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Clinical trial

Percutaneous Interruption of the Coracohumeral Ligament for the Treatment of Frozen Shoulder.

ID
Name
2020-11998
Description
Percutaneous Interruption of the Coracohumeral Ligament for the treatment of Frozen Shoulder.
Trial arms
Trial start
2020-11-17
Estimated PCD
2022-03-16
Trial end
2023-01-19
Status
Completed
Treatment
Tenex
Local anesthetic plus Tenex into the coracohumeral ligament for adhesive capsulitis
Arms:
Tenex plus local anesthetic
Local anesthetic
Only local anesthetic into the coracohumeral ligament for adhesive capsulitis
Arms:
Local Anesthetic, Tenex plus local anesthetic
Size
46
Primary endpoint
Comparison of Range of Motion of the Shoulder
Immediately following procedure, up to 60 minutes
Eligibility criteria
Inclusion Criteria: * Established Diagnosis of Adhesive capsulitis (AC) Ligament Flavum \>3mm, diagnosed by US evaluation decreased shoulder ROM in external rotation and abduction (50% of unaffected side) * Patients who have tried other conventional therapies like steroid treatments, surgical treatments, physiotherapy with little (defined by less than 20 degrees improvement in shoulder ROM - external rotation) to no improvement in the shoulder ROM Exclusion Criteria: * Age less than 18 years and greater than 89 years * Patients with AC but showing improvement in shoulder ROM progressively (defined by improvement in ROM \> 200 external rotation or 20 degrees per week when undergoing physiotherapy) * Patients who are currently pregnant
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 46, 'type': 'ACTUAL'}}
Updated at
2024-05-29

1 organization

1 product

1 indication

Organization
Albert Einstein College of Medicine
Product
Local anesthetic
Indication
Frozen Shoulder