Low Back Pain Clinical Trial

Official title:

Comparative Effectiveness of Management Strategies for Acute Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01726803
• Other study ID #: 1R18HS018672
• Status: Completed
• Phase: N/A
• Start date: April 2011
• Est. completion date: November 2014

Study information

• Verified date: December 2017
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: November 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• Early Physical Therapy with Usual Care
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
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.

Locations

Country	Name	City	State
United States	Intermountain Health Care	Salt Lake City	Utah
United States	The University of Utah Healthcare System	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	Intermountain Health Care, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oswestry Disability Index	10-item Oswestry Disability Index assessing low back pain-related disability. Scores range from 0-100 with higher numbers indicating greater disability.	3 months
Secondary	Numeric Pain Rating	0-10 numeric rating of low back pain intensity, score range from 0-10 with higher numbers indicating greater pain intensity.	3 months
Secondary	EQ-5D	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 months
Secondary	Fear-Avoidance Beliefs Questionnaire (Work Subscale)	Measures fear-avoidance beliefs related to work. Scores range from 0-42 with higher numbers representing greater levels of fear avoidance beliefs about work.	3 months
Secondary	Patient Global Rating of Improvement (Percentage of Participants Reporting Successful Outcome)	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.	3 months
Secondary	Health Care Utilization (MRI)	Utilization of healthcare for low back pain (MRI utilization)	12 months
Secondary	Pain Catastrophizing	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.	3 months
Secondary	Lost Work Time	Missed work due to LBP	12 months