RecruitingNot ApplicableNCT06229964

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

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


Sponsor

Universitair Ziekenhuis Brussel

Enrollment

110 participants

Start Date

Feb 28, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying SSNB + IACI and Sham SSNB + IACI for people with adhesive capsulitis and frozen shoulder. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERSSNB + 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

OTHERSham 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


Locations(1)

Universitair Ziekenhuis Brussel

Brussels, Belgium

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NCT06229964


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