Clinical trial NCT01726803: Comparative Effectiveness of Acute Low Back Pain Management
Official title: Comparative Effectiveness of Management Strategies for Acute Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Low Back Pain
Primary Care
Physical Therapy
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Intermountain Health Care, Inc.
First posted: 2012-11-15
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Oswestry Disability Index
timeFrame: 3 months
Secondary outcomes:
measure: Numeric Pain Rating
timeFrame: 3 months
measure: EQ-5D
timeFrame: 3 months
measure: Fear-Avoidance Beliefs Questionnaire (Work Subscale)
timeFrame: 3 months
measure: Patient Global Rating of Improvement (Percentage of Participants Reporting Successful Outcome)
timeFrame: 3 months
measure: Health Care Utilization (MRI)
timeFrame: 12 months
measure: Pain Catastrophizing
timeFrame: 3 months
measure: Lost Work Time
timeFrame: 12 months
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Intermountain Health Care
state: Utah
city: Salt Lake City
country: United States
facility: The University of Utah Healthcare System
state: Utah
Study officials:
affiliation: University of Utah and Intermountain Healthcare
name: Julie M Fritz, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.