- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01238536
Lumbar Epidural Steroid Injections for Spinal Stenosis Multicenter Randomized, Controlled Trial (LESS Trial) (LESS)
Multicenter Randomized Controlled Trial of Epidural Steroid Injections for Spinal Stenosis in Persons 50 and Older
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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California
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Redwood City, California, United States, 94063
- Kaiser Permanente Northern California
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Roseville, California, United States, 95661
- Kaiser Permanente Northern California
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Colorado
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Denver, Colorado, United States, 80045
- University of Colorado
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Massachusetts
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Boston, Massachusetts, United States, 02467
- Brigham and Women's Hospital
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Michigan
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Detroit, Michigan, United States, 48202
- Henry Ford Hospital
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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Oregon
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Portland, Oregon, United States
- Oregon Health and Science University
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Texas
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Dallas, Texas, United States, 75216
- Dallas VA Medical Center
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Virginia
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Richmond, Virginia, United States, 23235
- Virginia Spine Research Institute
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Washington
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Seattle, Washington, United States, 98104
- Harborview Medical Center, University of Washington
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Pain in the low back, buttock, and/or lower extremity (pain NRS>=5) with standing, walking and/or spinal extension (buttock/leg>back pain).
- Modified Roland-Morris score of at least 7.
- Mild-severe lumbar central canal spinal stenosis (Boden et al. criteria18) identified by MRI or CT scan.
- Lower extremity symptoms consistent with neurogenic claudication.
- Must be able to read English and complete the assessment instruments.
- Age 50 or older.
Exclusion Criteria:
- Cognitive impairment that renders the patient unable to give informed consent or provide accurate data.
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
- Severe vascular, pulmonary or coronary artery disease that limits ambulation including recent myocardial infarction (within 6 months).
- Spinal instability requiring surgical fusion.
- Severe osteoporosis as defined by multiple compression fractures or a fracture at the same level as the stenosis.
- Metastatic cancer.
- Excessive alcohol consumption or evidence of non-prescribed or illegal drug use.
- Possible pregnancy or other reason that precludes the use of fluoroscopy.
- Concordant pain with internal rotation of the hip (or known hip joint pathology).
- Active local or systemic infection.
- Abnormal coagulation.
- Allergy to local anesthetic, steroid or contrast.
- Previous lumbar spine surgery.
- Epidural steroid injection within previous 6 months.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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) |
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 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 Names:
|
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.
|
Epidural injectate will be 2cc of .25-1%
lidocaine followed by 1-3cc of 1% lidocaine in an opaque syringe.
Epidural injectate will be 2cc of .25-1%
lidocaine followed by 1-3cc of 1% lidocaine in an opaque syringe.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Roland Morris
Time Frame: 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.
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6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Numeric Rating Scale
Time Frame: 6 weeks
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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.
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6 weeks
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Roland Morris Disability Questionnaire (RDQ)
Time Frame: 12 months
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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.
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12 months
|
Leg Pain NRS
Time Frame: 12 months
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Leg Pain NRS 0-10 scale
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12 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Janna L Friedly, MD, University of Washington
Publications and helpful links
General Publications
- Friedly JL, Bresnahan BW, Comstock B, Turner JA, Deyo RA, Sullivan SD, Heagerty P, Bauer Z, Nedeljkovic SS, Avins AL, Nerenz D, Jarvik JG. Study protocol- Lumbar Epidural steroid injections for Spinal Stenosis (LESS): a double-blind randomized controlled trial of epidural steroid injections for lumbar spinal stenosis among older adults. BMC Musculoskelet Disord. 2012 Mar 29;13:48. doi: 10.1186/1471-2474-13-48.
- Turner JA, Comstock BA, Standaert CJ, Heagerty PJ, Jarvik JG, Deyo RA, Wasan AD, Nedeljkovic SS, Friedly JL. Can patient characteristics predict benefit from epidural corticosteroid injections for lumbar spinal stenosis symptoms? Spine J. 2015 Nov 1;15(11):2319-31. doi: 10.1016/j.spinee.2015.06.050. Epub 2015 Jun 19.
- Suri P, Pashova H, Heagerty PJ, Jarvik JG, Turner JA, Comstock BA, Bauer Z, Annaswamy TM, Nedeljkovic SS, Wasan AD, Friedly JL. Short-term improvements in disability mediate patient satisfaction after epidural corticosteroid injections for symptomatic lumbar spinal stenosis. Spine (Phila Pa 1976). 2015 Sep 1;40(17):1363-70. doi: 10.1097/BRS.0000000000001000.
- Friedly JL, Comstock BA, Turner JA, Heagerty PJ, Deyo RA, Sullivan SD, Bauer Z, Bresnahan BW, Avins AL, Nedeljkovic SS, Nerenz DR, Standaert C, Kessler L, Akuthota V, Annaswamy T, Chen A, Diehn F, Firtch W, Gerges FJ, Gilligan C, Goldberg H, Kennedy DJ, Mandel S, Tyburski M, Sanders W, Sibell D, Smuck M, Wasan A, Won L, Jarvik JG. A randomized trial of epidural glucocorticoid injections for spinal stenosis. N Engl J Med. 2014 Jul 3;371(1):11-21. doi: 10.1056/NEJMoa1313265. Erratum In: N Engl J Med. 2014 Jul 24;371(4):390.
- Friedly JL, Comstock BA, Turner JA, Heagerty PJ, Deyo RA, Bauer Z, Avins AL, Nedeljkovic SS, Nerenz DR, Shi XR, Annaswamy T, Standaert CJ, Smuck M, Kennedy DJ, Akuthota V, Sibell D, Wasan AD, Diehn F, Suri P, Rundell SD, Kessler L, Chen AS, Jarvik JG. Long-Term Effects of Repeated Injections of Local Anesthetic With or Without Corticosteroid for Lumbar Spinal Stenosis: A Randomized Trial. Arch Phys Med Rehabil. 2017 Aug;98(8):1499-1507.e2. doi: 10.1016/j.apmr.2017.02.029. Epub 2017 Apr 8.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Musculoskeletal Diseases
- Pathological Conditions, Anatomical
- Spinal Diseases
- Bone Diseases
- Back Pain
- Low Back Pain
- Constriction, Pathologic
- Spinal Stenosis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Sensory System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Membrane Transport Modulators
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Anti-Asthmatic Agents
- Respiratory System Agents
- Dexamethasone
- Methylprednisolone Acetate
- Anesthetics
- Lidocaine
- Betamethasone
- Anesthetics, Local
Other Study ID Numbers
- 39023D
- R01HS019222-01 (U.S. AHRQ Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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