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NCT04640220 Clinical Trial

Improvement of Range of Motion in Frozen Shoulder in Breast Cancer Survivors

Breast Neoplasm Clinical Trial

Official title:
The Effectiveness of Intra-articular Steroid Injection in Breast Cancer Survivors With Adhesive Capsulitis According to the Thickness of Axillary Capsulitis Thickness

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04640220
Other study ID # 2020-07-064-002
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 26, 2020
Est. completion date December 31, 2021

Study information
Verified date January 2022
Source Yeungnam University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The prevalence of shoulder joint disease is high in breast cancer patients. The cause of adhesive capsulitis is not clearly identified. However, the following are known as relevant factors that are the restriction of the use of the arm after surgery, inflammation due to autoimmune action, radiation therapy, and adhesion of the surgical site. The purpose of this study is to compare and analyze the effect of intrathecal steroid injection in breast cancer survivors with adhesive capsulitis.

Recruitment information / eligibility
Status Completed
Enrollment 28
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: - Patients who underwent breast cancer surgery within 6 months. - Patients with shoulder pain and limited range of motion Exclusion Criteria: - Patients with infection - Bilateral shoulder pain patient - Patients with uncontrolled diabetes

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Intra-articular steroid injection
Ultrasound-guided Gleno-humeral joint steroid (Triamcinolone 40mg with 0.5% lidocaine ) injection

Locations
Country Name City State
Korea, Republic of Yeungnam University Hospital Daegu

Sponsors (1)
Lead Sponsor Collaborator
Yeungnam University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Range of motion of shoulder joint A goniometer is an instrument which measures the available range of motion at a joint.Flexion, Extension,Adduction,Abduction, Internal Rotation,External rotation Change from baseline at 3 months
Secondary Change in score on Shoulder Pain and Disability Index (SPADI) SPADI is a scale consisting of 0-10; 0 being the best and 10 being the worse pain ever; higher scores mean a worse outcome. Change from baseline at 3 months
Secondary Axillary recess capsule thickness Ultrasound measurements of axillary recess capsule thickness in unilateral frozen shoulder Change from baseline at 3 months
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