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

Study acronym: FROSTBLOCK
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Primary completion date: May 31, 2026 to May 31, 2027
    • Enrollment target: 100 to 110
    • Study completion date: May 31, 2027 to May 31, 2028
    • Start date: Feb 1, 2025 to Feb 28, 2025
    v4
  2. Trial status: Not Yet Recruiting to Recruitingv3 Show 7 more changesShow less
    • Start date changed from estimate of Apr 1, 2024 to Feb 1, 2025
    • Study sites: 0 to 1
    • Primary completion date: Mar 31, 2026 to May 31, 2026
    • Study completion date: Apr 1, 2027 to May 31, 2027
    • Eligibility criteria expanded, about 161 words
    • Study description expanded, about 71 words
    • Publications: 1 to 5
  3. Phase: Phase 3 to Not applicablev2 Show 4 more changesShow less
    • Enrollment target: 80 to 100
    • Eligibility criteria expanded, about 30 words
    • Secondary endpoints: 13 to 14
    • Study description expanded, about 737 words
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06229964
Lead Sponsor Universitair Ziekenhuis Brussel
Conditions
(from sponsor)		 Frozen Shoulder, Adhesive Capsulitis
Related terms Bursitis, Joint Diseases, Musculoskeletal Diseases
Enrollment 110 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov