Acromioclavicular ArthropathyNCT03951480
Care of AcromioClavicular Arthropathy in Manual Medicine Versus Corticosteroid Infiltration (ACAM)
A study testing Manual medicine and Corticosteroids infiltration in people with Acromioclavicular Arthropathy, run by Centre Hospitalier Departemental Vendee at 1 site in France.
Trial summary
Acromioclavicular pains are one of the etiologies of shoulder pains, the prevalence of which is relatively high, ranging from 5 to 47% in the general population. The cause is usually degenerative, occurring mainly after the age of 40, especially in male manual workers. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Acromioclavicular Arthropathy
- What is being tested?
- Manual medicine and Corticosteroids infiltration
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 24 Nov 2020to 6 Jun 2025
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 30 to 80 years old
- Shoulder ou proximal arm pain with elective pain on palpation of the acromioclavicular joint + Positive cross arm test + Positive O'Brien test
- NEER test negative: pain < 4
- Symptomatic acromioclavicular arthropathy confirmed on radiography
- Pain at rest or activity (EVA ≥ 4) for more than 3 months
- Patient with the ability to understand the protocol and who has signed an informed consent
- Patient with social security coverage
- NSAID or per os or topical analgesics may also be taken at the same time as participation in the study.
Who cannot join
- Contraindication to scapular or cervical manipulation
- Contraindication to infiltration (unbalanced diabetes, unbalanced hypertension, ongoing infections)
- Local or generalized infection
- Known history of severe bleeding disorders, anticoagulant therapy in progress (AVK, NACO) and Plavix
- Severe hypertension > 160/100 mmHg and/or uncontrolled
- Unbalanced diabetes (last HbA1c > 8,5%)
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- Live vaccines in the 3 months preceding the study and throughout the study (MMR, yellow fever, Bacillus Calmette-Guerin, oral polio vaccine)
- Known hypersensitivity to Diprosten® including its excipients (methyl parahydroxybenzoate, propylparahydroxybenzoate, benzyl alcohol)
- Inflammatory rheumatism (RA, PPR, SPA)
- Microcrystalline rheumatism of the shoulder (drop ou CCA)
- History of surgery or trauma that justified surgical or arthroscopic intervention of the shoulder
- Previous infiltrations of the shoulder less than 6 months old
- Patient with a diagnosis of associated fibromyalgia
- Severe cases of water retention and/or sodium (hypernatremia), particularly in cases of heart failure, decompensated liver failure (edema, ascites) and severe renal failure
- Immunocompromised or hemodialysed patients
- Pregnant or breastfeeding women
- Patient with reproductive capacity and refusing effective contraception
- Patients Under guardianship, curators, or deprived of liberty
- Patients participating in another interventional clinical research protocol involving a drug or medical device
- Patients unable to follow the protocol, as determined by the investigator's judgment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Care of AcromioClavicular Arthropathy in Manual Medicine Versus Corticosteroid Infiltration : Non-inferiority Study
Acromioclavicular pains are one of the etiologies of shoulder pains, the prevalence of which is relatively high, ranging from 5 to 47% in the general population. The cause is usually degenerative, occurring mainly after the age of 40, especially in male manual workers. This pathology is described as the great forger of the shoulder, ignored by clinicians because it is often uninvestigated, whereas an interrogation and a complete clinical examination are sufficient to make the diagnosis.
Acromioclavicular pathologies are better known to orthopaedic surgeons, particularly in traumatic pathologies but also in degenerative pathologies. However, before operating on acromioclavicular osteoarthritis, interventions whose results are sometimes disappointing, a well-managed medical treatment usually helps to relieve pain.
Read more
The precise clinical examination and a radiological examination focused on the joint make it possible to diagnose acromioclavicular arthropathy, the key is to think about it and look for it.
Care includes explanation of the diagnosis, drug treatments, physiotherapy techniques and self-exercise as well as osteoarticular manipulations, which are less frequently practiced or performed in isolation outside the medical setting.
The results of the different treatments have been little studied, with studies that don't always allow us to distinguish several etiologies of shoulder pains. Most studies compare surgical techniques with each or with medical techniques. However, there are very few studies comparing traditional medical care with manual medicine.
In order to compare the different non-surgical therapies for the care of acromioclavicular arthropathies of degenerative origin, the investigators propose a dedicated study.
This is a non-inferiority, prospective, open, randomized, two-armed study comparing the efficacy of manipulations by a physician with a training in manual medicine versus cortisone infiltration Under ultrasound control.
After diagnosis of degenerative pathology of the acromioclavicular joint, patients meeting the inclusion criteria will be randomized to the infiltration arm or to the manipulations arm.
The assessment will be based on the pain during and after the procedure.
- Conditions
- Acromioclavicular Arthropathy
- Being tested
- Manual medicine, Corticosteroids infiltration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual medicineOther
At a rate of 3 sessions of a maximum of 30 minutes each at one week interval. Depending on the clinical evolution, it is possible to stop manual medicine sessions according to the therapist's assessment as in current practice. If the patient has an EVA pain of activity < 2, manipulations will not be continued. The patient being considered as not very symptomatic.
Corticosteroids infiltrationDrug
A unique echo-guided infiltration of one syringe of 1 mL of cortisone product
| Study group | Role | What they receive |
|---|---|---|
| Manual medicine | Experimental | Not described Receives: Other: Manual medicine |
| Corticosteroids infiltration | Active comparator | Not described Receives: Drug: Corticosteroids infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
The main objective of this study is to compare the medium-term efficacy on pain of manual medical care of degenerative acromioclavicular arthropathy versus infiltrative care Under ultrasound detection with a cortisone product
Use of a visual analogue scale to measure pain
Measured: At three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start24 Nov 2020
- Primary completion29 Aug 2024
- Study completion6 Jun 2025
Why it stopped: Inclusion target not met. Inclusion period not extended.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acromioclavicular ArthropathyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Departemental Vendee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexia MICHAUT, Principal investigator, CHD Vendée
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03951480
- Sponsor's protocol ID
- CHD 023-19
- Status last verified
- Jul 2025
- First submitted
- 25 Apr 2019
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Michaut A, Planche L, Auzanneau L, Cormier G. Management of acromioclavicular joint disease by manual therapy versus corticosteroid injections: the protocol of a non-inferiority study. BMJ Open. 2020 Dec 10;10(12):e034439. doi: 10.1136/bmjopen-2019-034439.
PubMed 33303428
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Care of AcromioClavicular Arthropathy in Manual Medicine Versus Corticosteroid Infiltration : Non-inferiority Study
- ClinicalTrials.gov ID
- NCT03951480
- Acronym / sponsor ID
- CHD 023-19
- Conditions
- Acromioclavicular Arthropathy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inclusion target not met. Inclusion period not extended.
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Centre Hospitalier Departemental VendeeUniversity, hospital or other
- Study start
- 24 Nov 2020 (actual)
- Primary completion
- 29 Aug 2024 (actual)
- Study completion
- 6 Jun 2025 (actual)
- First posted
- 15 May 2019 (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.
Acromioclavicular pains are one of the etiologies of shoulder pains, the prevalence of which is relatively high, ranging from 5 to 47% in the general population. The cause is usually degenerative, occurring mainly after the age of 40, especially in male manual workers. This pathology is described as the great forger of the shoulder, ignored by clinicians because it is often uninvestigated, whereas an interrogation and a complete clinical examination are sufficient to make the diagnosis.
Acromioclavicular pathologies are better known to orthopaedic surgeons, particularly in traumatic pathologies but also in degenerative pathologies. However, before operating on acromioclavicular osteoarthritis, interventions whose results are sometimes disappointing, a well-managed medical treatment usually helps to relieve pain.
The precise clinical examination and a radiological examination focused on the joint make it possible to diagnose acromioclavicular arthropathy, the key is to think about it and look for it.
Care includes explanation of the diagnosis, drug treatments, physiotherapy techniques and self-exercise as well as osteoarticular manipulations, which are less frequently practiced or performed in isolation outside the medical setting.
The results of the different treatments have been little studied, with studies that don't always allow us to distinguish several etiologies of shoulder pains. Most studies compare surgical techniques with each or with medical techniques. However, there are very few studies comparing traditional medical care with manual medicine.
In order to compare the different non-surgical therapies for the care of acromioclavicular arthropathies of degenerative origin, the investigators propose a dedicated study.
This is a non-inferiority, prospective, open, randomized, two-armed study comparing the efficacy of manipulations by a physician with a training in manual medicine versus cortisone infiltration Under ultrasound control.
After diagnosis of degenerative pathology of the acromioclavicular joint, patients meeting the inclusion criteria will be randomized to the infiltration arm or to the manipulations arm.
The assessment will be based on the pain during and after the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual medicine | Experimental | Other: Manual medicine |
| Corticosteroids infiltration | Active comparator | Drug: Corticosteroids infiltration |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients aged 30 to 80 years old
- Shoulder ou proximal arm pain with elective pain on palpation of the acromioclavicular joint + Positive cross arm test + Positive O'Brien test
- NEER test negative: pain < 4
- Symptomatic acromioclavicular arthropathy confirmed on radiography
- Pain at rest or activity (EVA ≥ 4) for more than 3 months
Key exclusion criteria (20 listed)
- Contraindication to scapular or cervical manipulation
- Contraindication to infiltration (unbalanced diabetes, unbalanced hypertension, ongoing infections)
- Local or generalized infection
- Known history of severe bleeding disorders, anticoagulant therapy in progress (AVK, NACO) and Plavix
- Severe hypertension > 160/100 mmHg and/or uncontrolled
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 |
|---|---|---|
| Manual medicineAt a rate of 3 sessions of a maximum of 30 minutes each at one week interval. Depending on the clinical evolution, it is possible to stop manual medicine sessions according to the therapist's assessment as in current practice. If the patient has an EVA pain of activity < 2, manipulations will not be continued. The patient being considered as not very symptomatic. | Other | Manual medicine |
| Corticosteroids infiltrationA unique echo-guided infiltration of one syringe of 1 mL of cortisone product | Drug | Corticosteroids infiltration |
Primary outcome
The main objective of this study is to compare the medium-term efficacy on pain of manual medical care of degenerative acromioclavicular arthropathy versus infiltrative care Under ultrasound detection with a cortisone product
Time frame: At three months
Use of a visual analogue scale to measure pain
Results and safety
The study was stopped early (reason given: Inclusion target not met. Inclusion period not extended.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Derived from this study: PubMed 33303428Michaut A, Planche L, Auzanneau L, Cormier G. Management of acromioclavicular joint disease by manual therapy versus corticosteroid injections: the protocol of a non-inferiority study. BMJ Open. 2020 Dec 10;10(12):e034439. doi: 10.1136/bmjopen-2019-034439.
- 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. This study is not recruiting at the moment.
Alexia MICHAUT principal investigator
CHD Vendée
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual medicine and Corticosteroids infiltration in people with Acromioclavicular Arthropathy, run by Centre Hospitalier Departemental Vendee 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 8 inclusion and 20 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: stopped early, as of the sponsor's last update on 14 Jul 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. 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?
The study was stopped early (reason given: Inclusion target not met. Inclusion period not extended.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The main objective of this study is to compare the medium-term efficacy on pain of manual medical care of degenerative acromioclavicular arthropathy versus infiltrative care Under ultrasound detection with a cortisone product (time frame: At three months). 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 NCT03951480, which also lists 1 linked publication.
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 14 Jul 2025.