Ultrasound-guided Hydrodistension in Patients With Adhesive Capsulitis

Not Applicable

Completed

• Conditions: Adhesive Capsulitis

• Registration Number: NCT06062654
• Lead Sponsor: Istituto Ortopedico Rizzoli

Brief Summary

The present study aims to compare the efficacy of assisted rehabilitation treatment, in terms of improvement of pain and shoulder articulation, in patients with stage 2 adhesive capsulitis compared with unassisted home rehabilitation treatment. This evaluation is performed following the glenohumeral capsular hydrodistension procedure performed under ultrasound monitoring.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-01
• Primary Completion: 2023-04-28
• Study First Submitted: 2023-08-31
• Study First Submitted QC: 2023-09-28
• Study First Posted: 2023-10-02
• Study Completion: 2023-12-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-01
• Last Update Posted: 2024-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• Male or female patients, aged between 18 and 65 years;
• Stage 2 adhesive capsulitis of the shoulder, with diagnosis made by clinical, radiographic evaluation in two projections (antero-posterior, lateral) and ultrasound.

Exclusion Criteria

• Patients unable to give consent;
• Pregnant women;
• Patients with poly-drug allergies (anesthetics, corticosteroids); 3.
• Patients with other conditions with similar clinical picture (calcific tendinopathy, glenohumeral arthrosis, rotator cuff injury, etc...).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Shoulder Pain and Disability Index (SPADI)	6 months	It consists of a self-administered questionnaire with values from 0 to 130 (0 non-painful and granted shoulder activity, 130 painful and non-granted shoulder activity) consisting of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions about the severity of the patient's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty the patient has with various activities of daily living that require the use of the upper extremities.

Secondary Outcome Measures

Name	Time	Method
American Shoulder and Elbow Scale (ASES)	6 months	It consists of a questionnaire, with values from 0 to 100 (0 non-painful shoulder joint, granted, 100 non-granted shoulder joint, complete disability), on limitations in activities of daily living, one part patient self-assessment and one by the specialist.
Visual Analogue Scale (VAS)	6 months	One-dimensional scale, with values from 0 to 10 (0 no pain, 10 high pain) assessing pain intensity.
Disability of the Arm, Shoulder and Hand (DASH)	6 months	It consists of a questionnaire self-completed of more than 30 questions, with values from 0 to 100 (0 shoulder activity granted, no disability, 100 shoulder activity not granted, complete disability) prepared to measure function and symptoms in patients with any musculoskeletal impairment of the upper extremity. The questions refer to the ability to perform certain actions in the last week and the symptoms that arose while performing these actions.

Trial Locations

Locations (1)

Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, Italy