Evaluation of the effectiveness of lumbar interlaminar epidural injections in managing chronic pain of lumbar disc herniation or radiculitis: a randomized, double-blind, controlled trial.
BACKGROUND
The pathophysiology of lumbar radicular pain is the subject of ongoing research, with a reported prevalence of sciatica or radiculitis ranging from 1.2% to 43%. Among the numerous non-surgical interventions available, epidural injections are the most commonly performed interventions in the United States in managing chronic low back and lower extremity pain.


METHODS
A randomized, double-blind, controlled trial.


METHODS
An interventional pain management practice, a specialty referral center, a private practice setting in the United States.


OBJECTIVE
To evaluate the effectiveness of lumbar interlaminar epidural injections with local anesthetic, with or without steroids, in managing chronic low back and lower extremity pain secondary to disc herniation or radiculitis in providing effective and long-lasting pain relief.


METHODS
Patients were assigned to one of 2 groups with local anesthetic only or with local anesthetic mixed with non-particulate betamethasone. Randomization was performed by computer-generated random allocations sequence by simple randomization. Seventy patients were included in this analysis.


METHODS
Patient outcomes were measured at baseline, 3, 6, and 12 months post-treatment with the Numeric Rating Scale (NRS), the Oswestry Disability Index 2.0 (ODI), employment status, and opioid intake. Decrease of > or = 50% of NRS scores and Oswestry scores were considered significant.


RESULTS
Significant pain relief (> or = 50%) was seen at 12 months in 74% of patients in Group I and 86% in Group II, and 69% and 83% in ODI scores respectively. Significant differences were noted in pain relief characteristics at 6 months between Group I and Group II (p = 0.001) and functional status improvement was significantly better in Group II at 6 months and 12 months (p = 0.019 and 0.045). The overall average procedures per year were 4.3 in Group I and 4.2 in Group II with an average total relief per year of 42.2 +/- 10.5 weeks in Group I and 41.4 +/- 11.0 weeks in Group II over a period of 52 weeks in the successful group.


CONCLUSIONS
The study limitations include the lack of a placebo group and the fact that this is a preliminary report of 35 patients in each group.


CONCLUSIONS
Overall, 74% of patients in Group I without steroids and 86% in Group II with steroids with lumbar disc herniation or radiculitis might benefit from lumbar interlaminar epidural injections.
Manchikanti
Laxmaiah
L
Pain Management Center of Paducah, Paducah, KY, USA. drlm@thepainmd.com
Singh
Vijay
V
Falco
Frank J E
FJ
Cash
Kimberly A
KA
Pampati
Vidyasagar
V
D000328:Adult; D000772:Anesthesia, Local / Q000379:methods*; D002908:Chronic Disease; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007268:Injections, Epidural / Q000379:methods; D007403:Intervertebral Disc / Q000187:drug effects; D007405:Intervertebral Disc Displacement / Q000150:complications / Q000188:drug therapy*; D017116:Low Back Pain / Q000188:drug therapy* / Q000209:etiology; D008159:Lumbar Vertebrae / Q000187:drug effects*; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care / Q000379:methods; D010147:Pain Measurement / Q000379:methods; D011843:Radiculopathy / Q000150:complications / Q000188:drug therapy*; D013126:Spinal Nerve Roots / Q000187:drug effects / Q000473:pathology / Q000503:physiopathology; D016896:Treatment Outcome