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COMPLETED NA

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

NCT02647658 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 2,300 participants
Start Date 2016-03
Est. Completion 2019-06-30
Phase NA

Sponsor

University of Pittsburgh

1,082 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02647658

The ClinicalTrials.gov registry entry for NCT02647658 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 2,300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pittsburgh, which has 1,082 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02647658 reports 5 study locations spanning 5 distinct geographic areas — top geographies include Maryland, Massachusetts, Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02647658?

This trial is sponsored by University of Pittsburgh, which has 1,082 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial