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

Primary Purpose

Adhesive Capsulitis

Status
Active
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Hospital-assisted Rehabilitation
Home-based Rehabilitation
Sponsored by
Istituto Ortopedico Rizzoli
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adhesive Capsulitis focused on measuring Shoulder, Adhesive Capsulitis, Ultrasound

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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...).

Sites / Locations

  • Istituto Ortopedico Rizzoli

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hospital-assisted Rehabilitation Treatment

Home-based Rehabilitation Treatment

Arm 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.

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
Visual Analogue Scale (VAS)
One-dimensional scale, with values from 0 to 10 (0 no pain, 10 high pain) assessing pain intensity.
Visual Analogue Scale (VAS)
One-dimensional scale, with values from 0 to 10 (0 no pain, 10 high pain) assessing pain intensity.
Visual Analogue Scale (VAS)
One-dimensional scale, with values from 0 to 10 (0 no pain, 10 high pain) assessing pain intensity.
Visual Analogue Scale (VAS)
One-dimensional scale, with values from 0 to 10 (0 no pain, 10 high pain) assessing pain intensity.
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.
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.
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.
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.

Full Information

First Posted
August 31, 2023
Last Updated
September 28, 2023
Sponsor
Istituto Ortopedico Rizzoli
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1. Study Identification

Unique Protocol Identification Number
NCT06062654
Brief Title
Ultrasound-guided Hydrodistension in Patients With Adhesive Capsulitis
Acronym
CAVD21
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
April 28, 2023 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Ortopedico Rizzoli

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adhesive Capsulitis
Keywords
Shoulder, Adhesive Capsulitis, Ultrasound

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hospital-assisted Rehabilitation Treatment
Arm Type
Experimental
Arm 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.
Arm Title
Home-based Rehabilitation Treatment
Arm Type
Active Comparator
Arm 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
Intervention Type
Other
Intervention Name(s)
Hospital-assisted Rehabilitation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Home-based Rehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Shoulder Pain and Disability Index (SPADI)
Description
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.
Time Frame
Baseline (0 months)
Title
Shoulder Pain and Disability Index (SPADI)
Description
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.
Time Frame
2 months
Title
Shoulder Pain and Disability Index (SPADI)
Description
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.
Time Frame
4 months
Title
Shoulder Pain and Disability Index (SPADI)
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Disability of the Arm, Shoulder and Hand (DASH)
Description
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.
Time Frame
Baseline (0 months)
Title
Disability of the Arm, Shoulder and Hand (DASH)
Description
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.
Time Frame
2 months
Title
Disability of the Arm, Shoulder and Hand (DASH)
Description
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.
Time Frame
4 months
Title
Disability of the Arm, Shoulder and Hand (DASH)
Description
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.
Time Frame
6 months
Title
Visual Analogue Scale (VAS)
Description
One-dimensional scale, with values from 0 to 10 (0 no pain, 10 high pain) assessing pain intensity.
Time Frame
Baseline (0 months)
Title
Visual Analogue Scale (VAS)
Description
One-dimensional scale, with values from 0 to 10 (0 no pain, 10 high pain) assessing pain intensity.
Time Frame
2 months
Title
Visual Analogue Scale (VAS)
Description
One-dimensional scale, with values from 0 to 10 (0 no pain, 10 high pain) assessing pain intensity.
Time Frame
4 months
Title
Visual Analogue Scale (VAS)
Description
One-dimensional scale, with values from 0 to 10 (0 no pain, 10 high pain) assessing pain intensity.
Time Frame
6 months
Title
American Shoulder and Elbow Scale (ASES)
Description
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.
Time Frame
Baseline (0 months)
Title
American Shoulder and Elbow Scale (ASES)
Description
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.
Time Frame
2 months
Title
American Shoulder and Elbow Scale (ASES)
Description
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.
Time Frame
4 months
Title
American Shoulder and Elbow Scale (ASES)
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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...).
Facility Information:
Facility Name
Istituto Ortopedico Rizzoli
City
Bologna
ZIP/Postal Code
40136
Country
Italy

12. IPD Sharing Statement

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Ultrasound-guided Hydrodistension in Patients With Adhesive Capsulitis

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