Steroids Versus Gabapentin

This study is currently recruiting participants.
Verified March 2014 by Johns Hopkins University
Sponsor:
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
Information provided by (Responsible Party):
Steven P. Cohen, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01495923
First received: December 15, 2011
Last updated: March 10, 2014
Last verified: March 2014
  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.


Condition Intervention
Sciatica
Radiculopathy
Procedure: epidural steroid injection
Procedure: Sham epidural steroid injection
Drug: Gabapentin
Drug: Placebo gabapentin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-blind, Comparative-effectiveness Study Comparing Epidural Steroid Injections to Gabapentin in Patients With Lumbosacral Radiculopathy

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • leg pain [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • leg pain [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Back pain [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Back pain [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Oswestry disability index [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    functional capacity

  • Oswestry disability index [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    functional capacity

  • satisfaction [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Question: Are you satisfied with the results of your treatment?

  • satisfaction [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Question: Are you satisfied with the results of your treatment?


Estimated Enrollment: 142
Study Start Date: December 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Epidural steroids
Injection of steroids into the epidural space
Procedure: epidural steroid injection
Injection of steroids and local anesthetic into the epidural space
Drug: Placebo gabapentin
Titration of placebo gabapentin
Active Comparator: Gabapentin
Titration of gabapentin to effect
Procedure: Sham epidural steroid injection
Injection of saline into the back muscles
Drug: Gabapentin
Titration of gabapentin to effect

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.

  Eligibility

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01495923

Contacts
Contact: Connie Kurihara, RN 301-400-2595 conniekurihara@gmail.com
Contact: Steven Cohen, MD 410-955-1822 scohen40@jhmi.edu

Locations
United States, California
Naval Hospital-San Diego Recruiting
San Diego, California, United States, 92134
Contact: Carol A Drastal, RN    619-379-5625    Carol.Drastal.Ctr@med.navy.mil   
Principal Investigator: Steven Hanling, MD         
Sub-Investigator: Ivan Lesnik, MD         
United States, Maryland
Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21205
Contact: Mirinda White, RN    443-287-0409    mander47@jhmi.edu   
Principal Investigator: Steven P Cohen, MD         
Walter Reed National Military Medical Center Recruiting
Bethesda, Maryland, United States, 20889
Contact: Connie Kurihara, RN    310-400-2595    conniekurihara@gmail.com   
Sub-Investigator: David Jamison, MD         
Sponsors and Collaborators
Johns Hopkins University
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)
  More Information

No publications provided

Responsible Party: Steven P. Cohen, Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01495923     History of Changes
Other Study ID Numbers: 358308-4
Study First Received: December 15, 2011
Last Updated: March 10, 2014
Health Authority: United States: Federal Government

Keywords provided by Johns Hopkins University:
low back pain
radiculopathy
injection

Additional relevant MeSH terms:
Sciatica
Radiculopathy
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Sciatic Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs

ClinicalTrials.gov processed this record on April 17, 2014