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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07172984
Acronym
Respi-IR
Enrollment
136
Registered
2025-09-15
Start date
2025-09-19
Completion date
2028-09-20
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain Management, Respiratory Monitoring, Rheumatological Injection

Keywords

rheumatological injection, local anesthesia during intra-articular injection, respiratory rate monitoring

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.

Interventions

PROCEDUREbreathing 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.

PROCEDUREAnesthesia

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.

Sponsors

Université Savoie Mont Blanc
CollaboratorOTHER
Centre Hospitalier Metropole Savoie
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pain during rheumatological injectionduring injectionPain 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.

Secondary

MeasureTime frameDescription
anxiety during procedureduring the procedureAnxiety 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.
Cardiac coherence scoreduring procedureCardiac 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.
pain correlated with cardiac coherence scoreend of interventionPain 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.

Countries

France

Contacts

Primary Contactleo blervaque
urc@ch-metropole-savoie.fr+33 4 79 96 58 13

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026