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

NCT04640220 | Completed

• 1 other identifier: 2020-07-064-002
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasm; Shoulder Capsulitis; Range of Motion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in score on Shoulder Pain and Disability Index (SPADI)

  Change from baseline at 3 months

• Axillary recess capsule thickness

  Change from baseline at 3 months

Study Arms (1)

Adhesive capsulitis in breast cancer survivors

EXPERIMENTAL

Intra-articular steroid injection

Procedure: Intra-articular steroid injection

Interventions

Intra-articular steroid injection PROCEDURE

Ultrasound-guided Gleno-humeral joint steroid (Triamcinolone 40mg with 0.5% lidocaine ) injection

Adhesive capsulitis in breast cancer survivors

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who underwent breast cancer surgery within 6 months.
• Patients with shoulder pain and limited range of motion

You may not qualify if:

• Patients with infection
• Bilateral shoulder pain patient
• Patients with uncontrolled diabetes

Sponsors & Collaborators

• Yeungnam University Hospital: lead

Study Sites (1)

Yeungnam University Hospital

Daegu, 42127, South Korea

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Steroids

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Dong Gyu Dong Gyu, M.D., Ph.D.

  College of medicine, Yeungnam University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: Adhesive capsulitis patients who underwent breast cancer operation

Study Record Dates

• First Submitted: November 12, 2020
• First Posted: November 23, 2020
• Study Start: October 26, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: January 10, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)