Risk Factors for Shoulder Joint Motion Restriction

Risk Factors for Shoulder Joint Motion Restriction in Breast Cancer Survivors

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer Survivors
• Intervention / Treatment: Other: measurement of tissue stiffness (N/m); Other: measurement of passive muscle tone (Hz); Other: measurement of creep of tissue; Other: measurement of the range of shoulder joint motion; Other: measurement of skin temperature; Other: measurement of pain; Other: measurement of pain pressure threshold; Other: measurement of grip strength

• Study Type: Observational
• Enrollment (Anticipated): 72

Contacts and Locations

• Study Contact: Name: Nilüfer Kablan, PhD; Phone Number: +905067638556; Email: niluferkablan@yahoo.com
• Study Contact Backup: Name: Gülser Cinbaz, MSc; Phone Number: +905558503576; Email: gulser.cinbaz@gmail.com

Study Locations

• Turkey
  • Istanbul, Turkey
    • Istanbul Medeniyet University
    • Contact: Gülser Cinbaz; Phone Number: +905558502576; Email: gulser.cinbaz@gmail.com
    • Principal Investigator: Nilüfer Kablan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Breast cancer survivors with or without shoulder joint restriction will be evaluated

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Experimental Group; Breast cancer survivors with shoulder joint motion restriction	Other: measurement of tissue stiffness (N/m); Stiffness values will be measured with myotonPro on centers of coordination located along the myofascial chain; Other: measurement of passive muscle tone (Hz); muscle tones will be measured with myotonPro on centers of coordination located along along the myofascial chain; Other: measurement of creep of tissue; creep of tissue will be measured with myotonPro on centers of coordination located along the myofascial chain; Other: 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.; Other: measurement of skin temperature; measurements will be taken by the thermographic camera; Other: measurement of pain; Pain will be evaluated by visual analog scale (VAS); Other: measurement of pain pressure threshold; Pain pressure threshold will be evaluated by a digital algometer; Other: measurement of grip strength; The grip strength of both hand will be evaluated by "hand-held" dynamometer.
Control group; Breast cancer survivors without shoulder joint motion restriction	Other: measurement of tissue stiffness (N/m); Stiffness values will be measured with myotonPro on centers of coordination located along the myofascial chain; Other: measurement of passive muscle tone (Hz); muscle tones will be measured with myotonPro on centers of coordination located along along the myofascial chain; Other: measurement of creep of tissue; creep of tissue will be measured with myotonPro on centers of coordination located along the myofascial chain; Other: 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.; Other: measurement of skin temperature; measurements will be taken by the thermographic camera; Other: measurement of pain; Pain will be evaluated by visual analog scale (VAS); Other: measurement of pain pressure threshold; Pain pressure threshold will be evaluated by a digital algometer; Other: measurement of grip strength; The grip strength of both hand will be evaluated by "hand-held" dynamometer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
measurement of tissue stiffness (N/m)	Stiffness values will be measured with myotonPro on centers of coordination located along the myofascial chain	Baseline
measurement of passive muscle tone (Hz)	muscle tones will be measured with myotonPro on centers of coordination located along the myofascial chain	Baseline
measurement of creep of tissue	creep of tissue will be measured with myotonPro on centers of coordination located along the myofascial chain	Baseline
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
measurement of pain pressure threshold	Pain pressure threshold will be evaluated by a digital algometer	Baseline
measurement of grip strength	The grip strength of both hand will be evaluated by "hand-held" dynamometer.	Baseline

Collaborators and Investigators

• Sponsor: Istanbul Medeniyet University

Study record dates

Study Major Dates

• Study Start (Anticipated): August 15, 2022
• Primary Completion (Anticipated): August 15, 2023
• Study Completion (Anticipated): February 15, 2024

Study Registration Dates

• First Submitted: May 18, 2022
• First Submitted That Met QC Criteria: May 18, 2022
• First Posted (Actual): May 23, 2022

Study Record Updates

• Last Update Posted (Actual): May 31, 2022
• Last Update Submitted That Met QC Criteria: May 25, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: breast cancer; range of motion
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 2022/0226

Plan for Individual participant data (IPD)

Study Data/Documents

1. Individual Participant Data Set
   Information identifier: 18192154
2. Individual Participant Data Set
   Information identifier: 25977305
3. Individual Participant Data Set
   Information identifier: 26079868
4. Individual Participant Data Set
   Information identifier: 29332760
5. Individual Participant Data Set
   Information identifier: 32031629
6. Individual Participant Data Set
   Information identifier: 32767329
7. Individual Participant Data Set

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No