Comparative Effectiveness of Acute Low Back Pain Management

Comparative Effectiveness of Management Strategies for Acute Low Back Pain

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Other: Usual Care; Other: Early Physical Therapy with Usual Care

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84108
      • The University of Utah Healthcare System
    • Salt Lake City, Utah, United States, 84106
      • Intermountain Health Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: 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 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.	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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Health Care Utilization (MRI)	Utilization of healthcare for low back pain (MRI utilization)	12 months
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
Lost Work Time	Missed work due to LBP	12 months

Collaborators and Investigators

• Sponsor: University of Utah
• Collaborators: Intermountain Health Care, Inc.
• Investigators: Principal Investigator: Julie M Fritz, PT, PhD, University of Utah and Intermountain Healthcare

Publications and helpful links

General Publications

• Sisco-Taylor BL, Magel JS, McFadden M, Greene T, Shen J, Fritz JM. Changes in Pain Catastrophizing and Fear-Avoidance Beliefs as Mediators of Early Physical Therapy on Disability and Pain in Acute Low-Back Pain: A Secondary Analysis of a Clinical Trial. Pain Med. 2022 May 30;23(6):1127-1137. doi: 10.1093/pm/pnab292.
• Magel J, Fritz JM, Greene T, Kjaer P, Marcus RL, Brennan GP. Outcomes of Patients With Acute Low Back Pain Stratified by the STarT Back Screening Tool: Secondary Analysis of a Randomized Trial. Phys Ther. 2017 Mar 1;97(3):330-337. doi: 10.2522/ptj.20160298.
• Fritz JM, Magel JS, McFadden M, Asche C, Thackeray A, Meier W, Brennan G. Early Physical Therapy vs Usual Care in Patients With Recent-Onset Low Back Pain: A Randomized Clinical Trial. JAMA. 2015 Oct 13;314(14):1459-67. doi: 10.1001/jama.2015.11648.

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: November 8, 2012
• First Submitted That Met QC Criteria: November 9, 2012
• First Posted (Estimate): November 15, 2012

Study Record Updates

• Last Update Posted (Actual): October 9, 2018
• Last Update Submitted That Met QC Criteria: December 12, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Primary Care; Low Back Pain; Physical Therapy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 1R18HS018672 (U.S. AHRQ Grant/Contract)