Targeted Interventions to Prevent Chronic Low Back Pain in High Risk Patients



Status:Active, not recruiting
Conditions:Back Pain, Back Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - Any
Updated:3/24/2019
Start Date:March 2016
End Date:September 2019

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Targeted Interventions to Prevent Chronic Low Back Pain in High Risk Patients: A Multi-Site Pragmatic Randomized Controlled Trial

Low back pain (LBP) is a common problem among US adults. Initial episodes tend to be
self-limited ("acute"), but some people can progress to a state of persistent pain. Often
termed "chronic" LBP (cLBP), this condition can cause prolonged difficulty with most daily
activities, including job performance. Most patients see chiropractors or primary care
physicians (PCPs) for initial episodes of LBP. This study will compare two approaches for
preventing patients with acute LBP (aLBP) from developing cLBP. Both treatments can be
delivered in an outpatient PCP setting. The first approach is to provide PCPs with
information regarding a patient's risk of transitioning from aLBP to cLBP and to encourage
PCPs to treat patients according to accepted clinical guidelines. The second approach is to
provide the same risk information and have PCPs team up with physical therapists to deliver
psychologically-informed physical therapy (PIPT) for those patients determined to be at high
risk for transitioning to cLBP. PIPT is designed to help patients identify and overcome
physical and psychological barriers to recovery. The 1,860 patients expected to be recruited
from five regional sites (Pittsburgh, Pennsylvania; Boston, Massachusetts; Baltimore,
Maryland; Charleston, South Carolina; and Salt Lake City, Utah) will start the study when
their LBP is in an acute phase. The study's primary aims are to compare the proportions of
cLBP and measures of functional ability between the two groups at 6 months. Secondary aims
are to measure the number of LBP-related x-rays, MRIs, surgeries, and other medical
procedures during a 12-month follow-up period. The same outcomes will be assessed for an
observational cohort of 6,900 patients with aLBP at low to medium risk for transitioning to
cLBP across the 5 sites. This study was designed with input from a variety of national and
local stakeholders, including patients with LBP, providers, payers, professional
organizations, purchasers, and policy representatives.


Inclusion Criteria:

- 18 years of age or older

- Receiving care for acute low back pain during a primary care clinic visit

- Able to provide informed consent

Exclusion Criteria:

- Medical contraindications to physical therapy based on the judgment of the primary
care provider as documented in the medical record (i.e., "red flag" signs and symptoms
of a potentially serious condition such as cauda equina syndrome, major or rapidly
progressing neurological deficit, cancer, spinal infection or fracture)
We found this trial at
5
sites
200 Lothrop St
Pittsburgh, Pennsylvania 15213
Phone: 412-605-3927
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Phone: 443-287-7432
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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Boston, Massachusetts 02118
Phone: 617-414-6201
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Phone: 843-792-2940
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Salt Lake City, Utah 84143
Phone: 801-314-2529
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Salt Lake City, UT
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