The Efficacy of Ultrasound-guided Hydrodilatation With Hyaluronic Acid for Patients With Adhesive Capsulitis

Adhesive Capsulitis Clinical Trial

Official title:

The Efficacy of Ultrasound-guided Hydrodilatation With Hyaluronic Acid for Patients With Adhesive Capsulitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02708706
• Other study ID #: 2014-10-009B
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: December 2020

Study information

• Verified date: May 2022
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

1. a duration of complaints more than 3 months

2. 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:

1. prior manipulation of the affected shoulder under anesthesia;

2. other conditions involving the shoulder ( rheumatoid arthritis, Hill-Sachs lesions, osteoarthritis, damage to the glenohumeral cartilage,osteoporosis, or malignancies in the shoulder region);

3. neurologic deficits affecting shoulder function in normal daily activities;

4. shoulder pain caused by cervical radiculopathy

5. a history of drug allergy to hyaluronic acid;

6. pregnancy or lactation;

7. received injection into the affected shoulder during the preceding 3 months

Related Conditions & MeSH terms

• Adhesive Capsulitis
• Bursitis

Intervention

Drug:
• hyaluronic acid (hyruan)
2cc hyaluronic acid

Other:
• physical therapy
patient received traditional physical therapy, including therapeutic exercise and stretch exercise

Locations

Country	Name	City	State
Taiwan	Taipei veteran general hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in constant shoulder score	visual analog scale	at 6, 12 wk
Secondary	change in glenohumeral joint range of motion	Shoulder flexion, abduction, external rotation and internal rotation were measured with goniometer with patient in supine position.	at 6, 12 wk
Secondary	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.	at 6, 12 wk
Secondary	change in pain intensity	pain intensity was measured by visual analog scale.	at 6, 12 wk
Secondary	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.	at 6, 12 wk