Steroids Versus Gabapentin

Sciatica Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01495923
• Other study ID #: 358308-4
• Status: Completed
• Phase: N/A
• First received: December 15, 2011
• Last updated: January 1, 2015
• Start date: December 2011
• Est. completion date: September 2014

Study information

• Verified date: January 2015
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: September 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Radiculopathy
• Sciatica

Intervention

Procedure:
• epidural steroid injection
Injection of steroids and local anesthetic into the epidural space
• Sham epidural steroid injection
Injection of saline into the back muscles

Drug:
• Gabapentin
Titration of gabapentin to effect
• Placebo gabapentin
Titration of placebo gabapentin

Locations

Country	Name	City	State
United States	Johns Hopkins	Baltimore	Maryland
United States	Walter Reed National Military Medical Center	Bethesda	Maryland
United States	Naval Hospital-San Diego	San Diego	California

Sponsors (8)

Lead Sponsor	Collaborator
Johns Hopkins University	Brooke Army Medical Center, Case Western Reserve University, DC VA Hospital, Landstuhl Regional Medical Center, Milton S. Hershey Medical Center, United States Naval Medical Center, San Diego, Walter Reed National Military Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	leg pain		1 month	No
Primary	leg pain		3 months	No
Secondary	Back pain		1 month	No
Secondary	Back pain		3 months	No
Secondary	Oswestry disability index	functional capacity	1 month	No
Secondary	Oswestry disability index	functional capacity	3 months	No
Secondary	satisfaction	Question: Are you satisfied with the results of your treatment?	1 month	No
Secondary	satisfaction	Question: Are you satisfied with the results of your treatment?	3 months	No