Back to resultsEffectiveness of Lumbar Traction in Lumbar Disk Herniation
Primary Purpose
Lumbar Disk Herniation
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
cortivazol treatment
lumbar traction
Sponsored by
About this trial
This is an interventional treatment trial for Lumbar Disk Herniation
Eligibility Criteria
Inclusion :
- patient with lumbar disc herniation with radiculopathy, over 18 years and consenting
Exclusion :
- sciatic complicated (motor deficit or cauda equina syndrome), against indication for medical treatment and / or lumbar traction
- previous lumbar surgery
- sciatica without disc herniation
Sites / Locations
- Chu ReimsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
cortivazol
Traction arm
Arm Description
anti-inflammatory therapy and epidural
Medical treatment associated with 5 lumbar traction sessions
Outcomes
Primary Outcome Measures
Decrease radicular pain (25%)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02793440
Brief Title
Effectiveness of Lumbar Traction in Lumbar Disk Herniation
Official Title
Clinical Results After Medical Therapy Alone or Medical Therapy Associated With Lumbar Traction in the Treatment of Nerve Root Pain of Lumbar Disc Herniation With Disco-radicular Conflict
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 2, 2013 (Actual)
Primary Completion Date
July 2, 2022 (Anticipated)
Study Completion Date
January 2, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Reims
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to compare the clinical outcome of medical treatment associated with lumbar traction and medical treatment alone in the treatment of lumbar disk herniation.
Detailed Description
This is a prospective and randomized study. Medical treatment = anti-inflammatory therapy and epidural Medical treatment associated with lumbar traction medical treatment = + 5 lumbar traction sessions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Disk Herniation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
412 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
cortivazol
Arm Type
Active Comparator
Arm Description
anti-inflammatory therapy and epidural
Arm Title
Traction arm
Arm Type
Experimental
Arm Description
Medical treatment associated with 5 lumbar traction sessions
Intervention Type
Other
Intervention Name(s)
cortivazol treatment
Intervention Type
Other
Intervention Name(s)
lumbar traction
Primary Outcome Measure Information:
Title
Decrease radicular pain (25%)
Time Frame
to 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion :
patient with lumbar disc herniation with radiculopathy, over 18 years and consenting
Exclusion :
sciatic complicated (motor deficit or cauda equina syndrome), against indication for medical treatment and / or lumbar traction
previous lumbar surgery
sciatica without disc herniation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Hugues SALMON
Phone
326784365
Ext
33
Email
jhsalmon@chu-reims.fr
Facility Information:
Facility Name
Chu Reims
City
Reims
ZIP/Postal Code
51092
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Hugues SALMON
Phone
326784365
Ext
33
Email
jhsalmon@chu-reims.fr
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of Lumbar Traction in Lumbar Disk Herniation
We'll reach out to this number within 24 hrs