Treatment for Frozen Shoulder using Corticosteroid Injection and Nerve Block

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Ultrasound-guided shoulder injections for frozen shoulder

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• Evaluating physical therapy and steroid injections for frozen shoulder treatment

  This study is testing whether combining physical therapy with steroid injections helps people with frozen shoulder feel better compared to just getting steroid injections and waiting to see what happens.

  Recruiting Phase 4 Massachusetts General Hospital · Boston, Massachusetts · NCT02283996

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.