A Prospective Randomized Controlled Trial of Standardized C7-T1 Epidural Steroid Injections Versus Targeted Injection Via Cervical Epidural Catheter for the Treatment of Cervical Radicular Pain
Triamcinolone 80mg
Neurologic Manifestations+2
+ Pain
+ Signs and Symptoms
Treatment Study
Summary
Study start date: March 1, 2014
Actual date on which the first participant was enrolled.Cervical radicular pain is a common, painful, disabling problem, often treated by epidural steroid injection (ESI). Two techniques of steroid delivery into the cervical epidural space include the transforaminal and interlaminar approaches. We aimed to determine if the CIESI with versus without a catheter is associated with superior clinical outcomes at follow-up. We hypothesized that the use of a targeted epidural catheter technique would result in superior pain control, function, decreased analgesic use, and lower surgical incidence as compared to standard CIESI at C7-T1.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.79 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * All patients ages 18-75 with C2-6 unilateral radicular pain who are scheduled to undergo cervical epidural steroid injection treatment. * Pain lasting greater than 2 weeks. * Pain resistant to a trial of conservative therapy (i.e. oral steroids,nonsteroidal anti-inflammatory drugs, opioids, muscle relaxants, physical therapy or chiropractic care) Exclusion Criteria: * Patient refusal. * Lack of consent. * Systemic infection or local infection over planned injection site in posterior cervical spine. * Bleeding disorder, current use of anticoagulants or anti-platelet medications. * Intrinsic spinal cord lesions in the cervical region. * History of central neurologic, cerebrovascular, demyelinating or muscular disease. * Concomitant use of oral or injected steroids. * Allergy to medications being used for injection procedures. * Inability to communicate with staff or to participate in follow up. * Pregnancy. * Inability to perform handgrip or arm strength testing. * Cognitive deficit or motor neuron disease. * Daily opiate use that preceded the onset of cervical radicular symptoms or daily opiate use exceeding 3 months prior to study inclusion
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Northwestern University Feinberg School of Medicine
Chicago, United StatesOpen Northwestern University Feinberg School of Medicine in Google Maps