ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Epidural Steroid Injection

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.

Epidural Local Anesthetic Injection

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.


Participant Flow:   Overall Study
    Epidural Steroid Injection   Epidural Local Anesthetic Injection
STARTED   200   200 
COMPLETED   153   150 
NOT COMPLETED   47   50 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Epidural Steroid Injection

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.

Epidural Local Anesthetic Injection

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 Total of all reporting groups

Baseline Measures
   Epidural Steroid Injection   Epidural Local Anesthetic Injection   Total 
Overall Participants Analyzed 
[Units: Participants]
 200   200   400 
Age 
[Units: Years]
Mean (Standard Deviation)
 68.0  (9.8)   68.1  (10.2)   68  (10.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      117  58.5%      104  52.0%      221  55.3% 
Male      83  41.5%      96  48.0%      179  44.8% 


  Outcome Measures

1.  Primary:   Roland Morris   [ Time Frame: 6 weeks ]

2.  Secondary:   Pain Numeric Rating Scale   [ Time Frame: 6 weeks ]

3.  Secondary:   Roland Morris Disability Questionnaire (RDQ)   [ Time Frame: 12 months ]

4.  Secondary:   Leg Pain NRS   [ Time Frame: 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI 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
e-mail: friedlyj@uw.edu


Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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