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A randomized , double-blind controlled trial of lumbar interlaminar epidural injections in central spinal stenosis : 2-year follow-up . 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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Intervention_Pharmacological
Epidural injections
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Intervention_Pharmacological
epidural injections
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Intervention_Pharmacological
lumbar interlaminar epidural injections
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Intervention_Pharmacological
lumbar interlaminar epidural injections with or without steroids
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Intervention_Pharmacological
lumbar interlaminar epidural injections of local anesthetic ( lidocaine 0.5 % ) 6 mL
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Intervention_Pharmacological
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
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Outcome_Pain
numeric pain rating scale ( NRS
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Outcome_Physical
Oswestry Disability Index ( ODI )
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Outcome_Pain
50 % improvement in pain
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Outcome_Physical
disability scores
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Outcome_Physical
Significant relief and functional status improvement
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Participant_Condition
lumbar spinal stenosis
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Participant_Sample-size
120
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Participant_Condition
lumbar central spinal stenosis