Schizophrenia; PsychosisIM-ZBULLENCT05995457
The IM-ZBULLE Study : " Z-track " and " Airlock " Techniques During Intramuscular Injection of Haloperidol Decanoate
A study testing Intramuscular injection of Haloperidol decanoate using the "Z-track" and "Airlock" techniques and Intramuscular injection of Haloperidol decanoate using standard techniques in people with Schizophrenia; Psychosis, run by Centre Hospitalier St Anne at 1 site in France.
Trial summary
Intramuscular injection (IMI) is the process of administering a drug treatment into muscle tissue. The transmission of skills in this care practice is essentially based on the experience of peers. In France, there are no official guidelines for this technical procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia; Psychosis
- What is being tested?
- Intramuscular injection of Haloperidol decanoate using the "Z-track" and "Airlock" techniques and Intramuscular injection of Haloperidol decanoate using standard techniques
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2023to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Adult ;
- having an outpatient treatment in a Mental Health Community Center ("Centre Médico-Psychologique" CMP in french) ;
- with an CIM-10 diagnosis between F20-F29 (Schizophrenia, schizotypal disorder and delusional disorders);
- communicative and able to give free and informed consent to the study;
- prescribed Haloperidol decanoate;
- covered by the french social security
Who cannot join
- Minor ;
- pregnant women ;
- with insufficient understanding of the French language to understand the VAS;
- suffering from any of the following known somatic comorbidity : coagulation disorder, leucopenia, immunosuppression;
- currently prescribed treatment: immunosuppressant, anticoagulant, antibiotic, antiretroviral, other products administered by IMI at dorsogluteal injection sites (antibiotic therapy, hormone therapy, vitamin therapy).
Trial locations and contacts
1 site in 1 country.
Cécile BERGOT contact
France1 site
Rayan BCHINI
Villejuif, 94800
Rayan BCHINI, Master 2 IPA, +33142117590, rayan.francoisbchini@gh-paulguiraud.fr
About this study
Official title: Efficacy of the Combination of " Z-track " and " Airlock " Techniques During Intramuscular Injection of Haloperidol Decanoate in Adult Patients With Schizophrenic or Related Disorder : A Multicenter Randomized Controlled Trial
Intramuscular injection (IMI) is the process of administering a drug treatment into muscle tissue. The transmission of skills in this care practice is essentially based on the experience of peers. In France, there are no official guidelines for this technical procedure.
Haloperidol decanoate is widely used in psychiatry. This long-acting antipsychotic treatment considerably reduces the risk of relapse and hospitalization. It is administered by IMI. This treatment is invasive, painful and risks complications for the patient. Nurses must ensure that the treatment is as painless as possible, and adapt their practice in line with current recommendations.
Read more
Among the various IMI techniques available, the "Z-track" and the "Airlock" limit leakage into subcutaneous tissues when the needle is withdrawn, by locking the active product into the muscular tissues. According to an exploratory study (n=303), 73% of nurses observe active product leakage after injections, and 89% of nurses are not familiar with either the "Z-track" or "Airlock" techniques.
Many foreign studies have been carried out to demonstrate the relevance of these techniques, particularly in terms of pain reduction during treatment, but the results have yet to be confirmed.
The investigators hypothesize that the combined use of the "Z-track" and "Airlock" techniques during intramuscular injection of Haloperidol decanoate is more effective in reducing patient pain than usual practice.
Read the detailed description
This is a multicenter, prospective, randomized, double-blind, controlled, study in 2 parallel groups.
Experimental and control administration protocols will be standardized to harmonize injection practices between the different nurses providing care, and to control some variables. Nurses will have been trained in these protocols and in experimental injection techniques.
The experimental group will be offered an intramuscular injection using the "Z-track" and "Airlock" techniques, while the control group will have an "usual" injection.
An intermediate analysis of futility and efficacy is planned once 50% of the planned sample has completed the study.
The object of the research is the intramuscular injection procedure - Product injected: haloperidol decanoate (Haldol Decanoas®).
- Conditions
- Schizophrenia; Psychosis
- Being tested
- Intramuscular injection of Haloperidol decanoate using the "Z-track" and "Airlock" techniques, Intramuscular injection of Haloperidol decanoate using standard techniques
- Keywords
- Schizophrenia, Haloperidol decanoate
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intramuscular injection of Haloperidol decanoate using the "Z-track" and "Airlock" techniquesOther
Intramuscular injection involves administering the drug treatment Haloperidol decanoate into muscle tissue using the "Z-track" and "Airlock" techniques
Intramuscular injection of Haloperidol decanoate using standard techniquesOther
Intramuscular injection involves administering the drug Haloperidol decanoate into muscle tissue using the usual technique.
| Study group | Role | What they receive |
|---|---|---|
| Intramuscular injection of Haloperidol decanoate using the "Z-track" and "Airlock" techniques | Experimental | Intramuscular injection involves administering the drug treatment Haloperidol decanoate into muscle tissue using the "Z-track" and "Airlock" techniques. Receives: Other: Intramuscular injection of Haloperidol decanoate using the "Z-track" and "Airlock" techniques |
| Control arm, Intramuscular injection as usual | Other | Intramuscular injection involves administering the drug Haloperidol decanoate into muscle tissue using the usual technique Receives: Other: Intramuscular injection of Haloperidol decanoate using standard techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain reduction
To evaluate the efficacy of combining the "Z-track" and "Airlock" techniques concerning reducing pain in adult patients treated with Haloperidol decanoate. The primary outcome measure is pain reduction, assessed using a millimeter-scale visual analogic scale (VAS) to measure pain perceived by the patient 5 minutes after the treatment. The score is between 0 (minimum) and 10 (maximum) centimeters. The higher the score, the worse the result.
Measured: Day 0 intervention day T
Secondary outcomes (5)
Drug leakage reduction
To measure the loss (leakage) of active product when the needle is withdrawn : The outcome measure is a reduction in the loss of active product by assessing the diameter (using a millimeter scale) of active product that flow back through the puncture site using an absorbent pad.
Measured: Day 0 intervention day
Impact of the injection
To measure the impact of combining the "Z-track" and "Airlock" techniques on potential complications related to treatment : The outcome measure is the reduction in signs of secondary complications, as measured by a pre- and post-injection clinical examination and a phone call to the patient between Day 1 and Day 3.
Measured: Day 0 to Day 3
Improving participants satisfaction
To measure overall patient satisfaction with the combination of "Z-track" and "Airlock" intramuscular injection techniques. The outcome measure is participant satisfaction, assessed using Attkisson's CSQ-8 questionnaire. This scale comprises 8 questions. Depending on the answer, each question awards 1 to 4 points. The score is therefore between 8 (minimum) and 32 (maximum) points. The higher the score, the better the result.
Measured: Day 14 or Day 21 or Day 28 depending to the frequency established by the prescription1
Improving the therapeutic alliance
To measure therapeutic alliance during follow-up :The outcome measure is the overall therapeutic alliance score, using the Working Alliance Inventory (WAI) scale before and after intervention. This scale comprises 12 questions. Each question awards 1 to 5 points, depending on the answer. The score is between 12 (minimum) and 60 (maximum) points. The higher the score, the better the result.
Measured: Day 0 (intervention day) and Day 14 or Day 21 or Day 28 depending to the frequency established by the prescription
Identifying the obstacles and levers to changing practices
To identify the levers and obstacles to nurses' change of practice : The outcome measure is the identification of levers and obstacles to change in professional practice among psychiatric nurses, by means of a complementary qualitative descriptive study.
Measured: During 14 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start1 Sep 2023 (estimated)
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Schizophrenia; PsychosisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier St AnneThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier St Anne
- Sponsor type
- University, hospital or other
- Collaborators
- Groupe Hospitalier Paul Guiraud, Etablissement Public de Santé Barthélemy Durand
- Responsible party
- Sponsor
- Investigators
- Rayan BCHINI, Principal investigator, GHU Paris Psychiatry & Neurosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05995457
- Sponsor's protocol ID
- D23-P001
- Acronym
- IM-ZBULLE
- Status last verified
- Aug 2023
- First submitted
- 18 Jul 2023
- Last updated
- 23 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bchini R, Goutte N. [Evidence-based practice and nursing: intramuscular injection in psychiatry]. Soins Psychiatr. 2023 May-Jun;44(346):21-26. doi: 10.1016/j.spsy.2023.04.006. Epub 2023 Jun 7. French.
PubMed 37328226Rodger MA, King L. Drawing up and administering intramuscular injections: a review of the literature. J Adv Nurs. 2000 Mar;31(3):574-82. doi: 10.1046/j.1365-2648.2000.01312.x.
PubMed 10718876Wynaden D, Landsborough I, Chapman R, McGowan S, Lapsley J, Finn M. Establishing best practice guidelines for administration of intra muscular injections in the adult: a systematic review of the literature. Contemp Nurse. 2005 Dec;20(2):267-77. doi: 10.5172/conu.20.2.267.
PubMed 16393108Sanlialp Zeyrek A, Takmak S, Kurban NK, Arslan S. Systematic review and meta-analysis: Physical-procedural interventions used to reduce pain during intramuscular injections in adults. J Adv Nurs. 2019 Dec;75(12):3346-3361. doi: 10.1111/jan.14183. Epub 2019 Sep 13.
PubMed 31452229Keen MF. Comparison of intramuscular injection techniques to reduce site discomfort and lesions. Nurs Res. 1986 Jul-Aug;35(4):207-10.
PubMed 3636818Kim KS. [Comparison of two intramuscular injection technics on the severity of discomfort and lesions at the injection site]. Kanho Hakhoe Chi. 1988 Dec;18(3):257-68. doi: 10.4040/jnas.1988.18.3.257. Korean.
PubMed 3230758Quartermaine S, Taylor R. A comparative study of depot injection techniques. Nurs Times. 1995 Jul 26-Aug 1;91(30):36-9.
PubMed 7644369Mac Gabhann L. A comparison of two depot injection techniques. Nurs Stand. 1998 Jun 3-9;12(37):39-41. doi: 10.7748/ns1998.06.12.37.39.c2512.
PubMed 9732632Yilmaz DK, Dikmen Y, Kokturk F, Dedeoglu Y. The effect of air-lock technique on pain at the site of intramuscular injection. Saudi Med J. 2016 Mar;37(3):304-8. doi: 10.15537/smj.2016.3.13113.
PubMed 26905354Kara D, Yapucu Gunes U. The effect on pain of three different methods of intramuscular injection: A randomized controlled trial. Int J Nurs Pract. 2016 Apr;22(2):152-9. doi: 10.1111/ijn.12358. Epub 2014 Jul 11.
PubMed 25039702Ayinde O, Hayward RS, Ross JDC. The effect of intramuscular injection technique on injection associated pain; a systematic review and meta-analysis. PLoS One. 2021 May 3;16(5):e0250883. doi: 10.1371/journal.pone.0250883. eCollection 2021.
PubMed 33939726Heshmatifar N, Salari M, Rad M, Afshari Saleh T, Borzoee F, Rastaghi S. A New Approach on the pain management of intramuscular injection: A Triple-Blind Randomized Clinical Trial. Pain Manag Nurs. 2022 Jun;23(3):353-358. doi: 10.1016/j.pmn.2021.01.010. Epub 2021 Mar 11.
PubMed 33714700Bloch Y, Mendlovic S, Strupinsky S, Altshuler A, Fennig S, Ratzoni G. Injections of depot antipsychotic medications in patients suffering from schizophrenia: do they hurt? J Clin Psychiatry. 2001 Nov;62(11):855-9. doi: 10.4088/jcp.v62n1104.
PubMed 11775044
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Combination of " Z-track " and " Airlock " Techniques During Intramuscular Injection of Haloperidol Decanoate in Adult Patients With Schizophrenic or Related Disorder : A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05995457
- Acronym / sponsor ID
- IM-ZBULLE / D23-P001
- Conditions
- Schizophrenia; Psychosis
- Keywords
- Schizophrenia, Haloperidol decanoate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Centre Hospitalier St AnneUniversity, hospital or other
- Collaborators
- Groupe Hospitalier Paul Guiraud, Etablissement Public de Santé Barthélemy Durand
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 16 Aug 2023 (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.
Intramuscular injection (IMI) is the process of administering a drug treatment into muscle tissue. The transmission of skills in this care practice is essentially based on the experience of peers. In France, there are no official guidelines for this technical procedure.
Haloperidol decanoate is widely used in psychiatry. This long-acting antipsychotic treatment considerably reduces the risk of relapse and hospitalization. It is administered by IMI. This treatment is invasive, painful and risks complications for the patient. Nurses must ensure that the treatment is as painless as possible, and adapt their practice in line with current recommendations.
Among the various IMI techniques available, the "Z-track" and the "Airlock" limit leakage into subcutaneous tissues when the needle is withdrawn, by locking the active product into the muscular tissues. According to an exploratory study (n=303), 73% of nurses observe active product leakage after injections, and 89% of nurses are not familiar with either the "Z-track" or "Airlock" techniques.
Many foreign studies have been carried out to demonstrate the relevance of these techniques, particularly in terms of pain reduction during treatment, but the results have yet to be confirmed.
The investigators hypothesize that the combined use of the "Z-track" and "Airlock" techniques during intramuscular injection of Haloperidol decanoate is more effective in reducing patient pain than usual practice.
Detailed description
This is a multicenter, prospective, randomized, double-blind, controlled, study in 2 parallel groups.
Experimental and control administration protocols will be standardized to harmonize injection practices between the different nurses providing care, and to control some variables. Nurses will have been trained in these protocols and in experimental injection techniques.
The experimental group will be offered an intramuscular injection using the "Z-track" and "Airlock" techniques, while the control group will have an "usual" injection.
An intermediate analysis of futility and efficacy is planned once 50% of the planned sample has completed the study.
The object of the research is the intramuscular injection procedure - Product injected: haloperidol decanoate (Haldol Decanoas®).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intramuscular injection of Haloperidol decanoate using the "Z-track" and "Airlock" techniques | Experimental | Other: Intramuscular injection of Haloperidol decanoate using the "Z-track" and "Airlock" techniquesIntramuscular injection involves administering the drug treatment Haloperidol decanoate into muscle tissue using the "Z-track" and "Airlock" techniques. |
| Control arm, Intramuscular injection as usual | Other | Other: Intramuscular injection of Haloperidol decanoate using standard techniquesIntramuscular injection involves administering the drug Haloperidol decanoate into muscle tissue using the usual technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult ;
- having an outpatient treatment in a Mental Health Community Center ("Centre Médico-Psychologique" CMP in french) ;
- with an CIM-10 diagnosis between F20-F29 (Schizophrenia, schizotypal disorder and delusional disorders);
- communicative and able to give free and informed consent to the study;
- prescribed Haloperidol decanoate;
Key exclusion criteria (5 listed)
- Minor ;
- pregnant women ;
- with insufficient understanding of the French language to understand the VAS;
- suffering from any of the following known somatic comorbidity : coagulation disorder, leucopenia, immunosuppression;
- currently prescribed treatment: immunosuppressant, anticoagulant, antibiotic, antiretroviral, other products administered by IMI at dorsogluteal injection sites (antibiotic therapy, hormone therapy, vitamin therapy).
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 |
|---|---|---|
| Intramuscular injection of Haloperidol decanoate using the "Z-track" and "Airlock" techniquesIntramuscular injection involves administering the drug treatment Haloperidol decanoate into muscle tissue using the "Z-track" and "Airlock" techniques | Other | Intramuscular injection of Haloperidol decanoate using the "Z-track" and "Airlock" techniques |
| Intramuscular injection of Haloperidol decanoate using standard techniquesIntramuscular injection involves administering the drug Haloperidol decanoate into muscle tissue using the usual technique. | Other | Control arm, Intramuscular injection as usual |
Primary outcome
pain reduction
Time frame: Day 0 intervention day T
To evaluate the efficacy of combining the "Z-track" and "Airlock" techniques concerning reducing pain in adult patients treated with Haloperidol decanoate. The primary outcome measure is pain reduction, assessed using a millimeter-scale visual analogic scale (VAS) to measure pain perceived by the patient 5 minutes after the treatment. The score is between 0 (minimum) and 10 (maximum) centimeters. The higher the score, the worse the result.
5 secondary outcomes
Drug leakage reduction
Time frame: Day 0 intervention day
Impact of the injection
Time frame: Day 0 to Day 3
Improving participants satisfaction
Time frame: Day 14 or Day 21 or Day 28 depending to the frequency established by the prescription1
Improving the therapeutic alliance
Time frame: Day 0 (intervention day) and Day 14 or Day 21 or Day 28 depending to the frequency established by the prescription
Identifying the obstacles and levers to changing practices
Time frame: During 14 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
- Background: PubMed 37328226Bchini R, Goutte N. [Evidence-based practice and nursing: intramuscular injection in psychiatry]. Soins Psychiatr. 2023 May-Jun;44(346):21-26. doi: 10.1016/j.spsy.2023.04.006. Epub 2023 Jun 7. French.
- Background: PubMed 10718876Rodger MA, King L. Drawing up and administering intramuscular injections: a review of the literature. J Adv Nurs. 2000 Mar;31(3):574-82. doi: 10.1046/j.1365-2648.2000.01312.x.
- Background: PubMed 16393108Wynaden D, Landsborough I, Chapman R, McGowan S, Lapsley J, Finn M. Establishing best practice guidelines for administration of intra muscular injections in the adult: a systematic review of the literature. Contemp Nurse. 2005 Dec;20(2):267-77. doi: 10.5172/conu.20.2.267.
- Background: PubMed 31452229Sanlialp Zeyrek A, Takmak S, Kurban NK, Arslan S. Systematic review and meta-analysis: Physical-procedural interventions used to reduce pain during intramuscular injections in adults. J Adv Nurs. 2019 Dec;75(12):3346-3361. doi: 10.1111/jan.14183. Epub 2019 Sep 13.
- Background: PubMed 3636818Keen MF. Comparison of intramuscular injection techniques to reduce site discomfort and lesions. Nurs Res. 1986 Jul-Aug;35(4):207-10.
- Background: PubMed 3230758Kim KS. [Comparison of two intramuscular injection technics on the severity of discomfort and lesions at the injection site]. Kanho Hakhoe Chi. 1988 Dec;18(3):257-68. doi: 10.4040/jnas.1988.18.3.257. Korean.
- Background: PubMed 7644369Quartermaine S, Taylor R. A comparative study of depot injection techniques. Nurs Times. 1995 Jul 26-Aug 1;91(30):36-9.
- Background: PubMed 9732632Mac Gabhann L. A comparison of two depot injection techniques. Nurs Stand. 1998 Jun 3-9;12(37):39-41. doi: 10.7748/ns1998.06.12.37.39.c2512.
- Background: PubMed 26905354Yilmaz DK, Dikmen Y, Kokturk F, Dedeoglu Y. The effect of air-lock technique on pain at the site of intramuscular injection. Saudi Med J. 2016 Mar;37(3):304-8. doi: 10.15537/smj.2016.3.13113.
- Background: PubMed 25039702Kara D, Yapucu Gunes U. The effect on pain of three different methods of intramuscular injection: A randomized controlled trial. Int J Nurs Pract. 2016 Apr;22(2):152-9. doi: 10.1111/ijn.12358. Epub 2014 Jul 11.
- Background: PubMed 33939726Ayinde O, Hayward RS, Ross JDC. The effect of intramuscular injection technique on injection associated pain; a systematic review and meta-analysis. PLoS One. 2021 May 3;16(5):e0250883. doi: 10.1371/journal.pone.0250883. eCollection 2021.
- Background: PubMed 33714700Heshmatifar N, Salari M, Rad M, Afshari Saleh T, Borzoee F, Rastaghi S. A New Approach on the pain management of intramuscular injection: A Triple-Blind Randomized Clinical Trial. Pain Manag Nurs. 2022 Jun;23(3):353-358. doi: 10.1016/j.pmn.2021.01.010. Epub 2021 Mar 11.
- Individual participant dataSharing planned: No
Related trials for Schizophrenia; Psychosis
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Japanese Adult Participants With Schizophrenia
Schizophrenia
Active, not recruitingPhase 2/3
Low Amplitude Pulse Seizure Therapy Versus Standard Ultra-Brief Right Unilateral Electroconvulsive Therapy
Suicidal Ideation, Major Depressive Disorder
RecruitingObservational study
Effectiveness and Adverse-effect Switch Evaluation of Xanomeline and Trospium Chloride (KarXT)
Schizophrenia
Not yet recruitingPhase 1
A Study to Assess the Safety, Tolerability and Pharmacokinetics of XEP527 in Patients With Stable Schizophrenia
Schizophrenia
Not yet recruitingPhase 1
Phase I Trial of HHK101 in Patients With Schizophrenia
Schizophrenia
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. This study is not recruiting at the moment.
Cécile BERGOT contact
Rayan BCHINI principal investigator
GHU Paris Psychiatry & Neurosciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intramuscular injection of Haloperidol decanoate using the "Z-track" and "Airlock" techniques and Intramuscular injection of Haloperidol decanoate using standard techniques in people with Schizophrenia; Psychosis, run by Centre Hospitalier St Anne 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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 23 Aug 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rayan BCHINI, IPA (33 1 42 11 75 90, rayan.francoisbchini@gh-paulguiraud.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain reduction (time frame: Day 0 intervention day T). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05995457, which also lists 13 linked publications.
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 23 Aug 2023.