RAdiology Consultation Effectiveness

NCT ID: NCT06762665

Last Updated: 2025-03-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 270 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-12
• Study Completion Date: 2027-09-01

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.

Conditions

Radiology Interventional; Spinal Injections; Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Physical Consultation (PC)

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.

Group Type: ACTIVE_COMPARATOR

Spinal injection

Intervention Type: PROCEDURE

Patients underwent a spinal injection procedure under CT scan

pre-operative consultation

Intervention Type: OTHER

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.

Teleconsultation (TC)

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.

Group Type: ACTIVE_COMPARATOR

Spinal injection

Intervention Type: PROCEDURE

Patients underwent a spinal injection procedure under CT scan

pre-operative consultation

Intervention Type: OTHER

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.

No Consultation (NC)

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.

Group Type: ACTIVE_COMPARATOR

Spinal injection

Intervention Type: PROCEDURE

Patients underwent a spinal injection procedure under CT scan

Interventions

Spinal injection

Patients underwent a spinal injection procedure under CT scan

Intervention Type: PROCEDURE

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 complications.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maxime PASTOR, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

University Hospital of Montpellier

Montpellier, Occitnaie, France

Site Status: RECRUITING

Countries

France

Central Contacts

Maxme PASTOR, MD

Role: CONTACT

maxime-pastor@chu-montpellier.fr

06 72 32 79 83 ext. +33

Catherine CYTEVAL, MD PhD

Role: CONTACT

c-cyteval@chu-montpellier.fr

Facility Contacts

Céline ENGRAND, PhD

Role: primary

c-engrand@chu-montpellier.fr

0467338607 ext. +33

Other Identifiers

RECHMPL24_0113

Identifier Type: -

Identifier Source: org_study_id