RAdiology Consultation Effectiveness

NCT06762665 | Recruiting

• 1 other identifier: RECHMPL24_0113
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

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

Keywords

Consultation; Remote consultation; Radiology interventional; Spinal Injections; Health care

Outcome Measures

Primary Outcomes (1)

• 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

  30 days after the surgical procedure

Secondary Outcomes (6)

• Patient satisfaction with care

  30 days after the surgical procedure

• Assessment of Intervention Anxiety

  Patient anxiety will be assessed at Day 0, just before the invervention

• Assessment of Medication Consumption

  The Medication Consumption will be recorded throughout the study (120 days)

• Assessment of Procedure-Symptom Adequacy Improvement

  before the procedure

• The Numeric Pain Rating Scale (NPRS)

  To assess short-term pain 15 days after the surgical procedure

Study Arms (3)

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.

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.

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.

Procedure: Spinal injection

Interventions

Spinal injection PROCEDURE

Patients underwent a spinal injection procedure under CT scan

No Consultation (NC); Physical Consultation (PC); Teleconsultation (TC)

pre-operative consultation 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.

Physical Consultation (PC); Teleconsultation (TC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

University Hospital of Montpellier

Montpellier, Occitnaie, 34295, France

RECRUITING

MeSH Terms

Conditions

Back Pain

Interventions

Injections, Spinal

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Maxime PASTOR, MD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maxme PASTOR, MD

CONTACT

06 72 32 79 83; maxime-pastor@chu-montpellier.fr

Catherine CYTEVAL, MD PhD

CONTACT

c-cyteval@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2024
• First Posted: January 7, 2025
• Study Start: February 12, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 20, 2025

Record last verified: 2025-03

Locations

FR (1)