Comparative Effectiveness of Acute Low Back Pain Management
| Status: | Completed |
|---|---|
| Conditions: | Back Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 10/10/2018 |
| Start Date: | April 2011 |
| End Date: | November 2014 |
Comparative Effectiveness of Management Strategies for Acute Low Back Pain
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.
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.
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
We found this trial at
2
sites
Click here to add this to my saved trials
Click here to add this to my saved trials