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NCT Number: NCT06762665

RAdiology Consultation 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.

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Key information

Conditions

Radiology Interventional Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Injections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Montpellier

Montpellier, Occitnaie, 34295, France

Location status: Recruiting

Location contact

Céline ENGRAND, PhD

CONTACT

[email protected]

0467338607 ext. +33

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spinal injection

Procedure

Patients underwent a spinal injection procedure under CT scan

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.

Primary outcomes

  1. Comparison of the Numeric Pain Rating Scale (NPRS) between the 3 groups

    Time frame: 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 outcomes

  1. Patient satisfaction with care

    Time frame: 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

  2. Assessment of Intervention Anxiety

    Time frame: 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

  3. Assessment of Medication Consumption

    Time frame: 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.

  4. Assessment of Procedure-Symptom Adequacy Improvement

    Time frame: before the procedure

    The percentage of procedures deemed fully adequate for the patient's symptoms and imaging, as determined by the radiologist's evaluation.

  5. The Numeric Pain Rating Scale (NPRS)

    Time frame: To assess short-term pain 15 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

  6. The Numeric Pain Rating Scale (NPRS)

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Catherine CYTEVAL, MD PhD

CONTACT

[email protected]

Maxme PASTOR, MD

CONTACT

[email protected]

06 72 32 79 83 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

Impact of Interventional Radiology Consultation on the Spinal Infiltrations Effectiveness

Acronym: RACE

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 7, 2025
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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