The Value of Standardized Respiratory Rate Monitoring Exercises During Rheumatological Injection Procedures
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Anesthesia, breathing group.
- Who it may be relevant to
- Registry conditions: Rheumatological Injection, Pain Management, Respiratory Monitoring. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Value of Standardized Respiratory Rate Monitoring Exercises During Rheumatological Infiltration Procedures - A Single-blind, Randomized, Controlled Non-inferiority Study
Overview
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.
Detailed description
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.
Interventions
- Procedure 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. - Procedure 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.
Primary outcome measures
- Pain during rheumatological injection [Time frame: during injection]
Secondary outcome measures (3)
- anxiety during procedure [Time frame: during the procedure]
- Cardiac coherence score [Time frame: during procedure]
- pain correlated with cardiac coherence score [Time frame: end of intervention]
Eligibility criteria
Inclusion criteria
- Patient scheduled to undergo therapeutic ultrasound-guided joint or periarticular injection.
- Patient able to sign an informed consent form to participate in the study
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
France · 1 center
- Centre Hospitalier Métropole Savoie — Chambéry
Identifiers
NCT: NCT07172984 · CHMS25001 · 2025-A00019-40