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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02776865
Other study ID # 2015-09-009C
Secondary ID
Status Recruiting
Phase N/A
First received May 16, 2016
Last updated May 17, 2016
Start date October 2015

Study information

Verified date March 2016
Source Taipei Veterans General Hospital, Taiwan
Contact Jia chi Wang, MD
Email jcwang0726@gmail.com
Is FDA regulated No
Health authority Taiwan: Institutional Review Board
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date
Est. primary completion date October 2016
Accepts healthy volunteers No
Gender Both
Age group 40 Years to 80 Years
Eligibility Inclusion Criteria:

1. chronic shoulder pain with duration of complaints more than 3 months

2. diagnosis of frozen shoulder or rotator cuff disorder

Exclusion Criteria:

1. other conditions involving the shoulder ( rheumatoid arthritis, Hill-Sachs lesions,osteoporosis, or malignancies in the shoulder region);

2. neurologic deficits affecting shoulder function in normal daily activities;

3. shoulder pain caused by cervical radiculopathy

4. a history of drug allergy to xylocaine

5. pregnancy or lactation;

6. received injection into the affected shoulder during the preceding 3 months

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
suprascapular nerve block
4ml 2% xylocaine
Other:
physical therapy
patient received traditional physical therapy, including therapeutic exercise and stretch exercise

Locations

Country Name City State
Taiwan Taipei veteran general hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary change in constant shoulder score the total constant score ranges from 0 to 100 points, with higher scores indicative of better function. The score is divided into four sections: pain, activity of daily living, ROM and strength at 4, 12 wk No
Secondary change in pain intensity pain intensity was measured by visual analog scale. at 4, 12 wk No
Secondary 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. at 6, 12 wk No
Secondary change in glenohumeral joint range of motion Shoulder flexion, abduction, external rotation and internal rotation were measured with goniometer with patient in supine position. at 4, 12 wk No
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