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OpenTrials
Completed

NCT Number: NCT04640220

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

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.

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Key information

Conditions

Breast Neoplasm Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Range of Motion Shoulder Capsulitis Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Yeungnam University Hospital

Daegu, 42127, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intra-articular steroid injection

Procedure

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Yeungnam University Hospital

Other

Registry information

Official study title

The Effectiveness of Intra-articular Steroid Injection in Breast Cancer Survivors With Adhesive Capsulitis According to the Thickness of Axillary Capsulitis Thickness

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 23, 2020
Registry last updated
Jan 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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