N/A
N=2,300
Targeted Interventions to Prevent Chronic Low Back Pain in High Risk Patients
Low Back Pain
Bottom Line
View on ClinicalTrials.gov: NCT02647658 ↗Enrolled (actual)
2,300
Serious AEs
—
Results posted
Feb 2020
Primary outcome: Primary: Number of Patients Who Reported Transition From Acute to Chronic Low Back Pain (cLBP) — 312; 318 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Guideline Based Care plus Psychologically Informed Physical Therapy (Behavioral); Guideline Based Care (GBC) (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pittsburgh
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Who Reported Transition From Acute to Chronic Low Back Pain (cLBP) |
312; 318 | — |
| PRIMARY Functional Disability |
27.3; 29.5 | — |
| SECONDARY Number of Patients Referred to Physical Therapy |
658; 335 | — |
| SECONDARY Number of Patients Prescribed Opioids |
300; 270 | — |
| SECONDARY Number of Patients With Orders for Diagnostic Imaging Tests |
74; 73 | — |
| SECONDARY Number of Patients Referred to Other Rehabilitation or Pain Management Specialist |
45; 26 | — |
| SECONDARY Number of Patients Referred to Surgery Specialist |
38; 44 | — |
| SECONDARY Number of Patients Undergoing Interventional Pain Procedures |
32; 43 | — |
| SECONDARY Number of Patients Who Had Back Surgery |
29; 19 | — |
Summary
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT02647658). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.