Care of AcromioClavicular Arthropathy in Manual Medicine Versus Corticosteroid Infiltration (ACAM)

  • STATUS
    Recruiting
  • End date
    Sep 15, 2023
  • participants needed
    136
  • sponsor
    Centre Hospitalier Departemental Vendee
Updated on 15 December 2021

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. 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.

Details
Condition Acromioclavicular Arthropathy
Treatment Manual medicine, Manual medicine, Corticosteroids infiltration
Clinical Study IdentifierNCT03951480
SponsorCentre Hospitalier Departemental Vendee
Last Modified on15 December 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients aged 40 to 70 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

Exclusion Criteria

Contraindication to scapular or cervical manipulation
Contraindication to infiltration (unbalanced diabetes, unbalanced hypertension
Local or generalized infection
ongoing infections)
Severe hypertension > 160/100 mmHg and/or uncontrolled
Known history of severe bleeding disorders, anticoagulant therapy in progress (AVK
Unbalanced diabetes (last HbA1c > 8,5%)
NACO) and Plavix
Live vaccines in the 3 months preceding the study and throughout the study (MMR
Inflammatory rheumatism (RA, PPR, SPA)
yellow fever, Bacillus Calmette-Guerin, oral polio vaccine)
Microcrystalline rheumatism of the shoulder (drop ou CCA)
Known hypersensitivity to Diprosten® including its excipients (methyl
parahydroxybenzoate, propylparahydroxybenzoate, benzyl alcohol)
Previous infiltrations of the shoulder less than 6 months old
Patient with a diagnosis of associated fibromyalgia
History of surgery or trauma that justified surgical or arthroscopic intervention of
Immunocompromised or hemodialysed patients
the shoulder
Pregnant or breastfeeding women
Patient with reproductive capacity and refusing effective contraception
Patients Under guardianship, curators, or deprived of liberty
Severe cases of water retention and/or sodium (hypernatremia), particularly in cases
Patients unable to follow the protocol, as determined by the investigator's judgment
of heart failure, decompensated liver failure (edema, ascites) and severe renal
failure
Patients participating in another interventional clinical research protocol involving
a drug or medical device
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