Steroids Versus Gabapentin

NCT01495923 | Completed Results

• 1 other identifier: NA_00047152
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 3

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.

Conditions

Sciatica; Radiculopathy

Keywords

low back pain; radiculopathy; injection

Outcome Measures

Primary Outcomes (4)

• Average Leg Pain at 1 Month Measured Using the Numeric Pain Scale

  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.

  1 month after the start of treatment

• Average Leg Pain at 3 Months Measured Using the Numeric Pain Scale

  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.

  3 months from the start of treatment

• Worst Leg Pain at 1 Month Measured Using the Numeric Pain Scale

  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.

  1 month from the start of treatment

• Worst Leg Pain at 3 Months Measured Using the Numeric Pain Scale

  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.

  3 months from the start of treatment

Secondary Outcomes (9)

• Average Back Pain at 1 Month Measured Using the Numeric Pain Scale

  1 month fromt he start of treatment

• Average Back Pain at 3 Months Measured Using the Numeric Pain Scale

  3 months from the start of treatment

• Outcomes Related to Disability Measured at 1 Month Using the Oswestry Disability Index

  1 month after the start of treatment

• Outcomes Related to Disability Measured at 3 Month Using the Oswestry Disability Index

  3 months after the start of treatment

• Global Perceived Effect of Treatment at 3 Months After the Start of Treatment

  3 months after the start of treatment

Study Arms (2)

Epidural steroids

EXPERIMENTAL

Injection of steroids into the epidural space

Procedure: epidural steroid injection; Drug: Placebo gabapentin

Gabapentin

ACTIVE COMPARATOR

Titration of gabapentin to effect

Procedure: Sham epidural steroid injection; Drug: Gabapentin

Interventions

epidural steroid injection PROCEDURE

Injection of steroids and local anesthetic into the epidural space

Epidural steroids

Sham epidural steroid injection PROCEDURE

Injection of saline into the back muscles

Gabapentin

Gabapentin DRUG

Titration of gabapentin to effect

Gabapentin

Placebo gabapentin DRUG

Titration of placebo gabapentin

Epidural steroids

Eligibility Criteria

• Age: 17 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Walter Reed National Military Medical Center: collaborator
• Brooke Army Medical Center: collaborator
• Landstuhl Regional Medical Center: collaborator
• Washington D.C. Veterans Affairs Medical Center: collaborator
• United States Naval Medical Center, San Diego: collaborator
• Case Western Reserve University: collaborator
• Milton S. Hershey Medical Center: collaborator

Study Sites (3)

Naval Hospital-San Diego

San Diego, California, 92134, United States

Location

Johns Hopkins

Baltimore, Maryland, 21205, United States

Location

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

Related Publications (1)

• Cohen SP, Hanling S, Bicket MC, White RL, Veizi E, Kurihara C, Zhao Z, Hayek S, Guthmiller KB, Griffith SR, Gordin V, White MA, Vorobeychik Y, Pasquina PF. Epidural steroid injections compared with gabapentin for lumbosacral radicular pain: multicenter randomized double blind comparative efficacy study. BMJ. 2015 Apr 16;350:h1748. doi: 10.1136/bmj.h1748.

  PMID: 25883095 DERIVED

MeSH Terms

Conditions

Sciatica; Radiculopathy; Low Back Pain

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Back Pain

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Steven Cohen
• Organization: The Johns Hopkins Hospital

scohen40@jhmi.edu

410-955-1818

Study Officials

• Steven P Cohen, MD

  Walter Reed Army Institute of Research (WRAIR)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 15, 2011
• First Posted: December 20, 2011
• Study Start: December 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: September 1, 2014
• Last Updated: April 11, 2017
• Results First Posted: April 11, 2017

Record last verified: 2017-02

Locations

US (3)