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NCT01144923 · ClinicalTrials.gov registry record · NA
Conservative Therapy Versus Epidural Steroids for Cervical Radiculopathy
A NA study of Cervical Radiculopathy, sponsored by Johns Hopkins University.
- Completed
- Registry status
- NA
- Development phase
- 169
- Enrollment target
- 2
- Study locations
NCT01144923 is a NA study of Cervical Radiculopathy that has completed, run by Johns Hopkins University. The registered enrollment target is 169 participants, above the 64-participant average among 3 other Cervical Radiculopathy trials with a reported enrollment target (164% higher). The trial reports 2 study locations across 2 states.
The verdict
NCT01144923, a NA study of Cervical Radiculopathy, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- NA
- Development phase
- 169 participants
- Enrollment target
- 2
- Study locations
Study Summary
The main objective of this study is to determine whether interventional treatment (i.e. epidural steroids), conservative therapy, or the combination, is superior for cervical radiculopathy. One hundred and sixty eight patients with radicular neck pain will be randomized in a 1:1:1 ratio to receive either cervical epidural steroid injections (CESI), non-interventional management with physical therapy and medications, or a combination of the two. The first follow-up visit will be at 1-month. In patients who obtain some benefit but continue to report significant pain, either a 2nd CESI can be done, the patient's medications can be adjusted, or both in the combination group. Those patients who fail to obtain any benefit will exit the study to receive another treatment or alternative care. The second follow-up visit will be at 3-months. Similar to the 1-month follow-up, the doctor may elect to change nothing in patients who are satisfied, adjust medications, schedule the patient for another CESI, or do both in the combination group. Patients who fail to obtain any benefit can exit the study to receive alternative treatment. The final follow-up visit will be at 6 months.
Conditions Studied
Interventions
- OTHER Gabapentin and/or Nortriptyline, Physical therapy
- PROCEDURE Epidural Steroid Injections (ESI)
- OTHER Combination treatment
Study Locations (2)
District of Columbia
- Walter Reed Army Medical Center - Washington D.C.
Maryland
- Johns Hopkins Medical Institutions - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 169 participants |
| Start Date | 2010-06 |
| Est. Completion | 2013-11 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01144923
The ClinicalTrials.gov registry entry for NCT01144923 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 169 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 64-participant average among 3 other Cervical Radiculopathy trials with a reported enrollment target (164% higher). The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Cervical Radiculopathy appearing as the primary indexed condition, and to 3 interventions - of which Gabapentin and/or Nortriptyline, Physical therapy is the first listed.
NCT01144923 reports 2 study locations spanning 2 distinct geographic areas - top geographies include District of Columbia, Maryland.
Frequently Asked Questions
What is clinical trial NCT01144923 about?
NCT01144923 is a clinical study titled "Conservative Therapy Versus Epidural Steroids for Cervical Radiculopathy". The main objective of this study is to determine whether interventional treatment (i.e. epidural steroids), conservative therapy, or the combination, is superior for cervical radiculopathy. One hundred and sixty eight patients with radicular neck pain will be randomized in a 1:1:1 ratio to receive e...
What is the current status of trial NCT01144923?
This trial is currently completed. It is a NA study. The enrollment target is 169 participants. The study started on 2010-06. Estimated completion is 2013-11.
What conditions does trial NCT01144923 study?
This clinical trial studies the following conditions: Cervical Radiculopathy.
What interventions are being tested in trial NCT01144923?
The interventions under investigation include: Gabapentin and/or Nortriptyline, Physical therapy (OTHER), Epidural Steroid Injections (ESI) (PROCEDURE), Combination treatment (OTHER).
Who is sponsoring clinical trial NCT01144923?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01144923 being conducted?
This trial has 2 study locations across District of Columbia, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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