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

Not Applicable

Completed

• Conditions: Adhesive Capsulitis
• Interventions: Drug: hyaluronic acid (hyruan); Other: physical therapy

• Registration Number: NCT02708706
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

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

Study Timeline

• Study First Submitted: 2016-02-15
• Study Start: 2016-03
• Study First Submitted QC: 2016-03-09
• Study First Posted: 2016-03-15
• Primary Completion: 2020-12
• Study Completion: 2020-12
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-10
• Last Update Posted: 2022-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
physical therapy and hyaluronic acid	hyaluronic acid (hyruan)	patient received ultrasound-guided hydrodilatation with hyaluronic acid plus physical therapy
physical therapy and hyaluronic acid	physical therapy	patient received ultrasound-guided hydrodilatation with hyaluronic acid plus physical therapy
physical therapy only	physical therapy	patient received physical therapy only

Primary Outcome Measures

Name	Time	Method
change in constant shoulder score	at 6, 12 wk	visual analog scale

Secondary Outcome Measures

Name	Time	Method
change in glenohumeral joint range of motion	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	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	at 6, 12 wk	pain intensity was measured by visual analog scale.
change in Shoulder Pain And disability index	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.

Trial Locations

Locations (1)

Taipei veteran general hospital; 🇨🇳 Taipei, Taiwan