Radiology InterventionalRACENCT06762665
RAdiology Consultation Effectiveness
A study testing Spinal injection and pre-operative consultation in people with Radiology Interventional and Spinal Injections, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Performing a consultation with the radiologist before a spinal invasive procedure serves to foster a trusting physician-patient relationship. It also provides an opportunity for the comprehensive explanation of the procedure, its aftermath, and any patient inquiries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiology Interventional, Spinal Injections, Back Pain
- What is being tested?
- Spinal injection and pre-operative consultation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteFrance
- Study dates
- 12 Feb 2025to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years of age or older
- Referred to the imaging department for a peri-spinal injection under CT guidance.
- Low back pain, dorsal pain, or neck pain with an average pain intensity of ≥ 5/10 on NPRS.
Who cannot join
- Patient unable to read and/or write French
- Patient unable to condut a teleconsultation (no phone, no internet connection)
- Current pregnancy, breastfeeding, or lack of effective contraception for women of childbearing age
- Lack of consent
- Legally protected population:
- Adults protected by law (guardianship, curatorship, or judicial protection)
Show all 11Show fewer
- Non-emancipated minors
- Individuals unable to express consent (research conducted in emergency situations)
- Individuals deprived of liberty (by judicial or administrative decision, or involuntary hospitalization)
- Not affiliated with a social security scheme or not benefiting from such a scheme
- Participation in another research study with an ongoing exclusion period
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Catherine CYTEVAL, MD PhD contact
France1 site, 1 recruiting
- Recruiting
University Hospital of Montpellier
Montpellier, Occitnaie, 34295
Céline ENGRAND, PhD, 0467338607 ext. +33, c-engrand@chu-montpellier.fr
About this study
Official title: Impact of Interventional Radiology Consultation on the Spinal Infiltrations Effectiveness
Performing a consultation with the radiologist before a spinal invasive procedure serves to foster a trusting physician-patient relationship. It also provides an opportunity for the comprehensive explanation of the procedure, its aftermath, and any patient inquiries. We believe that this proactive approach has the potential to alleviate pre-procedure anxiety, thereby contributing to an enhanced overall experience of the intervention and its outcomes. Despite these potential benefits, it is noteworthy that such consultations are not systematically implemented, and their impact on the intervention effictness remains unexplored in existing literature.
The hypothesis is grounded in the belief that patients who perform a consultation preceding their spinal intervention are likely to witness improvements in both the overall experience of the procedure and its effectiveness.
- Conditions
- Radiology Interventional, Spinal Injections, Back Pain
- Being tested
- Spinal injection, pre-operative consultation
- Keywords
- Consultation, Remote consultation, Radiology interventional, Spinal Injections, Health care
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal injectionProcedure or surgery
Patients underwent a spinal injection procedure under CT scan
pre-operative consultationOther
Pre-operative consultation, in person or by teleconsultation, consists of an interview about the patient's history and symptoms. This is followed by a clinical examination and consultation of the patient's imaging file, to confirm the request for paraspinal infiltration and its location. In addition, the radiologist explains the procedure to the patient, supplementing the explanatory documents already provided at the time of the appointment, and outlines the results that may be expected and any complications.
| Study group | Role | What they receive |
|---|---|---|
| Physical Consultation (PC) | Active comparator | These patients have a consultation with the radiologist prior to the intervention, including an interview about their medical history and symptoms, a clinical examination, a review of the imaging file, an explanation of the procedure, and the opportunity to ask questions. Receives: Procedure: Spinal injection; Other: pre-operative consultation |
| Teleconsultation (TC) | Active comparator | These patients have a teleconsultation with the radiologist prior to the intervention, including an interview about their medical history and symptoms, a review of the imaging file, an explanation of the procedure, and the opportunity to ask questions. Receives: Procedure: Spinal injection; Other: pre-operative consultation |
| No Consultation (NC) | Active comparator | These patients not have a consultation prior to the procedure: The radiologist reviews the imaging file remotely. The explanation of the procedure is provided through documents, and questions are answered only on the day of the intervention. Receives: Procedure: Spinal injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the Numeric Pain Rating Scale (NPRS) between the 3 groups
Measuring pain on a numerical scale is a common method used to assess and communicate the intensity of a person's pain. The Numeric Pain Rating Scale (NPRS) is a numerical scale ranging from 0 to 10, where 0 represents no pain, and 10 represents the worst imaginable pain.
Patients are asked to rate their pain by choosing a number that best reflects their current level of pain.
Interpretation:
0: No pain 1-3: Mild pain 4-6: Moderate pain 7-10: Severe pain
Measured: 30 days after the surgical procedure
Secondary outcomes (6)
Patient satisfaction with care
Satisfaction survey for healthcare is crucial to understanding the experiences of patients : The patient will be asked if he is satisfied:
his medical care ( yes/no) If no : why and the arm to which he would have liked to belong
Measured: 30 days after the surgical procedure
Assessment of Intervention Anxiety
The level of patient anxiety measured using a standardized anxiety scale (State-Trait Anxiety Inventory) The questionnaire includes 2 separate scales to assess state anxiety (how subjects feel now) and trait anxiety (how subjects usually feel). Each scale comprises 20 items.
each item is rated from 0 to 3, so each scale is rated from 0 to 60, the higher the score, the greater the anxiety
Measured: Patient anxiety will be assessed at Day 0, just before the invervention
Assessment of Medication Consumption
The total quantity and frequency of analgesic, anti-inflammatory (NSAIDs), corticosteroid, and anxiolytic medications consumed by patients, recorded through patient self-reports and medical records.
Measured: The Medication Consumption will be recorded throughout the study (120 days)
Assessment of Procedure-Symptom Adequacy Improvement
The percentage of procedures deemed fully adequate for the patient's symptoms and imaging, as determined by the radiologist's evaluation.
Measured: before the procedure
The Numeric Pain Rating Scale (NPRS)
Measuring pain on a numerical scale is a common method used to assess and communicate the intensity of a person's pain. The Numeric Pain Rating Scale (NPRS) is a numerical scale ranging from 0 to 10, where 0 represents no pain, and 10 represents the worst imaginable pain.
Patients are asked to rate their pain by choosing a number that best reflects their current level of pain.
Interpretation:
0: No pain 1-3: Mild pain 4-6: Moderate pain 7-10: Severe pain
Measured: To assess short-term pain 15 days after the surgical procedure
The Numeric Pain Rating Scale (NPRS)
Measuring pain on a numerical scale is a common method used to assess and communicate the intensity of a person's pain. The Numeric Pain Rating Scale (NPRS) is a numerical scale ranging from 0 to 10, where 0 represents no pain, and 10 represents the worst imaginable pain.
Patients are asked to rate their pain by choosing a number that best reflects their current level of pain.
Interpretation:
0: No pain 1-3: Mild pain 4-6: Moderate pain 7-10: Severe pain
Measured: To assess short-term pain 90 days after the surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start12 Feb 2025
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiology InterventionalStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maxime PASTOR, MD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06762665
- Sponsor's protocol ID
- RECHMPL24_0113
- Acronym
- RACE
- Status last verified
- Mar 2025
- First submitted
- 31 Dec 2024
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Interventional Radiology Consultation on the Spinal Infiltrations Effectiveness
- ClinicalTrials.gov ID
- NCT06762665
- Acronym / sponsor ID
- RACE / RECHMPL24_0113
- Conditions
- Radiology Interventional, Spinal Injections, Back Pain
- Keywords
- Consultation, Remote consultation, Radiology interventional, Spinal Injections, Health care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 12 Feb 2025 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 7 Jan 2025 (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.
Performing a consultation with the radiologist before a spinal invasive procedure serves to foster a trusting physician-patient relationship. It also provides an opportunity for the comprehensive explanation of the procedure, its aftermath, and any patient inquiries. We believe that this proactive approach has the potential to alleviate pre-procedure anxiety, thereby contributing to an enhanced overall experience of the intervention and its outcomes. Despite these potential benefits, it is noteworthy that such consultations are not systematically implemented, and their impact on the intervention effictness remains unexplored in existing literature.
The hypothesis is grounded in the belief that patients who perform a consultation preceding their spinal intervention are likely to witness improvements in both the overall experience of the procedure and its effectiveness.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Physical Consultation (PC) | Active comparator | Procedure: Spinal injection, Other: pre-operative consultationThese patients have a consultation with the radiologist prior to the intervention, including an interview about their medical history and symptoms, a clinical examination, a review of the imaging file, an explanation of the procedure, and the opportunity to ask questions. |
| Teleconsultation (TC) | Active comparator | Procedure: Spinal injection, Other: pre-operative consultationThese patients have a teleconsultation with the radiologist prior to the intervention, including an interview about their medical history and symptoms, a review of the imaging file, an explanation of the procedure, and the opportunity to ask questions. |
| No Consultation (NC) | Active comparator | Procedure: Spinal injectionThese patients not have a consultation prior to the procedure: The radiologist reviews the imaging file remotely. The explanation of the procedure is provided through documents, and questions are answered only on the day of the intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient 18 years of age or older
- Referred to the imaging department for a peri-spinal injection under CT guidance.
- Low back pain, dorsal pain, or neck pain with an average pain intensity of ≥ 5/10 on NPRS.
Key exclusion criteria (11 listed)
- Patient unable to read and/or write French
- Patient unable to condut a teleconsultation (no phone, no internet connection)
- Current pregnancy, breastfeeding, or lack of effective contraception for women of childbearing age
- Lack of consent
- Legally protected population:
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 |
|---|---|---|
| Spinal injectionPatients underwent a spinal injection procedure under CT scan | Procedure or surgery | No Consultation (NC), Physical Consultation (PC), Teleconsultation (TC) |
| pre-operative consultationPre-operative consultation, in person or by teleconsultation, consists of an interview about the patient's history and symptoms. This is followed by a clinical examination and consultation of the patient's imaging file, to confirm the request for paraspinal infiltration and its location. In addition, the radiologist explains the procedure to the patient, supplementing the explanatory documents already provided at the time of the appointment, and outlines the results that may be expected and any complications. | Other | Physical Consultation (PC), Teleconsultation (TC) |
Primary outcome
Comparison of the Numeric Pain Rating Scale (NPRS) between the 3 groups
Time frame: 30 days after the surgical procedure
Measuring pain on a numerical scale is a common method used to assess and communicate the intensity of a person's pain. The Numeric Pain Rating Scale (NPRS) is a numerical scale ranging from 0 to 10, where 0 represents no pain, and 10 represents the worst imaginable pain. Patients are asked to rate their pain by choosing a number that best reflects their current level of pain. Interpretation: 0: No pain 1-3: Mild pain 4-6: Moderate pain 7-10: Severe pain
6 secondary outcomes
Patient satisfaction with care
Time frame: 30 days after the surgical procedure
Assessment of Intervention Anxiety
Time frame: Patient anxiety will be assessed at Day 0, just before the invervention
Assessment of Medication Consumption
Time frame: The Medication Consumption will be recorded throughout the study (120 days)
Assessment of Procedure-Symptom Adequacy Improvement
Time frame: before the procedure
The Numeric Pain Rating Scale (NPRS)
Time frame: To assess short-term pain 15 days after the surgical procedure
The Numeric Pain Rating Scale (NPRS)
Time frame: To assess short-term pain 90 days after the surgical procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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.
Catherine CYTEVAL, MD PhD contact
Maxime PASTOR, MD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal injection and pre-operative consultation in people with Radiology Interventional and Spinal Injections, run by University Hospital, Montpellier 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 3 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 20 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maxme PASTOR, MD (06 72 32 79 83 ext. +33, maxime-pastor@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the Numeric Pain Rating Scale (NPRS) between the 3 groups (time frame: 30 days after the surgical procedure). 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 20 Mar 2025.