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
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Breast Neoplasm
• Breast Neoplasms
• Bursitis
• Range of Motion
• Shoulder Capsulitis

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