Actively Recruiting

Phase Not Applicable
Age: 18Years - 99Years
All Genders
NCT06229964

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

Led by Universitair Ziekenhuis Brussel · Updated on 2025-02-19

100

Participants Needed

1

Research Sites

121 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Provided written informed consent to participate in the study
  • Diagnosed with Frozen Shoulder defined by pain and restricted shoulder motion lasting more than 1 month with normal shoulder X-rays
  • Able to speak Dutch or French
  • Aged 18 years or older
Not Eligible

You will not qualify if you...

  • Posttraumatic or postsurgical stiff shoulder syndrome
  • Shoulder symptoms started after trauma
  • Rheumatologic or neurologic diseases involving the shoulder
  • Cervical radiculopathy
  • Blood clotting disorders
  • Allergy to local anesthetics or MRI contrast agent
  • Unable to understand study procedures
  • Psychiatric illness
  • Pregnancy
  • Previous suprascapular nerve block in the same shoulder
  • Received intra-articular corticosteroid injection in the same shoulder within 3 months before study
  • Systemic yeast infections
  • Low blood volume (hypovolaemia)
  • Infections at the injection site
  • History of malignant hyperthermia, major conduction disorders, acute heart failure, shock, or seizures

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Universitair Ziekenhuis Brussel

Brussels, Belgium, 1090

Actively Recruiting

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Research Team

M

Marc Schiltz, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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