Back to resultsTransforaminal Versus Lateralized Interlaminar Cervical Epidurals
Primary Purpose
Cervicogenic Upper Extremity Radiculopathy
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Cervicogenic Upper Extremity Radiculopathy focused on measuring CT-fluoroscopy, Corticosteroid injection
Eligibility Criteria
Inclusion Criteria:
- Unilateral cervicogenic upper extremity radiculopathy (with or without accompanying neck pain)
- Baseline numerical pain scale (NRS) score > 4
Exclusion Criteria:
- Recent (i.e., < 2 months) cervical spine surgery
- Recent (i.e., < 1 month) cervical epidural or upper extremity corticosteroid injection
- Contraindication or inability to the undergo procedure
- Inability to provide informed consent
- Expected inability to complete follow-up assessment
- Contraindication to receiving contrast material (precluding an epidurogram)
Sites / Locations
- Duke Radiology and Orthopaedic ClinicRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Transforaminal Cervical Epidural Corticosteroid Injections
Lateralized Interlaminar Epidural Corticosteroid Injections
Arm Description
Outcomes
Primary Outcome Measures
Numerical Rating Scale (averaged over past 24 hours)
The pain numerical rating scale (NRS) is a well-validated tool for quantitatively assessing patients' pain. The NRS asks patients to rate their current pain intensity on an 11-point scale ranging from 0 ("no pain") to 10 ("worst possible pain")
Secondary Outcome Measures
NRS (averaged over past 24 hours)
The pain numerical rating scale (NRS) is a well-validated tool for quantitatively assessing patients' pain. The NRS asks patients to rate their current pain intensity on an 11-point scale ranging from 0 ("no pain") to 10 ("worst possible pain")
NRS (averaged over past 24 hours)
The pain numerical rating scale (NRS) is a well-validated tool for quantitatively assessing patients' pain. The NRS asks patients to rate their current pain intensity on an 11-point scale ranging from 0 ("no pain") to 10 ("worst possible pain")
Change in NRS (averaged over past 24 hours)
The pain numerical rating scale (NRS) is a well-validated tool for quantitatively assessing patients' pain. The NRS asks patients to rate their current pain intensity on an 11-point scale ranging from 0 ("no pain") to 10 ("worst possible pain")
Neck Disability Index (NDI)
The NDI a well-validated measurement tool that contains 10 items: seven related to activities of daily living, two related to pain, and one related to concentration. Each item is scored from 0 to 5 and the total score is expressed as a percentage, with higher scores corresponding to greater disability.
Neck Disability Index (NDI)
The NDI a well-validated measurement tool that contains 10 items: seven related to activities of daily living, two related to pain, and one related to concentration. Each item is scored from 0 to 5 and the total score is expressed as a percentage, with higher scores corresponding to greater disability.
Neck Disability Index (NDI)
The NDI a well-validated measurement tool that contains 10 items: seven related to activities of daily living, two related to pain, and one related to concentration. Each item is scored from 0 to 5 and the total score is expressed as a percentage, with higher scores corresponding to greater disability.
Change in Neck Disability Index (NDI)
The NDI a well-validated measurement tool that contains 10 items: seven related to activities of daily living, two related to pain, and one related to concentration. Each item is scored from 0 to 5 and the total score is expressed as a percentage, with higher scores corresponding to greater disability.
EQ-5D at 2 weeks
EQ-5D is a standardized measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal.
EQ-5D at 2 months
EQ-5D is a standardized measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal.
EQ-5D at 4 months
EQ-5D is a standardized measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal.
Change in EQ-5D
EQ-5D is a standardized measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal.
Work Ability Index at 2 weeks
The Work Ability Index (WAI) is a validated, reliable measure of a worker's ability to do his or her job that has been shown to predict work disability, retirement and mortality.
Work Ability Index at 2 months
The Work Ability Index (WAI) is a validated, reliable measure of a worker's ability to do his or her job that has been shown to predict work disability, retirement and mortality.
Work Ability Index at 4 months
The Work Ability Index (WAI) is a validated, reliable measure of a worker's ability to do his or her job that has been shown to predict work disability, retirement and mortality.
Change in Work Ability Index
The Work Ability Index (WAI) is a validated, reliable measure of a worker's ability to do his or her job that has been shown to predict work disability, retirement and mortality.
Frequency of minor Adverse Events
Frequency of minor Adverse Events
Frequency of major Adverse Events
Frequency of major Adverse Events
Frequency of contrast spread into the neuroforamen for each group
Rate of inadvertent intravascular contrast injections
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03389620
Brief Title
Transforaminal Versus Lateralized Interlaminar Cervical Epidurals
Official Title
Comparison of Cervical Transforaminal Epidural Corticosteroid Injections With Lateralized Interlaminar Epidural Corticosteroid Injections for Treatment of Cervicogenic Upper Extremity Radiculopathy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 5, 2018 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare two methods of giving epidural steroid injections for nerve pain in the arm that comes from the neck. An epidural steroid injection can be given in two different ways, either in the back of the spine within the neck or in the neck next to the nerve root going to the arm. Both are standard medical treatments. The investigators would like to see how effective these treatments are, and if there are any differences in effectiveness or safety between these two routes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervicogenic Upper Extremity Radiculopathy
Keywords
CT-fluoroscopy, Corticosteroid injection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
116 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Transforaminal Cervical Epidural Corticosteroid Injections
Arm Type
Active Comparator
Arm Title
Lateralized Interlaminar Epidural Corticosteroid Injections
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
dexamethasone
Intervention Description
0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds
Primary Outcome Measure Information:
Title
Numerical Rating Scale (averaged over past 24 hours)
Description
The pain numerical rating scale (NRS) is a well-validated tool for quantitatively assessing patients' pain. The NRS asks patients to rate their current pain intensity on an 11-point scale ranging from 0 ("no pain") to 10 ("worst possible pain")
Time Frame
2 months
Secondary Outcome Measure Information:
Title
NRS (averaged over past 24 hours)
Description
The pain numerical rating scale (NRS) is a well-validated tool for quantitatively assessing patients' pain. The NRS asks patients to rate their current pain intensity on an 11-point scale ranging from 0 ("no pain") to 10 ("worst possible pain")
Time Frame
2 weeks
Title
NRS (averaged over past 24 hours)
Description
The pain numerical rating scale (NRS) is a well-validated tool for quantitatively assessing patients' pain. The NRS asks patients to rate their current pain intensity on an 11-point scale ranging from 0 ("no pain") to 10 ("worst possible pain")
Time Frame
4 months
Title
Change in NRS (averaged over past 24 hours)
Description
The pain numerical rating scale (NRS) is a well-validated tool for quantitatively assessing patients' pain. The NRS asks patients to rate their current pain intensity on an 11-point scale ranging from 0 ("no pain") to 10 ("worst possible pain")
Time Frame
Baseline, 2 weeks, 2 months, 4 months
Title
Neck Disability Index (NDI)
Description
The NDI a well-validated measurement tool that contains 10 items: seven related to activities of daily living, two related to pain, and one related to concentration. Each item is scored from 0 to 5 and the total score is expressed as a percentage, with higher scores corresponding to greater disability.
Time Frame
2 weeks
Title
Neck Disability Index (NDI)
Description
The NDI a well-validated measurement tool that contains 10 items: seven related to activities of daily living, two related to pain, and one related to concentration. Each item is scored from 0 to 5 and the total score is expressed as a percentage, with higher scores corresponding to greater disability.
Time Frame
2 months
Title
Neck Disability Index (NDI)
Description
The NDI a well-validated measurement tool that contains 10 items: seven related to activities of daily living, two related to pain, and one related to concentration. Each item is scored from 0 to 5 and the total score is expressed as a percentage, with higher scores corresponding to greater disability.
Time Frame
4 months
Title
Change in Neck Disability Index (NDI)
Description
The NDI a well-validated measurement tool that contains 10 items: seven related to activities of daily living, two related to pain, and one related to concentration. Each item is scored from 0 to 5 and the total score is expressed as a percentage, with higher scores corresponding to greater disability.
Time Frame
Baseline, 2 weeks, 2 months, 4 months
Title
EQ-5D at 2 weeks
Description
EQ-5D is a standardized measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal.
Time Frame
2 weeks
Title
EQ-5D at 2 months
Description
EQ-5D is a standardized measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal.
Time Frame
2 months
Title
EQ-5D at 4 months
Description
EQ-5D is a standardized measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal.
Time Frame
4 months
Title
Change in EQ-5D
Description
EQ-5D is a standardized measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal.
Time Frame
Baseline, 2 weeks, 2 months, 4 months
Title
Work Ability Index at 2 weeks
Description
The Work Ability Index (WAI) is a validated, reliable measure of a worker's ability to do his or her job that has been shown to predict work disability, retirement and mortality.
Time Frame
2 weeks
Title
Work Ability Index at 2 months
Description
The Work Ability Index (WAI) is a validated, reliable measure of a worker's ability to do his or her job that has been shown to predict work disability, retirement and mortality.
Time Frame
2 months
Title
Work Ability Index at 4 months
Description
The Work Ability Index (WAI) is a validated, reliable measure of a worker's ability to do his or her job that has been shown to predict work disability, retirement and mortality.
Time Frame
4 months
Title
Change in Work Ability Index
Description
The Work Ability Index (WAI) is a validated, reliable measure of a worker's ability to do his or her job that has been shown to predict work disability, retirement and mortality.
Time Frame
2 week, 3 months, 4 months
Title
Frequency of minor Adverse Events
Time Frame
immediately post-procedure
Title
Frequency of minor Adverse Events
Time Frame
2 days post procedure
Title
Frequency of major Adverse Events
Time Frame
immediately post-procedure
Title
Frequency of major Adverse Events
Time Frame
2 days post procedure
Title
Frequency of contrast spread into the neuroforamen for each group
Time Frame
During procedure
Title
Rate of inadvertent intravascular contrast injections
Time Frame
During procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Unilateral cervicogenic upper extremity radiculopathy (with or without accompanying neck pain)
Baseline numerical pain scale (NRS) score > 4
Exclusion Criteria:
Recent (i.e., < 2 months) cervical spine surgery
Recent (i.e., < 1 month) cervical epidural or upper extremity corticosteroid injection
Contraindication or inability to the undergo procedure
Inability to provide informed consent
Expected inability to complete follow-up assessment
Contraindication to receiving contrast material (precluding an epidurogram)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Timothy Amrhein, MD
Phone
919-684-7770
Email
timothy.amrhein@duke.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy Amrhein, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Radiology and Orthopaedic Clinic
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Timothy Amrhein, MD
Phone
919-684-7770
Email
timothy.amrhein@duke.edu
12. IPD Sharing Statement
Learn more about this trial
Transforaminal Versus Lateralized Interlaminar Cervical Epidurals
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