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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01238536
First Posted: November 10, 2010
Last Update Posted: November 16, 2017
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.
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
November 8, 2010
November 10, 2010
November 16, 2017
April 2011
August 2013   (Final data collection date for primary outcome measure)
Roland Morris [ Time Frame: 6 weeks ]
The primary outcome measure will be back specific functional status, measured by the Roland Scale at 6 weeks. 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.
Same as current
Complete list of historical versions of study NCT01238536 on ClinicalTrials.gov Archive Site
Pain Numeric Rating Scale [ Time Frame: 6 weeks ]
Leg Pain NRS is a second primary outcome at 6 weeks whereas back pain NRS is a secondary outcome.
Pain Numeric Rating Scale [ Time Frame: 6 weeks ]
Not Provided
Not Provided
 
Lumbar Epidural Steroid Injections for Spinal Stenosis Multicenter Randomized, Controlled Trial (LESS Trial)
Multicenter Randomized Controlled Trial of Epidural Steroid Injections for Spinal Stenosis in Persons 50 and Older
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.

Lumbar spinal stenosis is one of the most common causes of low back pain in the elderly and can lead to significant disability. The symptoms of spinal stenosis range from low back pain to neurogenic claudication with lower extremity pain, weakness and/or sensory changes related to activities. As spinal stenosis can affect the central canal as well as the lateral recesses and intervertebral foramen variably, symptoms can involve single or multiple myotomes and dermatomes. Since the causes of spinal stenosis are most frequently degenerative changes, the symptoms of spinal stenosis often, but not always, worsen over time. Despite the prevalence of spinal stenosis, treatment of spinal stenosis remains somewhat controversial. Common treatments include conservative measures such as non-steroidal anti-inflammatories (NSAIDS), activity modification and physical therapy as well as more invasive treatments such as epidural steroid injections and surgery. Although surgery has been demonstrated to provide some benefit to many individuals with spinal stenosis, ESI are being used with increasing frequency as a less invasive, potentially more cost effective and safer treatment for spinal stenosis. However, there is a lack of data to demonstrate the effectiveness and safety of epidural steroid injections for spinal stenosis, particularly in the older adults.

Because of the compelling need for effective therapy for patients suffering from spinal stenosis and because epidural steroid injections are rapidly becoming standard of care for treating these patients - even in the absence of compelling clinical evidence - we are conducting a randomized, controlled trial in order to test the hypothesis that lumbar epidural steroid injections improve functional status and pain associated with spinal stenosis. The main objective of the study is to conduct a blinded, randomized controlled trial (RCT) in elderly patients with spinal stenosis to test if the effectiveness of epidural steroid injections (ESI) plus local anesthetic (LA) is greater than LA alone.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Spinal Stenosis
  • Low Back Pain
  • Procedure: 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.
  • Procedure: Epidural local anesthetic injection
    Epidural injectate will be 2cc of .25-1% lidocaine followed by 1-3cc of 1% lidocaine in an opaque syringe.
  • Drug: 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.
    Other Name: Kenalog, depo-medrol, betamethasone or dexamethasone
  • Drug: Epidural local anesthetic injection
    Epidural injectate will be 2cc of .25-1% lidocaine followed by 1-3cc of 1% lidocaine in an opaque syringe.
    Other Name: lidocaine
  • Experimental: 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 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)

    Interventions:
    • Procedure: Epidural steroid with local anesthetic injection
    • Drug: Epidural steroid injection
  • Active Comparator: 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.
    Interventions:
    • Procedure: Epidural local anesthetic injection
    • Drug: Epidural local anesthetic injection

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
September 2015
August 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Pain in the low back, buttock, and/or lower extremity (pain NRS>=5) with standing, walking and/or spinal extension (buttock/leg>back pain).
  2. Modified Roland-Morris score of at least 7.
  3. Mild-severe lumbar central canal spinal stenosis (Boden et al. criteria18) identified by MRI or CT scan.
  4. Lower extremity symptoms consistent with neurogenic claudication.
  5. Must be able to read English and complete the assessment instruments.
  6. Age 50 or older.

Exclusion Criteria:

  1. Cognitive impairment that renders the patient unable to give informed consent or provide accurate data.
  2. Clinical co-morbidities that could interfere with the collection of data concerning pain and function.

    Known dx of fibromyalgia, chronic widespread pain, amputees, parkinsons, head injury, dementia, stroke, other neurologic conditions Collect date about cervical spinal stenosis, painful peripheral neuropathy, EMGs

  3. Severe vascular, pulmonary or coronary artery disease that limits ambulation including recent myocardial infarction (within 6 months).
  4. Spinal instability requiring surgical fusion.
  5. Severe osteoporosis as defined by multiple compression fractures or a fracture at the same level as the stenosis.
  6. Metastatic cancer.
  7. Excessive alcohol consumption or evidence of non-prescribed or illegal drug use.
  8. Possible pregnancy or other reason that precludes the use of fluoroscopy.
  9. Concordant pain with internal rotation of the hip (or known hip joint pathology).
  10. Active local or systemic infection.
  11. Abnormal coagulation.
  12. Allergy to local anesthetic, steroid or contrast.
  13. Previous lumbar spine surgery.
  14. Epidural steroid injection within previous 6 months.
Sexes Eligible for Study: All
50 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01238536
39023-A
R01HS019222-01 ( U.S. AHRQ Grant/Contract )
Yes
Not Provided
Not Provided
Janna Friedly, University of Washington
University of Washington
  • 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
Principal Investigator: Janna L Friedly, MD University of Washington
University of Washington
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP