Comparative Effectiveness of Early Physical Therapy Versus Usual Care for Low Back Pain

NCT01556581 | Completed Results

• 1 other identifier: 211107
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of this study is to compare the effectiveness of two management strategies for patients with a recent onset of low back pain (LBP). One is based on usual care and the other is based on early access to physical therapy following a pragmatic treatment-based classification approach. The secondary purposes are to compare the subsequent healthcare utilization associated with two management strategies as well as to evaluate the importance of psychosocial factors on outcomes within both groups of treatment. The overall hypothesis guiding the study is that the additional initial treatment expense incurred by early implementation will result in superior short-term clinical effectiveness, and will be more cost-effective in the long-term due to reduced healthcare utilization. We will also explore the importance of psychosocial factors on outcomes within both treatment groups, which may provide insights for further improving treatment strategies.

Conditions

Low Back Pain

Keywords

back pain; primary care; physical therapy

Outcome Measures

Primary Outcomes (1)

• Modified Oswestry Disability Index

  The Modified Oswestry Disability Questionnaire (OSW) is a 10-item condition-specific measure of functional status (pain and disability) for patients with low back pain (LBP). Each question has 6 possible answers (0 = worse, 5 = best). The raw score is doubled to provide a percent score from 0 to 100%; with 0 equaling no disability and 100% equalling the worst possible outcome. It measures pain-related disability. We used the modified version that replaces the sex life item with an employment/ homemaking item due to poor compliance with the former. The OSW is widely used in research on non-operative management of patients with LBP, with high levels of test-retest reliability among stable patients (ICC = 0.90), good construct validity, and responsiveness to change for patients with acute LBP. It has a minimum clinically important difference of 6 points.

  12 months

Secondary Outcomes (2)

• Numeric Pain Rating Scale (NPRS)

  12 months

• Global Rating of Change (GRC) of +3 or More (Minimum Clinically Important Change)

  12 Months

Study Arms (2)

Usual Care (UC)

ACTIVE COMPARATOR

The usual care (UC) group will be managed with stepped care approach, receiving a screening exam, advice, education, activity limitation profile and medications if needed, but no early physical therapy.

Procedure: Usual Care (UC)

Early Physical Therapy (PT)

ACTIVE COMPARATOR

All subjects in this group will get usual care approach in addition to immediately receiving eight sessions of physical therapy based on a pragmatic treatment based classification system for treating low back pain.

Procedure: Early Physical Therapy (PT)

Interventions

Usual Care (UC) PROCEDURE

Initial management for all patients will include an activity-limiting profile for up to 30 days and a 10-day supply of medications if needed (NSAIDs and muscle relaxers). All patients will then receive advice and education about the favorable natural history of LBP and the advantages of remaining as active as possible. All patients will be recommended to follow-up with their primary care provider using normal procedures if they are not satisfied with their progress.

Usual Care (UC)

Early Physical Therapy (PT) PROCEDURE

Patients in the early PT group will receive the same treatment as the usual care group, but will then be referred to physical therapy within 3 days. The physical therapy treatment will be based on the Treatment Based Classification system (an approach that places patients into either an extension-oriented, core strength/stabilization, or a spinal manipulation treatment group based on signs and symptoms).

Early Physical Therapy (PT)

Eligibility Criteria

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

You may qualify if:

• Military personnel on active duty and eligible for healthcare at a military treatment facility
• A primary complaint of low back pain defined as symptoms of pain and/or numbness between the 12th rib and buttocks with or without symptoms into the leg(s), which, in the opinion of the provider, are originating from tissues of the lumbar region.
• Duration of current episode of low back pain \< 90 days
• Age 18 - 60 years (or emancipated minors on active duty)
• Available for the following 4 weeks to complete a regimen of treatment

You may not qualify if:

• Oswestry Disability Index \< 20%
• History of receiving any medical care for this episode of low back pain within the last 3 months
• Prior surgery to the thoraco-lumbar spine or pelvis
• This episode of back pain is due to a traumatic fracture
• Pending a medical or physical evaluation board or discharge process, pending any litigation related to the condition, or planning on getting out of the military within the next 9 months.
• Any "red flags" that would indicate a potentially serious condition or other significant disease process. These could include but not limited to cauda equina syndrome, large or rapidly progressing neurological deficit, fracture, cancer, ankylosing spondylitis, or other systemic disease.
• Current episode occurred because of a motor vehicle accident
• Currently pregnant (or history of pregnancy in the previous 6 months)

Sponsors & Collaborators

• Madigan Army Medical Center: lead
• U.S. Army Medical Research and Development Command: collaborator
• William Beaumont Army Medical Center: collaborator

Study Sites (1)

Madigan Army Medical Center

Tacoma, Washington, 98431, United States

Location

Related Publications (5)

• Fritz JM, Childs JD, Wainner RS, Flynn TW. Primary care referral of patients with low back pain to physical therapy: impact on future health care utilization and costs. Spine (Phila Pa 1976). 2012 Dec 1;37(25):2114-21. doi: 10.1097/BRS.0b013e31825d32f5.

  PMID: 22614792 BACKGROUND

• Fritz JM, Brennan GP, Hunter SJ, Magel JS. Initial management decisions after a new consultation for low back pain: implications of the usage of physical therapy for subsequent health care costs and utilization. Arch Phys Med Rehabil. 2013 May;94(5):808-16. doi: 10.1016/j.apmr.2013.01.008. Epub 2013 Jan 18.

  PMID: 23337426 BACKGROUND

• Fritz JM, Cleland JA, Speckman M, Brennan GP, Hunter SJ. Physical therapy for acute low back pain: associations with subsequent healthcare costs. Spine (Phila Pa 1976). 2008 Jul 15;33(16):1800-5. doi: 10.1097/BRS.0b013e31817bd853.

  PMID: 18628714 BACKGROUND

• Rhon DI, Miller RB, Fritz JM. Effectiveness and Downstream Healthcare Utilization for Patients That Received Early Physical Therapy Versus Usual Care for Low Back Pain: A Randomized Clinical Trial. Spine (Phila Pa 1976). 2018 Oct 1;43(19):1313-1321. doi: 10.1097/BRS.0000000000002619.

  PMID: 29489568 DERIVED

• Rhon D, Fritz J. COMParative Early Treatment Effectiveness between physical therapy and usual care for low back pain (COMPETE): study protocol for a randomized controlled trial. Trials. 2015 Sep 23;16:423. doi: 10.1186/s13063-015-0959-8.

  PMID: 26399603 DERIVED

MeSH Terms

Conditions

Low Back Pain; Back Pain

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Dan Rhon
• Organization: Madigan Army Medical Center

daniel.i.rhon.ctr@mail.mil

253-968-0780

Study Officials

• Julie Fritz, PT, PhD

  University of Utah

  STUDY CHAIR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2012
• First Posted: March 16, 2012
• Study Start: February 1, 2012
• Primary Completion: July 27, 2016
• Study Completion: October 1, 2017
• Last Updated: July 14, 2020
• Results First Posted: July 14, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 3 years
• Access Criteria: Any data sharing must go through a Data Sharing Agreement through the Defense Health Agency

Locations

US (1)