Targeted Interventions to Prevent Chronic Low Back Pain in High Risk Patients
CompletedNot applicableNCT02647658
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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. This study will compare two approaches for preventing patients with acute LBP (aLBP) from developing cLBP using a pragmatic, cluster randomized trial. 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. The 1,860 patients expected to be enrolled at 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 referrals to physical therapists and specialists, opioid prescriptions, LBP-related x-rays or MRIs, surgeries, and other medical procedures during a 12-month follow-up period.
Study details
- Official title
- Targeted Interventions to Prevent Chronic Low Back Pain in High Risk Patients: A Multi-Site Pragmatic Cluster Randomized Controlled Trial
- Conditions
- Interventions
- Behavioral: Guideline Based Care plus Psychologically Informed Physical Therapy
- Behavioral: Guideline Based Care (GBC)
- Sponsor
- University of Pittsburgh
- Collaborators
- Boston Medical Center; Intermountain Health Care, Inc.; Johns Hopkins University; Medical University of South Carolina; Patient-Centered Outcomes Research Institute
- Start date
- 2016-03
- Primary completion
- 2019-03-01
- Sex
- All
- Age range
- from 18 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 5
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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)
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02647658