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

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ClinicalTrials.gov Identifier: NCT04640220
Recruitment Status : Completed
First Posted : November 23, 2020
Last Update Posted : January 10, 2022
Sponsor:
Information provided by (Responsible Party):
Dong Gyu Lee, Yeungnam University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Breast Neoplasm Shoulder Capsulitis Range of Motion Procedure: Intra-articular steroid injection Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Adhesive capsulitis patients who underwent breast cancer operation
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effectiveness of Intra-articular Steroid Injection in Breast Cancer Survivors With Adhesive Capsulitis According to the Thickness of Axillary Capsulitis Thickness
Actual Study Start Date : October 26, 2020
Actual Primary Completion Date : December 31, 2021
Actual Study Completion Date : December 31, 2021

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Adhesive capsulitis in breast cancer survivors
Intra-articular steroid injection
 Procedure: Intra-articular steroid injection
Ultrasound-guided Gleno-humeral joint steroid (Triamcinolone 40mg with 0.5% lidocaine ) injection


Outcome Measures
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Primary Outcome Measures :
  1. Range of motion of shoulder joint [ Time Frame: 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 :
  1. Change in score on Shoulder Pain and Disability Index (SPADI) [ Time Frame: 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.

  2. Axillary recess capsule thickness [ Time Frame: Change from baseline at 3 months ]
    Ultrasound measurements of axillary recess capsule thickness in unilateral frozen shoulder


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04640220


Locations
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Korea, Republic of
Yeungnam University Hospital
Daegu, Korea, Republic of, 42127
Sponsors and Collaborators
Yeungnam University Hospital
Investigators
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Principal Investigator: Dong Gyu Dong Gyu, M.D., Ph.D. College of medicine, Yeungnam University
More Information
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Responsible Party: Dong Gyu Lee, Assistant professor, Yeungnam University Hospital
ClinicalTrials.gov Identifier: NCT04640220    
Other Study ID Numbers: 2020-07-064-002
First Posted: November 23, 2020    Key Record Dates
Last Update Posted: January 10, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Bursitis
Neoplasms by Site
Neoplasms
 Breast Diseases
Skin Diseases
Joint Diseases
Musculoskeletal Diseases