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Completed

NCT Number: NCT01495923

Steroids Versus Gabapentin

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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Key information

Conditions

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

Age range

17 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Naval Hospital-San Diego, San Diego, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

epidural steroid injection

Procedure

Injection of steroids and local anesthetic into the epidural space

Sham epidural steroid injection

Procedure

Injection of saline into the back muscles

Gabapentin

Drug

Titration of gabapentin to effect

Placebo gabapentin

Drug

Titration of placebo gabapentin

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

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

Registry information

Official study title

Randomized, Double-blind, Comparative-effectiveness Study Comparing Epidural Steroid Injections to Gabapentin in Patients With Lumbosacral Radiculopathy

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Dec 20, 2011
Registry last updated
Apr 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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