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

Not Applicable

Completed

• Conditions: Range of Motion; Breast Neoplasm; Shoulder Capsulitis
• Interventions: Procedure: Intra-articular steroid injection

• Registration Number: NCT04640220
• Lead Sponsor: Yeungnam University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-26
• Study First Submitted: 2020-11-12
• Study First Submitted QC: 2020-11-17
• Study First Posted: 2020-11-23
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-06
• Last Update Posted: 2022-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 28

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Adhesive capsulitis in breast cancer survivors	Intra-articular steroid injection	Intra-articular steroid injection

Primary Outcome Measures

Name	Time	Method
Range of motion of shoulder joint	Change from baseline at 3 months	A goniometer is an instrument which measures the available range of motion at a joint.Flexion, Extension,Adduction,Abduction, Internal Rotation,External rotation

Secondary Outcome Measures

Name	Time	Method
Axillary recess capsule thickness	Change from baseline at 3 months	Ultrasound measurements of axillary recess capsule thickness in unilateral frozen shoulder
Change in score on Shoulder Pain and Disability Index (SPADI)	Change from baseline at 3 months	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.

Trial Locations

Locations (1)

Yeungnam University Hospital; 🇰🇷 Daegu, Korea, Republic of