LESS
Trial question
What is the role of epidural corticosteroid injections in patients with lumbar spinal stenosis?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
55.0% female
45.0% male
N = 400
400 patients (221 female, 179 male).
Inclusion criteria: patients who had lumbar central spinal stenosis and moderate-to-severe leg pain and disability.
Key exclusion criteria: no stenosis of the central canal, spondylolisthesis requiring surgery, and a history of lumbar surgery or received epidural corticosteroid injections within the previous 6 months.
Interventions
N=200 corticosteroid plus lidocaine (1 to 3 ml of 0.25% to 1% lidocaine followed by 1 to 3 ml of triamcinolone (60 to 120 mg), betamethasone (6 to 12 mg), dexamethasone (8 to 10 mg), or methylprednisolone (60 to 120 mg)).
N=200 lidocaine (equivalent volume of 0.25% to 1% lidocaine alone).
Primary outcome
Change in Roland-Morris Disability Questionnaire score at 6 weeks
4.2 points
3.1 points
4.2 points
3.2 points
2.1 points
1.1 points
0.0 points
Corticosteroid plus
lidocaine
Lidocaine
No significant
difference ↔
No significant difference in change in Roland-Morris Disability Questionnaire score at 6 weeks (4.2 points vs. 3.1 points; AD 1 points, 95% CI -0.1 to 2.1).
Secondary outcomes
No significant difference in intensity of leg pain (-2.8 vs. -2.6; AD -0.2 , 95% CI -0.8 to 0.4).
No significant difference in intensity of back pain at 6 weeks (4.3 vs. 4.4; AD -0.1 , 95% CI -0.7 to 0.4).
No significant difference in BPI interference scale score at 6 weeks (3.5 points vs. 3.8 points; AD -0.4 points, 95% CI -1 to 0.2).
Safety outcomes
No significant differences in ≥ 1 adverse event, serious adverse events.
Significant difference in total adverse events (0.17 events vs. 0.29 events).
Conclusion
In patients who had lumbar central spinal stenosis and moderate-to-severe leg pain and disability, corticosteroid plus lidocaine was not superior to lidocaine with respect to change in Roland-Morris Disability Questionnaire score at 6 weeks.
Reference
Friedly JL, Comstock BA, Turner JA et al. A randomized trial of epidural glucocorticoid injections for spinal stenosis. N Engl J Med. 2014 Jul 3;371(1):11-21.
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