Arthro-distension with early and intensive mobilization for shoulder adhesive capsulitis: A randomized controlled trial.

Arthro-distension Early and intensive mobilization Efficacy Frozen shoulder Randomized controlled trial Shoulder adhesive capsulitis

Journal

Annals of physical and rehabilitation medicine
ISSN: 1877-0665
Titre abrégé: Ann Phys Rehabil Med
Pays: Netherlands
ID NLM: 101502773

Informations de publication

Date de publication:
01 Jun 2024
Historique:
received: 23 08 2023
revised: 18 03 2024
accepted: 22 03 2024
medline: 3 6 2024
pubmed: 3 6 2024
entrez: 2 6 2024
Statut: aheadofprint

Résumé

There are several therapeutic options for the management of shoulder adhesive capsulitis (AC). The superiority of arthro-distension over intra-articular steroid injection (ISI) for AC remains controversial. To evaluate the efficacy of a single arthro-distension procedure combined with early and intensive mobilization (ADM) and physiotherapy, versus ISI and physiotherapy, in people with AC lasting ≥3 months. This was a prospective, 2 parallel-group, 2-center, observer-blind randomized controlled trial conducted in tertiary care settings. Adults with AC were randomly assigned to the treatment or control group. Efficacy was assessed using the self-administered Shoulder Pain and Disability Index (SPADI). Total, pain and disability SPADI scores 15 days, 6 weeks, and 3, 6 and 12 months after the procedure (total SPADI at 15 days: primary outcome; other outcomes were secondary) were compared between groups using analysis of covariance (ANCOVA). A post hoc analysis stratified on the initial range of passive glenohumeral abduction, which had not been pre-specified, was conducted. There were 33 participants in each group. Both groups improved over time. Mean (SD) total SPADI score at 15 days was 33.8 (19.6) in the treatment group and 32.8 (17.5) in the control group, p = 0.393. There were no significant differences for any variables in the overall sample. The post hoc analysis found ADM to be associated with a significant decrease in total SPADI score at 15 days compared with ISI (p = 0.049) in individuals with initial passive glenohumeral abduction >45°. The effects of ADM on pain and function were not statistically different from those of ISI. However, ADM may be useful in individuals with initial passive glenohumeral abduction >45°. NCT00724113.

Sections du résumé

BACKGROUND BACKGROUND
There are several therapeutic options for the management of shoulder adhesive capsulitis (AC). The superiority of arthro-distension over intra-articular steroid injection (ISI) for AC remains controversial.
OBJECTIVES OBJECTIVE
To evaluate the efficacy of a single arthro-distension procedure combined with early and intensive mobilization (ADM) and physiotherapy, versus ISI and physiotherapy, in people with AC lasting ≥3 months.
METHODS METHODS
This was a prospective, 2 parallel-group, 2-center, observer-blind randomized controlled trial conducted in tertiary care settings. Adults with AC were randomly assigned to the treatment or control group. Efficacy was assessed using the self-administered Shoulder Pain and Disability Index (SPADI). Total, pain and disability SPADI scores 15 days, 6 weeks, and 3, 6 and 12 months after the procedure (total SPADI at 15 days: primary outcome; other outcomes were secondary) were compared between groups using analysis of covariance (ANCOVA). A post hoc analysis stratified on the initial range of passive glenohumeral abduction, which had not been pre-specified, was conducted.
RESULTS RESULTS
There were 33 participants in each group. Both groups improved over time. Mean (SD) total SPADI score at 15 days was 33.8 (19.6) in the treatment group and 32.8 (17.5) in the control group, p = 0.393. There were no significant differences for any variables in the overall sample. The post hoc analysis found ADM to be associated with a significant decrease in total SPADI score at 15 days compared with ISI (p = 0.049) in individuals with initial passive glenohumeral abduction >45°.
CONCLUSIONS CONCLUSIONS
The effects of ADM on pain and function were not statistically different from those of ISI. However, ADM may be useful in individuals with initial passive glenohumeral abduction >45°.
DATABASE REGISTRATION UNASSIGNED
NCT00724113.

Identifiants

DOI: 10.1016/j.rehab.2024.101852 PMID: 38824872
pubmed: 38824872
pii: S1877-0657(24)00036-8
doi: 10.1016/j.rehab.2024.101852
pii:
doi:

Banques de données

ClinicalTrials.gov
['NCT00724113']

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

101852

Informations de copyright

Copyright © 2024 Elsevier Masson SAS. All rights reserved.

Déclaration de conflit d'intérêts

Declaration of competing interest Prof. Christelle Nguyen has the following conflicts of interest: grants or contracts from the French Ministry of Health; consulting fees from Thuasne and Merz; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Thuasne, Novartis, Pfizer, and Lilly; support for attending meetings and/or travel from Grünenthal; and participation on a Data Safety Monitoring Board or Advisory Board from Thuasne. The other authors do not have any conflict of interest.

Auteurs

Louis Jacob (L)

Université Paris Cité, AP-HP, Lariboisière-Fernand Widal Hospital, Department of Physical Medicine and Rehabilitation, Paris, France; Université Paris Cité, INSERM U1153, Epidemiology of Ageing and Neurodegenerative Diseases (EpiAgeing), Paris, France; Research and Development Unit, Parc Sanitari Sant Joan de Déu, CIBERSAM, ISCIII, Dr. Antoni Pujadas, 42, Sant Boi de Llobregat, Barcelona 08830, Spain. Electronic address: louis.jacob@aphp.fr.

Sandra Lasbleiz (S)

Université Paris Cité, AP-HP, Lariboisière-Fernand Widal Hospital, Department of Rheumatology, Paris, France.

Katherine Sanchez (K)

AP-HP.Centre-Université Paris Cité, Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis, 75014, Paris, France.

Odile Morchoisne (O)

Université Paris Cité, AP-HP, Lariboisière-Fernand Widal Hospital, Department of Rheumatology, Paris, France.

Marie-Martine Lefèvre-Colau (MM)

AP-HP.Centre-Université Paris Cité, Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis, 75014, Paris, France; AP-HP.Centre-Université Paris Cité, Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis, 75014, Paris, France.

Christelle Nguyen (C)

Université Paris Cité, Faculté de Santé, UFR de Médecine, 75006 Paris, France; AP-HP.Centre-Université Paris Cité, Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis, 75014, Paris, France; INSERM UMR-S 1124, Toxicité Environnementale, Cibles Thérapeutiques, Signalisation Cellulaire et Biomarqueurs (T3S), Campus Saint-Germain-des-Prés, 75006 Paris, France.

François Rannou (F)

Université Paris Cité, Faculté de Santé, UFR de Médecine, 75006 Paris, France; AP-HP.Centre-Université Paris Cité, Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis, 75014, Paris, France; INSERM UMR-S 1124, Toxicité Environnementale, Cibles Thérapeutiques, Signalisation Cellulaire et Biomarqueurs (T3S), Campus Saint-Germain-des-Prés, 75006 Paris, France.

Antoine Feydy (A)

Université Paris Cité, AP-HP, Cochin Hospital, Department of Musculoskeletal Radiology, Paris, France.

Jean-Jacques Portal (JJ)

Université Paris Cité, AP-HP, Lariboisière-Fernand Widal Hospital, Department of Clinical Research, Paris, France.

Alexis Schnitzler (A)

Université Paris Cité, AP-HP, Lariboisière-Fernand Widal Hospital, Department of Physical Medicine and Rehabilitation, Paris, France; Université Paris Cité, INSERM U1153, Epidemiology of Ageing and Neurodegenerative Diseases (EpiAgeing), Paris, France.

Eric Vicaut (E)

Université Paris Cité, AP-HP, Lariboisière-Fernand Widal Hospital, Department of Clinical Research, Paris, France.

Jean-Denis Laredo (JD)

Université Paris Cité, AP-HP, Lariboisière-Fernand Widal Hospital, Department of Musculoskeletal Radiology, Paris, France.

Pascal Richette (P)

Université Paris Cité, AP-HP, Lariboisière-Fernand Widal Hospital, Department of Rheumatology, Paris, France.

Philippe Orcel (P)

Université Paris Cité, AP-HP, Lariboisière-Fernand Widal Hospital, Department of Rheumatology, Paris, France.

Johann Beaudreuil (J)

Université Paris Cité, AP-HP, Lariboisière-Fernand Widal Hospital, Department of Physical Medicine and Rehabilitation, Paris, France; Université Paris Cité, AP-HP, Lariboisière-Fernand Widal Hospital, Department of Rheumatology, Paris, France.

Classifications MeSH