Comparative Effectiveness of Acute Low Back Pain Management

NCT01726803 | Completed Results DMC

• 1 other identifier: 1R18HS018672
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 2

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.

Conditions

Low Back Pain

Keywords

Low Back Pain; Primary Care; Physical Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Numeric Pain Rating

  3 months

• EQ-5D

  3 months

• Fear-Avoidance Beliefs Questionnaire (Work Subscale)

  3 months

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

  3 months

• Health Care Utilization (MRI)

  12 months

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

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

Early Physical Therapy with Usual Care

EXPERIMENTAL

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

Interventions

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.

Early Physical Therapy with Usual Care

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.

Early Physical Therapy with Usual Care; Usual Care

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead
• Intermountain Health Care, Inc.: collaborator

Study Sites (2)

Intermountain Health Care

Salt Lake City, Utah, 84106, United States

Location

The University of Utah Healthcare System

Salt Lake City, Utah, 84108, United States

Location

Related Publications (3)

• 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.

  PMID: 34613379 DERIVED

• 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.

  PMID: 28204740 DERIVED

• 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.

  PMID: 26461996 DERIVED

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Julie Fritz
• Organization: University of Utah

julie.fritz@hsc.utah.edu

801-581-6861

Study Officials

• Julie M Fritz, PT, PhD

  University of Utah and Intermountain Healthcare

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D.

Study Record Dates

• First Submitted: November 8, 2012
• First Posted: November 15, 2012
• Study Start: April 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2014
• Last Updated: October 9, 2018
• Results First Posted: October 9, 2018

Record last verified: 2017-12

Locations

US (2)