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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorUniversitair Ziekenhuis Brussel

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • SSNB + IACI
  • Sham SSNB + IACI

Treatment groups

110 Participants
are divided into 2 treatment groups

Locations

1
Universitair Ziekenhuis Brussel1090, Brussels Belgium

Sponsors and collaborators

Universitair Ziekenhuis Brussel

Lead sponsor