Comparative Effectiveness of Acute Low Back Pain Management

Not Applicable

Completed

Interventions: Other: Usual Care
Other: Early Physical Therapy with Usual Care

Brief 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 & 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

Arm && Interventions

Group	Intervention	Description
Usual Care	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.
Early Physical Therapy with Usual Care	Early Physical Therapy with Usual Care	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.
Early Physical Therapy with Usual Care	Usual Care	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.

Primary Outcome Measures

Name	Time	Method
Oswestry Disability Index	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 Outcome Measures

Name	Time	Method
Numeric Pain Rating	3 months	0-10 numeric rating of low back pain intensity, score range from 0-10 with higher numbers indicating greater pain intensity.
EQ-5D	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.
Fear-Avoidance Beliefs Questionnaire (Work Subscale)	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.
Health Care Utilization (MRI)	12 months	Utilization of healthcare for low back pain (MRI utilization)
Patient Global Rating of Improvement (Percentage of Participants Reporting Successful Outcome)	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.
Pain Catastrophizing	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.
Lost Work Time	12 months	Missed work due to LBP

Locations (2): The University of Utah Healthcare System
🇺🇸
Salt Lake City, Utah, United States
Intermountain Health Care
🇺🇸
Salt Lake City, Utah, United States