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NCT01238536 · ClinicalTrials.gov registry record · Phase 4
Lumbar Epidural Steroid Injections for Spinal Stenosis Multicenter Randomized, Controlled Trial (LESS Trial)
A Phase 4 study, sponsored by University of Washington.
- Completed
- Registry status
- Phase 4
- Development phase
- 400
- Enrollment target
NCT01238536: Completed Phase 4 study, sponsored by University of Washington.
NCT01238536 is a Phase 4 study that has completed, run by University of Washington. The registered enrollment target is 400 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01238536, a Phase 4 study, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 400 participants
- Enrollment target
Study Summary
The broad, long-term objective of this research protocol is to improve the quality of life for patients suffering from lumbar spinal stenosis. This objective will be met by examining the safety and clinical efficacy of epidural steroid injections for treatment of pain associated with lumbar spinal stenosis. This prospective, randomized, double-blind controlled trial (RCT) will test the hypothesis that the effectiveness of epidural steroid injections (ESI) plus local anesthetic (LA) is greater than epidural injections of LA alone in older adults with lumbar spinal stenosis.
Primary Outcome
The primary outcome measure will be back specific functional status, measured by the Roland Scale at 6 weeks. The RDQ is a back pain specific functional status questionnaire adapted from the Sickness Impact Profile (SIP). The RDQ consists of 24 yes/no items, which represent common dysfunctions in daily activities experienced by subjects with low back pain. A single unweighted score is derived by summing the 24 items, with higher scores indicating worse function with 0 (no disability) to 24 (maxi
Interventions
- PROCEDURE Epidural steroid with local anesthetic injection
- PROCEDURE Epidural local anesthetic injection
- DRUG Epidural steroid injection
- DRUG Epidural local anesthetic injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2011-04 |
| Est. Completion | 2015-09 |
| Phase | Phase 4 |
What the finished NCT01238536 record still lists
NCT01238536 is an interventional study that assigns participants to a tested intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (23% lower).
The record links to 0 conditions, and to 4 interventions - of which Epidural steroid with local anesthetic injection is the first listed.
NCT01238536 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01238536 about?
NCT01238536 is a clinical study titled "Lumbar Epidural Steroid Injections for Spinal Stenosis Multicenter Randomized, Controlled Trial (LESS Trial)". The broad, long-term objective of this research protocol is to improve the quality of life for patients suffering from lumbar spinal stenosis. This objective will be met by examining the safety and clinical efficacy of epidural steroid injections for treatment of pain associated with lumbar spinal s...
What is the current status of trial NCT01238536?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 400 participants. The study started on 2011-04. Estimated completion is 2015-09.
What interventions are being tested in trial NCT01238536?
The interventions under investigation include: Epidural steroid with local anesthetic injection (PROCEDURE), Epidural local anesthetic injection (PROCEDURE), Epidural steroid injection (DRUG), Epidural local anesthetic injection (DRUG).
Who is sponsoring clinical trial NCT01238536?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01238536's enrollment target sits among peer trials
400 211th of 2000 higher than 1,784 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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