RAdiology Consultation Effectiveness

Official title

Impact of Interventional Radiology Consultation on the Spinal Infiltrations Effectiveness

Overview

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.

Interventions

• Procedure Spinal injection
  Patients underwent a spinal injection procedure under CT scan
• Other pre-operative consultation
  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

Primary outcome measures

• Comparison of the Numeric Pain Rating Scale (NPRS) between the 3 groups [Time frame: 30 days after the surgical procedure]

Secondary outcome measures (6)

• 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

France · 1 center

• University Hospital of Montpellier — Montpellier

Identifiers

NCT: NCT06762665 · RECHMPL24_0113

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗