Shoulder InjuriesNCT06485934
Kinesiophobia Scale for the Upper Extremity
An observational study of Shoulder Injuries, run by Emre Şenocak at 2 sites in Turkey (Türkiye).
Trial summary
Questionnaires/scales used to evaluate kinesiophobia in the literature are limited and are not specific to the upper extremity in existing scales. For this reason, the primary purpose and subject of the study is to develop a multi-factor kinesiophobia scale specific to shoulder problems. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Shoulder Injuries
- How many people
- 150 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 22 Jul 2024to 1 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Traumatological, orthopedic and rheumatological pathologies that cause fear of movement in the upper extremity
Who may be able to join
- Tampa Kinesiophobia Score >37 points
- Presence of traumatological, orthopedic and rheumatological pathology in the upper extremity
- Mini-Mental State Examination score >24 points
Who cannot join
- Malignancy,
- Psychiatric drug use,
- Use of painkillers during evaluation periods,
- Those who received physiotherapy before the study (last 6 months),
- Those whose education level is below secondary school level,
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 2 recruiting
- Not yet recruiting
Clinic of İstanbul Hand-Microsurgery Rehabilitation
Istanbul, 34104
Ozan Tuncel, +90 531 885 5844, info@elcerrahi.com
Ozan Tuncel, MsC, +90 533 321 18 32, fztozantuncel@gmail.com
- Recruiting
Clinic of İstanbul Hand-Microsurgery Rehabilitation
Istanbul
Ozan Tuncel, Physiotherapist, +905533211832, fztozantuncel@gmail.com
About this study
Official title: Development of the Multidimensional Kinesiophobia Scale for the Upper Extremity: A Scale Development Study
Questionnaires/scales used to evaluate kinesiophobia in the literature are limited and are not specific to the upper extremity in existing scales. For this reason, the primary purpose and subject of the study is to develop a multi-factor kinesiophobia scale specific to shoulder problems.
The study is an observational research. Participants will be interviewed twice in total. All primary and secondary outcomes will be assessed at the first meeting. The second come will be performed within 5-7 days after the first assessment. In the second come, only the new kinesiophobia scale that is intended to be developed will be applied.
- Conditions
- Shoulder Injuries
- Keywords
- Kinesiophobia, Shoulder, Development of Scale
- Medical subject headings
- Shoulder Injuries, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Observational Group | All of the outcomes will be applied to patients who come to the outpatient clinic due to shoulder problems. Then, 1 week later, participants will be recalled to apply the multidimensional kinesiophobia scale a second time. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multidimensional Kinesiophobia Scale (To be developed)
It is desired to be developed to evaluate the fear of movement that occurs due to upper extremity injuries.
Measured: Baseline of the study
Multidimensional Kinesiophobia Scale (To be developed)
It is desired to be developed to evaluate the fear of movement that occurs due to upper extremity injuries.
Measured: 5-7 days after baseline assessment
Secondary outcomes (3)
Visual Analog Scale
Assesses pain severity. It scores between 0-10 points. A high score indicates high pain intensity.
Measured: Baseline of the study
Tampa Kinesiophobia Scale
It consists of 17 items. Assesses the fear of movement. Total score is 68 points. A high score indicates high fear.
Measured: Baseline of the study
Demographic Data Form
This form was created by researchers and it consist of personal informations such as gender, marital status, education, age, body mass index, dominant and affected extremity, name of pathology,
Measured: Baseline of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start22 Jul 2024
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder InjuriesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emre Şenocak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Emre Şenocak, Karadeniz Technical University
- Investigators
- Abdurrahman Tanhan, PhD, Study chair, Bitlis Eren UniversityZeynep Hoşbay, Associate Professor, Study chair, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06485934
- Sponsor's protocol ID
- 2024/74
- Status last verified
- Nov 2025
- First submitted
- 27 Jun 2024
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of the Multidimensional Kinesiophobia Scale for the Upper Extremity: A Scale Development Study
- ClinicalTrials.gov ID
- NCT06485934
- Acronym / sponsor ID
- 2024/74
- Conditions
- Shoulder Injuries
- Keywords
- Kinesiophobia, Shoulder, Development of Scale
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Emre ŞenocakUniversity, hospital or other
- Study start
- 22 Jul 2024 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 3 Jul 2024 (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.
Questionnaires/scales used to evaluate kinesiophobia in the literature are limited and are not specific to the upper extremity in existing scales. For this reason, the primary purpose and subject of the study is to develop a multi-factor kinesiophobia scale specific to shoulder problems.
The study is an observational research. Participants will be interviewed twice in total. All primary and secondary outcomes will be assessed at the first meeting. The second come will be performed within 5-7 days after the first assessment. In the second come, only the new kinesiophobia scale that is intended to be developed will be applied.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational Group | – | –All of the outcomes will be applied to patients who come to the outpatient clinic due to shoulder problems. Then, 1 week later, participants will be recalled to apply the multidimensional kinesiophobia scale a second time. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Traumatological, orthopedic and rheumatological pathologies that cause fear of movement in the upper extremity
Key inclusion criteria (3 listed)
- Tampa Kinesiophobia Score >37 points
- Presence of traumatological, orthopedic and rheumatological pathology in the upper extremity
- Mini-Mental State Examination score >24 points
Key exclusion criteria (5 listed)
- Malignancy,
- Psychiatric drug use,
- Use of painkillers during evaluation periods,
- Those who received physiotherapy before the study (last 6 months),
- Those whose education level is below secondary school level,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Multidimensional Kinesiophobia Scale (To be developed)
Time frame: Baseline of the study
It is desired to be developed to evaluate the fear of movement that occurs due to upper extremity injuries.
Multidimensional Kinesiophobia Scale (To be developed)
Time frame: 5-7 days after baseline assessment
It is desired to be developed to evaluate the fear of movement that occurs due to upper extremity injuries.
3 secondary outcomes
Visual Analog Scale
Time frame: Baseline of the study
Tampa Kinesiophobia Scale
Time frame: Baseline of the study
Demographic Data Form
Time frame: Baseline of the study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Individual participant dataSharing planned: Undecided
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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.
Abdurrahman Tanhan, PhD study chair
Bitlis Eren University
Zeynep Hoşbay, Associate Professor study chair
Biruni University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Injuries, run by Emre Şenocak at 2 sites 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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emre Şenocak, PhD (+90 553 569 56 92, emre.senocak@windowslive.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multidimensional Kinesiophobia Scale (To be developed) (time frame: Baseline of the study). The study lists 2 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 19 Nov 2025.