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A randomized, double-blind, active-control trial of the effectiveness of lumbar interlaminar epidural injections in
Laxmaiah Manchikanti1, Vijay Singh, Kimberly A Cash
1Pain Management Center of Paducah, Paducah, KY, and University of Louisville, Louisville, KY; Spine Pain Diagnostics Associates, Niagara, WI; Mid Atlantic Spine & Pain Physicians of Newark, Newark, DE, and Temple University Hospital, Philadelphia, PA.
Background:
Among the multiple nonsurgical modalities, epidural injections are one of the most commonly utilized treatment modalities in managing chronic low back and lower extremity pain due to disc herniation and radiculitis. There is a paucity of randomized trials from contemporary interventional pain management settings utilizing fluoroscopy with long-term follow-up.
Study Design:
Randomized, double-blind, active-controlled trial with 2-year follow-up.
Setting:
An interventional pain management practice in the United States.
Objective:
The objective was to assess the effectiveness of lumbar interlaminar epidural injections of local anesthetic with or without steroids for managing chronic low back pain of disc herniation or radiculitis.
Methods:
Two groups of patients were studied, with 60 patients in each group receiving either local anesthetic only or local anesthetic mixed with betamethasone.
Outcome Measures:
The primary outcome measure was defined as pain relief and functional status improvement of 50%. The outcomes were assessed by numeric rating scale (NRS) of pain and functional status with Oswestry Disability Index (ODI). Secondary outcome measures included employment status and opioid intake.
Results:
Results showed significant improvement in 60% of patients in Group I and 70% of patients in Group II at the end of 2 years. In addition, in the successful groups, those with at least 3 weeks of relief (with the first 2 procedures), the improvement was 72% in Group I and 71% in Group II. Results were somewhat superior for pain relief at 6 months and functional status at 12 months in the steroid group. Thus, the results indicate that a patient's failure to respond to local anesthetic alone, may be treated with addition of steroids.
Limitations:
The results of the study are limited by the lack of a placebo group.
Conclusion:
Lumbar interlaminar epidural injections of local anesthetic with or without steroids is an effective modality, in patients with chronic function limiting low back and lower extremity pain secondary to disc herniation after failure of conservative modalities.
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