Comparison of Rotator Interval Injection Versus Intraarticular Hydrodilatation in Frozen Shoulder

NCT03678038 | Completed

• 1 other identifier: 2018-07-008B
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Adhesive Capsulitis

Keywords

adhesive capsulitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• pain intensity

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

• glenohumeral joint range of motion

  Change at baseline, 6 weeks, 12 weeks

Study Arms (2)

rotator interval injection

EXPERIMENTAL

patient received ultrasound-guided steroid injection via rotator interval

Drug: Triamcinolone (Shincort) injection to rotator interval

posterior recess injection

ACTIVE COMPARATOR

patient received ultrasound-guided steroid injection via posterior recess

Drug: Triamcinolone (Shincort) injection to posterior glenuhumeral recess

Interventions

Triamcinolone (Shincort) injection to rotator interval DRUG

via rotator interval.

rotator interval injection

Triamcinolone (Shincort) injection to posterior glenuhumeral recess DRUG

via posterior glenuhumeral recess

posterior recess injection

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of frozen shoulder by physical examination and ultrasonography

You may not qualify if:

• other conditions involving the shoulder ( rheumatoid arthritis, Hill-Sachs lesions,osteoporosis, or malignancies in the shoulder region)
• neurologic deficits affecting shoulder function in normal daily activities
• shoulder pain caused by cervical radiculopathy
• a history of drug allergy to xylocaine or corticosteroid
• pregnancy or lactation;
• received injection into the affected shoulder during the preceding 3 months
• history of surgeries on the affected shoulders
• Secondary frozen shoulder

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 241, Taiwan

Location

MeSH Terms

Conditions

Bursitis

Interventions

Triamcinolone

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2018
• First Posted: September 19, 2018
• Study Start: September 28, 2018
• Primary Completion: January 15, 2021
• Study Completion: March 15, 2021
• Last Updated: April 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)