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Steroid Injection for Adhesive Capsulitis

Not Applicable
Conditions
Adhesive Capsulitis
Interventions
Registration Number
NCT04364425
Lead Sponsor
Taipei Veterans General Hospital, Taiwan
Brief Summary

This study was conducted to compare the efficacy of hydrodilatation with low dose steroid with high dose steroid for treating adhesive capsulitis.

Detailed Description

Design: a prospective, double-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 low dose steroid ) and group 2 (hydrodilatation with high dose steroid). 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

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
80
Inclusion Criteria
  1. clinical diagnosis of adhesive capsulitis
  2. a duration of complaints more than 3 months
  3. 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
GroupInterventionDescription
low dose steroidNormal salinepatient received ultrasound-guided 40mg triamcinolone + 4cc xylocaine + 12cc NS
high dose steroidNormal salinepatient received ultrasound-guided 10mg triamcinolone + 4cc xylocaine + 15cc NS
low dose steroidlidocaine hydrochloridepatient received ultrasound-guided 40mg triamcinolone + 4cc xylocaine + 12cc NS
low dose steroidTriamcinolone Acetonidepatient received ultrasound-guided 40mg triamcinolone + 4cc xylocaine + 12cc NS
high dose steroidTriamcinolone Acetonidepatient received ultrasound-guided 10mg triamcinolone + 4cc xylocaine + 15cc NS
high dose steroidlidocaine hydrochloridepatient received ultrasound-guided 10mg triamcinolone + 4cc xylocaine + 15cc NS
Primary Outcome Measures
NameTimeMethod
change in pain intensity0, 6, 12 wks.

pain intensity was measured by visual analog scale (0-10)

Secondary Outcome Measures
NameTimeMethod
change in glenohumeral joint range of motion0, 6, 12 wks.

Shoulder flexion, abduction, external rotation and internal rotation were measured with goniometer with patient in supine position.

change in Shoulder Pain And disability index0, 6, 12 wks.

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

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