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NCT02647658 · ClinicalTrials.gov registry record · NA
Targeted Interventions to Prevent Chronic Low Back Pain in High Risk Patients
A NA study of Low Back Pain, sponsored by University of Pittsburgh.
- Completed
- Registry status
- NA
- Development phase
- 2,300
- Enrollment target
- 5
- Study locations
NCT02647658: Completed NA study of Low Back Pain, sponsored by University of Pittsburgh.
NCT02647658 is a NA study of Low Back Pain that has completed, run by University of Pittsburgh. The registered enrollment target is 2,300 participants, above the 485-participant average among 122 other Low Back Pain trials with a reported enrollment target (374% higher). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02647658, a NA study of Low Back Pain, has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- NA
- Development phase
- 2,300 participants
- Enrollment target
- 5
- Study locations
Study 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.
Primary Outcome
Measured using a 2-item Chronic Low Back Pain (LBP) questionnaire. Patient endorses low back pain that interferes with regular daily activities more than 3 months and more then 1/2 the days in the past 6 months.
Conditions Studied
Interventions
- BEHAVIORAL Guideline Based Care plus Psychologically Informed Physical Therapy
- BEHAVIORAL Guideline Based Care (GBC)
Study Locations (5)
Maryland
- Johns Hopkins University - Baltimore
Massachusetts
- Boston Medical Center - Boston
Pennsylvania
- University of Pittsburgh Medical Center - Pittsburgh
South Carolina
- Medical University of South Carolina - Charleston
Utah
- Intermountain Healthcare - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,300 participants |
| Start Date | 2016-03 |
| Est. Completion | 2019-06-30 |
| Phase | NA |
What the finished NCT02647658 record still lists
NCT02647658 is an interventional study that assigns participants to a tested intervention. Its 2,300 participants enrollment target places it among the larger protocols in the corpus, above the 485-participant average among 122 other Low Back Pain trials with a reported enrollment target (374% higher).
The record links to 1 condition, with Low Back Pain appearing as the primary indexed condition, and to 2 interventions - of which Guideline Based Care plus Psychologically Informed Physical Therapy is the first listed.
NCT02647658 lists 5 locations in 5 states (Maryland, Massachusetts, Pennsylvania).
Frequently Asked Questions
What is clinical trial NCT02647658 about?
NCT02647658 is a clinical study titled "Targeted Interventions to Prevent Chronic Low Back Pain in High Risk Patients". 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 performa...
What is the current status of trial NCT02647658?
This trial is currently completed. It is a NA study. The enrollment target is 2,300 participants. The study started on 2016-03. Estimated completion is 2019-06-30.
What conditions does trial NCT02647658 study?
This clinical trial studies the following conditions: Low Back Pain.
What interventions are being tested in trial NCT02647658?
The interventions under investigation include: Guideline Based Care plus Psychologically Informed Physical Therapy (BEHAVIORAL), Guideline Based Care (GBC) (BEHAVIORAL).
Who is sponsoring clinical trial NCT02647658?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02647658 being conducted?
This trial has 5 study locations across Maryland, Massachusetts, Pennsylvania, South Carolina, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Low Back Pain
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02647658's enrollment target sits among peer trials
2,300 6th of 122 higher than 117 of 122 other Low Back Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Low Back Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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