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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:

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

Current Primary Outcome: change in constant shoulder score [ Time Frame: at 6, 12 wk ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• change in glenohumeral joint range of motion [ Time Frame: at 6, 12 wk ]
  Shoulder flexion, abduction, external rotation and internal rotation were measured with goniometer with patient in supine position.
• change in Short Form-36 [ Time Frame: at 6, 12 wk ]
  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 [ Time Frame: at 6, 12 wk ]
  pain intensity was measured by visual analog scale.
• change in Shoulder Pain And disability index [ Time Frame: at 6, 12 wk ]
  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.

Original Secondary Outcome: Same as current

Information By: Taipei Veterans General Hospital, Taiwan

Dates:
Date Received: February 15, 2016
Date Started: August 2015
Date Completion:
Last Updated: March 9, 2016
Last Verified: December 2015