- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02095197
C7-T1 Epidural Steroid Injections Versus Targeted Injection for Treatment of Cervical Radicular Pain
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Northwestern University Feinberg School of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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. |
C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine.
Total volume is 2 cc.
Other Names:
|
Active Comparator: 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. |
C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine.
Total volume is 2 cc.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With ≥50% Pain Reduction on the Numeric Rating Score (NRS) for Pain
Time Frame: 1 month
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Decrease of > 6.8 Point Reduction in Medication Quntification Scale (MQS-III)
Time Frame: 1 month
|
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).
|
1 month
|
Patient Global Impression of Change Score (PGIC) Less Than 3
Time Frame: 1 month
|
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
Time Frame: 1 month
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: David R Walega, M.D., Northwestern University Feinberg School of Medicine
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU00089080 (Other Identifier: Northwestern University IRB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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