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NCT01933399 · ClinicalTrials.gov registry record · NA

Comparison of Extensible and Inextensible Lumbosacral Orthoses for Lower Back Pain

A NA study of Low Back Pain, sponsored by Medical University of South Carolina.

Completed
Registry status
NA
Development phase
98
Enrollment target
1
Study location

NCT01933399: Completed NA study of Low Back Pain, sponsored by Medical University of South Carolina.

NCT01933399 is a NA study of Low Back Pain that has completed, run by Medical University of South Carolina. The registered enrollment target is 98 participants, below the 503-participant average among 122 other Low Back Pain trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01933399, a NA study of Low Back Pain, has completed, sponsored by Medical University of South Carolina.

COMPLETED
Registry status
NA
Development phase
98 participants
Enrollment target
1
Study location

Study Summary

This study is designed to discern if the use of a lumbosacral orthesis (LSO, also call a back support) improves the short-term outcome of lower back pain. participants will receive standard care (physical therapy, physician treatment), with one group also receiving an extensible LSO, and another group receiving an inextensible LSO. The inextensible LSO has been shown to increase stiffness of the trunk in individuals while wearing it. The hypothesis is that the group wearing the inextensible LSO will have improved outcomes over the other two groups (standard care or standard care plus the extensible LSO).

Primary Outcome

Change score from baseline and the score at the second week. The Oswestry Disabilty Index is a 100 point self-assessment of disabilty due to lower back pain or complications from lower back pain. A score of 40 or more points is interpreted as signficant disability due to lower back pain. A score between 20 and 40 respresents disability, but the individual is still able to function to some degree with activities of daily living, but has to modify their behavior. A score less than 20 implies that

Conditions Studied

Interventions

  • OTHER Standard of Care
  • OTHER Inextensible LSO (stiff back support)
  • OTHER Extensible LSO, a back support that is flexible

Study Locations (1)

South Carolina

  • Medical University of South Carolina - Charleston

Trial Details

FieldValue
Enrollment Target 98 participants
Start Date 2007-09
Est. Completion 2013-12
Phase NA

What the finished NCT01933399 record still lists

NCT01933399 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, below the 503-participant average among 122 other Low Back Pain trials with a reported enrollment target (81% lower).

The record links to 1 condition, with Low Back Pain appearing as the primary indexed condition, and to 3 interventions - of which Standard of Care is the first listed.

NCT01933399 reports a single indexed study location in South Carolina.

Frequently Asked Questions

What is clinical trial NCT01933399 about?

NCT01933399 is a clinical study titled "Comparison of Extensible and Inextensible Lumbosacral Orthoses for Lower Back Pain". This study is designed to discern if the use of a lumbosacral orthesis (LSO, also call a back support) improves the short-term outcome of lower back pain. participants will receive standard care (physical therapy, physician treatment), with one group also receiving an extensible LSO, and another gro...

What is the current status of trial NCT01933399?

This trial is currently completed. It is a NA study. The enrollment target is 98 participants. The study started on 2007-09. Estimated completion is 2013-12.

What conditions does trial NCT01933399 study?

This clinical trial studies the following conditions: Low Back Pain.

What interventions are being tested in trial NCT01933399?

The interventions under investigation include: Standard of Care (OTHER), Inextensible LSO (stiff back support) (OTHER), Extensible LSO, a back support that is flexible (OTHER).

Who is sponsoring clinical trial NCT01933399?

This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01933399 being conducted?

This trial has 1 study location across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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 NCT01933399's enrollment target sits among peer trials

98 61st of 122 higher than 62 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.

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

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Source: ClinicalTrials.gov NCT01933399, the US trial registry maintained by the National Library of Medicine. NCT01933399 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.