Ultrasound-guided Hydrodistension in Patients With Adhesive Capsulitis (CAVD21)

Istituto Ortopedico Rizzoli

Status: Completed

Conditions: Adhesive Capsulitis

Treatments: Other: Home-based Rehabilitation; Other: Hospital-assisted Rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT06062654

CAVD21

Details and patient eligibility

About

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.

Enrollment: 46 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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...).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

Hospital-assisted Rehabilitation Treatment

Experimental group

Description:

Patients in the experimental group will undergo 10 sessions (about 2 each week) of rehabilitation treatment at the outpatient clinics of the U.O. Physical Medicine and Rehabilitation Unit of the Rizzoli Orthopedic Institute. The rehabilitation protocol consists of a series of commuting exercises and passive/active mobilization exercises of the glenohumeral joint.

Treatment:

Other: Home-based Rehabilitation

Other: Hospital-assisted Rehabilitation

Home-based Rehabilitation Treatment

Active Comparator group

Description:

Patients in the experimental group will have 10 sessions (about 2 each week) of rehabilitation treatment with exercises to be performed self-assisted at home. The rehabilitation protocol consists of a series of commuting exercises and passive/active mobilization exercises of the glenohumeral joint

Treatment:

Other: Home-based Rehabilitation

Other: Hospital-assisted Rehabilitation