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Frozen Shoulder Treatment with IA Corticosteroid Injection and Suprascapular Nerve Block
EU CTIS ID: 2024-513057-78-00
What this study is testing
The aim of this study is to determine if there is any difference in pain relief and function in patients with Frozen Shoulder when given an Gleno-Humeral (GH) IACI with a SSNB compared to an GH IACI with a sham SSNB. In another part of the study, we will try to determine which set of clinical examination tests and/or MRI criteria has the best diagnostic accuracy in early-stage Frozen Shoulder. Finally, we want to identify which patients will benefit most from GH IACI or the combination of GH IACI and SSNB. The results of this trial will help to guide clinical practice treating patients with FS and improve resource allocation. The key primary endpoint is the change in shoulder-related disability 3 months after intervention vs control, assessed through a validated questionnaire the Shoulder Pain and Disability Index (SPADI).
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
- Control subjects for the diagnostic accuracy part of the study protocol: Subjects suffering from shoulder pain that do not fulfill the diagnostic criteria of Frozen Shoulder
- Control subjects for the diagnostic accuracy part of the study protocol: Contralateral shoulder of Frozen Shoulder subjects
You likely can't join if
- Subjects with posttraumatic or postsurgical stiff shoulder syndrome
- Psychiatric illness
- Pregnancy
- Systematic yeast infections
- Hypovolaemia
- Infections at the injection site
See the full eligibility 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
- Control subjects for the diagnostic accuracy part of the study protocol: Subjects suffering from shoulder pain that do not fulfill the diagnostic criteria of Frozen Shoulder
- Control subjects for the diagnostic accuracy part of the study protocol: Contralateral shoulder of Frozen Shoulder subjects
- Subjects with posttraumatic or postsurgical stiff shoulder syndrome
- Psychiatric illness
- Pregnancy
- Systematic yeast infections
- Hypovolaemia
- Infections at the injection site
- Medical history of malignant hyperthermia, major conductin disorders, acute cardiac de-compensation, shock conditions, convulsions
- 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
- History of trauma at the onset of symptoms
- Subjects with rheumatologic or neurologic disease involving the shoulder
- Subjects with cervical radiculopathy
- Subjects with coagulation disorder or treatments with anticoagulants
- Hypersensitivity to local anesthetics or MRI contrast agent
- Inability to understand the study procedures
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.