Clinical trial NCT02708706: The Efficacy of Ultrasound-guided Hydrodilatation With Hyaluronic Acid for Patients With Adhesive Capsulitis
Official title: The Efficacy of Ultrasound-guided Hydrodilatation With Hyaluronic Acid for Patients With Adhesive Capsulitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adhesive Capsulitis
Keywords: adhesive capsulitis
hyaluronic acid
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2016-03-15
Enrollment: 62
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: change in constant shoulder score
timeFrame: at 6, 12 wk
Secondary outcomes:
measure: change in glenohumeral joint range of motion
timeFrame: at 6, 12 wk
measure: change in Short Form-36
timeFrame: at 6, 12 wk
measure: change in pain intensity
timeFrame: at 6, 12 wk
measure: change in Shoulder Pain And disability index
timeFrame: at 6, 12 wk
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei veteran general hospital
Study officials:
References: