Treatment for Frozen Shoulder using Corticosteroid Injection and Nerve Block
A Double Blinded Randomized Controlled Trial (RCT) Exploring the Additional Effect of a Suprascapular Nerve Block in Combination with an Intra-Articular Corticosteroid Injection in Patients with Frozen Shoulder
This study is testing whether a combination of a corticosteroid injection and a nerve block can help people with Frozen Shoulder feel less pain and move their shoulder better compared to a fake treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Universitair Ziekenhuis Brussel Academic / other |
| Locations | 1 site (Brussels) |
| Trial ID | NCT06229964 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a glenohumeral intra-articular corticosteroid injection combined with a suprascapular nerve block compared to a sham nerve block in patients suffering from Frozen Shoulder. The study will measure outcomes such as shoulder-related disability, pain, and stiffness through a double-blinded randomized approach. Participants will be monitored for improvements in pain and function, with a focus on shared decision-making and patient education regarding their treatment options.
Who should consider this trial
Good fit: Ideal candidates are Dutch or French speaking adults aged 18 and older who have been diagnosed with Frozen Shoulder lasting more than one month.
Not a fit: Patients with posttraumatic or postsurgical shoulder stiffness, or those with certain medical conditions affecting the shoulder, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve pain relief and functional mobility for patients with Frozen Shoulder.
How similar studies have performed: Previous studies have shown promise with similar approaches, but this specific combination of treatments in a double-blinded format is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Brussels
- Universitair Ziekenhuis Brussel — Brussels, Belgium (Recruiting)
Study contacts
- Principal investigator: Marc Schiltz, MD — Universitair Ziekenhuis Brussel
- Study coordinator: Marc Schiltz, MD
- Email: marc.schiltz@uzbrussel.be
- Phone: +324777712
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.