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

Taipei Veterans General Hospital, Taiwan62 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Adhesive Capsulitis

Interventions

hyaluronic acid (hyruan)DRUG

2cc hyaluronic acid

physical therapyOTHER

patient received traditional physical therapy, including therapeutic exercise and stretch exercise

Eligibility

Sex: ALLMin age: 40 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Taipei veteran general hospital

Taipei, Taiwan

Outcomes

Primary Outcomes

change in constant shoulder score

visual analog scale

Time frame: at 6, 12 wk

Secondary Outcomes

change in glenohumeral joint range of motion

Shoulder flexion, abduction, external rotation and internal rotation were measured with goniometer with patient in supine position.

Time frame: at 6, 12 wk

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.

Time frame: at 6, 12 wk

change in pain intensity

pain intensity was measured by visual analog scale.

Time frame: at 6, 12 wk

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.

Time frame: at 6, 12 wk

Data from ClinicalTrials.gov

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