Risk Factors for Shoulder Joint Motion Restriction

Breast Cancer Survivors Clinical Trial

Official title:

Risk Factors for Shoulder Joint Motion Restriction in Breast Cancer Survivors

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05386641
• Other study ID #: 2022/0226
• Status: Not yet recruiting
• Start date: August 15, 2022
• Est. completion date: February 15, 2024

Study information

• Verified date: May 2022
• Source: Istanbul Medeniyet University
• Contact: Nilüfer Kablan, PhD
• Phone: +905067638556
• Email: niluferkablan[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In breast cancer patients, limitation of shoulder joint movement may occur following cancer treatment. Shoulder limitation causes a significant decrease in the patient's participation in activities of daily living. The aim of the study is to define these limitations, to evaluate in detail all the structures that cause the problem, and to determine the causes of the limitations in patients with shoulder joint movement limitation developed after breast cancer survivors.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 72
• Est. completion date: February 15, 2024
• Est. primary completion date: August 15, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 60 Years

Eligibility

Inclusion Criteria:

• Women between the ages of 30-60
• Having breast cancer treatment within 5 years

Exclusion Criteria:

• Not having agreed to participate in the study
• Presence of additional orthopedic (scoliosis, etc.), neurological (multiple sclerosis, stroke, etc.) and rheumatological diseases (ankylosing spondylitis, rheumatoid arthritis, etc.) that will affect upper extremity functions

Related Conditions & MeSH terms

• Breast Cancer Survivors
• Breast Neoplasms

Intervention

Other:
• measurement of tissue stiffness (N/m)
Stiffness values will be measured with myotonPro on centers of coordination located along the myofascial chain
• measurement of passive muscle tone (Hz)
muscle tones will be measured with myotonPro on centers of coordination located along along the myofascial chain
• measurement of creep of tissue
creep of tissue will be measured with myotonPro on centers of coordination located along the myofascial chain
• measurement of the range of shoulder joint motion
The range of shoulder flexion, abduction, extension and external-internal rotation movements will be measured with a universal goniometer.
• measurement of skin temperature
measurements will be taken by the thermographic camera
• measurement of pain
Pain will be evaluated by visual analog scale (VAS)
• measurement of pain pressure threshold
Pain pressure threshold will be evaluated by a digital algometer
• measurement of grip strength
The grip strength of both hand will be evaluated by "hand-held" dynamometer.

Locations

Country	Name	City	State
Turkey	Istanbul Medeniyet University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medeniyet University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measurement of tissue stiffness (N/m)	Stiffness values will be measured with myotonPro on centers of coordination located along the myofascial chain	Baseline
Primary	measurement of passive muscle tone (Hz)	muscle tones will be measured with myotonPro on centers of coordination located along the myofascial chain	Baseline
Primary	measurement of creep of tissue	creep of tissue will be measured with myotonPro on centers of coordination located along the myofascial chain	Baseline
Primary	measurement of the range of shoulder joint motion	The range of shoulder flexion, abduction, extension and external-internal rotation movements will be measured with a universal goniometer.	Baseline
Secondary	measurement of skin temperature	measurements will be taken from the area covering 3 cm of the surgical incision with a P45 thermographic camera with high thermal sensitivity	Baseline
Secondary	measurement of pain	Pain will be evaluated by visual analog scale (VAS). In the scale, the patient is asked to mark the most appropriate pain intensity on a scale ranging from 0 (no pain) to 10 (tolerable pain). The higher the score, the greater the pain intensity.	Baseline
Secondary	measurement of pain pressure threshold	Pain pressure threshold will be evaluated by a digital algometer	Baseline
Secondary	measurement of grip strength	The grip strength of both hand will be evaluated by "hand-held" dynamometer.	Baseline