Clinical trial NCT01238536: Lumbar Epidural Steroid Injections for Spinal Stenosis Multicenter Randomized, Controlled Trial (LESS Trial)
Official title: Multicenter Randomized Controlled Trial of Epidural Steroid Injections for Spinal Stenosis in Persons 50 and Older
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Spinal Stenosis
Low Back Pain
Keywords: Epidural Steroid Injection
Low Back Pain
Spinal Stenosis
Elderly
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Kaiser Permanente
name: University of California, San Francisco
name: Henry Ford Hospital
name: Harvard Pilgrim Health Care
name: Harvard Vanguard Medical Associates
name: University of Colorado, Denver
name: Mayo Clinic
name: Stanford University
name: Massachusetts General Hospital
name: Virginia Spine Research Institute
name: Oregon Health and Science University
name: Dallas VA Medical Center
First posted: 2010-11-10
Enrollment: 400
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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 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.

Primary outcomes:
measure: Roland Morris
timeFrame: 6 weeks
Secondary outcomes:
measure: Pain Numeric Rating Scale
timeFrame: 6 weeks
measure: Roland Morris Disability Questionnaire (RDQ)
timeFrame: 12 months
measure: Leg Pain NRS
timeFrame: 12 months
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Kaiser Permanente Northern California
state: California
city: Roseville
country: United States
facility: Kaiser Permanente Northern California
state: California
city: Denver
country: United States
facility: University of Colorado
state: Colorado
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Dallas
country: United States
facility: Dallas VA Medical Center
state: Texas
city: Richmond
country: United States
facility: Virginia Spine Research Institute
state: Virginia
city: Seattle
country: United States
facility: Harborview Medical Center, University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Janna L Friedly, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.