Steroids Versus Gabapentin
Overview[ - collapse ][ - ]
| Purpose | The purpose of this study is to determine whether pharmacotherapy or epidural steroid injections are a better treatment for lumbosacral radicular pain. 142 patients referred to a participating pain clinic with lumbosacral radiculopathy will be randomized in a 1:1 ratio to receive one of two treatments. Half (n=71) of the patients will be allocated to receive an epidural steroid injection (ESI; group I), with an equal number allocated to receive gabapentin (group II). Patients & evaluating physicians will be blinded. Follow-up will be through 3-months after treatment. |
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| Condition | Sciatica Radiculopathy |
| Intervention | Procedure: epidural steroid injection Procedure: Sham epidural steroid injection Drug: Gabapentin Drug: Placebo gabapentin |
| Phase | N/A |
| Sponsor | Johns Hopkins University |
| Responsible Party | Johns Hopkins University |
| ClinicalTrials.gov Identifier | NCT01495923 |
| First Received | December 15, 2011 |
| Last Updated | March 10, 2014 |
| Last verified | March 2014 |
Tracking Information[ + expand ][ + ]
| First Received Date | December 15, 2011 |
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| Last Updated Date | March 10, 2014 |
| Start Date | December 2011 |
| Estimated Primary Completion Date | December 2014 |
| Current Primary Outcome Measures |
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| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | Steroids Versus Gabapentin |
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| Official Title | Randomized, Double-blind, Comparative-effectiveness Study Comparing Epidural Steroid Injections to Gabapentin in Patients With Lumbosacral Radiculopathy |
| Brief Summary | The purpose of this study is to determine whether pharmacotherapy or epidural steroid injections are a better treatment for lumbosacral radicular pain. 142 patients referred to a participating pain clinic with lumbosacral radiculopathy will be randomized in a 1:1 ratio to receive one of two treatments. Half (n=71) of the patients will be allocated to receive an epidural steroid injection (ESI; group I), with an equal number allocated to receive gabapentin (group II). Patients & evaluating physicians will be blinded. Follow-up will be through 3-months after treatment. |
| Detailed Description | 142 patients referred to a participating pain clinic with lumbosacral radiculopathy will be randomized in a 1:1 ratio to receive one of two treatments. Half (n=71) of the patients will be allocated to receive an ESI (group I), with an equal number allocated to receive gabapentin (group II). Group I patients with unilateral symptoms will receive (unilateral) transforaminal ESI, while those with bilateral symptoms will receive (central) interlaminar ESI, as is common practice. In group II patients who receive gabapentin, the dose will be titrated to between 1800 mg/d and 2700 mg/d in TID dosing, but may be lowered or elevated (up to 3600 mg/d) depending on the clinical circumstances. To ensure blinding, these patients will also receive midline (for patients with bilateral symptoms who would receive interlaminar ESI) or unilateral paraspinal (for patients with unilateral symptoms who would receive transforaminal ESI) normal saline into the interspinal ligaments or paraspinal musculature, respectively. Injections and medication titration will commence on the same day. Rescue medications will consist of tramadol 50 mg 1 to 2 tablets every 6 hours PRN (up to 8/d) and/or ibuprofen 400-800 mg every 6 hours PRN (not-to-exceed 3000 mg/d). Patients already taking analgesics, including opioids, can continue on these medications "as needed". The first follow-up visit will be scheduled 1-month from the start of treatment. A positive outcome will be defined as a > 2-point decrease in leg pain coupled with a positive satisfaction rating. Subjects who obtain a positive outcome at their initial 1-month follow-up visit will remain in the study and return for the final 3-month follow-up visit. Those with a negative outcome will exit the study "per protocol" to receive standard care, which may consist of unblinded ESI, medical management with drugs such as gabapentin (for those who did not receive gabapentin) and antidepressants, and physical therapy. Subjects who obtain a positive outcome at 1-month but experience a recurrence before their 3-month follow-up visit will also exit the study per protocol, with their final outcome measures recorded before they receive standard care. At all follow-up visits, pill counts will be conducted to determine medication compliance. |
| Study Type | Interventional |
| Study Phase | N/A |
| Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
| Condition |
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| Intervention | Procedure: epidural steroid injection Injection of steroids and local anesthetic into the epidural space Procedure: Sham epidural steroid injection Injection of saline into the back muscles Drug: Gabapentin Titration of gabapentin to effect Drug: Placebo gabapentin Titration of placebo gabapentin |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Recruiting |
|---|---|
| Estimated Enrollment | 142 |
| Estimated Completion Date | December 2014 |
| Estimated Primary Completion Date | December 2014 |
| Eligibility Criteria | Inclusion Criteria: - Lumbosacral radicular pain based on history and physical exam (e.g. pain radiating into one or both lower extremities, sensory loss, muscle weakness, positive straight leg raising test etc.) - Numerical Rating Scale leg pain score > 4 (or if 3/10, greater or equal to back pain) - MRI evidence of spinal pathology consistent with symptoms Exclusion Criteria: - Untreated coagulopathy - Previous spine surgery - No MRI study - Leg pain > 4 years duration Epidural steroid injection within past 3 years Cauda equina syndrome Previous failed trials with gabapentin or pregabalin Allergic reactions to gabapentin or pregabalin Referrals from surgery for diagnostic injections for surgical evaluation Serious medical or psychiatric that condition that might preclude optimal outcome or interfere with participation, such as the need for uninterrupted anticoagulation. Pregnancy |
| Gender | Both |
| Ages | 17 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: Connie Kurihara, RN 301-400-2595 conniekurihara@gmail.com |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01495923 |
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| Other Study ID Numbers | 358308-4 |
| Has Data Monitoring Committee | No |
| Information Provided By | Johns Hopkins University |
| Study Sponsor | Johns Hopkins University |
| Collaborators | Walter Reed National Military Medical Center Brooke Army Medical Center Landstuhl Regional Medical Center DC VA Hospital United States Naval Medical Center, San Diego Case Western Reserve University Milton S. Hershey Medical Center |
| Investigators | Principal Investigator: Steven P Cohen, MD Walter Reed Army Institute of Research (WRAIR) |
| Verification Date | March 2014 |
Locations[ + expand ][ + ]
| Naval Hospital-San Diego | San Diego, California, United States, 92134 Contact: Carol A Drastal, RN | 619-379-5625 | Carol.Drastal.Ctr@med.navy.milPrincipal Investigator: Steven Hanling, MD Recruiting |
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| Johns Hopkins | Baltimore, Maryland, United States, 21205 Contact: Mirinda White, RN | 443-287-0409 | mander47@jhmi.eduPrincipal Investigator: Steven P Cohen, MD Recruiting |
| Walter Reed National Military Medical Center | Bethesda, Maryland, United States, 20889 Contact: Connie Kurihara, RN | 310-400-2595 | conniekurihara@gmail.comSub-Investigator: David Jamison, MD Recruiting |