Steroids Versus Gabapentin

Not Applicable

Completed

Conditions: Sciatica
Radiculopathy

Interventions: Procedure: Sham epidural steroid injection
Procedure: epidural steroid injection
Drug: Placebo gabapentin
Drug: Gabapentin

Registration Number: NCT01495923

Lead Sponsor: Johns Hopkins University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 145

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gabapentin	Sham epidural steroid injection	Titration of gabapentin to effect
Epidural steroids	epidural steroid injection	Injection of steroids into the epidural space
Epidural steroids	Placebo gabapentin	Injection of steroids into the epidural space
Gabapentin	Gabapentin	Titration of gabapentin to effect

Primary Outcome Measures

Name	Time	Method
Worst Leg Pain at 3 Months Measured Using the Numeric Pain Scale	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.
Average Leg Pain at 3 Months Measured Using the Numeric Pain Scale	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	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.
Average Leg Pain at 1 Month Measured Using the Numeric Pain Scale	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.

Secondary Outcome Measures

Name	Time	Method
Outcomes Related to Disability Measured at 3 Month Using the Oswestry Disability Index	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.
Proceeded to Surgery Within Year of Enrollment	Measured within the year of enrollment in the study	This is a measure of participants that proceeded to surgery within a year of enrollment
Outcomes Related to Disability Measured at 1 Month Using the Oswestry Disability Index	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.
Global Perceived Effect of Treatment at 3 Months After the Start of Treatment	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.
Average Back Pain at 1 Month Measured Using the Numeric Pain Scale	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	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.
Global Perceived Effect of Treatment at 1 Month After the Start of Treatment	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	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	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.

Trial Locations

Locations (3): Naval Hospital-San Diego
🇺🇸
San Diego, California, United States
Walter Reed National Military Medical Center
🇺🇸
Bethesda, Maryland, United States
Johns Hopkins
🇺🇸
Baltimore, Maryland, United States