Clinical trial NCT03101033: Epidural Neuroplasty for the Treatment of Herniated Lumbar Disk
Official title: Comparison of the Efficacy Between Transforaminal Steroid Epidural Injection and Epidural Neuroplasty for the Treatment of Herniated Lumbar Disc：A Single Center, Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Herniated Lumbar Disc
Keywords: Herniated lumbar disc
Epidural neuroplasty
Epidural injection
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2017-04-04
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: One hundred patients diagnosed as herniated lumbar disc will be recruited and divided into two groups. One group will be treated with Transforaminal steroid injection, the other with epidural neuroplasty. The VAS and ODI scores obtained at one month, three months and six months post-treatment will be analysed statistically.

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of herniated lumbar disc
* written informed consent obtained

Exclusion Criteria:

* Lumbar instability
* Piriformis syndrome
* Diabetes mellitus with uncontrolled blood glucose
* Severe osteoporosis
* Impaired function of cauda equina
* Severe sacral hiatus variation
* Interspinous ligament inflammation
* Myofascitis on lumbar and legs
* The third lumbar transverse process syndrome

Primary outcomes:
measure: Pain Assessed by Visual Analogue Scale
timeFrame: before treatment
measure: Pain Assessed by Visual Analogue Scale
timeFrame: at one-month post-treatment
measure: Pain Assessed by Visual Analogue Scale
timeFrame: at three-month post-treatment
measure: Pain Assessed by Visual Analogue Scale
timeFrame: at six-month post-treatment
Secondary outcomes:
measure: Functional Status Assessed by Oswestry Disability Index
timeFrame: before treatment
measure: Functional Status Assessed by Oswestry Disability Index
timeFrame: at one-month post-treatment
measure: Functional Status Assessed by Oswestry Disability Index
timeFrame: at three-month post-treatment
measure: Functional Status Assessed by Oswestry Disability Index
timeFrame: at six-month post-treatment
Other outcomes:
Locations:
city: Xian
country: China
facility: Fourth Military Medical University china
state: Shaanxi
Study officials:
affiliation: Fourth Military Medical University China
name: Yan Lu, MD,PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.