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

NCT ID: NCT01238536

Last Updated: 2017-12-13

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2015-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Spinal Stenosis Low Back Pain

Keywords

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Epidural Steroid Injection Low Back Pain Spinal Stenosis Elderly

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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)

Group Type EXPERIMENTAL

Epidural steroid with local anesthetic injection

Intervention Type PROCEDURE

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

Intervention Type DRUG

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.

Group Type ACTIVE_COMPARATOR

Epidural local anesthetic injection

Intervention Type PROCEDURE

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

Epidural local anesthetic injection

Intervention Type DRUG

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

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

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 Type 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.

Intervention Type DRUG

Other Intervention Names

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Kenalog, depo-medrol, betamethasone or dexamethasone lidocaine

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kaiser Permanente

OTHER

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role collaborator

Henry Ford Hospital

OTHER

Sponsor Role collaborator

Harvard Pilgrim Health Care

OTHER

Sponsor Role collaborator

Harvard Vanguard Medical Associates

OTHER

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role collaborator

Virginia Spine Research Institute

UNKNOWN

Sponsor Role collaborator

Oregon Health and Science University

OTHER

Sponsor Role collaborator

Dallas VA Medical Center

FED

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Janna Friedly

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Janna L Friedly, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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Kaiser Permanente Northern California

Redwood City, California, United States

Site Status

Kaiser Permanente Northern California

Roseville, California, United States

Site Status

University of Colorado

Denver, Colorado, United States

Site Status

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Henry Ford Hospital

Detroit, Michigan, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Oregon Health and Science University

Portland, Oregon, United States

Site Status

Dallas VA Medical Center

Dallas, Texas, United States

Site Status

Virginia Spine Research Institute

Richmond, Virginia, United States

Site Status

Harborview Medical Center, University of Washington

Seattle, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 22458343 (View on PubMed)

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.

Reference Type RESULT
PMID: 26096484 (View on PubMed)

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.

Reference Type RESULT
PMID: 26010037 (View on PubMed)

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.

Reference Type RESULT
PMID: 24988555 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28396242 (View on PubMed)

Other Identifiers

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R01HS019222-01

Identifier Type: AHRQ

Identifier Source: secondary_id

View Link

39023D

Identifier Type: -

Identifier Source: org_study_id