About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- SSNB + IACI
- Sham SSNB + IACI
Treatment groups
Locations
1Sponsors and collaborators
Universitair Ziekenhuis Brussel
Lead sponsor