Frozen Shoulder Treatment With Intra-Articular Corticosteroid Injection and Suprascapular Nerve B… (NCT06229964) | Clinical Trial Compass
RecruitingNot Applicable
Frozen Shoulder Treatment With Intra-Articular Corticosteroid Injection and Suprascapular Nerve Block
Belgium110 participantsStarted 2025-02-28
Plain-language 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.
Who can participate
Age range
18 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 received an IACI in the homolateral shoulder in the 3 months before inclusion• Systematic yeast infections
* Hypovolaemia
* Infections at the injection site
* Medical history of malignant hyperthermia, major conduction disorders, acute cardiac decompensation, shock conditions, convulsions
Control subjects for the diagnostic accuracy part of the study protocol
* Inclusion criteria:
* Written informed consent to participate in the study must be obtained from the sub-ject prior to initiation of an…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.