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

Primary Purpose

Acromioclavicular Arthropathy

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Manual medicine
Corticosteroids infiltration
Sponsored by
Centre Hospitalier Departemental Vendee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acromioclavicular Arthropathy

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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, 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%)
  • 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

Sites / Locations

  • Centre Hospitalier Départemental VendéeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Manual medicine

Corticosteroids infiltration

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 25, 2019
Last Updated
September 6, 2023
Sponsor
Centre Hospitalier Departemental Vendee
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1. Study Identification

Unique Protocol Identification Number
NCT03951480
Brief Title
Care of AcromioClavicular Arthropathy in Manual Medicine Versus Corticosteroid Infiltration (ACAM)
Official Title
Care of AcromioClavicular Arthropathy in Manual Medicine Versus Corticosteroid Infiltration : Non-inferiority Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 24, 2020 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Departemental Vendee

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acromioclavicular Arthropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
136 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Manual medicine
Arm Type
Experimental
Arm Title
Corticosteroids infiltration
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Manual medicine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Corticosteroids infiltration
Intervention Description
A unique echo-guided infiltration of one syringe of 1 mL of cortisone product
Primary Outcome Measure Information:
Title
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
Description
Use of a visual analogue scale to measure pain
Time Frame
At three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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%) 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Agnès Dorion
Phone
02.51.44.63.80
Ext
+33
Email
agnes.dorion@chd-vendee.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexia MICHAUT
Organizational Affiliation
CHD Vendée
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Départemental Vendée
City
La Roche-sur-Yon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexia MICHAUT

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33303428
Citation
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.
Results Reference
derived

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

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