NCT02793440

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
412

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 2, 2013

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

May 26, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 8, 2016

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2023

Completed
Last Updated

August 11, 2021

Status Verified

August 1, 2021

Enrollment Period

8.6 years

First QC Date

May 26, 2016

Last Update Submit

August 10, 2021

Conditions

Lumbar Disk Herniation

Outcome Measures

Primary Outcomes (1)

  • Decrease radicular pain (25%)

    to 4 weeks

Study Arms (2)

cortivazol

ACTIVE COMPARATOR

anti-inflammatory therapy and epidural

Other: cortivazol treatmentOther: lumbar traction

Traction arm

EXPERIMENTAL

Medical treatment associated with 5 lumbar traction sessions

Other: lumbar traction

Interventions

cortivazol treatmentOTHER
cortivazol
lumbar tractionOTHER
Traction armcortivazol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Chu Reims

Reims, 51092, France

RECRUITING

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Central Study Contacts

Jean-Hugues SALMON

CONTACT

326784365jhsalmon@chu-reims.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2016

First Posted

June 8, 2016

Study Start

December 2, 2013

Primary Completion

July 2, 2022

Study Completion

January 2, 2023

Last Updated

August 11, 2021

Record last verified: 2021-08

Locations

FR(1)