Management Strategies for Patients With Low Back Pain and Sciatica



Status:Active, not recruiting
Conditions:Back Pain, Back Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - 60
Updated:11/23/2018
Start Date:January 2015
End Date:October 2019

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Low back pain and sciatica is a common condition resulting in high costs and disability for
society and affected individuals. Presently there is a lack of evidence for what treatments
may help this condition early in the course of care. Improved early management could reduce
risks for persistent disability and high costs. The goal of this project is to examine the
clinical outcomes and costs associated with adding a physical therapy program to early
management of patients with low back pain and sciatica within primary care.

Low back pain (LBP) is a common and costly condition. When accompanied by sciatica, risks for
persistent disability and future invasive treatments increase. Most patients with LBP and
sciatica enter the healthcare system in primary care. Optimal primary care management is
currently unclear and little data are available to assist clinicians and inform patients of
the likely effects of common options. Practice guidelines agree that imaging, spinal
injections and surgeries should be reserved for patients whose symptoms do not diminish
within 4-8 weeks, yet utilization rates for these procedures are increasing rapidly, partly
due to the uncertainty of what options may be offered to patients for initial treatment.
Physical therapy is considered an option in the initial management period, but is used
inconsistently. It is currently unclear what can be expected from early physical therapy for
patients with LBP and sciatica, and what if any long-term effect it may have on clinical
outcomes or future healthcare utilization. The investigators research team has conducted a
series of clinical trials to clarify the evidence for the most effective physical therapy
procedures for patients with LBP and sciatica, and is now in a position to evaluate if the
use of early, evidence-based physical therapy can reduce the risk of future disability,
healthcare utilization and costs. The proposed study is a randomized trial comparing the
effectiveness of usual, guideline-based initial management of newly consulting patients with
LBP with sciatica with or without the addition of early physical therapy. Specific aims are
to compare the clinical effectiveness, costs (direct and indirect), and cost-effectiveness of
the addition of physical therapy. All patients will be managed with advice, education and
medication. One group will also receive 6-8 sessions of physical therapy Outcomes will
include measures of disability, pain, psychological distress, healthcare, utilization, and
costs over 1 year. This study will permit an examination of the effectiveness and costs
associated with the use of early physical therapy within primary care for patients with acute
LBP and sciatica. The results of this study will provide needed information to assist
clinicians and inform patients of their options for initial management of this common
condition.

Inclusion Criteria:

1. Symptoms of pain and/or numbness between the 12th rib and buttocks, which, in the
opinion of the primary care provider, are originating from tissues of the lumbar
region.

2. Symptoms of pain and/or numbness primarily into one leg that have extended below the
knee in the last 72 hours, and correspond to a lower lumbar nerve root distribution
(L4, L5, S1)

3. Current symptoms present for 90 days or fewer

4. Oswestry disability score > 20%

5. One or more of the following symptoms:

- Positive ipsilateral or contralateral straight leg raise test (reproduction of
symptoms at <70 degrees)

- Reflex, sensory, or strength deficits in a pattern consistent with lower lumbar
nerve root

Exclusion Criteria:

1. Any prior spine fusion surgery, or any surgery to the lumbosacral spine in the past
year

2. Current pregnancy

3. Currently receiving treatment for LBP from another healthcare provider (e.g.,
chiropractic, massage therapy, injections, etc.) or any treatment for LBP in prior 6
months.

4. Judgment of primary care provider of "red flags" of a potentially serious condition
including cauda equina, major or rapidly progressing neurologic deficit, fracture,
cancer, infection or systemic disease
We found this trial at
1
site
Salt Lake City, Utah 84108
Principal Investigator: Julie M Fritz, PT, PhD
Phone: 801-581-6861
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mi
from
Salt Lake City, UT
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