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CompletedNCT02708706Updated May 17, 2022

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

An interventional study of hyaluronic acid (hyruan) and physical therapy in Adhesive Capsulitis, sponsored by Taipei Veterans General Hospital, Taiwan. Completed at 1 site in Taiwan. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-05-17.

Sponsored by Taipei Veterans General Hospital, Taiwan · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
62
Allocation
Randomized
Ages
40 Years to 70 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Adhesive Capsulitis

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Keywords

  • adhesive capsulitis
  • hyaluronic acid
03

In context

Bursitis

411 studies on the registry are indexed under Bursitis; 112 are open to participants now.

This study's enrollment of 62 is above the median of 45 across 371 interventional studies indexed under Bursitis.

Browse Bursitis studies →

Lead sponsor

Taipei Veterans General Hospital, Taiwan is the lead sponsor of 325 studies on the registry; 72 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
62 participants (actual)

Study arms

  • Experimental
    physical therapy and hyaluronic acid

    patient received ultrasound-guided hydrodilatation with hyaluronic acid plus physical therapy

    Drug: hyaluronic acid (hyruan) · Other: physical therapy

  • Active comparator
    physical therapy only

    patient received physical therapy only

    Other: physical therapy

Interventions

  • Drughyaluronic acid (hyruan)

    2cc hyaluronic acid

    Also known as: hyaluronate

  • Otherphysical therapy

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

    Also known as: rehabilitation

06

What researchers measure

Primary outcomes

  1. change in constant shoulder score

    visual analog scale

    Time frame: at 6, 12 wk

Secondary outcomes

  1. 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

  2. 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

  3. change in pain intensity

    pain intensity was measured by visual analog scale.

    Time frame: at 6, 12 wk

  4. 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

07

Study locations

1 site
  • Taipei veteran general hospital
    Taipei, Taiwan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 17, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02708706
Lead sponsor
Taipei Veterans General Hospital, Taiwan
Responsible party
Sponsor
First posted
Mar 15, 2016
Start date
Mar 2016
Primary completion
Dec 2020
Completion
Dec 2020
Last update
May 17, 2022

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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