Comparison of Rotator Interval Injection Versus Intraarticular Hydrodilatation in Frozen Shoulder

Taipei Veterans General Hospital, Taiwan64 enrolled

Overview

This study was conducted to compare the efficacy of hydrodilatation with steroid via posterior approach versus rotator interval approach for treating patients with adhesive capsulitis.

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 rotator interval injection with steroid with that of steroid hydrodilatatoin for treating adhesive capsulitis. Design: a prospective, single-blinded, randomized, clinical trial Patient and methods: Patients with adhesive capsulitis were enrolled and randomly allocated into group 1 ( ultrasound guided rotator interval injection ) and group 2 (ultrasound guided steroid hydrodilatation). 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, and Shoulder Pain And Disability Index.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Adhesive Capsulitis

Interventions

Triamcinolone (Shincort) injection to rotator intervalDRUG

via rotator interval.

Triamcinolone (Shincort) injection to posterior glenuhumeral recessDRUG

via posterior glenuhumeral recess

Eligibility

Sex: ALLMin age: 35 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of frozen shoulder by physical examination and ultrasonography 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 or corticosteroid 5. pregnancy or lactation; 6. received injection into the affected shoulder during the preceding 3 months 7. history of surgeries on the affected shoulders 8. Secondary frozen shoulder

Locations (1)

Taipei Veterans General Hospital

Taipei, Taiwan

Outcomes

Primary Outcomes

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.function. The score is divided into four sections: pain, activity of daily living, ROM and strength

Time frame: Change of the score between 6 weeks and baseline, and change of the score between 12 weeks and baseline

Secondary Outcomes

pain intensity

pain intensity was measured by visual analog scale. Each patient was asked to indicate his/her current level of pain by marking a point on a 100-mm VAS, for which 0 represented no pain and 100 represented unbearable pain.

Time frame: Change of the score between 6 weeks and baseline, and change of the score between 12 weeks and baseline

glenohumeral joint range of motion

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

Time frame: Change at baseline, 6 weeks, 12 weeks

Data from ClinicalTrials.gov

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