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Completed

NCT Number: NCT02708706

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

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.

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Key information

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei veteran general hospital

Taipei, Taiwan

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hyaluronic acid (hyruan)

Drug

2cc hyaluronic acid

Other names: hyaluronate

Physical Therapy

Other

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

Other names: rehabilitation

Primary outcomes

  1. change in constant shoulder score

    Time frame: at 6, 12 wk

    visual analog scale

Secondary outcomes

  1. 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.

  2. 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.

  3. change in pain intensity

    Time frame: at 6, 12 wk

    pain intensity was measured by visual analog scale.

  4. 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.

Sponsors and collaborators

Lead sponsor

Taipei Veterans General Hospital, Taiwan

Other Gov

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Mar 15, 2016
Registry last updated
May 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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