Effectiveness of Lumbar Traction in Lumbar Disk Herniation | NCT02793440

Studies
Effectiveness of Lumbar Traction in Lumbar Disk Herniation

NCT02793440

Sponsor

CHU de Reims

Status

Unknown status

Last Update Posted

Aug 11, 2021Actual

Enrollment

412Estimated

Phase

Not Applicable

Conditions

Lumbar Disk Herniation

Interventions

cortivazol treatment
lumbar traction

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2, 2013Actual

Primary Completion Date

Jul 2, 2022Estimated

Completion Date

Jan 2, 2023Estimated

First Submitted Date

May 26, 2016

First Submission Date that Met QC Criteria

Jun 2, 2016

First Posted Date

Jun 8, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 10, 2021

Last Update Posted Date

Aug 11, 2021Actual

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

412Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
cortivazol	Active Comparator	anti-inflammatory therapy and epidural	Other: cortivazol treatment Other: lumbar traction
Traction arm	Experimental	Medical treatment associated with 5 lumbar traction sessions	Other: lumbar traction

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cortivazol treatment	Other		cortivazol
lumbar traction

Measure	Description	Time Frame
Decrease radicular pain (25%)		to 4 weeks

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jean-Hugues SALMON	Contact	326784365	33	jhsalmon@chu-reims.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chu Reims	Recruiting	Reims		51092	France

Condition Browse Module

MeSH Terms

ID	Term
D007405	Intervertebral Disc Displacement

Ancestor Terms

ID	Term
D013122	Spinal Diseases
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D006547	Hernia

Browse Leaves

Not provided

Browse Branches

Not provided