Comparative Effectiveness of Acute Low Back Pain Management

Utah System of Higher Education (USHE)

Status: Completed

Conditions: Low Back Pain

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01726803

1R18HS018672

Details and patient eligibility

About

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.

Enrollment: 220 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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220 participants in 2 patient groups

Usual Care

Active Comparator group

Description:

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.

Treatment:

Other: Usual Care

Early Physical Therapy with Usual Care

Experimental group

Description:

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.

Treatment:

Other: Early Physical Therapy with Usual Care

Other: Usual Care