Is Combined Steroid and Sodium Hyaluronate Hydrodilatation More Effective Than Isolated Steroid Hydrodilatation in Treating Patients With Adhesive Capsulitis
- Conditions
- Adhesive Capsulitis
- Interventions
- Drug: normal salineDrug: (Sodium Hyaluronate (Hyruan One , LG)
- Registration Number
- NCT05861570
- Lead Sponsor
- Taipei Veterans General Hospital, Taiwan
- Brief Summary
This study was conducted to compare the efficacy of hydrodilatation with steroid with hyaluronic acid and 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 steroid ) and group 2 (hydrodilatation with hyaluronic acid and 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, Shoulder Pain And Disability Index
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 84
- age 35-65 years
- onset of shoulder stiffness since over a month
- limitation in the passive range of motion (ROM) over 30° when compared with the contralateral side in at least two of these three movements: forward flexion, abduction, or external rotation.
- ultrasound findings of rotator cuff tears,
- plain radiography findings of significant glenohumeral joint arthritis,
- accompanying cervical radiculopathy,
- systemic inflammatory joint disease,
- intraarticular injection into the glenohumeral joint within the past 3 months
- history of surgery on the affected shoulders,
- regular use of systemic non-steroidal anti-inflammatory drugs or corticosteroids,
- allergy to corticosteroid or lidocaine.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description hydrodilatation with steroid normal saline patient received ultrasound-guided 3cc NS + 40mg triamcinolone + 4cc xylocaine hydrodilatation with steroid Triamcinolone Acetonide patient received ultrasound-guided 3cc NS + 40mg triamcinolone + 4cc xylocaine hydrodilatation with hyaluronic acid and steroid (Sodium Hyaluronate (Hyruan One , LG) patient received ultrasound-guided 3cc hyaluronic acid + 40mg triamcinolone + 4cc xylocaine hydrodilatation with steroid lidocaine hydrochloride patient received ultrasound-guided 3cc NS + 40mg triamcinolone + 4cc xylocaine hydrodilatation with hyaluronic acid and steroid lidocaine hydrochloride patient received ultrasound-guided 3cc hyaluronic acid + 40mg triamcinolone + 4cc xylocaine hydrodilatation with hyaluronic acid and steroid Triamcinolone Acetonide patient received ultrasound-guided 3cc hyaluronic acid + 40mg triamcinolone + 4cc xylocaine
- Primary Outcome Measures
Name Time Method change in pain intensity 0, 6, 12weeks pain intensity was measured by visual analog scale (0-10)
- Secondary Outcome Measures
Name Time Method change in glenohumeral joint range of motion 0, 6, 12weeks Shoulder flexion, abduction, external rotation and internal rotation were measured with goniometer with patient in supine position.
change in Shoulder Pain And disability index 0, 6, 12 weeks 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 Veterans General Hospital
🇨🇳Taipei City, Taiwan