An interventional study of Anesthesia and breathing group in Rheumatological Injection, Pain Management and Respiratory Monitoring, sponsored by Centre Hospitalier Metropole Savoie. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by Centre Hospitalier Metropole Savoie · Not applicable, Interventional, and Supportive care
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:
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.
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.
Centre Hospitalier Metropole Savoie is the lead sponsor of 22 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Receives local anesthesia with 5 cc of lidocaine before the infiltration procedure.
Procedure: Anesthesia
Explanations for performing 5-minute breathing cycles that facilitate the achievement of cardiac coherence, with visual feedback.
Procedure: breathing group
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.
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.
Pain during rheumatological injection
Pain perceived during rheumatological injection measured using the Visual Analog Scale between 0 to 10 (the higher score mean the worst outcome) and compared between groups.
Time frame: during injection
anxiety during procedure
Anxiety experienced during the procedure, measured by the Visual Analog Scale between 0 to 10, the higher score mean the worst outcome and compared between groups.
Time frame: during the procedure
Cardiac coherence score
Cardiac coherence score during injection (0 to 100, the higher score mean the better outcome) , provided by the EMWAVE device, compared between the breathing group and the anesthesia group.
Time frame: during procedure
pain correlated with cardiac coherence score
Pain measured using the Visual Analog Scale ( 0 to 10, the higher score mean the worst outcome) , correlated within the experimental group with the cardiac coherence score.
Time frame: end of intervention
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2025 (actual). Primary completion is estimated for Sep 2028, 36 months after the start.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Centre Hospitalier Metropole Savoie