drugset / Trial / NCT03101033
Epidural Neuroplasty for the Treatment of Herniated Lumbar Disk
Non-randomizedParallel-groupSingle-blindTreatment
Summary
The purpose of this study is to determine whether epidural neuroplasty has better efficacy than epidural steroid injection for the treatment of lumbar disc herniation.
Timeline
- Start
- 2015-05
- Primary completion
- 2016-02
- Completion
- 2016-06
Publications
- Background Lutz GE, Vad VB, Wisneski RJ. Fluoroscopic transforaminal lumbar epidural steroids: an outcome study. Arch Phys Med Rehabil. 1998 Nov;79(11):1362-6. doi: 10.1016/s0003-9993(98)90228-3.
- Background Veihelmann A, Devens C, Trouillier H, Birkenmaier C, Gerdesmeyer L, Refior HJ. Epidural neuroplasty versus physiotherapy to relieve pain in patients with sciatica: a prospective randomized blinded clinical trial. J Orthop Sci. 2006 Jul;11(4):365-9. doi: 10.1007/s00776-006-1032-y.
- Background Manchikanti L, Pampati V, Fellows B, Rivera J, Beyer CD, Damron KS. Role of one day epidural adhesiolysis in management of chronic low back pain: a randomized clinical trial. Pain Physician. 2001 Apr;4(2):153-66.
- Background Manchikanti L, Rivera JJ, Pampati V, Damron KS, McManus CD, Brandon DE, Wilson SR. One day lumbar epidural adhesiolysis and hypertonic saline neurolysis in treatment of chronic low back pain: a randomized, double-blind trial. Pain Physician. 2004 Apr;7(2):177-86.
- Background Vad VB, Bhat AL, Lutz GE, Cammisa F. Transforaminal epidural steroid injections in lumbosacral radiculopathy: a prospective randomized study. Spine (Phila Pa 1976). 2002 Jan 1;27(1):11-6. doi: 10.1097/00007632-200201010-00005.
- Background McCarron RF, Wimpee MW, Hudkins PG, Laros GS. The inflammatory effect of nucleus pulposus. A possible element in the pathogenesis of low-back pain. Spine (Phila Pa 1976). 1987 Oct;12(8):760-4. doi: 10.1097/00007632-198710000-00009.
- Background Kim HJ, Rim BC, Lim JW, Park NK, Kang TW, Sohn MK, Beom J, Kang S. Efficacy of epidural neuroplasty versus transforaminal epidural steroid injection for the radiating pain caused by a herniated lumbar disc. Ann Rehabil Med. 2013 Dec;37(6):824-31. doi: 10.5535/arm.2013.37.6.824. Epub 2013 Dec 23.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Betamethasone | Other / unclassified | 1 ml | Other |
| Comparator | Lidocaine | Other / unclassified | 4 ml | Other |
| Background | rHuPH20 | Protein / enzyme biologic | 1500 iu | Other |