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

RECRUITING

NCT06229964

NA

Sponsor: Universitair Ziekenhuis Brussel

Summary

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.

Official title: A Double Blinded Randomized Controlled Trial (RCT) Exploring the Additional Effect of a Suprascapular Nerve Block in Combination with an Intra-Articular Corticosteroid Injection in Patients with Frozen Shoulder

Key Details

Gender

All

Age Range

18 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2025-02-01

Completion Date

2027-05-31

Last Updated

2025-02-19

Healthy Volunteers

No

Conditions

Frozen Shoulder Adhesive Capsulitis

Interventions

OTHER

SSNB + IACI

Usual care: All patients complete rehabilitation under supervision of their own physiotherapist. The investigators will provide some guidelines and criteria but is the physiotherapist's choice how to implement these guidelines in clinical practice. Patient education on home-exercises Monitoring of peak pain, at rest/night and after rehabilitation sessions using a Numeric-Pain-Rating-Scale (0-10) (NPRS) to evaluate tissue irritability and guide physiotherapy and rehabilitation. Use of passive physiotherapy (cold, heat or electric therapies) to treat pain. Active and passive mobilization of the shoulder under the pain threshold, Maitland mobilization, stretch exercises such as: table slides, wall climbers. Use of affected upper limb in pain free Range-of-Motion (ROM) is tolerated and stimulated. Progressively increase time and frequency of Total-End-Range-Time (TERT) positions to increase ROM

OTHER

Sham SSNB + IACI

Usual care: All patients complete rehabilitation under supervision of their own physiotherapist. The investigators will provide some guidelines and criteria but is the physiotherapist's choice how to implement these guidelines in clinical practice. Patient education on home-exercises Monitoring of peak pain, at rest/night and after rehabilitation sessions using a Numeric-Pain-Rating-Scale (0-10) (NPRS) to evaluate tissue irritability and guide physiotherapy and rehabilitation. Use of passive physiotherapy (cold, heat or electric therapies) to treat pain. Active and passive mobilization of the shoulder under the pain threshold, Maitland mobilization, stretch exercises such as: table slides, wall climbers. Use of affected upper limb in pain free Range-of-Motion (ROM) is tolerated and stimulated. Progressively increase time and frequency of Total-End-Range-Time (TERT) positions to increase ROM

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

Locations (1)

Universitair Ziekenhuis Brussel

Brussels, Belgium

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