Management of acromioclavicular joint disease by manual therapy versus corticosteroid injections: the protocol of a non-inferiority study
Introduction Degenerative acromioclavicular joint pain accounts for about 4% of shoulder pain. Various medical and non-medical treatment strategies are available for acromioclavicular joint disease but it is difficult to conduct a comparative evaluation of these treatments. The few studies dealing w...
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BMJ Publishing Group
2020-12-01
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| Series: | BMJ Open |
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| author | Grégoire Cormier Lucie Auzanneau Lucie Planche Alexia Michaut |
| author_facet | Grégoire Cormier Lucie Auzanneau Lucie Planche Alexia Michaut |
| author_sort | Grégoire Cormier |
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| description | Introduction Degenerative acromioclavicular joint pain accounts for about 4% of shoulder pain. Various medical and non-medical treatment strategies are available for acromioclavicular joint disease but it is difficult to conduct a comparative evaluation of these treatments. The few studies dealing with the medical management of the disease have conducted no comparative assessment of drug therapies, physiotherapy, joint manipulation and corticosteroid injections. The primary goal of this study is to determine whether manual therapy is not inferior to ultrasound-guided injection of a corticosteroid preparation to decrease acromiocalvicular joint pain at 3 months.Methods and analysis The acromioclavicular arthropathy managed by manual therapy is a monocentric, comparative, randomised, controlled, non-inferiority study conducted in the Rheumatology Department of Vendée Departmental Hospital, involving two parallel groups receiving either corticosteroid injections or manual therapy. The inclusion criteria are patients who suffer from pain in the shoulder or the proximal part of the arm, with pain located on palpation of the acromioclavicular joint associated with a positive cross-arm test and a positive O’Brien test. Randomisation will be at a 1:1 ratio. The injection group will receive a single ultrasound-guided injection of 1 mL of Diprostène and the manual therapy group will receive between one and three sessions at intervals of one per week. The primary outcome will be to compare the Visual Analogue Scale for pain-activity-related score at 3 months for both groups.Ethics and dissemination The study project has been approved by the appropriate ethics committee (Committee for the Protection of Patients Ouest II in Angers, 30 April 2019, with the registration number of 2019/22). In agreement with current French regulations, signed informed written consent will be obtained from each patient. Results of the main trial and of the secondary endpoints will be submitted for publication in a peer-reviewed journal.Trial registration number NCT03951480. |
| format | Article |
| id | doaj-art-97730bacde8c40b6a5572cd60742faff |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-12-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-97730bacde8c40b6a5572cd60742faff2025-08-20T02:32:48ZengBMJ Publishing GroupBMJ Open2044-60552020-12-01101210.1136/bmjopen-2019-034439Management of acromioclavicular joint disease by manual therapy versus corticosteroid injections: the protocol of a non-inferiority studyGrégoire Cormier0Lucie Auzanneau1Lucie Planche2Alexia Michaut32 Department of Rheumatology, CHD Vendée, La Roche sur Yon, France4 Methodologist, centre de Recherche Clinique, CHD Vendée, La Roche-sur-Yon, Pays de la Loire, France4 Biometrics and Statistic Platform, CHU Nantes, Nantes, FranceDepartment of Rheumatology, Departmental Hospital Center, La Roche sur Yon, Vendée, FranceIntroduction Degenerative acromioclavicular joint pain accounts for about 4% of shoulder pain. Various medical and non-medical treatment strategies are available for acromioclavicular joint disease but it is difficult to conduct a comparative evaluation of these treatments. The few studies dealing with the medical management of the disease have conducted no comparative assessment of drug therapies, physiotherapy, joint manipulation and corticosteroid injections. The primary goal of this study is to determine whether manual therapy is not inferior to ultrasound-guided injection of a corticosteroid preparation to decrease acromiocalvicular joint pain at 3 months.Methods and analysis The acromioclavicular arthropathy managed by manual therapy is a monocentric, comparative, randomised, controlled, non-inferiority study conducted in the Rheumatology Department of Vendée Departmental Hospital, involving two parallel groups receiving either corticosteroid injections or manual therapy. The inclusion criteria are patients who suffer from pain in the shoulder or the proximal part of the arm, with pain located on palpation of the acromioclavicular joint associated with a positive cross-arm test and a positive O’Brien test. Randomisation will be at a 1:1 ratio. The injection group will receive a single ultrasound-guided injection of 1 mL of Diprostène and the manual therapy group will receive between one and three sessions at intervals of one per week. The primary outcome will be to compare the Visual Analogue Scale for pain-activity-related score at 3 months for both groups.Ethics and dissemination The study project has been approved by the appropriate ethics committee (Committee for the Protection of Patients Ouest II in Angers, 30 April 2019, with the registration number of 2019/22). In agreement with current French regulations, signed informed written consent will be obtained from each patient. Results of the main trial and of the secondary endpoints will be submitted for publication in a peer-reviewed journal.Trial registration number NCT03951480.https://bmjopen.bmj.com/content/10/12/e034439.full |
| spellingShingle | Grégoire Cormier Lucie Auzanneau Lucie Planche Alexia Michaut Management of acromioclavicular joint disease by manual therapy versus corticosteroid injections: the protocol of a non-inferiority study BMJ Open |
| title | Management of acromioclavicular joint disease by manual therapy versus corticosteroid injections: the protocol of a non-inferiority study |
| title_full | Management of acromioclavicular joint disease by manual therapy versus corticosteroid injections: the protocol of a non-inferiority study |
| title_fullStr | Management of acromioclavicular joint disease by manual therapy versus corticosteroid injections: the protocol of a non-inferiority study |
| title_full_unstemmed | Management of acromioclavicular joint disease by manual therapy versus corticosteroid injections: the protocol of a non-inferiority study |
| title_short | Management of acromioclavicular joint disease by manual therapy versus corticosteroid injections: the protocol of a non-inferiority study |
| title_sort | management of acromioclavicular joint disease by manual therapy versus corticosteroid injections the protocol of a non inferiority study |
| url | https://bmjopen.bmj.com/content/10/12/e034439.full |
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