💬In plain words
What the trial is, and whether it could suit you
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-tre
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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
HealthTeky