Clinical trial NCT06762665: RAdiology Consultation Effectiveness
Official title: Impact of Interventional Radiology Consultation on the Spinal Infiltrations Effectiveness
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Radiology Interventional
Spinal Injections
Back Pain
Keywords: Consultation
Remote consultation
Radiology interventional
Spinal Injections
Health care
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2025-01-07
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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)
  * 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

Primary outcomes:
measure: Comparison of the Numeric Pain Rating Scale (NPRS) between the 3 groups
timeFrame: 30 days after the surgical procedure
Secondary outcomes:
measure: Patient satisfaction with care
timeFrame: 30 days after the surgical procedure
measure: Assessment of Intervention Anxiety
timeFrame: Patient anxiety will be assessed at Day 0, just before the invervention
measure: Assessment of Medication Consumption
timeFrame: The Medication Consumption will be recorded throughout the study (120 days)
measure: Assessment of Procedure-Symptom Adequacy Improvement
timeFrame: before the procedure
measure: The Numeric Pain Rating Scale (NPRS)
timeFrame: To assess short-term pain 15 days after the surgical procedure
measure: The Numeric Pain Rating Scale (NPRS)
timeFrame: To assess short-term pain 90 days after the surgical procedure
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University Hospital of Montpellier
state: Occitnaie
Study officials:
affiliation: University Hospital, Montpellier
name: Maxime PASTOR, MD
role: PRINCIPAL_INVESTIGATOR
References: