A randomized, double-blind controlled trial of lumbar interlaminar epidural
injections in central spinal stenosis: 2-year follow-up.
Author(s): Manchikanti L(1), Cash KA, McManus CD, Damron KS, Pampati V, Falco FJ.
Affiliation(s): Author information:
(1)Pain Management Center of Paducah, Paducah, KY, and University of Louisville,
Louisville, KY, and Mid Atlantic Spine & Pain Physicians of Newark, Newark, DE.
Publication date & source: 2015, Pain Physician. , 18(1):79-92
BACKGROUND: While low back pain is the number one cause of disability in the
United States, lumbar spinal stenosis along with intervertebral disc herniation
and degenerative spondylolisthesis is one of the 3 most common diagnosis of low
back and leg pain for which surgery is performed. Numerous modalities of
treatments including drug therapy and complex surgical fusions have been
recommended for treatment of central spinal stenosis. Epidural injections are one
of the commonly performed nonsurgical interventions in managing central spinal
stenosis; however, there has been paucity of literature in reference to efficacy
of epidural injections in managing central spinal stenosis with lumbar
interlaminar epidural injections.
STUDY DESIGN: A randomized, double-blind, active controlled trial.
SETTING: Private interventional pain management practice and specialty referral
center in the United States.
OBJECTIVE: To assess the effectiveness of lumbar interlaminar epidural injections
with or without steroids in providing effective and long-lasting pain relief with
improvement in functional status for the management of chronic low back and lower
extremity pain related to lumbar central spinal stenosis.
METHODS: A randomized, double-blind, active-control trial was designed with the
inclusion of 120 patients assigned to 2 groups. Group I patients received lumbar
interlaminar epidural injections of local anesthetic (lidocaine 0.5%) 6 mL,
whereas Group II received lumbar interlaminar epidural injections with local
anesthetic (lidocaine 0.5%) 5 mL mixed with 1 mL of steroids and 6 mg of
betamethasone.
OUTCOMES ASSESSMENT: Outcomes were assessed utilizing the numeric pain rating
scale (NRS) and Oswestry Disability Index (ODI) at 3, 6, 12, 18, and 24 months
post treatment. The primary outcome measure was significant improvement, defined
as 50% improvement in pain and disability scores.
RESULTS: Significant relief and functional status improvement was seen in 72% and
73% of patients in Groups I and II at the end of 2 years considering all
participants; however, this was 84% and 85% in the successful group. Overall
significant improvement was achieved for 65.7 ± 37.3 weeks in Group 1 and 68.9 ±
37.7 weeks in Group II at the end of 2 years when all participants were
considered; whereas, this was 77 ± 27.8 weeks and 77.9 ± 30.2 weeks when they
were separated into successful categories. The average number of procedures per
patient was 5 to 6 in both groups.
LIMITATIONS: Limitations of this trial include lack of placebo control group and
treatment of patients with multiple procedures over a period of 2 years.
CONCLUSION: Lumbar interlaminar epidural injections of local anesthetic with or
without steroids provide relief in a significant proportion of patients with
lumbar central spinal stenosis.
CLINICAL TRIAL: NCT00681447.
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