Breast Cancer SurvivorsNCT05386641
Risk Factors for Shoulder Joint Motion Restriction
An observational study of Breast Cancer Survivors, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 30 to 60 years, women only
- Conditions the study is for
- Breast Cancer Survivors
- What is being tested?
- measurement of tissue stiffness (N/m), measurement of passive muscle tone (Hz) and measurement of creep of tissue
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2022to 15 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- Women only
- No healthy volunteers
- Adult
Study population: Breast cancer survivors with or without shoulder joint restriction will be evaluated
Who may be able to join
- Women between the ages of 30-60
- Having breast cancer treatment within 5 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
İstanbul Medeniyet University
Istanbul
Gülser Cinbaz, +905558502576, gulser.cinbaz@gmail.com
Nilüfer Kablan
About this study
Official title: 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.
- Conditions
- Breast Cancer Survivors
- Being tested
- measurement of tissue stiffness (N/m), measurement of passive muscle tone (Hz), measurement of creep of tissue, measurement of the range of shoulder joint motion, measurement of skin temperature
- Keywords
- breast cancer, range of motion
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measurement of tissue stiffness (N/m)Other
Stiffness values will be measured with myotonPro on centers of coordination located along the myofascial chain
measurement of passive muscle tone (Hz)Other
muscle tones will be measured with myotonPro on centers of coordination located along along the myofascial chain
measurement of creep of tissueOther
creep of tissue will be measured with myotonPro on centers of coordination located along the myofascial chain
measurement of the range of shoulder joint motionOther
The range of shoulder flexion, abduction, extension and external-internal rotation movements will be measured with a universal goniometer.
measurement of skin temperatureOther
measurements will be taken by the thermographic camera
measurement of painOther
Pain will be evaluated by visual analog scale (VAS)
measurement of pain pressure thresholdOther
Pain pressure threshold will be evaluated by a digital algometer
measurement of grip strengthOther
The grip strength of both hand will be evaluated by "hand-held" dynamometer.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Breast cancer survivors with shoulder joint motion restriction Receives: 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 | |
| Control group | Breast cancer survivors without shoulder joint motion restriction Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
measurement of tissue stiffness (N/m)
Stiffness values will be measured with myotonPro on centers of coordination located along the myofascial chain
Measured: Baseline
measurement of passive muscle tone (Hz)
muscle tones will be measured with myotonPro on centers of coordination located along the myofascial chain
Measured: Baseline
measurement of creep of tissue
creep of tissue will be measured with myotonPro on centers of coordination located along the myofascial chain
Measured: 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.
Measured: Baseline
Secondary outcomes (4)
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
Measured: 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.
Measured: Baseline
measurement of pain pressure threshold
Pain pressure threshold will be evaluated by a digital algometer
Measured: Baseline
measurement of grip strength
The grip strength of both hand will be evaluated by "hand-held" dynamometer.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start15 Aug 2022 (estimated)
- Primary completion15 Aug 2023 (estimated)
- Study completion15 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer SurvivorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nilufer Kablan, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05386641
- Sponsor's protocol ID
- 2022/0226
- Status last verified
- May 2022
- First submitted
- 18 May 2022
- Last updated
- 31 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Shoulder Joint Motion Restriction in Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT05386641
- Acronym / sponsor ID
- 2022/0226
- Conditions
- Breast Cancer Survivors
- Keywords
- breast cancer, range of motion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 15 Aug 2022 (estimated)
- Primary completion
- 15 Aug 2023 (estimated)
- Study completion
- 15 Feb 2024 (estimated)
- First posted
- 23 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | – | 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 strengthBreast cancer survivors with shoulder joint motion restriction |
| Control group | – | 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 strengthBreast cancer survivors without shoulder joint motion restriction |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Breast cancer survivors with or without shoulder joint restriction will be evaluated
Key inclusion criteria (2 listed)
- Women between the ages of 30-60
- Having breast cancer treatment within 5 years
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| measurement of tissue stiffness (N/m)Stiffness values will be measured with myotonPro on centers of coordination located along the myofascial chain | Other | Control group, Experimental Group |
| measurement of passive muscle tone (Hz)muscle tones will be measured with myotonPro on centers of coordination located along along the myofascial chain | Other | Control group, Experimental Group |
| measurement of creep of tissuecreep of tissue will be measured with myotonPro on centers of coordination located along the myofascial chain | Other | Control group, Experimental Group |
| measurement of the range of shoulder joint motionThe range of shoulder flexion, abduction, extension and external-internal rotation movements will be measured with a universal goniometer. | Other | Control group, Experimental Group |
| measurement of skin temperaturemeasurements will be taken by the thermographic camera | Other | Control group, Experimental Group |
| measurement of painPain will be evaluated by visual analog scale (VAS) | Other | Control group, Experimental Group |
| measurement of pain pressure thresholdPain pressure threshold will be evaluated by a digital algometer | Other | Control group, Experimental Group |
| measurement of grip strengthThe grip strength of both hand will be evaluated by "hand-held" dynamometer. | Other | Control group, Experimental Group |
Primary outcome
measurement of tissue stiffness (N/m)
Time frame: Baseline
Stiffness values will be measured with myotonPro on centers of coordination located along the myofascial chain
measurement of passive muscle tone (Hz)
Time frame: Baseline
muscle tones will be measured with myotonPro on centers of coordination located along the myofascial chain
measurement of creep of tissue
Time frame: Baseline
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
Time frame: Baseline
The range of shoulder flexion, abduction, extension and external-internal rotation movements will be measured with a universal goniometer.
4 secondary outcomes
measurement of skin temperature
Time frame: Baseline
measurement of pain
Time frame: Baseline
measurement of pain pressure threshold
Time frame: Baseline
measurement of grip strength
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Survivors, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nilüfer Kablan, PhD (+905067638556, niluferkablan@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measurement of tissue stiffness (N/m) (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2022.