Conservative Therapy Versus Epidural Steroids for Cervical Radiculopathy
Status: | Recruiting |
---|---|
Conditions: | Neurology, Women's Studies |
Therapuetic Areas: | Neurology, Reproductive |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/30/2013 |
Start Date: | June 2010 |
Contact: | Steven P Cohen, MD |
Email: | scohen40@jhmi.edu |
Phone: | 410-955-1818 |
Randomized, Comparative-effectiveness Study Comparing Epidural Steroid Injections to Conservative Management With Medications and Physical Therapy in Patients With 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 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.
Inclusion Criteria:
1. Cervical radicular pain based on history and physical exam (e.g. pain radiating into
one or both extremities, sensory loss, muscle weakness, Spurling's test etc.)
2. NRS arm pain score > 3
3. MRI evidence of disc pathology consistent with symptoms
Exclusion Criteria:
1. Untreated coagulopathy
2. Previous spine surgery
3. No MRI study
4. Arm pain > 4 years duration
5. Epidural steroid injection within past 3 years
6. Radiculopathy not resulting from disc pathology (e.g. foraminal stenosis or tumor)
7. Signs or symptoms or myelopathy or spinal cord compression
8. Previous failed trials with gabapentin or pregabalin, and nortriptyline or
amitriptyline
9. Allergic reactions to gabapentin or nortriptyline
10. Referrals from surgery for diagnostic injections for surgical evaluation
11. Serious medical (e.g. congestive heart failure) or psychiatric (untreated depression)
condition that might preclude optimal outcome
12. Pregnancy
We found this trial at
2
sites
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6900 Georgia Ave NW
Washington, District of Columbia 20307
Washington, District of Columbia 20307
(202) 782-6849
Walter Reed Army Medical Center The Walter Reed National Military Medical Center is one of...
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