Assessment of therapeutic clinical trials for adhesive capsulitis of the shoulder

Abstract

Background: Adhesive capsulitis is a debilitating shoulder condition with unknown etiology and complex diagnosis. Treatment options include conservative and operative measures. Exploring the therapeutic trials targeting adhesive capsulitis can help shed light on effective treatment modalities, and pinpoint inadequacies and areas of improvement. Methods: On June 15, 2022, interventional therapeutic clinical trials related to adhesive capsulitis on Clinicaltrials.gov were screened. Trial characteristics including phase, duration, enrollment, study design, type of intervention, outcomes, and location were collected. Publications linked to trials in our study were reviewed for outcome reporting. Results: A total of 70 trials were included in our study. The majority of the trials had no FDA-defined phase (70%). Only 9 publications were associated with the trials, constituting a low publication rate of 13%. Majority of trials had an enrollment size between 11 and 50 participants (54%), and more than 90% were initiated after the start of 2010. Asia/Australia witnessed the highest number of trials with 31 trials. Physical therapy was the most commonly involved intervention type (50%) and disability/function was the most commonly explored primary outcome (71%). Majority of trials included a single institution (83%), were randomized (91%), and adopted an interventional model with parallel assignment (87%). Fourteen trials (20%) adopted an open labeled approach. Conclusion: The majority of trials that were undertaken remain with unpublished results. Trial results need to be published to help physicians navigate treatments and establish therapeutic protocols. Involving multiple institutions and reinforcing blinding can help decrease bias and increase the validity and reliability of trial results.

Keywords

• Frozen shoulder
• Adhesive capsulitis
• Trial
• Methodological quality
• Systematic review
• Treatment