Transforaminal Versus Lateralized Interlaminar Cervical Epidurals
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Transforaminal Cervical Epidural Corticosteroid Injections
|
Drug: dexamethasone
0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds
|
| Experimental: Lateralized Interlaminar Epidural Corticosteroid Injections
|
Drug: dexamethasone
0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds
|
Outcome Measures
Primary Outcome Measures
- Numerical Rating Scale (averaged over past 24 hours) [2 months]
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) [2 weeks]
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) [4 months]
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) [Baseline, 2 weeks, 2 months, 4 months]
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) [2 weeks]
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) [2 months]
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) [4 months]
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) [Baseline, 2 weeks, 2 months, 4 months]
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 [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 [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 [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 [Baseline, 2 weeks, 2 months, 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.
- Work Ability Index [2 week]
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 [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 [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 [2 week, 3 months, 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.
- Frequency of minor Adverse Events [immediately post-procedure]
- Frequency of minor Adverse Events [2 days post procedure]
- Frequency of major Adverse Events [immediately post-procedure]
- Frequency of major Adverse Events [2 days post procedure]
- Frequency of contrast spread into the neuroforamen for each group [During procedure]
- Rate of inadvertent intravascular contrast injections [During procedure]
Eligibility Criteria
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Duke Radiology and Orthopaedic Clinic | Durham | North Carolina | United States | 27710 |
Sponsors and Collaborators
- Duke University
Investigators
- Principal Investigator: Timothy Amrhein, MD, Duke University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Pro00083262