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| ID | Type | Description | Link |
|---|---|---|---|
| STU00089080 | Other Identifier | Northwestern University IRB |
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Cervical radicular pain is a common, disabling problem, occurs in 83:100,000 individuals per year. Symptoms are most often caused by intervertebral disc herniation (21.9%) or central or foraminal stenosis from spondylosis (68.4%). Patients complain of pain in the head, neck, scapula or arm. The diagnosis of radicular pain is made clinically by history and physical examination, supported by imaging studies and electrodiagnostic tests. No study has compared the differences in pain, medication utilization, functional outcomes, or patient satisfaction between interlaminar and targeted epidural injections in the cervical spine. In theory, the technique of targeted epidural steroid delivery with a catheter has a lower risk of accidental vascular trespass or disc penetration during the procedure, and far less risk of dural penetration or spinal cord injury at rostral levels of the cervical spinal cord as compared with the interlaminar technique. The investigators hypothesize that this technique results in superior pain control, decreased medication use, improved function and fewer repeat injections. This data could improve patient safety and affect the evolving treatment guidelines for cervical epidural injections.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Catheter delivery | Other | Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc. No Catheter Delivery will be used to deliver the medication. |
|
| Catheter targeted delivery | Active Comparator | Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc. Catheter targeted delivery will be used to deliver the medication. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triamcinolone 80mg | Drug | C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With ≥50% Pain Reduction on the Numeric Rating Score (NRS) for Pain | The percentage of participants who reported ≥50% pain reduction on the numeric rating score for pain at the 1 month follow-up assessment period. Numeric Rating Scale (NRS) for pain consists of a range where 0 (is no pain) and 10 (is extreme pain). Percentage of participants with pain reduction = 100% (number of participants with pain reduction/all participants) | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Decrease of > 6.8 Point Reduction in Medication Quntification Scale (MQS-III) | The Medication Quantification Scale was designed as a method of quantifying different drug regimens (Harden et al, Journal of Pain, 2005). The detriment weights derived from the healthcare survey for each of the 22 medication classes are the critical values that when multiplied by a dosage score it gives a patient MQS score. It computes a single numeric value for a patient's pain medication profile. We recorded the names and doses of each medication being used then quantified the total burden of each subject's medication using the MQS-III. which assigns a measurement to each drug based on both the dose taken and its burdensomeness (derived from expert consensus). |
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David R Walega, M.D. | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University Feinberg School of Medicine | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27922950 | Derived | McCormick ZL, Nelson A, Bhave M, Zhukalin M, Kendall M, McCarthy RJ, Khan D, Nagpal G, Walega DR. A Prospective Randomized Comparative Trial of Targeted Steroid Injection Via Epidural Catheter Versus Standard C7-T1 Interlaminar Approach for the Treatment of Unilateral Cervical Radicular Pain. Reg Anesth Pain Med. 2017 Jan-Feb;42(1):82-89. doi: 10.1097/AAP.0000000000000521. |
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| ID | Title | Description |
|---|---|---|
| FG000 | No Catheter Delivery | Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc. No Catheter Delivery will be used to deliver the medication. Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc. |
| FG001 | Catheter Targeted Delivery | Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc. Catheter targeted delivery will be used to deliver the medication. Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | No Catheter Delivery | Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc. No Catheter Delivery will be used to deliver the medication. Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With ≥50% Pain Reduction on the Numeric Rating Score (NRS) for Pain | The percentage of participants who reported ≥50% pain reduction on the numeric rating score for pain at the 1 month follow-up assessment period. Numeric Rating Scale (NRS) for pain consists of a range where 0 (is no pain) and 10 (is extreme pain). Percentage of participants with pain reduction = 100% (number of participants with pain reduction/all participants) | Posted | Number | 95% Confidence Interval | percentage of participants | 1 month |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | No Catheter Delivery | Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc. No Catheter Delivery will be used to deliver the medication. Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Walega, MD | Northwestern University, Feinberg School of Medicine | 312-695-2500 | d-walega@northwestern.edu |
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| ID | Term |
|---|---|
| D019547 | Neck Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014221 | Triamcinolone |
| D014222 | Triamcinolone Acetonide |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| 1 month |
| Patient Global Impression of Change Score (PGIC) Less Than 3 | PGIC is a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change as: 1=Very Much Improved, 2=Much Improved, 3=Minimally Improved, 4=No Change, 5=Minimally Worse, 6=Much Worse, 7=Very Much Worse. A PGIC score less than 3 means the patient reported "much improved" to "very much improved." | 1 month |
| Greater Than or Equal to a 30% Reduction in Oswestry Neck Disability Index Score | This questionnaire has been designed to give us information to how neck pain has affected the ability to manage in everyday life. There are ten sections, 0 to 5 rating scale, in which zero means 'No pain' and 5 means 'Worst imaginable pain'. All the points can be summed to a total score. The maximum points scored is 50. The reported score divided by 50 is then transformed to a percentage score by multiplying by 100. The Minimum dectectable change (90 % confidence) is 5 points or 10 percent. | 1 month |
| Catheter Targeted Delivery |
Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc. Catheter targeted delivery will be used to deliver the medication. Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Catheter Targeted Delivery | Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc. Catheter targeted delivery will be used to deliver the medication. Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc. |
|
|
|
| Secondary | Decrease of > 6.8 Point Reduction in Medication Quntification Scale (MQS-III) | The Medication Quantification Scale was designed as a method of quantifying different drug regimens (Harden et al, Journal of Pain, 2005). The detriment weights derived from the healthcare survey for each of the 22 medication classes are the critical values that when multiplied by a dosage score it gives a patient MQS score. It computes a single numeric value for a patient's pain medication profile. We recorded the names and doses of each medication being used then quantified the total burden of each subject's medication using the MQS-III. which assigns a measurement to each drug based on both the dose taken and its burdensomeness (derived from expert consensus). | Posted | Count of Participants | Participants | 1 month |
|
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|
|
| Secondary | Patient Global Impression of Change Score (PGIC) Less Than 3 | PGIC is a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change as: 1=Very Much Improved, 2=Much Improved, 3=Minimally Improved, 4=No Change, 5=Minimally Worse, 6=Much Worse, 7=Very Much Worse. A PGIC score less than 3 means the patient reported "much improved" to "very much improved." | Posted | Count of Participants | Participants | 1 month |
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|
|
| Secondary | Greater Than or Equal to a 30% Reduction in Oswestry Neck Disability Index Score | This questionnaire has been designed to give us information to how neck pain has affected the ability to manage in everyday life. There are ten sections, 0 to 5 rating scale, in which zero means 'No pain' and 5 means 'Worst imaginable pain'. All the points can be summed to a total score. The maximum points scored is 50. The reported score divided by 50 is then transformed to a percentage score by multiplying by 100. The Minimum dectectable change (90 % confidence) is 5 points or 10 percent. | Both demonstrate a difference from pretreatment baseline (P=0.05). | Posted | Count of Participants | Participants | 1 month |
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|
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Catheter Targeted Delivery | Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc. Catheter targeted delivery will be used to deliver the medication. Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc. | 0 | 36 | 0 | 36 |
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| D011083 |
| Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |