Epidural Neuroplasty for the Treatment of Herniated Lumbar Disk

Not Applicable

Completed

• Conditions: Herniated Lumbar Disc
• Interventions: Device: Mechanical epidural neuroplasty; Drug: Transforaminal epidural compound betamethasone injection; Drug: Caudal epidural compound betamethasone injection; Drug: Epidural hyaluronidase injection

• Registration Number: NCT03101033
• Lead Sponsor: yan lu

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.

Study Timeline

• Study Start: 2015-05
• Primary Completion: 2016-02
• Study Completion: 2016-06
• Study First Submitted: 2017-03-14
• Study First Submitted QC: 2017-03-29
• Study First Posted: 2017-04-04
• Results First Submitted: 2017-04-09
• Status Verified: 2017-11
• Results First Submitted QC: 2017-11-23
• Last Update Submitted: 2017-11-23
• Results First Posted: 2018-09-04
• Last Update Posted: 2018-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epidural neuroplasty group	Mechanical epidural neuroplasty	This group will be given epidural neuroplasty once enrolled.
Epidural neuroplasty group	Caudal epidural compound betamethasone injection	This group will be given epidural neuroplasty once enrolled.
Epidural neuroplasty group	Epidural hyaluronidase injection	This group will be given epidural neuroplasty once enrolled.
Transforaminal steroid injection group	Transforaminal epidural compound betamethasone injection	This group will be given transforaminal betamethasone injection once enrolled, if no obvious pain relief was reported, another epidural injection will be given one week later.

Primary Outcome Measures

Name	Time	Method
Pain Assessed by Visual Analogue Scale	at six-month post-treatment	VAS (Visual analogue scale), with the highest score of 10, representing the most severe pain one could experience, and the lowest score of 0, representing no pain at all. The higher score means more severe pain.

Secondary Outcome Measures

Name	Time	Method
Functional Status Assessed by Oswestry Disability Index	at six-month post-treatment	ODI (Oswestry disability index) consists of 10 subscales, which evaluates pain intensity, and functional satus of personal care, lifting, walking, sitting, standing, sleeping, sex, social life, traveling. Each subscales range from 0 to 5, with the higher score indicating more severe functional damage. the ODI score ranges from 0 to 100. it equals the sum of all the subscales and divided by 50. If the patients answers 9 subscale questions, then the total sum should be divided by 45, and by this analogy.

Trial Locations

Locations (1)

Fourth Military Medical University china; 🇨🇳 Xian, Shaanxi, China