Rotator Cuff InjuriesNCT07118163
The Relationship Pain Beliefs With Kinesiophobia, Catastrophizing, Pain Knowledge, and Shoulder Functional Disability in Individuals With Shoulder Pain
An observational study of Rotator Cuff Injuries and Shoulder Pain Chronic, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
This cross-sectional observational study aims to examine the relationship between psychological and organic pain beliefs and kinesiophobia, pain catastrophizing, pain knowledge, and shoulder functional disability (SPADI) in individuals with shoulder pain. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rotator Cuff Injuries, Shoulder Pain Chronic, Impingement Syndrome
- What is being tested?
- Other
- How many people
- 109 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2025to 15 Nov 2025
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study includes individuals aged between 18 and 75 who present with shoulder pain and seek care at a healthcare facility. Participants must have sufficient cognitive ability to complete the questionnaires independently. Participation in the study will be on a voluntary basis.
Who may be able to join
- Individuals aged between 18 and 75 years
- Presence of shoulder pain for at least 3 months
- At least one positive finding in each of the following categories:
- Painful arc during flexion or abduction
- Positive Neer's or Kennedy-Hawkins tests
- Pain during resisted external rotation, abduction, or empty can test
Who cannot join
- History of shoulder dislocation or fracture in the past 12 months
- Presence of full-thickness rotator cuff tear
- Previous shoulder surgery
- Received physiotherapy or corticosteroid injection for the shoulder in the past 3 months
- Presence of adhesive capsulitis (passive shoulder range of motion < 50%)
- Presence of systemic diseases such as cancer or rheumatic disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relationship Pain Beliefs With Kinesiophobia, Catastrophizing, Pain Knowledge, and Disability in Individuals With Shoulder Pain
This cross-sectional observational study aims to examine the relationship between psychological and organic pain beliefs and kinesiophobia, pain catastrophizing, pain knowledge, and shoulder functional disability (SPADI) in individuals with shoulder pain. The study seeks to clarify how pain-related beliefs influence physical and psychological outcomes in musculoskeletal shoulder pain.
- Being tested
- Other, No intervention; Observational study
- Keywords
- Rotator cuff, Shoulder Pain, Organic Pain Beliefs
- Medical subject headings
- Rotator Cuff Injuries, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OtherOther
No intervention was applied in this study.
No intervention; Observational studyOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Patients with shoulder pain | Not described Receives: Other: Other; Other: No intervention; Observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Beliefs
To examine how psychological and organic pain beliefs
Measured: Baseline
Secondary outcomes (4)
Kinesiophobia
To examine fear of movement
Measured: Baseline
Catastrophizing
To examine tendency to catastrophize pain experiences.
Measured: Baseline
Pain Knowledge
To examine level of knowledge and understanding of pain neurophysiology
Measured: Baseline
Shoulder Pain and Disability Index (SPADI)
To examine the disability level of patients
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start15 Aug 2025
- Primary completion15 Nov 2025
- Study completion15 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff InjuriesStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Büşra Aksan Sadıkoğlu, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07118163
- Sponsor's protocol ID
- IUC25
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2025
- Last updated
- 4 Aug 2026
- 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 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Pain Beliefs With Kinesiophobia, Catastrophizing, Pain Knowledge, and Disability in Individuals With Shoulder Pain
- ClinicalTrials.gov ID
- NCT07118163
- Acronym / sponsor ID
- IUC25
- Keywords
- Rotator cuff, Shoulder Pain, Organic Pain Beliefs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 15 Aug 2025 (actual)
- Primary completion
- 15 Nov 2025 (actual)
- Study completion
- 15 Nov 2025 (actual)
- First posted
- 12 Aug 2025 (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.
This cross-sectional observational study aims to examine the relationship between psychological and organic pain beliefs and kinesiophobia, pain catastrophizing, pain knowledge, and shoulder functional disability (SPADI) in individuals with shoulder pain. The study seeks to clarify how pain-related beliefs influence physical and psychological outcomes in musculoskeletal shoulder pain.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with shoulder pain | – | Other: Other, Other: No intervention; Observational study |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study includes individuals aged between 18 and 75 who present with shoulder pain and seek care at a healthcare facility. Participants must have sufficient cognitive ability to complete the questionnaires independently. Participation in the study will be on a voluntary basis.
Key inclusion criteria (6 listed)
- Individuals aged between 18 and 75 years
- Presence of shoulder pain for at least 3 months
- At least one positive finding in each of the following categories:
- Painful arc during flexion or abduction
- Positive Neer's or Kennedy-Hawkins tests
Key exclusion criteria (6 listed)
- History of shoulder dislocation or fracture in the past 12 months
- Presence of full-thickness rotator cuff tear
- Previous shoulder surgery
- Received physiotherapy or corticosteroid injection for the shoulder in the past 3 months
- Presence of adhesive capsulitis (passive shoulder range of motion < 50%)
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 |
|---|---|---|
| OtherNo intervention was applied in this study. | Other | Patients with shoulder pain |
| No intervention; Observational studyNo intervention | Other | Patients with shoulder pain |
Primary outcome
Pain Beliefs
Time frame: Baseline
To examine how psychological and organic pain beliefs
4 secondary outcomes
Kinesiophobia
Time frame: Baseline
Catastrophizing
Time frame: Baseline
Pain Knowledge
Time frame: Baseline
Shoulder Pain and Disability Index (SPADI)
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Rotator Cuff Injuries and Shoulder Pain Chronic, run by Istanbul University - Cerrahpasa 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 6 inclusion and 6 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: finished, as of the sponsor's last update on 4 Aug 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Beliefs (time frame: Baseline). 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 4 Aug 2026.