RAdiology Consultation Effectiveness (RACE)

University Hospital Center (CHU)

Status: Enrolling

Conditions: Back Pain; Spinal Injections; Radiology Interventional

Treatments: Other: pre-operative consultation; Procedure: Spinal injection

Study type: Interventional

Funder types: Other

Identifiers

NCT06762665

RECHMPL24_0113

Details and patient eligibility

About

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.

Enrollment: 270 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

270 participants in 3 patient groups

Physical Consultation (PC)

Active Comparator group

Description:

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.

Treatment:

Procedure: Spinal injection

Other: pre-operative consultation

Teleconsultation (TC)

Active Comparator group

Description:

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.

Treatment:

Procedure: Spinal injection

Other: pre-operative consultation

No Consultation (NC)

Active Comparator group

Description:

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.

Treatment:

Procedure: Spinal injection