Clinical trial NCT06062654: Ultrasound-guided Hydrodistension in Patients With Adhesive Capsulitis
Official title: Ultrasound-guided Hydrodistension in Patients With Adhesive Capsulitis: a Randomized Interventional Study Aimed at Evaluating the Efficacy of Hospital-assisted Rehabilitation Treatment Compared to Home-based Rehabilitation Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adhesive Capsulitis
Keywords: Shoulder
Adhesive Capsulitis
Ultrasound
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2023-10-02
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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...).

Primary outcomes:
measure: Shoulder Pain and Disability Index (SPADI)
timeFrame: Baseline (0 months)
measure: Shoulder Pain and Disability Index (SPADI)
timeFrame: 2 months
measure: Shoulder Pain and Disability Index (SPADI)
timeFrame: 4 months
measure: Shoulder Pain and Disability Index (SPADI)
timeFrame: 6 months
Secondary outcomes:
measure: Disability of the Arm, Shoulder and Hand (DASH)
timeFrame: Baseline (0 months)
measure: Disability of the Arm, Shoulder and Hand (DASH)
timeFrame: 2 months
measure: Disability of the Arm, Shoulder and Hand (DASH)
timeFrame: 4 months
measure: Disability of the Arm, Shoulder and Hand (DASH)
timeFrame: 6 months
measure: Visual Analogue Scale (VAS)
timeFrame: Baseline (0 months)
measure: Visual Analogue Scale (VAS)
timeFrame: 2 months
measure: Visual Analogue Scale (VAS)
timeFrame: 4 months
measure: Visual Analogue Scale (VAS)
timeFrame: 6 months
measure: American Shoulder and Elbow Scale (ASES)
timeFrame: Baseline (0 months)
measure: American Shoulder and Elbow Scale (ASES)
timeFrame: 2 months
measure: American Shoulder and Elbow Scale (ASES)
timeFrame: 4 months
measure: American Shoulder and Elbow Scale (ASES)
timeFrame: 6 months
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
Study officials:
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