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NCT00802724 · ClinicalTrials.gov registry record · Phase 1

Classification-Directed Treatment of Low Back Pain

A Phase 1 study, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

Completed
Registry status
Phase 1
Development phase
101
Enrollment target

NCT00802724: Completed Phase 1 study, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

NCT00802724 is a Phase 1 study that has completed, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 101 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00802724, a Phase 1 study, has completed, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

COMPLETED
Registry status
Phase 1
Development phase
101 participants
Enrollment target

Study Summary

The primary purpose of this proposal is to conduct a prospective, randomized, controlled clinical trial to examine whether or not treatment based on a person's direction-specific, impairment-based LBP classification is more effective than Non-specific treatment in improving short- (6 weeks) and long-term (6 and 12 months) outcomes in people with chronic LBP. We hypothesize that treatment based on a person's direction-specific, impairment-based LBP classification (Classification-specific) will result in better outcomes than Non-specific treatment. Our approach to classification-directed treatment is based on the proposal that a person's LBP is the result of adopting direction-specific strategies of movement and alignment of the spine which then are used repeatedly during the person's everyday activities. The exposure of spine tissue to repeated loading in the same direction across a day is proposed to accelerate the accumulation of stress, microtrauma, and eventually LBP. We also hypothesize that until the factors contributing to the use of the direction-specific strategies of the spine are modified, the LBP problem will persist or recur. Identification of homogeneous subgroups of people with LBP will enhance 1) the power of clinical trials, 2) prognosis, and 3) the ability to identify mechanisms contributing to different LBP problems.

Primary Outcome

Functional limitation measure

Interventions

  • BEHAVIORAL Classification-directed treatment
  • BEHAVIORAL Non-specific treatment

Trial Details

FieldValue
Enrollment Target 101 participants
Start Date 2007-02
Est. Completion 2010-11
Phase Phase 1

What the finished NCT00802724 record still lists

NCT00802724 is an interventional study that assigns participants to a tested intervention. The registered 101 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% higher).

The record links to 0 conditions, and to 2 interventions - of which Classification-directed treatment is the first listed.

NCT00802724 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00802724 about?

NCT00802724 is a clinical study titled "Classification-Directed Treatment of Low Back Pain". The primary purpose of this proposal is to conduct a prospective, randomized, controlled clinical trial to examine whether or not treatment based on a person's direction-specific, impairment-based LBP classification is more effective than Non-specific treatment in improving short- (6 weeks) and long...

What is the current status of trial NCT00802724?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 101 participants. The study started on 2007-02. Estimated completion is 2010-11.

What interventions are being tested in trial NCT00802724?

The interventions under investigation include: Classification-directed treatment (BEHAVIORAL), Non-specific treatment (BEHAVIORAL).

Who is sponsoring clinical trial NCT00802724?

This trial is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00802724's enrollment target sits among peer trials

101 546th of 2000 higher than 1,455 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT00802724, the US trial registry maintained by the National Library of Medicine. NCT00802724 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.