Clinical trial NCT01495923: Steroids Versus Gabapentin
Official title: Randomized, Double-blind, Comparative-effectiveness Study Comparing Epidural Steroid Injections to Gabapentin in Patients With Lumbosacral Radiculopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sciatica
Radiculopathy
Keywords: low back pain
radiculopathy
injection
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Walter Reed National Military Medical Center
name: Brooke Army Medical Center
name: Landstuhl Regional Medical Center
name: Washington D.C. Veterans Affairs Medical Center
name: United States Naval Medical Center, San Diego
name: Case Western Reserve University
name: Milton S. Hershey Medical Center
First posted: 2011-12-20
Enrollment: 145
Sex: ALL
Minimum age (years): 17
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Average Leg Pain at 1 Month Measured Using the Numeric Pain Scale
timeFrame: 1 month after the start of treatment
measure: Average Leg Pain at 3 Months Measured Using the Numeric Pain Scale
timeFrame: 3 months from the start of treatment
measure: Worst Leg Pain at 1 Month Measured Using the Numeric Pain Scale
timeFrame: 1 month from the start of treatment
measure: Worst Leg Pain at 3 Months Measured Using the Numeric Pain Scale
timeFrame: 3 months from the start of treatment
Secondary outcomes:
measure: Average Back Pain at 1 Month Measured Using the Numeric Pain Scale
timeFrame: 1 month fromt he start of treatment
measure: Average Back Pain at 3 Months Measured Using the Numeric Pain Scale
timeFrame: 3 months from the start of treatment
measure: Outcomes Related to Disability Measured at 1 Month Using the Oswestry Disability Index
timeFrame: 1 month after the start of treatment
measure: Outcomes Related to Disability Measured at 3 Month Using the Oswestry Disability Index
timeFrame: 3 months after the start of treatment
measure: Global Perceived Effect of Treatment at 3 Months After the Start of Treatment
timeFrame: 3 months after the start of treatment
measure: Global Perceived Effect of Treatment at 1 Month After the Start of Treatment
timeFrame: 1 month after the start of treatment
measure: Worst Back Pain at 1 Month Measured Using the Numeric Pain Scale
timeFrame: 1 month from the start of treatment
measure: Worst Back Pain at 3 Months Measured Using the Numeric Pain Scale
timeFrame: 3 months after the start of treatment
measure: Proceeded to Surgery Within Year of Enrollment
timeFrame: Measured within the year of enrollment in the study
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Naval Hospital-San Diego
state: California
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
Study officials:
affiliation: Walter Reed Army Institute of Research (WRAIR)
name: Steven P Cohen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.