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Comparison of Rotator Interval Injection Versus Intraarticular Hydrodilatation in Frozen Shoulder

Comparing the Efficacy of Rotator Interval Steroid Injection Versus Steroid Intraarticular Hydrodilatation in the Treatment of Frozen Shoulder

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03678038
Enrollment
64
Registered
2018-09-19
Start date
2018-09-28
Completion date
2021-03-15
Last updated
2021-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adhesive Capsulitis

Keywords

adhesive capsulitis

Brief summary

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.

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 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.

Interventions

DRUGTriamcinolone (Shincort) injection to rotator interval

via rotator interval.

DRUGTriamcinolone (Shincort) injection to posterior glenuhumeral recess

via posterior glenuhumeral recess

Sponsors

Taipei Veterans General Hospital, Taiwan
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
35 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Shoulder Pain And disability indexChange of the score between 6 weeks and baseline, and change of the score between 12 weeks and baselineThe 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

Secondary

MeasureTime frameDescription
pain intensityChange of the score between 6 weeks and baseline, and change of the score between 12 weeks and baselinepain 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.
glenohumeral joint range of motionChange at baseline, 6 weeks, 12 weeksShoulder flexion, abduction, external rotation and internal rotation were measured with goniometer with patient in supine position

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026