RAdiology Consultation Effectiveness (RACE)

Impact of Interventional Radiology Consultation on the Spinal Infiltrations Effectiveness

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.

Study Overview

• Status: Recruiting
• Conditions: Back Pain; Radiology Interventional; Spinal Injections
• Intervention / Treatment: Procedure: Spinal injection; Other: pre-operative consultation

• Study Type: Interventional
• Enrollment (Estimated): 270
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maxme PASTOR, MD; Phone Number: +33 06 72 32 79 83; Email: maxime-pastor@chu-montpellier.fr
• Study Contact Backup: Name: Catherine CYTEVAL, MD PhD; Email: c-cyteval@chu-montpellier.fr

Study Locations

• France
  • Occitnaie
    • Montpellier, Occitnaie, France, 34295
      • Recruiting
      • University Hospital of Montpellier
      • Contact: Céline ENGRAND, PhD; Phone Number: +33 0467338607; Email: c-engrand@chu-montpellier.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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 complications.
Active Comparator: 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.	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 complications.
Active Comparator: 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.	Procedure: Spinal injection; Patients underwent a spinal injection procedure under CT scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction with care	Satisfaction survey for healthcare is crucial to understanding the experiences of patients : The patient will be asked if he is satisfied: his medical care ( yes/no) If no : why and the arm to which he would have liked to belong	30 days after the surgical procedure
Assessment of Intervention Anxiety	The level of patient anxiety measured using a standardized anxiety scale (State-Trait Anxiety Inventory) The questionnaire includes 2 separate scales to assess state anxiety (how subjects feel now) and trait anxiety (how subjects usually feel). Each scale comprises 20 items. each item is rated from 0 to 3, so each scale is rated from 0 to 60, the higher the score, the greater the anxiety	Patient anxiety will be assessed at Day 0, just before the invervention
Assessment of Medication Consumption	The total quantity and frequency of analgesic, anti-inflammatory (NSAIDs), corticosteroid, and anxiolytic medications consumed by patients, recorded through patient self-reports and medical records.	The Medication Consumption will be recorded throughout the study (120 days)
Assessment of Procedure-Symptom Adequacy Improvement	The percentage of procedures deemed fully adequate for the patient's symptoms and imaging, as determined by the radiologist's evaluation.	before the procedure
The Numeric Pain Rating Scale (NPRS)	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	To assess short-term pain 15 days after the surgical procedure
The Numeric Pain Rating Scale (NPRS)	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	To assess short-term pain 90 days after the surgical procedure

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Maxime PASTOR, MD, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: December 31, 2024
• First Submitted That Met QC Criteria: December 31, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 17, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Health care; Consultation; Remote consultation; Radiology interventional; Spinal Injections
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain
• Other Study ID Numbers: RECHMPL24_0113

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No