Frozen Shoulder Treatment With Intra-Articular Corticosteroid Injection and Suprascapular Nerve Block

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Frozen Shoulder, Adhesive Capsulitis

In brief

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.

Key facts

Study ID

NCT06229964

Run by

Universitair Ziekenhuis Brussel

People needed

110

Starts

2025-02-28

Expected to finish

2028-05-31

Last updated by the study team

2026-06-01

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify 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

You may not qualify if…

• 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

Where it is running

• Universitair Ziekenhuis Brussel — Brussels, Belgium (enrolling)

Full record on ClinicalTrials.gov

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