Epidural Neuroplasty for the Treatment of Herniated Lumbar Disk

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Status: Completed

Conditions: Herniated Lumbar Disc

Treatments: Device: Mechanical epidural neuroplasty; Drug: Caudal epidural compound betamethasone injection; Drug: Transforaminal epidural compound betamethasone injection; Drug: Epidural hyaluronidase injection

Study type: Interventional

Funder types: Other

Identifiers

NCT03101033

20150401

Details and patient eligibility

About

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.

Full 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.

Enrollment: 92 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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92 participants in 2 patient groups

Epidural neuroplasty group

Experimental group

Description:

This group will be given epidural neuroplasty once enrolled.

Treatment:

Drug: Epidural hyaluronidase injection

Device: Mechanical epidural neuroplasty

Drug: Caudal epidural compound betamethasone injection

Transforaminal steroid injection group

Active Comparator group

Description:

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.

Treatment:

Drug: Transforaminal epidural compound betamethasone injection