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 | 110 participants |
| Start Date | 2025-02-28 |
| Primary Completion | 2027-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 110 participants in total. It began in 2025-02-28 with a primary completion date of 2027-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 any study-mandated procedure * Subjects suffering from shoulder pain that do not fulfill the diagnostic criteria of Frozen Shoulder * Dutch or French speaking persons * Age ≥ 18 years * Contralateral shoulder of Frozen Shoulder subjects * 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 or treatments with anticoagulants * Hypersensitivity to MRI contrast agent * Inability to understand the study procedures * Psychiatric illness * Pregnancy * Systematic yeast infections * Hypovolaemia * Infections at the injection site * Medical history of malignant hyperthermia, major conductin disorders, acute cardi-ac decompensation, shock conditions, convulsions
Contact & Investigator
Marc Schiltz, MD
PRINCIPAL INVESTIGATOR
Universitair Ziekenhuis Brussel
Frequently Asked Questions
Who can join the NCT06229964 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Frozen Shoulder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06229964 currently recruiting?
Yes, NCT06229964 is actively recruiting participants. Contact the research team at marc.schiltz@uzbrussel.be for enrollment information.
Where is the NCT06229964 trial being conducted?
This trial is being conducted at Brussels, Belgium.
Who is sponsoring the NCT06229964 clinical trial?
NCT06229964 is sponsored by Universitair Ziekenhuis Brussel. The principal investigator is Marc Schiltz, MD at Universitair Ziekenhuis Brussel. The trial plans to enroll 110 participants.