Back to resultsImprovement of Range of Motion in Frozen Shoulder in Breast Cancer Survivors
Primary Purpose
Breast Neoplasm, Shoulder Capsulitis, Range of Motion
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Intra-articular steroid injection
Sponsored by
About this trial
This is an interventional treatment trial for Breast Neoplasm
Eligibility Criteria
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
Sites / Locations
- Yeungnam University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Adhesive capsulitis in breast cancer survivors
Arm Description
Intra-articular steroid injection
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Axillary recess capsule thickness
Ultrasound measurements of axillary recess capsule thickness in unilateral frozen shoulder
Full Information
NCT ID
NCT04640220
First Posted
November 12, 2020
Last Updated
January 6, 2022
Sponsor
Yeungnam University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04640220
Brief Title
Improvement of Range of Motion in Frozen Shoulder in Breast Cancer Survivors
Official Title
The Effectiveness of Intra-articular Steroid Injection in Breast Cancer Survivors With Adhesive Capsulitis According to the Thickness of Axillary Capsulitis Thickness
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
October 26, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yeungnam University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasm, Shoulder Capsulitis, Range of Motion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Adhesive capsulitis patients who underwent breast cancer operation
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Adhesive capsulitis in breast cancer survivors
Arm Type
Experimental
Arm Description
Intra-articular steroid injection
Intervention Type
Procedure
Intervention Name(s)
Intra-articular steroid injection
Intervention Description
Ultrasound-guided Gleno-humeral joint steroid (Triamcinolone 40mg with 0.5% lidocaine ) injection
Primary Outcome Measure Information:
Title
Range of motion of shoulder joint
Description
A goniometer is an instrument which measures the available range of motion at a joint.Flexion, Extension,Adduction,Abduction, Internal Rotation,External rotation
Time Frame
Change from baseline at 3 months
Secondary Outcome Measure Information:
Title
Change in score on Shoulder Pain and Disability Index (SPADI)
Description
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.
Time Frame
Change from baseline at 3 months
Title
Axillary recess capsule thickness
Description
Ultrasound measurements of axillary recess capsule thickness in unilateral frozen shoulder
Time Frame
Change from baseline at 3 months
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dong Gyu Dong Gyu, M.D., Ph.D.
Organizational Affiliation
College of medicine, Yeungnam University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yeungnam University Hospital
City
Daegu
ZIP/Postal Code
42127
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Improvement of Range of Motion in Frozen Shoulder in Breast Cancer Survivors
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