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NCT01726803 · ClinicalTrials.gov registry record · NA

Comparative Effectiveness of Acute Low Back Pain Management

A NA study, sponsored by University of Utah.

Completed
Registry status
NA
Development phase
220
Enrollment target

NCT01726803: Completed NA study, sponsored by University of Utah.

NCT01726803 is a NA study that has completed, run by University of Utah. The registered enrollment target is 220 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01726803, a NA study, has completed, sponsored by University of Utah.

COMPLETED
Registry status
NA
Development phase
220 participants
Enrollment target

Study Summary

Current practice guidelines for patients with acute low back pain (LBP) recommend a stepped care approach with initial treatment of education and advice to remain active. Referral to physical therapy is considered only when patients fail to recover after a few weeks. Recent research has led to the identification a subgroup of patients likely to experience rapid, pronounced, and sustained decreases in disability and pain with a brief manipulation and exercise intervention, suggesting it may be more cost-effective to manage this sub-group with early referral to physical therapy instead of the usual care approach. The integration of this evidence into routine practice has not been evaluated. We will assess the outcomes of integrating this evidence into the management of patients with low back pain. The study is a randomized trial, comparing management with early manipulation with the current care process model. Patients fitting the inclusion criteria will be randomized into one of two groups. One group will be managed with the current care process model. The other group will be managed consistent with the decision rule recommending early referral for a brief manipulation and exercise intervention during the first 4 weeks. Patients will be followed over 1 year. Outcomes will include measures of disability, pain, satisfaction, and direct medical costs. The study will examine the costs and effectiveness of integrating the alternative care model into practice.

Primary Outcome

10-item Oswestry Disability Index assessing low back pain-related disability. Scores range from 0-100 with higher numbers indicating greater disability.

Interventions

  • OTHER Usual Care
  • OTHER Early Physical Therapy with Usual Care

Trial Details

FieldValue
Enrollment Target 220 participants
Start Date 2011-04
Est. Completion 2014-11
Phase NA
University of Utah

818 total trials

What the finished NCT01726803 record still lists

NCT01726803 is an interventional study that assigns participants to a tested intervention. The registered 220 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (84% lower).

The record links to 0 conditions, and to 2 interventions - of which Usual Care is the first listed.

NCT01726803 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01726803 about?

NCT01726803 is a clinical study titled "Comparative Effectiveness of Acute Low Back Pain Management". Current practice guidelines for patients with acute low back pain (LBP) recommend a stepped care approach with initial treatment of education and advice to remain active. Referral to physical therapy is considered only when patients fail to recover after a few weeks. Recent research has led to the i...

What is the current status of trial NCT01726803?

This trial is currently completed. It is a NA study. The enrollment target is 220 participants. The study started on 2011-04. Estimated completion is 2014-11.

What interventions are being tested in trial NCT01726803?

The interventions under investigation include: Usual Care (OTHER), Early Physical Therapy with Usual Care (OTHER).

Who is sponsoring clinical trial NCT01726803?

This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01726803's enrollment target sits among peer trials

220 481st of 2000 higher than 1,516 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01726803, the US trial registry maintained by the National Library of Medicine. NCT01726803 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.