The Value of Standardized Respiratory Rate Monitoring Exercises During Rheumatological Injection Procedures

Официальное название

The Value of Standardized Respiratory Rate Monitoring Exercises During Rheumatological Infiltration Procedures - A Single-blind, Randomized, Controlled Non-inferiority Study

Обзор

The goal of this clinical trial is to demonstrate the non-inferiority of standardized breathing control exercises on perceived pain during rheumatological injections procedures compared to standard care consisting of the addition of a local anesthetic. The study population will consist of patients scheduled to undergo therapeutic ultrasound-guided joint or periarticular injection. The main question it aims to answer is: * Non-inferiority of breathing exercises compared to the addition of local anesthetic on pain and anxiety experienced during an infiltration procedure. * Correlation between the reduction in pain and anxiety experienced during a procedure and the cardiac coherence score obtained. Researchers will compare the anesthesia group (Arm A), which will receive local anesthesia with 5 cc of lidocaine before the infiltration procedure to the breathing group (Arm B), which will receive instructions before the injection procedure on how to perform 5-minute breathing cycles to facilitate the achievement of cardiac coherence to see if the pain perceived in Arm B is not greater than the pain perceived in Arm A. Participants will be kept blind to their randomization group. Arm A (anesthesia) will receive SHAM breathing exercises, while Arm B (breathing) will receive a placebo injection of anesthetic.

Подробное описание

This randomized, controlled, single-blind, single-center non-inferiority study aims to evaluate the impact of local anesthesia and breathing exercises on pain and anxiety management during joint or periarticular injections. Participants are patients referred to a rheumatology consultation or referred by an outside physician for injections requiring local anesthesia, such as those performed on the shoulder, elbow, knee, hip, or ankle.

Patients will be kept blind to their randomization group. In both groups, continuous heart rate recording will be performed during the procedure using the EmWave PRO device (to assess cardiorespiratory variability and calculate a cardiac coherence score).

In the "anesthesia" group, local anesthesia with 5 cc of lidocaine will be administered before the infiltration procedure, and the patient will receive breathing instructions as part of "SHAM" management, which will prevent them from achieving cardiac coherence.

In the "breathing" group, patients will perform 5-minute breathing exercises before the procedure (10-second cycles: 5 seconds of inhalation and 5 seconds of exhalation) to enable them to achieve the expected analgesic cardiac coherence. The practitioner performing the procedure will use 5 cc of saline solution instead of the usual anesthesia.

After infiltration, participants' pain, anxiety, and satisfaction will be measured using EVA scale.

Вмешательства

• Процедура Anesthesia
  Receives local anesthesia with 5 cc of lidocaine before the infiltration procedure.The patient will receive breathing instructions as part of "SHAM" treatment, which will not allow them to achieve cardiac coherence.
• Процедура breathing group
  The procedure will use 5 cc of saline solution instead of the usual anesthesia. Explanations for performing 5-minute breathing cycles that facilitate the achievement of cardiac coherence, with visual feedback.

Первичные конечные точки

• Pain during rheumatological injection [Срок оценки: during injection]

Вторичные конечные точки (3)

• anxiety during procedure [Срок оценки: during the procedure]
• Cardiac coherence score [Срок оценки: during procedure]
• pain correlated with cardiac coherence score [Срок оценки: end of intervention]

Критерии участия

Критерии включения

• Patient scheduled to undergo therapeutic ultrasound-guided joint or periarticular injection.
• Patient able to sign an informed consent form to participate in the study

Критерии исключения

• Patient able to sign an informed consent form to participate in the study - - Allergy to the injection product or anesthetic.
• Injection not allowing the use of a local anesthetic due to insufficient joint volume (e.g., fingers/toes).
• Epidural injection via the sacrococcygeal hiatus.
• Pregnant women

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Франция · 1 центр

• Centre Hospitalier Métropole Savoie — Chambéry

Идентификаторы

NCT: NCT07172984 · CHMS25001 · 2025-A00019-40

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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