NCT01238536

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2011

Longer than P75 for phase_4

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 10, 2010

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

December 13, 2017

Completed
Last Updated

December 13, 2017

Status Verified

November 1, 2017

Enrollment Period

2.3 years

First QC Date

November 8, 2010

Results QC Date

May 11, 2016

Last Update Submit

November 15, 2017

Conditions

Spinal StenosisLow Back Pain

Keywords

Epidural Steroid InjectionLow Back PainSpinal StenosisElderly

Outcome Measures

Primary Outcomes (1)

  • Roland Morris

    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.

    6 weeks

Secondary Outcomes (3)

  • Pain Numeric Rating Scale

    6 weeks

  • Roland Morris Disability Questionnaire (RDQ)

    12 months

  • Leg Pain NRS

    12 months

Study Arms (2)

Epidural Steroid injection

EXPERIMENTAL

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 injectionDrug: Epidural steroid injection

Epidural local anesthetic injection

ACTIVE COMPARATOR

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 injectionDrug: Epidural local anesthetic injection

Interventions

Epidural steroid with local anesthetic injectionPROCEDURE

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
Epidural local anesthetic injectionPROCEDURE

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

Epidural local anesthetic injection
Epidural steroid injectionDRUG

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.

Also known as: Kenalog, depo-medrol, betamethasone or dexamethasone
Epidural Steroid injection

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Kaiser Permanente Northern California

Redwood City, California, 94063, United States

Location

Kaiser Permanente Northern California

Roseville, California, 95661, United States

Location

University of Colorado

Denver, Colorado, 80045, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02467, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Oregon Health and Science University

Portland, Oregon, United States

Location

Dallas VA Medical Center

Dallas, Texas, 75216, United States

Location

Virginia Spine Research Institute

Richmond, Virginia, 23235, United States

Location

Harborview Medical Center, University of Washington

Seattle, Washington, 98104, United States

Location

Related Publications (5)

  • 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.

    PMID: 22458343BACKGROUND

  • 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.

    PMID: 26096484RESULT

  • 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.

    PMID: 26010037RESULT

  • 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.

    PMID: 24988555RESULT

  • 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.

    PMID: 28396242DERIVED

MeSH Terms

Conditions

Spinal StenosisLow Back Pain

Interventions

Anesthetics, LocalTriamcinolone AcetonideMethylprednisolone AcetateBetamethasoneDexamethasoneLidocaine

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesBack PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnestheticsCentral Nervous System DepressantsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesSensory System AgentsPeripheral Nervous System AgentsCentral Nervous System AgentsTherapeutic UsesTriamcinolonePregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedMethylprednisolonePrednisolonePregnadienetriolsAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Results Point of Contact

Title
Janna Friedly M.D.
Organization
University of Washington
friedlyj@uw.edu
206-744-3664

Study Officials

  • Janna L Friedly, MD

    University of Washington

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 8, 2010

First Posted

November 10, 2010

Study Start

April 1, 2011

Primary Completion

August 1, 2013

Study Completion

September 1, 2015

Last Updated

December 13, 2017

Results First Posted

December 13, 2017

Record last verified: 2017-11

Locations

US(10)