N/A
N=92
Epidural Neuroplasty for the Treatment of Herniated Lumbar Disk
Herniated Lumbar Disc
Bottom Line
View on ClinicalTrials.gov: NCT03101033 ↗Enrolled (actual)
92
Serious AEs
0.0%
Results posted
Sep 2018
Primary outcome: Primary: Pain Assessed by Visual Analogue Scale — 5.63; 5.92 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mechanical epidural neuroplasty (Device); Transforaminal epidural compound betamethasone injection (Drug); Caudal epidural compound betamethasone injection (Drug); Epidural hyaluronidase injection (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- yan lu
- Primary completion
- Feb 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Assessed by Visual Analogue Scale |
2.81; 4.06 | — |
| PRIMARY Pain Assessed by Visual Analogue Scale |
2.81; 4.06 | — |
| PRIMARY Pain Assessed by Visual Analogue Scale |
2.81; 4.06 | — |
| PRIMARY Pain Assessed by Visual Analogue Scale |
2.81; 4.06 | — |
| SECONDARY Functional Status Assessed by Oswestry Disability Index |
30.52; 46.39 | — |
| SECONDARY Functional Status Assessed by Oswestry Disability Index |
30.52; 46.39 | — |
| SECONDARY Functional Status Assessed by Oswestry Disability Index |
30.52; 46.39 | — |
| SECONDARY Functional Status Assessed by Oswestry Disability Index |
30.52; 46.39 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03101033). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.