Care of AcromioClavicular Arthropathy in Manual Medicine Versus Corticosteroid Infiltration (ACAM)
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|ClinicalTrials.gov Identifier: NCT03951480|
Recruitment Status : Not yet recruiting
First Posted : May 15, 2019
Last Update Posted : December 3, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Acromioclavicular Arthropathy||Other: Manual medicine Drug: Corticosteroids infiltration||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||136 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Care of AcromioClavicular Arthropathy in Manual Medicine Versus Corticosteroid Infiltration : Non-inferiority Study|
|Estimated Study Start Date :||December 2019|
|Estimated Primary Completion Date :||March 2022|
|Estimated Study Completion Date :||March 2022|
|Experimental: Manual medicine||
Other: Manual medicine
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.
|Active Comparator: Corticosteroids infiltration||
Drug: Corticosteroids infiltration
A unique echo-guided infiltration of one syringe of 1 mL of cortisone product
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03951480
|Contact: Lucie AUZANNEAU||02.51.44.63.80 ext +email@example.com|
|Centre Hospitalier Départemental Vendée||Not yet recruiting|
|La Roche-sur-Yon, France|
|Principal Investigator: Alexia MICHAUT|
|Principal Investigator:||Alexia MICHAUT||CHD Vendée|