N/A N=220 Randomized Double-blind Treatment

Comparative Effectiveness of Acute Low Back Pain Management

Low Back Pain

Bottom Line

View on ClinicalTrials.gov: NCT01726803 ↗

Enrolled (actual)

220

Serious AEs

0.0%

Results posted

Oct 2018

Primary outcome: Primary: Oswestry Disability Index — 9.8; 6.6 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Early Physical Therapy with Usual Care (Other); Usual Care (Other)
Age: Adult · 18+ yrs
Sex: All
Sponsor: University of Utah
Primary completion: Nov 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Oswestry Disability Index	9.8; 6.6	—
SECONDARY Numeric Pain Rating	1.8; 1.4	—
SECONDARY EQ-5D	0.88; 0.91	—
SECONDARY Fear-Avoidance Beliefs Questionnaire (Work Subscale)	7.5; 5.2	—
SECONDARY Patient Global Rating of Improvement (Percentage of Participants Reporting Successful Outcome)	49; 64	—
SECONDARY Health Care Utilization (MRI)	3; 4	—
SECONDARY Pain Catastrophizing	5.2; 3.0	—
SECONDARY Lost Work Time	46; 40	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01726803). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.