RAdiology Consultation Effectiveness

Not Applicable

Recruiting

• Conditions: Radiology Interventional; Spinal Injections; Back Pain

• Registration Number: NCT06762665
• Lead Sponsor: University Hospital, Montpellier

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-31
• Study First Submitted QC: 2024-12-31
• Study First Posted: 2025-01-07
• Study Start: 2025-02-12
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-20
• Primary Completion: 2027-06-01
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 270

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Comparison of the Numeric Pain Rating Scale (NPRS) between the 3 groups	30 days after the surgical procedure	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

Secondary Outcome Measures

Name	Time	Method
The Numeric Pain Rating Scale (NPRS)	To assess short-term pain 90 days after the surgical procedure	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
Patient satisfaction with care	30 days after the surgical procedure	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
Assessment of Intervention Anxiety	Patient anxiety will be assessed at Day 0, just before the invervention	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
Assessment of Medication Consumption	The Medication Consumption will be recorded throughout the study (120 days)	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.
Assessment of Procedure-Symptom Adequacy Improvement	before the procedure	The percentage of procedures deemed fully adequate for the patient's symptoms and imaging, as determined by the radiologist's evaluation.

Trial Locations

Locations (1)

University Hospital of Montpellier; 🇫🇷 Montpellier, Occitnaie, France