RhizolysisRhizolyseNCT04118218
Determination of Predictive Clinical Signs of Effective Rhizolysis Using the DFL Questionnaire.
A study testing Rhizolysis pain analysis in people with Rhizolysis and Diagnosis of Facet Joint Origin Lumbago, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
Rhizolysis or lumbar thermocoagulation is a therapeutic proposal for certain types of chronic lower back pain that is resistant to medical treatment and outside the field of surgical indications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rhizolysis, Diagnosis of Facet Joint Origin Lumbago
- What is being tested?
- Rhizolysis pain analysis
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 12 Dec 2017to 31 Mar 2020
- 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 suffering from chronic lower back pain developing for more than 6 months and resistant to the medical treatments.
- Patients with an indication of lumbar rhizolysis for their chronic lower back pain with a facet component, the starting point of which corresponds to the L4L5 and/or L5S1 stages.
- Patient not objecting to their participation in the study.
- Subject registered with a social security scheme
Who cannot join
- Adults under judicial protection
- Adult under guardianship or trusteeship
- Pregnant women
- Minors
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Clairval Private Hospital
Marseille, PACA, 13009
Jean Francois OUDET, +33683346567 ext. +33683346567, jf.oudet@ecten.eu
Marie Barba, +330664888704 ext. +330664888704, mh.barba@ecten.eu
About this study
Official title: Determination of Predictive Clinical Signs of Effective Rhizolysis Using the DFL Questionnaire (Diagnosis of Facet Joint Origin Lumbago).
Rhizolysis or lumbar thermocoagulation is a therapeutic proposal for certain types of chronic lower back pain that is resistant to medical treatment and outside the field of surgical indications.
A previous study has selected functional and physical signs selected by analysts and a group of experts from the modified "Delphi" prediction method. This study resulted in the creation of a questionnaire (DFL questionnaire) with 16 symptoms: 7 functional and 9 physical.
The aim of this new study is to select the symptoms that have the best positive predictive value among the 16 symptoms, to predict a good result of rhizolysis, on the criterion of their mitigation or disappearance in case of effective rhizolysis.
Read the detailed description
The frequency of chronic lower back pain is a major economic and social problem. Indeed, there are numerous solutions that can be offered to patients, but sometimes they are unsatisfactory as medical treatments are often insufficiently effective, surgical techniques are often invasive and indications can be limited.
Rhizolysis or lumbar thermocoagulation is a therapeutic proposal for certain types of chronic lower back pain that is resistant to medical treatment and outside the field of surgical indications. This technique, which is minimally invasive, is low-risk for patients and is widely used. However, few studies have shown its effectiveness, so the level of evidence is not enough to make this technique accepted as a standard.
A previous study has selected functional and physical signs for joint involvement in lower back pain. This selection was made by analysts and a group of experts from the modified "Delphi" prediction method. This study resulted in the creation of a questionnaire (DFL questionnaire) with 16 symptoms: 7 functional and 9 physical.
The aim of this new study is to select the symptoms that have the best positive predictive value among the 16 symptoms, to predict a good result of rhizolysis, on the criterion of their mitigation or disappearance in case of effective rhizolysis.
- Being tested
- Rhizolysis pain analysis
- Keywords
- DLF Questionnaire, rhizolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhizolysis pain analysisOther
Definition of the subgroup of good clinical outcome after rhizolysis (called "effective" rhizolysis) by lumbar VAS or lower extremity pain VAS or Oswestry index decreased at 6 weeks after rhizolysis.
The "efficiency" criterion based on the decrease in the dolorimeter or the Oswestry index corresponds to a decrease of at least 50% [1, 2, 3, 4].
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive DFL symptoms
- Comparison of the "effective rhizolysis" and "non-effective rhizolysis" subgroups at 6 weeks postoperatively to select the symptoms with the highest positive predictive value among the 16 symptoms of the DFL questionnaire based on the criterion of effectiveness of a decrease of 50% of VAS or Oswestry
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study start12 Dec 2017
- Primary completion31 Mar 2020 (estimated)
- Study completion31 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhizolysisStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Dr BARAT
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04118218
- Sponsor's protocol ID
- 2017-A01283-50
- Acronym
- Rhizolyse
- Status last verified
- Sep 2019
- First submitted
- 4 Oct 2019
- Last updated
- 8 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Predictive Clinical Signs of Effective Rhizolysis Using the DFL Questionnaire (Diagnosis of Facet Joint Origin Lumbago).
- ClinicalTrials.gov ID
- NCT04118218
- Acronym / sponsor ID
- Rhizolyse / 2017-A01283-50
- Keywords
- DLF Questionnaire, rhizolysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- Dr BARAT
- Study start
- 12 Dec 2017 (actual)
- Primary completion
- 31 Mar 2020 (estimated)
- Study completion
- 31 Mar 2020 (estimated)
- First posted
- 8 Oct 2019 (actual)
- 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.
Rhizolysis or lumbar thermocoagulation is a therapeutic proposal for certain types of chronic lower back pain that is resistant to medical treatment and outside the field of surgical indications.
A previous study has selected functional and physical signs selected by analysts and a group of experts from the modified "Delphi" prediction method. This study resulted in the creation of a questionnaire (DFL questionnaire) with 16 symptoms: 7 functional and 9 physical.
The aim of this new study is to select the symptoms that have the best positive predictive value among the 16 symptoms, to predict a good result of rhizolysis, on the criterion of their mitigation or disappearance in case of effective rhizolysis.
Detailed description
The frequency of chronic lower back pain is a major economic and social problem. Indeed, there are numerous solutions that can be offered to patients, but sometimes they are unsatisfactory as medical treatments are often insufficiently effective, surgical techniques are often invasive and indications can be limited.
Rhizolysis or lumbar thermocoagulation is a therapeutic proposal for certain types of chronic lower back pain that is resistant to medical treatment and outside the field of surgical indications. This technique, which is minimally invasive, is low-risk for patients and is widely used. However, few studies have shown its effectiveness, so the level of evidence is not enough to make this technique accepted as a standard.
A previous study has selected functional and physical signs for joint involvement in lower back pain. This selection was made by analysts and a group of experts from the modified "Delphi" prediction method. This study resulted in the creation of a questionnaire (DFL questionnaire) with 16 symptoms: 7 functional and 9 physical.
The aim of this new study is to select the symptoms that have the best positive predictive value among the 16 symptoms, to predict a good result of rhizolysis, on the criterion of their mitigation or disappearance in case of effective rhizolysis.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient suffering from chronic lower back pain developing for more than 6 months and resistant to the medical treatments.
- Patients with an indication of lumbar rhizolysis for their chronic lower back pain with a facet component, the starting point of which corresponds to the L4L5 and/or L5S1 stages.
- Patient not objecting to their participation in the study.
- Subject registered with a social security scheme
Key exclusion criteria (4 listed)
- Adults under judicial protection
- Adult under guardianship or trusteeship
- Pregnant women
- Minors
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 |
|---|---|---|
| Rhizolysis pain analysisDefinition of the subgroup of good clinical outcome after rhizolysis (called "effective" rhizolysis) by lumbar VAS or lower extremity pain VAS or Oswestry index decreased at 6 weeks after rhizolysis. The "efficiency" criterion based on the decrease in the dolorimeter or the Oswestry index corresponds to a decrease of at least 50% [1, 2, 3, 4]. | Other | – |
Primary outcome
Predictive DFL symptoms
Time frame: 6 weeks
• Comparison of the "effective rhizolysis" and "non-effective rhizolysis" subgroups at 6 weeks postoperatively to select the symptoms with the highest positive predictive value among the 16 symptoms of the DFL questionnaire based on the criterion of effectiveness of a decrease of 50% of VAS or Oswestry
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2019.
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 Rhizolysis pain analysis in people with Rhizolysis and Diagnosis of Facet Joint Origin Lumbago, run by GCS Ramsay Santé pour l'Enseignement et la Recherche 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 4 inclusion and 4 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 8 Oct 2019. 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 Francois OUDET (+33683346567, jeanfrancois.oudet@free.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive DFL symptoms (time frame: 6 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 8 Oct 2019.