Lumbar Disk HerniationNCT02793440
Effectiveness of Lumbar Traction in Lumbar Disk Herniation
A study testing cortivazol treatment and lumbar traction in people with Lumbar Disk Herniation, run by CHU de Reims at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Disk Herniation
- What is being tested?
- cortivazol treatment and lumbar traction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 412 participants
- Where
- 1 siteFrance
- Study dates
- 2 Dec 2013to 2 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient with lumbar disc herniation with radiculopathy, over 18 years and consenting
Who cannot join
- sciatic complicated (motor deficit or cauda equina syndrome), against indication for medical treatment and / or lumbar traction
- previous lumbar surgery
- sciatica without disc herniation
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Chu Reims
Reims, 51092
Jean-Hugues SALMON, 326784365 ext. 33, jhsalmon@chu-reims.fr
About this study
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
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.
Read the 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.
- Conditions
- Lumbar Disk Herniation
- Being tested
- cortivazol treatment, lumbar traction
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cortivazol treatmentOther
lumbar tractionOther
| Study group | Role | What they receive |
|---|---|---|
| cortivazol | Active comparator | anti-inflammatory therapy and epidural Receives: Other: cortivazol treatment; Other: lumbar traction |
| Traction arm | Experimental | Medical treatment associated with 5 lumbar traction sessions Receives: Other: lumbar traction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease radicular pain (25%)
Measured: to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2016 (estimated)
- Study start2 Dec 2013
- Primary completion2 Jul 2022 (estimated)
- Study completion2 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disk HerniationStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 412 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02793440
- Sponsor's protocol ID
- PO13106
- Status last verified
- Aug 2021
- First submitted
- 26 May 2016
- Last updated
- 11 Aug 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02793440
- Acronym / sponsor ID
- PO13106
- Conditions
- Lumbar Disk Herniation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 412 participants (estimated)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 2 Dec 2013 (actual)
- Primary completion
- 2 Jul 2022 (estimated)
- Study completion
- 2 Jan 2023 (estimated)
- First posted
- 8 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cortivazol | Active comparator | Other: cortivazol treatment, Other: lumbar tractionanti-inflammatory therapy and epidural |
| Traction arm | Experimental | Other: lumbar tractionMedical treatment associated with 5 lumbar traction sessions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patient with lumbar disc herniation with radiculopathy, over 18 years and consenting
Key exclusion criteria (3 listed)
- sciatic complicated (motor deficit or cauda equina syndrome), against indication for medical treatment and / or lumbar traction
- previous lumbar surgery
- sciatica without disc herniation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cortivazol treatment | Other | cortivazol |
| lumbar traction | Other | Traction arm, cortivazol |
Primary outcome
Decrease radicular pain (25%)
Time frame: to 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cortivazol treatment and lumbar traction in people with Lumbar Disk Herniation, run by CHU de Reims at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-Hugues SALMON (326784365 ext. 33, jhsalmon@chu-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease radicular pain (25%) (time frame: to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2021.