Back to resultsThe Efficacy of Ultrasound-guided Hydrodilatation With Hyaluronic Acid for Patients With Adhesive Capsulitis
Primary Purpose
Adhesive Capsulitis
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
hyaluronic acid (hyruan)
physical therapy
Sponsored by
About this trial
This is an interventional treatment trial for Adhesive Capsulitis focused on measuring adhesive capsulitis, hyaluronic acid
Eligibility Criteria
Inclusion Criteria:
- a duration of complaints more than 3 months
- a reduction in passive range of motion in at least 2 of the following: forward flexion, abduction, or external rotation of the affected shoulder of more than 30 degree compared with the other side.
Exclusion Criteria:
- prior manipulation of the affected shoulder under anesthesia;
- other conditions involving the shoulder ( rheumatoid arthritis, Hill-Sachs lesions, osteoarthritis, damage to the glenohumeral cartilage,osteoporosis, or malignancies in the shoulder region);
- neurologic deficits affecting shoulder function in normal daily activities;
- shoulder pain caused by cervical radiculopathy
- a history of drug allergy to hyaluronic acid;
- pregnancy or lactation;
- received injection into the affected shoulder during the preceding 3 months
Sites / Locations
- Taipei veteran general hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
physical therapy and hyaluronic acid
physical therapy only
Arm Description
patient received ultrasound-guided hydrodilatation with hyaluronic acid plus physical therapy
patient received physical therapy only
Outcomes
Primary Outcome Measures
change in constant shoulder score
visual analog scale
Secondary Outcome Measures
change in glenohumeral joint range of motion
Shoulder flexion, abduction, external rotation and internal rotation were measured with goniometer with patient in supine position.
change in Short Form-36
The SF-36 consists of eight sections: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. It consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
change in pain intensity
pain intensity was measured by visual analog scale.
change in Shoulder Pain And disability index
The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use. The SPADI takes 5 to 10 minutes for a patient to complete and is the only reliable and valid region-specific measure for the shoulder.
Full Information
NCT ID
NCT02708706
First Posted
February 15, 2016
Last Updated
May 10, 2022
Sponsor
Taipei Veterans General Hospital, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT02708706
Brief Title
The Efficacy of Ultrasound-guided Hydrodilatation With Hyaluronic Acid for Patients With Adhesive Capsulitis
Official Title
The Efficacy of Ultrasound-guided Hydrodilatation With Hyaluronic Acid for Patients With Adhesive Capsulitis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
March 2016 (Actual)
Primary Completion Date
December 2020 (Actual)
Study Completion Date
December 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Veterans General Hospital, Taiwan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study was conducted to compare the efficacy of hydrodilatation with hyaluronic acid under ultrasonographic guidance plus physical therapy (PT) with that of PT alone for treating adhesive capsulitis.
Detailed Description
Adhesive capsulitis is a common cause of shoulder pain, and the efficacy of most interventions is limited. This study was conducted to compare the efficacy of hydrodilatation with hyaluronic acid under ultrasonographic guidance plus physical therapy (PT) with that of PT alone for treating adhesive capsulitis.
Design: a prospective, single-blinded, randomized, clinical trial
Patient and methods:
Patients with adhesive capsulitis for at least 3 months were enrolled and randomly allocated into group 1 (hydrodilatation with hyaluronic acid under ultrasonographic guidance plus PT) and group 2 (PT alone). The patients were evaluated before treatment and were reevaluated 0, 6, and 12 weeks after the beginning of the treatment. Outcomes measures included a pain scale (visual analog scale), range of motion, Constant shoulder score, Shoulder Pain And Disability Index, and the Short Form-36
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adhesive Capsulitis
Keywords
adhesive capsulitis, hyaluronic acid
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
physical therapy and hyaluronic acid
Arm Type
Experimental
Arm Description
patient received ultrasound-guided hydrodilatation with hyaluronic acid plus physical therapy
Arm Title
physical therapy only
Arm Type
Active Comparator
Arm Description
patient received physical therapy only
Intervention Type
Drug
Intervention Name(s)
hyaluronic acid (hyruan)
Other Intervention Name(s)
hyaluronate
Intervention Description
2cc hyaluronic acid
Intervention Type
Other
Intervention Name(s)
physical therapy
Other Intervention Name(s)
rehabilitation
Intervention Description
patient received traditional physical therapy, including therapeutic exercise and stretch exercise
Primary Outcome Measure Information:
Title
change in constant shoulder score
Description
visual analog scale
Time Frame
at 6, 12 wk
Secondary Outcome Measure Information:
Title
change in glenohumeral joint range of motion
Description
Shoulder flexion, abduction, external rotation and internal rotation were measured with goniometer with patient in supine position.
Time Frame
at 6, 12 wk
Title
change in Short Form-36
Description
The SF-36 consists of eight sections: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. It consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Time Frame
at 6, 12 wk
Title
change in pain intensity
Description
pain intensity was measured by visual analog scale.
Time Frame
at 6, 12 wk
Title
change in Shoulder Pain And disability index
Description
The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use. The SPADI takes 5 to 10 minutes for a patient to complete and is the only reliable and valid region-specific measure for the shoulder.
Time Frame
at 6, 12 wk
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
a duration of complaints more than 3 months
a reduction in passive range of motion in at least 2 of the following: forward flexion, abduction, or external rotation of the affected shoulder of more than 30 degree compared with the other side.
Exclusion Criteria:
prior manipulation of the affected shoulder under anesthesia;
other conditions involving the shoulder ( rheumatoid arthritis, Hill-Sachs lesions, osteoarthritis, damage to the glenohumeral cartilage,osteoporosis, or malignancies in the shoulder region);
neurologic deficits affecting shoulder function in normal daily activities;
shoulder pain caused by cervical radiculopathy
a history of drug allergy to hyaluronic acid;
pregnancy or lactation;
received injection into the affected shoulder during the preceding 3 months
Facility Information:
Facility Name
Taipei veteran general hospital
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
The Efficacy of Ultrasound-guided Hydrodilatation With Hyaluronic Acid for Patients With Adhesive Capsulitis
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