Comparison of Rotator Interval Injection Versus Intraarticular Hydrodilatation in Frozen Shoulder

Adhesive Capsulitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03678038
• Other study ID #: 2018-07-008B
• Status: Completed
• Phase: N/A
• Start date: September 28, 2018
• Est. completion date: March 15, 2021

Study information

• Verified date: April 2021
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: March 15, 2021
• Est. primary completion date: January 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Adhesive Capsulitis
• Bursitis

Intervention

Drug:
• Triamcinolone (Shincort) injection to rotator interval
via rotator interval.
• Triamcinolone (Shincort) injection to posterior glenuhumeral recess
via posterior glenuhumeral recess

Locations

Country	Name	City	State
Taiwan	Taipei Veterans 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	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	Change of the score between 6 weeks and baseline, and change of the score between 12 weeks and baseline
Secondary	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.	Change of the score between 6 weeks and baseline, and change of the score between 12 weeks and baseline
Secondary	glenohumeral joint range of motion	Shoulder flexion, abduction, external rotation and internal rotation were measured with goniometer with patient in supine position	Change at baseline, 6 weeks, 12 weeks