Comparison of Rotator Interval Injection Versus Intraarticular Hydrodilatation in Frozen Shoulder

NCT ID: NCT03678038

Last Updated: 2021-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-28
• Study Completion Date: 2021-03-15

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.

Conditions

Adhesive Capsulitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

rotator interval injection

patient received ultrasound-guided steroid injection via rotator interval

Group Type: EXPERIMENTAL

Triamcinolone (Shincort) injection to rotator interval

Intervention Type: DRUG

via rotator interval.

posterior recess injection

patient received ultrasound-guided steroid injection via posterior recess

Group Type: ACTIVE_COMPARATOR

Triamcinolone (Shincort) injection to posterior glenuhumeral recess

Intervention Type: DRUG

via posterior glenuhumeral recess

Interventions

Triamcinolone (Shincort) injection to rotator interval

via rotator interval.

Intervention Type: DRUG

Triamcinolone (Shincort) injection to posterior glenuhumeral recess

via posterior glenuhumeral recess

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Taipei Veterans General Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

2018-07-008B

Identifier Type: -

Identifier Source: org_study_id