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

NCT ID: NCT07172984

Last Updated: 2026-01-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-19
• Study Completion Date: 2028-09-20

Brief Summary

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.

Conditions

Rheumatological Injection; Pain Management; Respiratory Monitoring

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Anesthesia group

Receives local anesthesia with 5 cc of lidocaine before the infiltration procedure.

Group Type: ACTIVE_COMPARATOR

Anesthesia

Intervention Type: PROCEDURE

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.

breathing group

Explanations for performing 5-minute breathing cycles that facilitate the achievement of cardiac coherence, with visual feedback.

Group Type: EXPERIMENTAL

breathing group

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Université Savoie Mont Blanc

OTHER

Sponsor Role: collaborator

Centre Hospitalier Metropole Savoie

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre Hospitalier Métropole Savoie

Chambéry, , France

Site Status: RECRUITING

Countries

France

Central Contacts

leo blervaque

Role: CONTACT

urc@ch-metropole-savoie.fr

+33 4 79 96 58 13 ext. +33

Other Identifiers

2025-A00019-40

Identifier Type: OTHER

Identifier Source: secondary_id

CHMS25001

Identifier Type: -

Identifier Source: org_study_id