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New treatment option for Radiculopathy
Official title Interest of the Virtual Reality as an Analgesic Support and in the Management the Pre-procedural Anxiety in Rheumatology
ClinicalTrials.gov ID: NCT05289999
What this study is testing
- What it's testing
- As a part of the current rheumatological practice skills, epidural injections through the sacrococcygeal hiatus take part in the strategy for managing radicular diseases. This technical act is easily performed in an outpatient context since it is a brief procedure, performed under clinical and ultrasound control, with good tolerance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adult patient (age ≥ 18 years)
- Hospitalized in a day-hospitalization department at the General Hospital of Le Mans
- For whom a diagnosis of radiculalgia with a duration of less than 6 months is made, for which the imaging is compatible with the symptoms according...
- For whom the indication of at least 2 epidural injections by the way of the sacrococcygeal hiatus is retained
- Having never experienced an epidural injection through the sacrococcygeal hiatus
You likely can't join if
- Patient with comorbidity of epilepsy
- Patient with a contraindication to performing epidural injections through the sacrococcygeal hiatus
- Patient suffering from blindness and / or deafness
- Person with a known significant intolerance towards the use of screens and / or virtual reality devices
- Patient receiving benzodiazepines and / or other sedative treatment
- Patient with a known depressive disease followed by a psychiatrist
See the full eligibility criteria
- Adult patient (age ≥ 18 years)
- Hospitalized in a day-hospitalization department at the General Hospital of Le Mans
- For whom a diagnosis of radiculalgia with a duration of less than 6 months is made, for which the imaging is compatible with the symptoms according to the clinician's interpretation
- For whom the indication of at least 2 epidural injections by the way of the sacrococcygeal hiatus is retained
- Having never experienced an epidural injection through the sacrococcygeal hiatus
- Patient able and willing to answer the auto-administered surveys
- Person affiliated or beneficiary of a social security
- Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research) after oral and written information
- Patient with comorbidity of epilepsy
- Patient with a contraindication to performing epidural injections through the sacrococcygeal hiatus
- Patient suffering from blindness and / or deafness
- Person with a known significant intolerance towards the use of screens and / or virtual reality devices
- Patient receiving benzodiazepines and / or other sedative treatment
- Patient with a known depressive disease followed by a psychiatrist
- Pregnant, breastfeeding or parturient woman
- Person deprived of liberty by judicial or administrative decision
- Person under forced psychiatric care
- Person subject to legal protection
- Person unable to express consent
- Patient who had participated in an treatment study during the last 30 days
- Severely impaired physical and / or mental health which, according to the investigator, may affect the compliance of the study participant
The study team makes the final eligibility decision.
Where it's taking place
- Le Mans, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Le Mans, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.