Degenerative Rotator Cuff DiseasePhase 2DEROTOXNCT05327972
DEgenerative ROtator Cuff Disease and Botulinum TOXin
A Phase 2 study testing The investigational medicinal product is incobotulinumtoxinA (XEOMIN®). in people with Degenerative Rotator Cuff Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The aim of the study is to assess the effectiveness of botulinum toxin in persistent shoulder pain due to degenerative rotator cuff disease. Read more about this study
- Who is it for?
- Ages 41 years and older
- Conditions the study is for
- Degenerative Rotator Cuff Disease
- What is being tested?
- The investigational medicinal product is incobotulinumtoxinA (XEOMIN®).
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jan 2023to Feb 2027
- Phase
- Phase 2
- 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 41 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 40 years;
- pain duration > 1 month;
- pain intensity ≥ 40/100 on visual analog scale;
- SPADI ≥ 30/100;
- medication against pain stable at least 30 days before enrolment;
- pain with or without weakness during the Jobe manoeuver;
Show all 12Show fewer
- ultrasonography within the 30 days, showing tendinopathy of the supra-spinatus, with or without tear;
- affiliation to health insurance Sécurité Sociale;
- ability to give consent, complete the weekly notebook (collection of drug treatments taken against pain);
- availability for the visits planned by the protocol;
- use of an effective method of contraception in women of childbearing potential, started at least 1 month before and lasting for at least 1 month after receiving study treatment.
- Negative urine test for women of childbearing age
Who cannot join
- reduced passive range of motion;
- antero-posterior instability;
- tendinous calcification;
- ultrasonography showing concomitant tear of the infra-spinatus or the subscapularis;
- corticosteroid injection within the previous 30 days;
- previous surgery of the shoulder;
Show all 21Show fewer
- humeral fracture, inflammatory joint disease and neoplastic disorders;
- contraindication to XEOMIN® (allergy to XEOMIN® or any other botulinum toxin product);
- skin infection at the planned injection site;
- participation in another interventional research involving the human person (RIPH) during the 3 months of follow-up of the DEROTOX Research; participation in another RIPH will be possible beyond these 3 months;
- concomitant use of aminoglycosides, cyclosporine, aminoquinolines and spectinomycine;
- patients with a history of aspiration pneumonia and dysphagia;
- patients on anticoagulant therapy or on therapy that may have an anticoagulant effect;
- Patients with bleeding disorders;
- Patients with amyotrophic lateral sclerosis, myasthenia gravis or, Lambert-Eaton syndrome;
- Patients with other conditions causing peripheral neuromuscular dysfunction;
- In target muscles that show pronounced weakness or atrophy;
- Women of childbearing age who have not performed a urine pregnancy test and or who have a positive urine pregnancy test;
- in case of pregnancy, breastfeeding
- injection of botulinum toxin in the last 6 months
- vulnerable people (under legal protection, guardianship or curatorship)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: DEgenerative ROtator Cuff Disease and Botulinum TOXin: a Randomized Trial
The aim of the study is to assess the effectiveness of botulinum toxin in persistent shoulder pain due to degenerative rotator cuff disease.
Read the detailed description
Epidemiology:
degenerative rotator cuff disease ranks first in shoulder disorders and is the main cause of chronic shoulder pain in general practice and in rheumatology clinics. It can be responsible for persistent shoulder pain, functional limitation and greatly contributes to occupational disability.
The pathogenesis of rotator cuff disease:
involves tendon impingement and intrinsic tendinopathic abnormality (supra-spinatus, infra-spinatus, teres minor and sub-scapularis muscles). They include apoptosis of the tenocytes that is induced by mechanical constraints and by local hypoxia. The consequences are secondary inflammation and matrix alteration.
Current therapeutic approach:
The first-line recommended treatment for degenerative rotator cuff disease is conservative and includes level 1 and 2 oral analgesics; a short sequence of nonsteroidal anti-inflammatory drugs, if necessary; local injections of corticosteroids; and physiotherapy (low level of evidence). Surgery is a conditional later option.
Study hypothesis:
Reducing mechanical constraints on the supra-spinatus tendon by botulinum toxin may prevent load-induced apoptosis of the tenocytes and tear progression that is associated with clinical expression, and prevent local hypoxia. Furthermore, the muscle inactivity induced by botulinum toxin is not awaited to provide any clinically relevant functional alteration.
Aim of the study:
The primary objective of the study is to assess the effectiveness of botulinum toxin in persistent shoulder pain due to degenerative rotator cuff disease at one-month follow-up, using Shoulder Pain And Disability Index (SPADI) as outcome criterion.
The secondary objective is to assess the effectiveness of botulinum toxin in persistent shoulder pain due to degenerative rotator cuff disease, at three-month follow-up, using SPADI as outcome criterion and safety, the SPADI sub-scores pain and function at 3 months, global improvement perceived at 1 month and 3 months, drug consumption over the 3 months of follow-up, and treatment acceptability at 1 month and 3 months; as well as the tolerance at 1 week.
- Conditions
- Degenerative Rotator Cuff Disease
- Being tested
- The investigational medicinal product is incobotulinumtoxinA (XEOMIN®)., PLACEBO
- Keywords
- Degenerative rotator cuff disease, Botulinum toxin, Clinical trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The investigational medicinal product is incobotulinumtoxinA (XEOMIN®).Drug
Two milliliters of a mixture comprised of XEOMIN® 100 U and saline solution 0.9% will be once injected in the supra-spinatus muscle using ultrasonography guidance.
PLACEBOOther
Two milliliters of a saline solution containing an inactive lyophilisate will be once injected in the supra-spinatus muscle using ultrasonography guidance.
| Study group | Role | What they receive |
|---|---|---|
| 1- Botulinum toxin | Experimental | The investigational medicinal product is incobotulinumtoxinA (XEOMIN®).
The dosage is:
Two milliliters of a mixture comprised of XEOMIN® 100 U and saline solution 0.9% will be once injected in the supra-spinatus muscle using ultrasonography guidance. Receives: Drug: The investigational medicinal product is incobotulinumtoxinA (XEOMIN®). |
| 2- PLACEBO | Placebo comparator | The placebo comparator represents a saline solution containing an inactive lyophilisate.
The dosage is:
Two milliliters of a saline solution containing an inactive lyophilisate will be once injected in the supra-spinatus muscle using ultrasonography guidance. Receives: Other: PLACEBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total score of the Shoulder Pain And Disability Index at 1 month. 0 to 100;
Total score of the Shoulder Pain And Disability Index :
Scale : 0 to 100, with higher score meaning worst outcome
Measured: 1 month
Secondary outcomes (1)
Sub-scores for pain and disability of the Shoulder Pain And Disability Index at 1 month and 3 months Total score of the Shoulder Pain And Disability Index at 3 months Safety at 1 week, 1 month and 3 months
Sub-scores for pain and disability of the Shoulder Pain And Disability Index :
Scale : 0 to 100, with higher score meaning worst outcome
Measured: week, 1 month and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start20 Jan 2023
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Degenerative Rotator Cuff DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Merz Pharmaceuticals GmbH
- Responsible party
- Sponsor
- Investigators
- Johann MD BEAUDREUIL, PHD, Principal investigator, Hôpital Lariboisière Fernand Widal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05327972
- Sponsor's protocol ID
- APHP210416
- Acronym
- DEROTOX
- Status last verified
- Jun 2025
- First submitted
- 7 Apr 2022
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Badley EM, Tennant A. Changing profile of joint disorders with age: findings from a postal survey of the population of Calderdale, West Yorkshire, United Kingdom. Ann Rheum Dis. 1992 Mar;51(3):366-71. doi: 10.1136/ard.51.3.366.
PubMed 1533506van der Heijden GJ. Shoulder disorders: a state-of-the-art review. Baillieres Best Pract Res Clin Rheumatol. 1999 Jun;13(2):287-309. doi: 10.1053/berh.1999.0021.
PubMed 10952865Luime JJ, Koes BW, Hendriksen IJ, Burdorf A, Verhagen AP, Miedema HS, Verhaar JA. Prevalence and incidence of shoulder pain in the general population; a systematic review. Scand J Rheumatol. 2004;33(2):73-81. doi: 10.1080/03009740310004667.
PubMed 15163107Bot SD, van der Waal JM, Terwee CB, van der Windt DA, Schellevis FG, Bouter LM, Dekker J. Incidence and prevalence of complaints of the neck and upper extremity in general practice. Ann Rheum Dis. 2005 Jan;64(1):118-23. doi: 10.1136/ard.2003.019349.
PubMed 15608309Linsell L, Dawson J, Zondervan K, Rose P, Randall T, Fitzpatrick R, Carr A. Prevalence and incidence of adults consulting for shoulder conditions in UK primary care; patterns of diagnosis and referral. Rheumatology (Oxford). 2006 Feb;45(2):215-21. doi: 10.1093/rheumatology/kei139. Epub 2005 Nov 1.
PubMed 16263781Hartvigsen J, Davidsen M, Hestbaek L, Sogaard K, Roos EM. Patterns of musculoskeletal pain in the population: a latent class analysis using a nationally representative interviewer-based survey of 4817 Danes. Eur J Pain. 2013 Mar;17(3):452-60. doi: 10.1002/j.1532-2149.2012.00225.x. Epub 2012 Oct 5.
PubMed 23042697Peters D, Davies P, Pietroni P. Musculoskeletal clinic in general practice: study of one year's referrals. Br J Gen Pract. 1994 Jan;44(378):25-9.
PubMed 8312034van der Windt DA, Koes BW, de Jong BA, Bouter LM. Shoulder disorders in general practice: incidence, patient characteristics, and management. Ann Rheum Dis. 1995 Dec;54(12):959-64. doi: 10.1136/ard.54.12.959.
PubMed 8546527Vecchio P, Kavanagh R, Hazleman BL, King RH. Shoulder pain in a community-based rheumatology clinic. Br J Rheumatol. 1995 May;34(5):440-2. doi: 10.1093/rheumatology/34.5.440.
PubMed 7788173Gartsman GM, Brinker MR, Khan M, Karahan M. Self-assessment of general health status in patients with five common shoulder conditions. J Shoulder Elbow Surg. 1998 May-Jun;7(3):228-37. doi: 10.1016/s1058-2746(98)90050-7.
PubMed 9658347Ostor AJ, Richards CA, Prevost AT, Speed CA, Hazleman BL. Diagnosis and relation to general health of shoulder disorders presenting to primary care. Rheumatology (Oxford). 2005 Jun;44(6):800-5. doi: 10.1093/rheumatology/keh598. Epub 2005 Mar 15.
PubMed 15769790Tekavec E, Joud A, Rittner R, Mikoczy Z, Nordander C, Petersson IF, Englund M. Population-based consultation patterns in patients with shoulder pain diagnoses. BMC Musculoskelet Disord. 2012 Nov 29;13:238. doi: 10.1186/1471-2474-13-238.
PubMed 23190941Virta L, Joranger P, Brox JI, Eriksson R. Costs of shoulder pain and resource use in primary health care: a cost-of-illness study in Sweden. BMC Musculoskelet Disord. 2012 Feb 10;13:17. doi: 10.1186/1471-2474-13-17.
PubMed 22325050Roquelaure Y, Ha C, Leclerc A, Touranchet A, Sauteron M, Melchior M, Imbernon E, Goldberg M. Epidemiologic surveillance of upper-extremity musculoskeletal disorders in the working population. Arthritis Rheum. 2006 Oct 15;55(5):765-78. doi: 10.1002/art.22222.
PubMed 17013824Wilson d'Almeida K, Godard C, Leclerc A, Lahon G. Sickness absence for upper limb disorders in a French company. Occup Med (Lond). 2008 Oct;58(7):506-8. doi: 10.1093/occmed/kqn084. Epub 2008 Jun 27.
PubMed 18587147
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DEgenerative ROtator Cuff Disease and Botulinum TOXin: a Randomized Trial
- ClinicalTrials.gov ID
- NCT05327972
- Acronym / sponsor ID
- DEROTOX / APHP210416
- Conditions
- Degenerative Rotator Cuff Disease
- Keywords
- Degenerative rotator cuff disease, Botulinum toxin, Clinical trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Merz Pharmaceuticals GmbH
- Study start
- 20 Jan 2023 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 14 Apr 2022 (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 aim of the study is to assess the effectiveness of botulinum toxin in persistent shoulder pain due to degenerative rotator cuff disease.
Detailed description
Epidemiology:
degenerative rotator cuff disease ranks first in shoulder disorders and is the main cause of chronic shoulder pain in general practice and in rheumatology clinics. It can be responsible for persistent shoulder pain, functional limitation and greatly contributes to occupational disability.
The pathogenesis of rotator cuff disease:
involves tendon impingement and intrinsic tendinopathic abnormality (supra-spinatus, infra-spinatus, teres minor and sub-scapularis muscles). They include apoptosis of the tenocytes that is induced by mechanical constraints and by local hypoxia. The consequences are secondary inflammation and matrix alteration.
Current therapeutic approach:
The first-line recommended treatment for degenerative rotator cuff disease is conservative and includes level 1 and 2 oral analgesics; a short sequence of nonsteroidal anti-inflammatory drugs, if necessary; local injections of corticosteroids; and physiotherapy (low level of evidence). Surgery is a conditional later option.
Study hypothesis:
Reducing mechanical constraints on the supra-spinatus tendon by botulinum toxin may prevent load-induced apoptosis of the tenocytes and tear progression that is associated with clinical expression, and prevent local hypoxia. Furthermore, the muscle inactivity induced by botulinum toxin is not awaited to provide any clinically relevant functional alteration.
Aim of the study:
The primary objective of the study is to assess the effectiveness of botulinum toxin in persistent shoulder pain due to degenerative rotator cuff disease at one-month follow-up, using Shoulder Pain And Disability Index (SPADI) as outcome criterion.
The secondary objective is to assess the effectiveness of botulinum toxin in persistent shoulder pain due to degenerative rotator cuff disease, at three-month follow-up, using SPADI as outcome criterion and safety, the SPADI sub-scores pain and function at 3 months, global improvement perceived at 1 month and 3 months, drug consumption over the 3 months of follow-up, and treatment acceptability at 1 month and 3 months; as well as the tolerance at 1 week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1- Botulinum toxin | Experimental | Drug: The investigational medicinal product is incobotulinumtoxinA (XEOMIN®).The investigational medicinal product is incobotulinumtoxinA (XEOMIN®). The dosage is: Two milliliters of a mixture comprised of XEOMIN® 100 U and saline solution 0.9% will be once injected in the supra-spinatus muscle using ultrasonography guidance. |
| 2- PLACEBO | Placebo comparator | Other: PLACEBOThe placebo comparator represents a saline solution containing an inactive lyophilisate. The dosage is: Two milliliters of a saline solution containing an inactive lyophilisate will be once injected in the supra-spinatus muscle using ultrasonography guidance. |
Who may qualify
- Ages
- 41 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- age > 40 years;
- pain duration > 1 month;
- pain intensity ≥ 40/100 on visual analog scale;
- SPADI ≥ 30/100;
- medication against pain stable at least 30 days before enrolment;
Key exclusion criteria (21 listed)
- reduced passive range of motion;
- antero-posterior instability;
- tendinous calcification;
- ultrasonography showing concomitant tear of the infra-spinatus or the subscapularis;
- corticosteroid injection within the previous 30 days;
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 |
|---|---|---|
| The investigational medicinal product is incobotulinumtoxinA (XEOMIN®).Two milliliters of a mixture comprised of XEOMIN® 100 U and saline solution 0.9% will be once injected in the supra-spinatus muscle using ultrasonography guidance. | Drug | 1- Botulinum toxin |
| PLACEBOTwo milliliters of a saline solution containing an inactive lyophilisate will be once injected in the supra-spinatus muscle using ultrasonography guidance. | Other | 2- PLACEBO |
Primary outcome
Total score of the Shoulder Pain And Disability Index at 1 month. 0 to 100;
Time frame: 1 month
Total score of the Shoulder Pain And Disability Index : Scale : 0 to 100, with higher score meaning worst outcome
1 secondary outcome
Sub-scores for pain and disability of the Shoulder Pain And Disability Index at 1 month and 3 months Total score of the Shoulder Pain And Disability Index at 3 months Safety at 1 week, 1 month and 3 months
Time frame: week, 1 month and 3 months
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 27 Jun 2025.
- Background: PubMed 1533506Badley EM, Tennant A. Changing profile of joint disorders with age: findings from a postal survey of the population of Calderdale, West Yorkshire, United Kingdom. Ann Rheum Dis. 1992 Mar;51(3):366-71. doi: 10.1136/ard.51.3.366.
- Background: PubMed 10952865van der Heijden GJ. Shoulder disorders: a state-of-the-art review. Baillieres Best Pract Res Clin Rheumatol. 1999 Jun;13(2):287-309. doi: 10.1053/berh.1999.0021.
- Background: PubMed 15163107Luime JJ, Koes BW, Hendriksen IJ, Burdorf A, Verhagen AP, Miedema HS, Verhaar JA. Prevalence and incidence of shoulder pain in the general population; a systematic review. Scand J Rheumatol. 2004;33(2):73-81. doi: 10.1080/03009740310004667.
- Background: PubMed 15608309Bot SD, van der Waal JM, Terwee CB, van der Windt DA, Schellevis FG, Bouter LM, Dekker J. Incidence and prevalence of complaints of the neck and upper extremity in general practice. Ann Rheum Dis. 2005 Jan;64(1):118-23. doi: 10.1136/ard.2003.019349.
- Background: PubMed 16263781Linsell L, Dawson J, Zondervan K, Rose P, Randall T, Fitzpatrick R, Carr A. Prevalence and incidence of adults consulting for shoulder conditions in UK primary care; patterns of diagnosis and referral. Rheumatology (Oxford). 2006 Feb;45(2):215-21. doi: 10.1093/rheumatology/kei139. Epub 2005 Nov 1.
- Background: PubMed 23042697Hartvigsen J, Davidsen M, Hestbaek L, Sogaard K, Roos EM. Patterns of musculoskeletal pain in the population: a latent class analysis using a nationally representative interviewer-based survey of 4817 Danes. Eur J Pain. 2013 Mar;17(3):452-60. doi: 10.1002/j.1532-2149.2012.00225.x. Epub 2012 Oct 5.
- Background: PubMed 8312034Peters D, Davies P, Pietroni P. Musculoskeletal clinic in general practice: study of one year's referrals. Br J Gen Pract. 1994 Jan;44(378):25-9.
- Background: PubMed 8546527van der Windt DA, Koes BW, de Jong BA, Bouter LM. Shoulder disorders in general practice: incidence, patient characteristics, and management. Ann Rheum Dis. 1995 Dec;54(12):959-64. doi: 10.1136/ard.54.12.959.
- Background: PubMed 7788173Vecchio P, Kavanagh R, Hazleman BL, King RH. Shoulder pain in a community-based rheumatology clinic. Br J Rheumatol. 1995 May;34(5):440-2. doi: 10.1093/rheumatology/34.5.440.
- Background: PubMed 9658347Gartsman GM, Brinker MR, Khan M, Karahan M. Self-assessment of general health status in patients with five common shoulder conditions. J Shoulder Elbow Surg. 1998 May-Jun;7(3):228-37. doi: 10.1016/s1058-2746(98)90050-7.
- Background: PubMed 15769790Ostor AJ, Richards CA, Prevost AT, Speed CA, Hazleman BL. Diagnosis and relation to general health of shoulder disorders presenting to primary care. Rheumatology (Oxford). 2005 Jun;44(6):800-5. doi: 10.1093/rheumatology/keh598. Epub 2005 Mar 15.
- Background: PubMed 23190941Tekavec E, Joud A, Rittner R, Mikoczy Z, Nordander C, Petersson IF, Englund M. Population-based consultation patterns in patients with shoulder pain diagnoses. BMC Musculoskelet Disord. 2012 Nov 29;13:238. doi: 10.1186/1471-2474-13-238.
- Haute Autorité de Santé. Clinical practice guidelines. Management of chronic painful shoulder without instability in adults. April 2005Link provided by the sponsor.
- Rouvière H, Delmas A. Anatomie humaine, descriptive, topographique et fonctionnelle, tome 3 : membres, système nerveux central. 13ème édition. Paris : Masson ; 1991Link provided by the sponsor.
- 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.
Johann MD BEAUDREUIL, PHD principal investigator
Hôpital Lariboisière Fernand Widal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing The investigational medicinal product is incobotulinumtoxinA (XEOMIN®). in people with Degenerative Rotator Cuff Disease, run by Assistance Publique - Hôpitaux de Paris 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 12 inclusion and 21 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 27 Jun 2025. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Johann MD BEAUDREUIL, PHD (+33(0) 1 49 95 63 08, johann.beaudreuil@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total score of the Shoulder Pain And Disability Index at 1 month. 0 to 100; (time frame: 1 month). 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 NCT05327972, which also lists 26 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 27 Jun 2025.