NCT01052571

Brief Summary

To evaluate differences in outcomes in patients receiving steroids compared to those patients randomized to the local anesthetic group who did not receive steroids. To evaluate and compare the adverse event profile in all patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P75+ for not_applicable low-back-pain

Timeline
Completed

Started Feb 2010

Longer than P75 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

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

January 18, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 20, 2010

Completed
12 days until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

October 21, 2015

Status Verified

October 1, 2015

Enrollment Period

1.9 years

First QC Date

January 18, 2010

Last Update Submit

October 20, 2015

Conditions

Low Back Pain

Keywords

Chronic low back painLumbar disc herniationLower extremity painLumbar radiculitisLocal anestheticSteroidLumbar transforaminal epidural injection

Outcome Measures

Primary Outcomes (1)

  • Numeric rating scale (NRS), Oswestry Disability Index (ODI), duration of significant pain relief, opioid intake, and return to work

    Outcomes are measured at baseline and at 3, 6, 12, 18, and 24 months post-treatment.

Secondary Outcomes (1)

  • Adverse event profile of side effects and complications.

    Adverse events are measured at baseline and at 3, 6, 12, 18, and 24 months post-treatment, and at any time during the procedure or after the procedure the adverse events are suspected or expected.

Study Arms (2)

Without Steroids

ACTIVE COMPARATOR

Group I patients receiving lumbar transforaminal epidural injections with an injection of local anesthetic (lidocaine 1% or bupivacaine 0.25%

Procedure: lumbar transforaminal epidural injections

steroids

ACTIVE COMPARATOR

Group II patients will receive lumbar transforaminal epidural injections with 1% lidocaine or 0.25% bupivacaine with 3 mg of steroid per level

Procedure: lumbar transforaminal epidural injections

Interventions

lumbar transforaminal epidural injectionsPROCEDURE

with an injection of local anesthetic or with 1% lidocaine or 0.25% bupivacaine with 3 mg of steroid per level

Also known as: Transforaminal Epidural
Without Steroidssteroids

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with disc herniation or radiculitis
  • Patients who are 18 years of age
  • Patients with a history of chronic function-limiting low back and lower extremity pain of at least 6 months duration
  • Patients who are competent to understand the study protocol and provide voluntary, written informed consent and participate in outcome measurements

You may not qualify if:

  • Previous lumbar surgery, radiculitis secondary to spinal stenosis without disc herniation
  • Uncontrollable or unstable opioid use
  • Uncontrolled psychiatric disorders
  • Uncontrolled medical illness either acute or chronic
  • Any conditions that could interfere with the interpretation of the outcome assessments
  • Pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ambulatory Surgery Center

Paducah, Kentucky, 42001, United States

Location

MeSH Terms

Conditions

Low Back PainIntervertebral Disc DisplacementRadiculopathy

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSpinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Laxmaiah Manchikanti, MD

    Ambulatory Surgery Center, Paducah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director

Study Record Dates

First Submitted

January 18, 2010

First Posted

January 20, 2010

Study Start

February 1, 2010

Primary Completion

January 1, 2012

Study Completion

August 1, 2014

Last Updated

October 21, 2015

Record last verified: 2015-10

Locations

US(1)