Ultrasound-guided Hydrodistension in Patients With Adhesive Capsulitis

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Adhesive Capsulitis

Intervention / Treatment
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* Other: Hospital-assisted Rehabilitation
* Other: Home-based Rehabilitation


Participation Criteria
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Eligibility Criteria
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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...).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hospital-assisted Rehabilitation Treatment<br>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. | Other: Hospital-assisted Rehabilitation<br>* Patients are assisted by a physical therapist to perform commuting exercises and active and passive mobilization of the glenohumeral joint in anterior elevation, external rotation, internal rotation, retroposition and abduction.<br>Other: Home-based Rehabilitation<br>* Patients were educated by a physical therapist to perform commuting exercises and active and passive mobilization of the glenohumeral joint in anterior elevation, external rotation, internal rotation, retroposition, and abduction, which they perform at home independently.<br>|
| Active Comparator: Home-based Rehabilitation Treatment<br>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 | Other: Hospital-assisted Rehabilitation<br>* Patients are assisted by a physical therapist to perform commuting exercises and active and passive mobilization of the glenohumeral joint in anterior elevation, external rotation, internal rotation, retroposition and abduction.<br>Other: Home-based Rehabilitation<br>* Patients were educated by a physical therapist to perform commuting exercises and active and passive mobilization of the glenohumeral joint in anterior elevation, external rotation, internal rotation, retroposition, and abduction, which they perform at home independently.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shoulder Pain and Disability Index (SPADI) | 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. | Baseline (0 months) | 
| Shoulder Pain and Disability Index (SPADI) | 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. | 2 months | 
| Shoulder Pain and Disability Index (SPADI) | 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. | 4 months | 
| Shoulder Pain and Disability Index (SPADI) | 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disability of the Arm, Shoulder and Hand (DASH) | 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. | Baseline (0 months) | 
| Disability of the Arm, Shoulder and Hand (DASH) | 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. | 2 months | 
| Disability of the Arm, Shoulder and Hand (DASH) | 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. | 4 months | 
| Disability of the Arm, Shoulder and Hand (DASH) | 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. | 6 months | 
| Visual Analogue Scale (VAS) | One-dimensional scale, with values from 0 to 10 (0 no pain, 10 high pain) assessing pain intensity. | Baseline (0 months) | 
| Visual Analogue Scale (VAS) | One-dimensional scale, with values from 0 to 10 (0 no pain, 10 high pain) assessing pain intensity. | 2 months | 
| Visual Analogue Scale (VAS) | One-dimensional scale, with values from 0 to 10 (0 no pain, 10 high pain) assessing pain intensity. | 4 months | 
| Visual Analogue Scale (VAS) | One-dimensional scale, with values from 0 to 10 (0 no pain, 10 high pain) assessing pain intensity. | 6 months | 
| American Shoulder and Elbow Scale (ASES) | 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. | Baseline (0 months) | 
| American Shoulder and Elbow Scale (ASES) | 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. | 2 months | 
| American Shoulder and Elbow Scale (ASES) | 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. | 4 months | 
| American Shoulder and Elbow Scale (ASES) | 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. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Shoulder, Adhesive Capsulitis, Ultrasound