drugset / Trial / NCT01238536
Lumbar Epidural Steroid Injections for Spinal Stenosis Multicenter Randomized, Controlled Trial (LESS Trial)
Phase 4
Completed
400 enrolled
University of Washington
Dallas VA Medical Center · collabHarvard Pilgrim Health Care · collabHarvard Vanguard Medical Associates · collabHenry Ford Hospital · collabKaiser Permanente · collabMassachusetts General Hospital · collabMayo Clinic · collabOregon Health and Science University · collabStanford University · collabUniversity of California, San Francisco · collabUniversity of Colorado, Denver · collabVirginia Spine Research Institute · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
The broad, long-term objective of this research protocol is to improve the quality of life for patients suffering from lumbar spinal stenosis. This objective will be met by examining the safety and clinical efficacy of epidural steroid injections for treatment of pain associated with lumbar spinal stenosis. This prospective, randomized, double-blind controlled trial (RCT) will test the hypothesis that the effectiveness of epidural steroid injections (ESI) plus local anesthetic (LA) is greater than epidural injections of LA alone in older adults with lumbar spinal stenosis.
Timeline
- Start
- 2011-04
- Primary completion
- 2013-08
- Completion
- 2015-09
Publications
- Background Friedly JL, Bresnahan BW, Comstock B, Turner JA, Deyo RA, Sullivan SD, Heagerty P, Bauer Z, Nedeljkovic SS, Avins AL, Nerenz D, Jarvik JG. Study protocol- Lumbar Epidural steroid injections for Spinal Stenosis (LESS): a double-blind randomized controlled trial of epidural steroid injections for lumbar spinal stenosis among older adults. BMC Musculoskelet Disord. 2012 Mar 29;13:48. doi: 10.1186/1471-2474-13-48.
- Results Turner JA, Comstock BA, Standaert CJ, Heagerty PJ, Jarvik JG, Deyo RA, Wasan AD, Nedeljkovic SS, Friedly JL. Can patient characteristics predict benefit from epidural corticosteroid injections for lumbar spinal stenosis symptoms? Spine J. 2015 Nov 1;15(11):2319-31. doi: 10.1016/j.spinee.2015.06.050. Epub 2015 Jun 19.
- Results Suri P, Pashova H, Heagerty PJ, Jarvik JG, Turner JA, Comstock BA, Bauer Z, Annaswamy TM, Nedeljkovic SS, Wasan AD, Friedly JL. Short-term improvements in disability mediate patient satisfaction after epidural corticosteroid injections for symptomatic lumbar spinal stenosis. Spine (Phila Pa 1976). 2015 Sep 1;40(17):1363-70. doi: 10.1097/BRS.0000000000001000.
- Results Friedly JL, Comstock BA, Turner JA, Heagerty PJ, Deyo RA, Sullivan SD, Bauer Z, Bresnahan BW, Avins AL, Nedeljkovic SS, Nerenz DR, Standaert C, Kessler L, Akuthota V, Annaswamy T, Chen A, Diehn F, Firtch W, Gerges FJ, Gilligan C, Goldberg H, Kennedy DJ, Mandel S, Tyburski M, Sanders W, Sibell D, Smuck M, Wasan A, Won L, Jarvik JG. A randomized trial of epidural glucocorticoid injections for spinal stenosis. N Engl J Med. 2014 Jul 3;371(1):11-21. doi: 10.1056/NEJMoa1313265.
- Friedly JL, Comstock BA, Turner JA, Heagerty PJ, Deyo RA, Bauer Z, Avins AL, Nedeljkovic SS, Nerenz DR, Shi XR, Annaswamy T, Standaert CJ, Smuck M, Kennedy DJ, Akuthota V, Sibell D, Wasan AD, Diehn F, Suri P, Rundell SD, Kessler L, Chen AS, Jarvik JG. Long-Term Effects of Repeated Injections of Local Anesthetic With or Without Corticosteroid for Lumbar Spinal Stenosis: A Randomized Trial. Arch Phys Med Rehabil. 2017 Aug;98(8):1499-1507.e2. doi: 10.1016/j.apmr.2017.02.029. Epub 2017 Apr 8.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Betamethasone | Other / unclassified | 6 mg | Other |
| Subject | Betamethasone | Other / unclassified | 12 mg | Other |
| Subject | Dexamethasone | Small molecule | 8 mg | Other |
| Subject | Dexamethasone | Small molecule | 10 mg | Other |
| Comparator | Lidocaine | Other / unclassified | 0.25 % | Other |
| Comparator | Lidocaine | Other / unclassified | 1 % | Other |
| Subject | Methylprednisolone | Other / unclassified | 60 mg | Other |
| Subject | Methylprednisolone | Other / unclassified | 120 mg | Other |
| Subject | Triamcinolone Acetonide | Other / unclassified | 40 mg | Other |
| Subject | Triamcinolone Acetonide | Other / unclassified | 120 mg | Other |