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Lumbar Epidural Steroid Injections for Spinal Stenosis Multicenter Randomized, Controlled Trial (LESS Trial) (LESS)

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ClinicalTrials.gov Identifier: NCT01238536
Recruitment Status : Completed
First Posted : November 10, 2010
Results First Posted : December 13, 2017
Last Update Posted : December 13, 2017
Sponsor:
Collaborators:
Kaiser Permanente
University of California, San Francisco
Henry Ford Hospital
Harvard Pilgrim Health Care
Harvard Vanguard Medical Associates
University of Colorado, Denver
Mayo Clinic
Stanford University
Massachusetts General Hospital
Virginia Spine Research Institute
Oregon Health and Science University
Dallas VA Medical Center
Information provided by (Responsible Party):
Janna Friedly, University of Washington

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Spinal Stenosis
Low Back Pain
Interventions Procedure: Epidural steroid with local anesthetic injection
Procedure: Epidural local anesthetic injection
Drug: Epidural steroid injection
Drug: Epidural local anesthetic injection
Enrollment 400
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Epidural Steroid Injection Epidural Local Anesthetic Injection
Hide Arm/Group Description

Intervention: Epidural steroid with local anesthetic injection

2cc of .25 - 1% lidocaine and glucocorticoid (Kenalog 40-120 mg, depo-medrol 60-120 mg, betamethasone 6-12 mg or dexamethasone 8-10 mg)in an opaque syringe.

Epidural steroid with local anesthetic injection: Epidural steroid injectate will be 2cc of 1% lidocaine followed by 1-3 cc of 40 mg/cc Kenalog (i.e. 40-120 mg Kenalog) or an equivalent steroid medication (depo-medrol 60-120 mg, betamethasone 6-12 mg or dexamethasone 8-10 mg) in an opaque syringe.

Epidural steroid injection: Epidural steroid injectate will be 2cc of .25 - 1% lidocaine followed by 1-3 cc of 40 mg/cc Kenalog (i.e. 40-120 mg Kenalog) or an equivalent steroid medication (depo-medrol 60-120 mg, betamethasone 6-12 mg or dexamethasone 8-10 mg) in an opaque syringe.

Intervention: Epidural injectate will be 2cc of .25-1% lidocaine followed by 1-3cc of 1% lidocaine in an opaque syringe.

Epidural local anesthetic injection: Epidural injectate will be 2cc of .25-1% lidocaine followed by 1-3cc of 1% lidocaine in an opaque syringe.

Period Title: Overall Study
Started 200 200
Completed 153 150
Not Completed 47 50
Arm/Group Title Epidural Steroid Injection Epidural Local Anesthetic Injection Total
Hide Arm/Group Description

Intervention: Epidural steroid with local anesthetic injection

2cc of .25 - 1% lidocaine and glucocorticoid (Kenalog 40-120 mg, depo-medrol 60-120 mg, betamethasone 6-12 mg or dexamethasone 8-10 mg)in an opaque syringe.

Epidural steroid with local anesthetic injection: Epidural steroid injectate will be 2cc of 1% lidocaine followed by 1-3 cc of 40 mg/cc Kenalog (i.e. 40-120 mg Kenalog) or an equivalent steroid medication (depo-medrol 60-120 mg, betamethasone 6-12 mg or dexamethasone 8-10 mg) in an opaque syringe.

Epidural steroid injection: Epidural steroid injectate will be 2cc of .25 - 1% lidocaine followed by 1-3 cc of 40 mg/cc Kenalog (i.e. 40-120 mg Kenalog) or an equivalent steroid medication (depo-medrol 60-120 mg, betamethasone 6-12 mg or dexamethasone 8-10 mg) in an opaque syringe.

Intervention: Epidural injectate will be 2cc of .25-1% lidocaine followed by 1-3cc of 1% lidocaine in an opaque syringe.

Epidural local anesthetic injection: Epidural injectate will be 2cc of .25-1% lidocaine followed by 1-3cc of 1% lidocaine in an opaque syringe.

Total of all reporting groups
Overall Number of Baseline Participants 200 200 400
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 200 participants 200 participants 400 participants
68.0  (9.8) 68.1  (10.2) 68  (10.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 200 participants 200 participants 400 participants
Female
117
  58.5%
104
  52.0%
221
  55.3%
Male
83
  41.5%
96
  48.0%
179
  44.8%
1.Primary Outcome
Title Roland Morris
Hide Description 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.
Time Frame 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
6 week follow up rate was 97% (n=193/200, n=193/200).
Arm/Group Title Epidural Steroid Injection Epidural Local Anesthetic Injection
Hide Arm/Group Description:

Intervention: Epidural steroid with local anesthetic injection

2cc of .25 - 1% lidocaine and glucocorticoid (Kenalog 40-120 mg, depo-medrol 60-120 mg, betamethasone 6-12 mg or dexamethasone 8-10 mg)in an opaque syringe.

Epidural steroid with local anesthetic injection: Epidural steroid injectate will be 2cc of 1% lidocaine followed by 1-3 cc of 40 mg/cc Kenalog (i.e. 40-120 mg Kenalog) or an equivalent steroid medication (depo-medrol 60-120 mg, betamethasone 6-12 mg or dexamethasone 8-10 mg) in an opaque syringe.

Epidural steroid injection: Epidural steroid injectate will be 2cc of .25 - 1% lidocaine followed by 1-3 cc of 40 mg/cc Kenalog (i.e. 40-120 mg Kenalog) or an equivalent steroid medication (depo-medrol 60-120 mg, betamethasone 6-12 mg or dexamethasone 8-10 mg) in an opaque syringe.

Intervention: Epidural injectate will be 2cc of .25-1% lidocaine followed by 1-3cc of 1% lidocaine in an opaque syringe.

Epidural local anesthetic injection: Epidural injectate will be 2cc of .25-1% lidocaine followed by 1-3cc of 1% lidocaine in an opaque syringe.

Overall Number of Participants Analyzed 193 193
Mean (Standard Deviation)
Unit of Measure: units on a scale
11.8  (6.3) 12.5  (6.4)
2.Secondary Outcome
Title Pain Numeric Rating Scale
Hide Description 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.
Time Frame 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Epidural Steroid Injection Epidural Local Anesthetic Injection
Hide Arm/Group Description:

Intervention: Epidural steroid with local anesthetic injection

2cc of .25 - 1% lidocaine and glucocorticoid (Kenalog 40-120 mg, depo-medrol 60-120 mg, betamethasone 6-12 mg or dexamethasone 8-10 mg)in an opaque syringe.

Epidural steroid with local anesthetic injection: Epidural steroid injectate will be 2cc of 1% lidocaine followed by 1-3 cc of 40 mg/cc Kenalog (i.e. 40-120 mg Kenalog) or an equivalent steroid medication (depo-medrol 60-120 mg, betamethasone 6-12 mg or dexamethasone 8-10 mg) in an opaque syringe.

Epidural steroid injection: Epidural steroid injectate will be 2cc of .25 - 1% lidocaine followed by 1-3 cc of 40 mg/cc Kenalog (i.e. 40-120 mg Kenalog) or an equivalent steroid medication (depo-medrol 60-120 mg, betamethasone 6-12 mg or dexamethasone 8-10 mg) in an opaque syringe.

Intervention: Epidural injectate will be 2cc of .25-1% lidocaine followed by 1-3cc of 1% lidocaine in an opaque syringe.

Epidural local anesthetic injection: Epidural injectate will be 2cc of .25-1% lidocaine followed by 1-3cc of 1% lidocaine in an opaque syringe.

Overall Number of Participants Analyzed 193 193
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.4  (2.9) 4.6  (2.9)
3.Secondary Outcome
Title Roland Morris Disability Questionnaire (RDQ)
Hide Description 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.
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Epidural Steroid Injection Epidural Local Anesthetic Injection
Hide Arm/Group Description:

Intervention: Epidural steroid with local anesthetic injection

2cc of .25 - 1% lidocaine and glucocorticoid (Kenalog 40-120 mg, depo-medrol 60-120 mg, betamethasone 6-12 mg or dexamethasone 8-10 mg)

Intervention: Epidural injectate will be 2cc of .25-1% lidocaine followed by 1-3cc of 1% lidocaine in an opaque syringe.
Overall Number of Participants Analyzed 180 174
Mean (Standard Deviation)
Unit of Measure: units on a scale
12.0  (6.5) 11.5  (7.1)
4.Secondary Outcome
Title Leg Pain NRS
Hide Description Leg Pain NRS 0-10 scale
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Epidural Steroid Injection Epidural Local Anesthetic Injection
Hide Arm/Group Description:

Intervention: Epidural steroid with local anesthetic injection

2cc of .25 - 1% lidocaine and glucocorticoid (Kenalog 40-120 mg, depo-medrol 60-120 mg, betamethasone 6-12 mg or dexamethasone 8-10 mg)

Intervention: Epidural injectate will be 2cc of .25-1% lidocaine followed by 1-3cc of 1% lidocaine in an opaque syringe.
Overall Number of Participants Analyzed 180 174
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.7  (3.1) 4.3  (3.1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Epidural Steroid Injection Epidural Local Anesthetic Injection
Hide Arm/Group Description

Intervention: Epidural steroid with local anesthetic injection

2cc of .25 - 1% lidocaine and glucocorticoid (Kenalog 40-120 mg, depo-medrol 60-120 mg, betamethasone 6-12 mg or dexamethasone 8-10 mg)in an opaque syringe.

Epidural steroid with local anesthetic injection: Epidural steroid injectate will be 2cc of 1% lidocaine followed by 1-3 cc of 40 mg/cc Kenalog (i.e. 40-120 mg Kenalog) or an equivalent steroid medication (depo-medrol 60-120 mg, betamethasone 6-12 mg or dexamethasone 8-10 mg) in an opaque syringe.

Epidural steroid injection: Epidural steroid injectate will be 2cc of .25 - 1% lidocaine followed by 1-3 cc of 40 mg/cc Kenalog (i.e. 40-120 mg Kenalog) or an equivalent steroid medication (depo-medrol 60-120 mg, betamethasone 6-12 mg or dexamethasone 8-10 mg) in an opaque syringe.

Intervention: Epidural injectate will be 2cc of .25-1% lidocaine followed by 1-3cc of 1% lidocaine in an opaque syringe.

Epidural local anesthetic injection: Epidural injectate will be 2cc of .25-1% lidocaine followed by 1-3cc of 1% lidocaine in an opaque syringe.

All-Cause Mortality
Epidural Steroid Injection Epidural Local Anesthetic Injection
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Epidural Steroid Injection Epidural Local Anesthetic Injection
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/200 (2.50%)      4/200 (2.00%)    
Surgical and medical procedures     
Hospitalization or Surgery * [1]  5/200 (2.50%)  5 4/200 (2.00%)  4
*
Indicates events were collected by non-systematic assessment
[1]
Any hospitalization or surgery was included as a serious adverse event. this included lumbar spine surgery for failure to improve symptoms or hospitalizations for any reason. None were deemed directly associated with the interventions.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Epidural Steroid Injection Epidural Local Anesthetic Injection
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   43/200 (21.50%)      31/200 (15.50%)    
General disorders     
All other self reported adverse events [1]  43/200 (21.50%)  57 31/200 (15.50%)  33
Injury, poisoning and procedural complications     
Dural puncture [2]  1/200 (0.50%)  1 1/200 (0.50%)  1
[1]
Patients were asked an open-ended question about whether they experienced any adverse event or unexpected adverse event. Patients described the AE, but there were no consistent descriptions to clearly separate into rates for each type of AE.
[2]
Dural puncture at time of procedure
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Janna Friedly M.D.
Organization: University of Washington
Phone: 206-744-3664
Responsible Party: Janna Friedly, University of Washington
ClinicalTrials.gov Identifier: NCT01238536     History of Changes
Other Study ID Numbers: 39023D
R01HS019222-01 ( U.S. AHRQ Grant/Contract )
First Submitted: November 8, 2010
First Posted: November 10, 2010
Results First Submitted: May 11, 2016
Results First Posted: December 13, 2017
Last Update Posted: December 13, 2017