NCT06229964 Frozen Shoulder Treatment with Intra-Articular Corticosteroid Injection and Suprascapular Nerve Block
| NCT ID | NCT06229964 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitair Ziekenhuis Brussel |
| Condition | Frozen Shoulder |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-02-01 |
| Primary Completion | 2026-05-31 |
Trial Parameters
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Brief Summary
Frozen shoulder remains a challenging disease to treat as pain and loss of range of motion can persist for many months or even years. This loss of function can have a severe impact on the patient's activities, participation and overall quality of life. The use of ultrasound-guided (USG) suprascapular nerve blocks (SSNB) and/or intra-articular corticoid injections (IACI) has been supported by many studies. However, double blinded randomized clinical trials using a combination of SSNB and IACI are rare. The primary objective of this study is to compare the effectiveness of a glenohumeral IACI combined with a SSNB, compared to a glenohumeral IACI combined with a sham SSNB. Outcome measures of interest are shoulder-related disability reported by the patients, shoulder pain and shoulder stiffness. These outcome parameters will be compared between both treatment arms with an intention-to-treat analysis. As key secondary objectives, the investigators aim to identify which physical examination tests, or combinations of those, are correlated with MRI diagnostic criteria and favor a more positive evolution. Finally, through predictive analysis the investigators will try to establish which patients benefit the most from the combined SSNB + IACI.
Eligibility Criteria
Inclusion Criteria: * Written informed consent to participate in the study must be obtained from the subject prior to initiation of any study-mandated procedure * Suffering from Frozen Shoulder, defined as: Frozen shoulder is a self-limiting disease characterized by pain and functional restriction in both active and passive shoulder motion lasting more than 1 month, for which radiographic findings of the shoulder joint are unremarkable. * Dutch or French speaking persons * Age ≥ 18 years Exclusion Criteria: * Subjects with posttraumatic or postsurgical stiff shoulder syndrome * History of trauma at the onset of symptoms * Subjects with rheumatologic or neurologic disease involving the shoulder * Subjects with cervical radiculopathy * Coagulation disorder * Hypersensitivity to local anesthetics or MRI contrast agent * Inability to understand the study procedures * Psychiatric illness * Pregnancy * Subjects who have received prior SSNB in the homolateral shoulder * Subjects who have rece