NCT03101033

Epidural Neuroplasty for the Treatment of Herniated Lumbar Disk

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: yan lu · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Herniated Lumbar Disc

Interventions

Type	Name	Description
DEVICE	Mechanical epidural neuroplasty	Guided by X-ray transillumination,an epidural needle will be inserted through sacral hiatus. A catheter （BS epidural catheter, BioSpine Co., Ltd, Korea） will be inserted through the epidural needle to the epidural space where disc herniation locates, mechanical adhesiolysis will be implemented.
DRUG	Transforaminal epidural compound betamethasone injection	Guided by X-ray transillumination, A puncture needle will be inserted to the intervertebral foramen in the vicinity of affected nerve root, and steroid injectant consists of 1 ml of Compound Betamethasone Injection (Diprospan®, Schering-Plough Labo N.V., Belgium) and 4ml of 0.2% lidocaine will be injected.
DRUG	Caudal epidural compound betamethasone injection	steroid injectant consists of 1 ml of Compound Betamethasone Injection (Diprospan® Schering-Plough Labo N.V., Belgium) and 4ml of 0.2% lidocaine will be injected through the epidural catheter after mechanical epidural neuroplasty.
DRUG	Epidural hyaluronidase injection	Hyaluronidase of 1500 IU （Sine®, SPH NO.1 Biochemical and Pharmaceutical Co., LTD）will be injected through the epidural catheter after mechanical epidural neuroplasty and caudal epidural compound betamethasone injection.

Timeline

• Start date: 2015-05-01
• Primary completion: 2016-02-01
• Completion: 2016-06-01
• First posted: 2017-04-04
• Last updated: 2018-09-04
• Results posted: 2018-09-04

Locations

1 site across 1 country: China