Risk Factors for Shoulder Joint Motion Restriction

Sponsor
Istanbul Medeniyet University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05386641
Collaborator
(none)
72
1
18
4

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
72 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Risk Factors for Shoulder Joint Motion Restriction in Breast Cancer Survivors
Anticipated Study Start Date :
Aug 15, 2022
Anticipated Primary Completion Date :
Aug 15, 2023
Anticipated Study Completion Date :
Feb 15, 2024

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. measurement of tissue stiffness (N/m) [Baseline]

    Stiffness values will be measured with myotonPro on centers of coordination located along the myofascial chain

  2. measurement of passive muscle tone (Hz) [Baseline]

    muscle tones will be measured with myotonPro on centers of coordination located along the myofascial chain

  3. measurement of creep of tissue [Baseline]

    creep of tissue will be measured with myotonPro on centers of coordination located along the myofascial chain

  4. measurement of the range of shoulder joint motion [Baseline]

    The range of shoulder flexion, abduction, extension and external-internal rotation movements will be measured with a universal goniometer.

Secondary Outcome Measures

  1. measurement of skin temperature [Baseline]

    measurements will be taken from the area covering 3 cm of the surgical incision with a P45 thermographic camera with high thermal sensitivity

  2. measurement of pain [Baseline]

    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.

  3. measurement of pain pressure threshold [Baseline]

    Pain pressure threshold will be evaluated by a digital algometer

  4. measurement of grip strength [Baseline]

    The grip strength of both hand will be evaluated by "hand-held" dynamometer.

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 60 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 İstanbul Medeniyet University Istanbul Turkey

Sponsors and Collaborators

  • Istanbul Medeniyet University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nilufer Kablan, Principal Investigator, Istanbul Medeniyet University
ClinicalTrials.gov Identifier:
NCT05386641
Other Study ID Numbers:
  • 2022/0226
First Posted:
May 23, 2022
Last Update Posted:
May 31, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Nilufer Kablan, Principal Investigator, Istanbul Medeniyet University
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 31, 2022