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RAdiology Consultation Effectiveness

Impact of Interventional Radiology Consultation on the Spinal Infiltrations Effectiveness

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06762665
Acronym
RACE
Enrollment
270
Registered
2025-01-07
Start date
2025-02-12
Completion date
2027-09-01
Last updated
2025-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Back Pain, Radiology Interventional, Spinal Injections

Keywords

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

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.

Interventions

PROCEDURESpinal injection

Patients underwent a spinal injection procedure under CT scan

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.

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Comparison of the Numeric Pain Rating Scale (NPRS) between the 3 groups30 days after the surgical procedureMeasuring 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

MeasureTime frameDescription
Patient satisfaction with care30 days after the surgical procedureSatisfaction 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 AnxietyPatient anxiety will be assessed at Day 0, just before the inverventionThe 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 ConsumptionThe 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 Improvementbefore the procedureThe percentage of procedures deemed fully adequate for the patient's symptoms and imaging, as determined by the radiologist's evaluation.
The Numeric Pain Rating Scale (NPRS)To assess short-term pain 15 days after the surgical procedureMeasuring 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

Countries

France

Contacts

Primary ContactMaxme PASTOR, MD
maxime-pastor@chu-montpellier.fr06 72 32 79 83
Backup ContactCatherine CYTEVAL, MD PhD
c-cyteval@chu-montpellier.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026