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

February 1, 2024 updated by: Istituto Ortopedico Rizzoli

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy, 40136
        • Istituto Ortopedico Rizzoli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hospital-assisted Rehabilitation Treatment
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
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.
Other: Home-based Rehabilitation
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.
Active Comparator: Home-based Rehabilitation Treatment
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
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.
Other: Home-based Rehabilitation
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Ortopedico Rizzoli

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Actual)

April 28, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

August 31, 2023

First Submitted That Met QC Criteria

September 28, 2023

First Posted (Actual)

October 2, 2023

Study Record Updates

Last Update Posted (Estimated)

February 2, 2024

Last Update Submitted That Met QC Criteria

February 1, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAVD21

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Adhesive Capsulitis

Clinical Trials on Hospital-assisted Rehabilitation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Finland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe