This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Steroids Versus Gabapentin

This study has been completed.
Sponsor:
Collaborators:
Walter Reed National Military Medical Center
Brooke Army Medical Center
Landstuhl Regional Medical Center
Washington D.C. Veterans Affairs Medical Center
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: February 28, 2017
Last verified: February 2017
  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
Intervention Model: Parallel Assignment
Masking: Participant, 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 Steven P. Cohen, Johns Hopkins University:

Primary Outcome Measures:
  • Average Leg Pain at 1 Month Measured Using the Numeric Pain Scale [ Time Frame: 1 month after the start of treatment ]
    This outcome measure compares the average leg pain at baseline to the average leg pain 1 month after the start of treatment. This is measured using the Numeric Pain Scale. The Numeric Pain Scale ranges from 0-10. 0 being no pain at all and 10 being the worst imaginable pain possible. The epidural steroid injection group is compared to the gabapentin group.

  • Average Leg Pain at 3 Months Measured Using the Numeric Pain Scale [ Time Frame: 3 months from the start of treatment ]
    This outcome measure compares the average leg pain at baseline to the average leg pain 3 month after the start of treatment. This is measured using the Numeric Pain Scale. The Numeric Pain Scale ranges from 0-10. 0 being no pain at all and 10 being the worst imaginable pain possible. The epidural steroid injection group is compared to the gabapentin group.

  • Worst Leg Pain at 1 Month Measured Using the Numeric Pain Scale [ Time Frame: 1 month from the start of treatment ]
    This outcome measure compares the average leg pain at baseline to the average leg pain 1 month after the start of treatment. This is measured using the Numeric Pain Scale. The Numeric Pain Scale ranges from 0-10. 0 being no pain at all and 10 being the worst imaginable pain possible. The epidural steroid injection group is compared to the gabapentin group.

  • Worst Leg Pain at 3 Months Measured Using the Numeric Pain Scale [ Time Frame: 3 months from the start of treatment ]
    This outcome measure compares the worst leg pain at baseline to the worst leg pain at 3 months after the start of treatment. This is measured using the Numeric Pain Scale. The Numeric Pain Scale ranges from 0-10. 0 being no pain at all and 10 being the worst imaginable pain possible. The epidural steroid injection group is compared to the gabapentin group.


Secondary Outcome Measures:
  • Average Back Pain at 1 Month Measured Using the Numeric Pain Scale [ Time Frame: 1 month fromt he start of treatment ]
    This outcome measure compares the average back pain at baseline to the average back pain 1 month after the start of treatment. This is measured using the Numeric Pain Scale. The Numeric Pain Scale ranges from 0-10. 0 being no pain at all and 10 being the worst imaginable pain possible. The epidural steroid injection group is compared to the gabapentin group.

  • Average Back Pain at 3 Months Measured Using the Numeric Pain Scale [ Time Frame: 3 months from the start of treatment ]
    This outcome measure compares the average back pain at baseline to the average back pain at 3 months after the start of treatment. This is measured using the Numeric Pain Scale. The Numeric Pain Scale ranges from 0-10. 0 being no pain at all and 10 being the worst imaginable pain possible. The epidural steroid injection group is compared to the gabapentin group.

  • Outcomes Related to Disability Measured at 1 Month Using the Oswestry Disability Index [ Time Frame: 1 month after the start of treatment ]
    Functional capacity measured using Oswestry disability index. The range of possible scores for Oswestry Disability Index are 0-100. 0 is equated with no disability and 100 is the maximum disability possible.

  • Outcomes Related to Disability Measured at 3 Month Using the Oswestry Disability Index [ Time Frame: 3 months after the start of treatment ]
    Functional capacity measured using Oswestry disability index. The range of possible scores for Oswestry Disability Index are 0-100. 0 is equated with no disability and 100 is the maximum disability possible.

  • Global Perceived Effect of Treatment at 3 Months After the Start of Treatment [ Time Frame: 3 months after the start of treatment ]
    The participant is asked "Are you satisfied with the treatment you have received so far? Participants could respond yes or no. This is measured 3 months after the start of treatment.

  • Global Perceived Effect of Treatment at 1 Month After the Start of Treatment [ Time Frame: 1 month after the start of treatment ]
    The participant is asked "Are you satisfied with the treatment you have received so far? Participants could respond yes or no. This is measured 1 month after the start of treatment.

  • Worst Back Pain at 1 Month Measured Using the Numeric Pain Scale [ Time Frame: 1 month from the start of treatment ]
    This outcome measure compares the worst back pain at baseline to the worst back pain at 1 months after the start of treatment. This is measured using the Numeric Pain Scale. The Numeric Pain Scale ranges from 0-10. 0 being no pain at all and 10 being the worst imaginable pain possible. The epidural steroid injection group is compared to the gabapentin group.

  • Worst Back Pain at 3 Months Measured Using the Numeric Pain Scale [ Time Frame: 3 months after the start of treatment ]
    This outcome measure compares the worst back pain at baseline to the worst back pain at 3 months after the start of treatment. This is measured using the Numeric Pain Scale. The Numeric Pain Scale ranges from 0-10. 0 being no pain at all and 10 being the worst imaginable pain possible. The epidural steroid injection group is compared to the gabapentin group.

  • Proceeded to Surgery Within Year of Enrollment [ Time Frame: Measured within the year of enrollment in the study ]
    This is a measure of participants that proceeded to surgery within a year of enrollment


Enrollment: 145
Study Start Date: December 2011
Study Completion Date: September 2014
Primary Completion Date: June 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 to 100 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
Naval Hospital-San Diego
San Diego, California, United States, 92134
United States, Maryland
Johns Hopkins
Baltimore, Maryland, United States, 21205
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889
Sponsors and Collaborators
Johns Hopkins University
Walter Reed National Military Medical Center
Brooke Army Medical Center
Landstuhl Regional Medical Center
Washington D.C. Veterans Affairs Medical Center
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Steven P. Cohen, Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01495923     History of Changes
Other Study ID Numbers: NA_00047152
Study First Received: December 15, 2011
Results First Received: August 10, 2016
Last Updated: February 28, 2017

Keywords provided by Steven P. Cohen, Johns Hopkins University:
low back pain
radiculopathy
injection

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

ClinicalTrials.gov processed this record on June 22, 2017