Actively Recruiting

Phase Not Applicable
Age: 18Years - 99Years
All Genders
ID06229964

A Double Blinded Randomized Controlled Trial Exploring the Additional Effect of a Suprascapular Nerve Block Combined With an Intra-Articular Corticosteroid Injection in Frozen Shoulder

Led by Universitair Ziekenhuis Brussel · Updated on 2026-06-01

110

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Frozen Shoulder is a common condition causing severe shoulder pain and loss of motion, which can last for months or even years, significantly affecting daily activities and quality of life. This research compares the effectiveness of two treatments: a combination of an ultrasound-guided suprascapular nerve block (SSNB) and an intra-articular corticosteroid injection (IACI) versus an IACI combined with a sham SSNB. The study also seeks to identify physical exam tests linked to MRI findings and to determine which patients benefit most from these treatments. Participants will be randomly assigned to receive either an active SSNB plus IACI or a short-acting SSNB plus IACI, with both groups receiving standard rehabilitation and physiotherapy. The active SSNB involves injections of methylprednisolone acetate and ropivacaine, while the sham SSNB uses linisol and the same IACI dose. Patient education, home exercises, and pain monitoring with a numeric scale will guide rehabilitation throughout the study. Participants will undergo assessments measuring shoulder pain, disability, range of motion, quality of life, and work ability over 12 months. Key tools include the Shoulder Pain and Disability Index (SPADI), Numeric Pain Rating Scale, and Constant-Murley score. Researchers will monitor adverse effects and use predictive analyses to understand treatment benefits. The study will follow participants from baseline through 12 months post-intervention to track changes and safety.

CONDITIONS

Brief 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...

  • Written informed consent to participate in the study must be obtained prior to any study procedures
  • Diagnosed with Frozen Shoulder, defined by pain and limited shoulder motion lasting more than 1 month with unremarkable shoulder X-rays
  • Ability to speak Dutch or French
  • Age 18 years or older
Not Eligible

You will not qualify if you...

  • Posttraumatic or postsurgical stiff shoulder syndrome
  • History of trauma at symptom onset
  • Rheumatologic or neurologic disease involving the shoulder
  • Cervical radiculopathy
  • Coagulation disorders
  • Hypersensitivity to local anesthetics or MRI contrast agent
  • Inability to understand the study procedures
  • Psychiatric illness
  • Pregnancy
  • Previous suprascapular nerve block in the same shoulder
  • Intra-articular corticosteroid injection in the same shoulder within 3 months before inclusion
  • Systematic yeast infections
  • Hypovolaemia
  • Infection at the injection site
  • History of malignant hyperthermia, major conduction disorders, acute cardiac decompensation, shock, or convulsions

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single treatment visit with rehabilitation continuing as part of usual care

Participants receive either a suprascapular nerve block combined with an intra-articular corticosteroid injection or a sham nerve block combined with an intra-articular corticosteroid injection. All participants complete rehabilitation under supervision of their own physiotherapist, including patient education on home-exercises and guided physiotherapy.

1 treatment visit (in-person) plus ongoing outpatient physiotherapy visits as per routine care

Follow-up

Duration - 12 months after treatment

Participants are monitored for pain relief, shoulder function, and adverse effects over 12 months after the intervention using various questionnaires and physical assessments.

Visits at 4 weeks, 3 months, 6 months, and 12 months post-treatment

Trial Site Locations

Total: 1 location

1

Universitair Ziekenhuis Brussel

Brussels, Belgium, 1090

Actively Recruiting

Loading map...

Research Team

M

Marc Schiltz, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Similar Trials

Effect of 3-Dimensional Shoulder Complex Pain Alignment (3-D...

Frozen Shoulder

Actively Recruiting

1 location

Evaluating the Safety and Efficacy of Bevacizumab Injection ...

Adhesive Capsulitis

Actively Recruiting

1 location

Additional Effects of Niel Asher Technique Along With Sleepe...

Adhesive Capsulitis

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

The Impact of Suprascapular Nerve Interventions in Patients with Frozen Shoulder: A Systematic Review and Meta-Analysis.

Christopher M Jump, Ashish Waghmare, Wael Mati...

https://pubmed.ncbi.nlm.nih.gov/34936584

The FROSTBLOCK trial: Protocol for a randomized controlled trial of intra-articular corticosteroid injection with or without suprascapular nerve block in frozen shoulder.

Marc Schiltz, Jonas Croes, Lina van Brabander...

https://pubmed.ncbi.nlm.nih.gov/41023761