Rheumatological InjectionRespi-IRNCT07172984
The Value of Standardized Respiratory Rate Monitoring Exercises During Rheumatological Injection Procedures
A study testing Anesthesia and breathing group in people with Rheumatological Injection and Pain Management, run by Centre Hospitalier Metropole Savoie at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatological Injection, Pain Management, Respiratory Monitoring
- What is being tested?
- Anesthesia and breathing group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteFrance
- Study dates
- 19 Sep 2025to 20 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient scheduled to undergo therapeutic ultrasound-guided joint or periarticular injection.
- Patient able to sign an informed consent form to participate in the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Métropole Savoie
Chambéry, 73000
About this study
Official title: The Value of Standardized Respiratory Rate Monitoring Exercises During Rheumatological Infiltration Procedures - A Single-blind, Randomized, Controlled Non-inferiority Study
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.
Read more
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.
Read the 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.
- Being tested
- Anesthesia, breathing group
- Keywords
- rheumatological injection, local anesthesia during intra-articular injection, respiratory rate monitoring
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnesthesiaProcedure or surgery
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 groupProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Anesthesia group | Active comparator | Receives local anesthesia with 5 cc of lidocaine before the infiltration procedure. Receives: Procedure: Anesthesia |
| breathing group | Experimental | Explanations for performing 5-minute breathing cycles that facilitate the achievement of cardiac coherence, with visual feedback. Receives: Procedure: breathing group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: during injection
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: end of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start19 Sep 2025
- Primary completion20 Sep 2028 (estimated)
- Study completion20 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatological InjectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Metropole Savoie
- Sponsor type
- University, hospital or other
- Collaborators
- Université Savoie Mont Blanc
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07172984
- Sponsor's protocol ID
- 2025-A00019-40
- Other IDs
- 2025-A00019-40
- Acronym
- Respi-IR
- Status last verified
- Oct 2026
- First submitted
- 8 Sep 2025
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Standardized Respiratory Rate Monitoring Exercises During Rheumatological Infiltration Procedures - A Single-blind, Randomized, Controlled Non-inferiority Study
- ClinicalTrials.gov ID
- NCT07172984
- Acronym / sponsor ID
- Respi-IR / 2025-A00019-40
- Keywords
- rheumatological injection, local anesthesia during intra-articular injection, respiratory rate monitoring
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Centre Hospitalier Metropole SavoieUniversity, hospital or other
- Collaborators
- Université Savoie Mont Blanc
- Study start
- 19 Sep 2025 (actual)
- Primary completion
- 20 Sep 2028 (estimated)
- Study completion
- 20 Sep 2028 (estimated)
- First posted
- 15 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anesthesia group | Active comparator | Procedure: AnesthesiaReceives local anesthesia with 5 cc of lidocaine before the infiltration procedure. |
| breathing group | Experimental | Procedure: breathing groupExplanations for performing 5-minute breathing cycles that facilitate the achievement of cardiac coherence, with visual feedback. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient scheduled to undergo therapeutic ultrasound-guided joint or periarticular injection.
- Patient able to sign an informed consent form to participate in the study
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AnesthesiaReceives 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 or surgery | Anesthesia group |
| breathing groupThe 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. | Procedure or surgery | breathing group |
Primary outcome
Pain during rheumatological injection
Time frame: during 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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anesthesia and breathing group in people with Rheumatological Injection and Pain Management, run by Centre Hospitalier Metropole Savoie at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact leo blervaque (+33 4 79 96 58 13 ext. +33, urc@ch-metropole-savoie.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain during rheumatological injection (time frame: during injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.