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

This study is ongoing, but not recruiting participants.
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
ClinicalTrials.gov Identifier:
NCT01238536
First received: November 8, 2010
Last updated: July 9, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Spinal Stenosis
Low Back Pain
Procedure: Epidural steroid with local anesthetic injection
Procedure: Epidural local anesthetic injection
Drug: Epidural steroid injection
Drug: Epidural local anesthetic injection
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multicenter Randomized Controlled Trial of Epidural Steroid Injections for Spinal Stenosis in Persons 50 and Older

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Roland Morris [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Pain Numeric Rating Scale [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Leg Pain NRS is a second primary outcome at 6 weeks whereas back pain NRS is a secondary outcome.


Enrollment: 400
Study Start Date: April 2011
Estimated Study Completion Date: September 2015
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.
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
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.
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 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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01238536

Locations
United States, California
Kaiser Permanente Northern California
Redwood City, California, United States, 94063
Kaiser Permanente Northern California
Roseville, California, United States, 95661
United States, Colorado
University of Colorado
Denver, Colorado, United States, 80045
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02467
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States
United States, Texas
Dallas VA Medical Center
Dallas, Texas, United States, 75216
United States, Virginia
Virginia Spine Research Institute
Richmond, Virginia, United States, 23235
United States, Washington
Harborview Medical Center, University of Washington
Seattle, Washington, United States, 98104
Sponsors and Collaborators
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
Investigators
Principal Investigator: Janna L Friedly, MD University of Washington
  More Information

No publications provided by University of Washington

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Janna Friedly, Assistant Professor, University of Washington
ClinicalTrials.gov Identifier: NCT01238536     History of Changes
Other Study ID Numbers: 39023-A, R01HS19222-01
Study First Received: November 8, 2010
Last Updated: July 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
Epidural Steroid Injection
Low Back Pain
Spinal Stenosis
Elderly

Additional relevant MeSH terms:
Back Pain
Constriction, Pathologic
Low Back Pain
Spinal Stenosis
Bone Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neurologic Manifestations
Pain
Pathological Conditions, Anatomical
Signs and Symptoms
Spinal Diseases
Anesthetics
Anesthetics, Local
BB 1101
Betamethasone
Betamethasone benzoate
Betamethasone sodium phosphate
Betamethasone Valerate
Betamethasone-17,21-dipropionate
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Lidocaine
Methylprednisolone
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate

ClinicalTrials.gov processed this record on October 23, 2014