CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 2,300 enrolled
Drug / intervention
Guideline Based Care plus Psychologically Informed Physical Therapy +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02647658
NCT02647658N/ACompleted

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

University of Pittsburgh·interventional·Posted Jan 6, 2016·Updated Feb 10, 2020

In Brief

A clinical study evaluating Guideline Based Care plus Psychologically Informed Physical Therapy and Guideline Based Care (GBC) for Low Back Pain. Completed, enrolled 2,300 participants across 5 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLow Back Pain
CountriesUnited States

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 6, 2016
Enrollment StartMar 1, 2016
Primary CompletionMar 1, 2019
Study CompletionJun 30, 2019
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 10.5 years ago

Interventions

Guideline Based Care plus Psychologically Informed Physical Therapybehavioral

PCP care is enhanced with a prompt referral to physical therapy (PT) that includes psychologically informed coaching directed towards education and reduced fear of movement

Guideline Based Care (GBC)behavioral

Management decisions are made between PCPs and patients with the guidance of best evidence but with no specific directives