Trial · NCT01238536
Lumbar Epidural Steroid Injections for Spinal Stenosis Multicenter Randomized, Controlled Trial (LESS Trial)
NCT01238536, Phase 4, Completed, University of Washington; results first posted 2017-12-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Lumbar Epidural Steroid Injections for Spinal Stenosis Multicenter Randomized, Controlled Trial (LESS Trial). Trials, record NCT01238536. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01238536
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Lumbar Epidural Steroid Injections for Spinal Stenosis Multicenter Randomized, Controlled Trial (LESS Trial)
- NCT number
- NCT01238536
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 400 participants, actual
- Lead sponsor
- University of Washington
- Conditions
- Spinal Stenosis, Low Back Pain
- Interventions
- Epidural steroid with local anesthetic injection, Epidural local anesthetic injection, Epidural steroid injection, Epidural local anesthetic injection
- First posted
- 2010-11-10
- Last updated
- 2017-12-13
- Results first posted
- 2017-12-13
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Roland Morris | 6 weeks | 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 (maximum disability). Our primary analysis will be a simple 2-group comparison of the mean Roland score as an evaluation of the short-term efficacy of epidural steroid injection. |
| Secondary | Pain Numeric Rating Scale | 6 weeks | Leg Pain NRS is a second primary outcome at 6 weeks We measured leg pain using a 0-10 pain NRS (0=no pain and 10=worst pain imaginable) assessing average pain over the past week. |
| Secondary | Roland Morris Disability Questionnaire (RDQ) | 12 months | 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 (maximum disability). Our primary analysis will be a simple 2-group comparison of the mean Roland score as an evaluation of the short-term efficacy of epidural steroid injection. |
| Secondary | Leg Pain NRS | 12 months | Leg Pain NRS 0-10 scale |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Roland Morris | 6 weeks | 6 week follow up rate was 97% (n=193/200, n=193/200). | units on a scale | MEAN |
| SECONDARY | Pain Numeric Rating Scale | 6 weeks | units on a scale | MEAN | |
| SECONDARY | Roland Morris Disability Questionnaire (RDQ) | 12 months | units on a scale | MEAN | |
| SECONDARY | Leg Pain NRS | 12 months | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Roland Morris | Epidural Steroid Injection | 11.8 | Standard Deviation 6.3 | units on a scale | |
| Roland Morris | Epidural Local Anesthetic Injection | 12.5 | Standard Deviation 6.4 | units on a scale | |
| Pain Numeric Rating Scale | Epidural Steroid Injection | 4.4 | Standard Deviation 2.9 | units on a scale | |
| Pain Numeric Rating Scale | Epidural Local Anesthetic Injection | 4.6 | Standard Deviation 2.9 | units on a scale | |
| Roland Morris Disability Questionnaire (RDQ) | Epidural Steroid Injection | 12.0 | Standard Deviation 6.5 | units on a scale | |
| Roland Morris Disability Questionnaire (RDQ) | Epidural Local Anesthetic Injection | 11.5 | Standard Deviation 7.1 | units on a scale | |
| Leg Pain NRS | Epidural Steroid Injection | 4.7 | Standard Deviation 3.1 | units on a scale | |
| Leg Pain NRS | Epidural Local Anesthetic Injection | 4.3 | Standard Deviation 3.1 | units on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Epidural Steroid Injection | 200 | |
| Overall Study | STARTED | Epidural Local Anesthetic Injection | 200 | |
| Overall Study | COMPLETED | Epidural Steroid Injection | 153 | |
| Overall Study | COMPLETED | Epidural Local Anesthetic Injection | 150 | |
| Overall Study | NOT COMPLETED | Epidural Steroid Injection | 47 | |
| Overall Study | NOT COMPLETED | Epidural Local Anesthetic Injection | 50 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Dural puncture | Injury, poisoning and procedural complications | Epidural Steroid Injection | 1 | 200 | 1 |
| other | Dural puncture | Injury, poisoning and procedural complications | Epidural Local Anesthetic Injection | 1 | 200 | 1 |
| other | All other self reported adverse events | General disorders | Epidural Steroid Injection | 43 | 200 | 57 |
| other | All other self reported adverse events | General disorders | Epidural Local Anesthetic Injection | 31 | 200 | 33 |
| serious | Hospitalization or Surgery | Surgical and medical procedures | Epidural Steroid Injection | 5 | 200 | 5 |
| serious | Hospitalization or Surgery | Surgical and medical procedures | Epidural Local Anesthetic Injection | 4 | 200 | 4 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Epidural Steroid Injection | ||
| Total, all-cause mortality | Epidural Local Anesthetic Injection | ||
| Total, other adverse events | Epidural Steroid Injection | 43 | 200 |
| Total, other adverse events | Epidural Local Anesthetic Injection | 31 | 200 |
| Total, serious adverse events | Epidural Steroid Injection | 5 | 200 |
| Total, serious adverse events | Epidural Local Anesthetic Injection | 4 | 200 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01HS019222 | Back pain Outcomes using Longitudinal Data (BOLD) | JARVIK, JEFFREY G | UNIVERSITY OF WASHINGTON | AGENCY FOR HEALTHCARE RESEARCH AND QUALITY | 2010 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Epidural Steroid Injection vs Epidural Local Anesthetic Injection: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01238536
GET https://conductscience.org/api/trials/v1/NCT01238536/registered