Lateral EpicondylitisNCT07906379
Investigation of Obsessive-Compulsive Disorder in Patients With Elbow Epicondylitis
An observational study of Lateral Epicondylitis and Medial Epicondylitis, run by Fatih Turkmensoy at 1 site in Turkey (Türkiye).
Trial summary
This study will compare obsessive-compulsive symptoms in adults with medial and/or lateral elbow epicondylitis (pain and tenderness on the inner and/or outer side of the elbow). The study will include 90 participants in two groups of 45. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lateral Epicondylitis, Medial Epicondylitis, Obsessive-Compulsive Symptoms
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Nov 2026to 2 May 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults aged 18 years or older presenting to the Orthopaedics and Traumatology outpatient clinic at Bursa Yuksek Ihtisas Training and Research Hospital with clinically diagnosed medial and/or lateral elbow epicondylitis. Eligible patients who provide written informed consent will be enrolled consecutively until each group includes 45 participants. Groups will be defined by the presence or absence of an identifiable history of associated mechanical loading, based on participant history and clinical assessment.
Who may be able to join
- Age 18 years or older.
- Clinically diagnosed medial and/or lateral elbow epicondylitis, based on tenderness on palpation over the medial epicondyle and/or the origin of the extensor carpi radialis brevis at the lateral epicondyle.
- Provision of written informed consent before study assessments.
- For the group without identifiable mechanical loading: no identifiable history of activities associated with mechanical loading of the affected elbow, based on participant history and clinical assessment.
- For the group with identifiable mechanical loading: a history of associated mechanical loading through activities such as manual work, sports, or caregiving, based on participant history and clinical assessment.
- No minimum symptom duration is required.
Who cannot join
- History of elbow trauma.
- History of humerus, radius, or ulna fracture in the affected upper extremity.
- Known psychiatric disorder, including obsessive-compulsive disorder.
- Receipt of psychiatric treatment within the preceding six months.
- Diabetes mellitus.
- Neurological disease, such as epilepsy, Alzheimer's disease, or hemiplegia.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Bursa Yuksek Ihtisas Training and Research Hospital
Bursa, Bursa
Fatih Turkmensoy, +905057960708, turkmensoyfatih@gmail.com
Fatih Turkmensoy, MD
About this study
Official title: Investigation of Obsessive-Compulsive Disorder in Patients With Medial and/or Lateral Elbow Epicondylitis
This study will compare obsessive-compulsive symptoms in adults with medial and/or lateral elbow epicondylitis (pain and tenderness on the inner and/or outer side of the elbow).
The study will include 90 participants in two groups of 45. One group will have no identifiable history of mechanical loading associated with their elbow condition. The other group will have a history of activities that place repeated strain on the elbow, such as manual work, sports, or caregiving. Group assignment will be based on medical history and clinical assessment, rather than random allocation.
Read more
Each participant will complete the Turkish self-report Yale-Brown Obsessive Compulsive Scale and the 37-item Turkish Maudsley Obsessional Compulsive Inventory once, at the study visit. The main outcome will be the Yale-Brown total score. The Maudsley total score will be a secondary outcome.
The study will assess symptoms, not establish a diagnosis of obsessive-compulsive disorder. No treatment will be assigned as part of the study, and no follow-up visits are planned.
Read the detailed description
This single-center observational study will recruit eligible, consenting adults consecutively until each group includes 45 participants. Data collection will take place over approximately six months, with each participant assessed at a single visit.
Clinical diagnosis of lateral epicondylitis will be based on tenderness elicited by palpation over the origin of the extensor carpi radialis brevis at the lateral epicondyle. Medial epicondylitis will be diagnosed by tenderness elicited by palpation over the medial epicondyle. Participants may have medial, lateral, or both forms of epicondylitis. Imaging confirmation and a minimum symptom duration will not be required.
The presence or absence of a history of mechanical loading associated with epicondylitis will be determined from the participant's history and clinical assessment, without a predefined duration or frequency threshold.
Participants will complete both questionnaires themselves. A psychiatrist who is unaware of group membership will score the coded questionnaires. Participant identity and group information will be maintained separately from the questionnaires and will be accessible only to the principal investigator.
- Keywords
- Elbow Epicondylitis, Mechanical Loading, Yale-Brown Obsessive Compulsive Scale, Maudsley Obsessional Compulsive Inventory
- Medical subject headings
- Tennis Elbow, Elbow Tendinopathy
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 |
|---|---|---|
| Epicondylitis Without Identifiable Mechanical Loading | Adults with clinically diagnosed medial and/or lateral elbow epicondylitis and no identifiable history of associated mechanical loading, based on participant history and clinical assessment. This group will include 45 participants. Each participant will complete the Turkish self-report Yale-Brown Obsessive Compulsive Scale and the 37-item Turkish Maudsley Obsessional Compulsive Inventory once at enrollment. | |
| Epicondylitis With Identifiable Mechanical Loading | Adults with clinically diagnosed medial and/or lateral elbow epicondylitis and an identifiable history of associated mechanical loading from activities such as manual work, sports, or caregiving, based on participant history and clinical assessment. This group will include 45 participants. Each participant will complete the Turkish self-report Yale-Brown Obsessive Compulsive Scale and the 37-item Turkish Maudsley Obsessional Compulsive Inventory once at enrollment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Turkish Self-Report Yale-Brown Obsessive Compulsive Scale Total Score
The total score will be compared between participants with and without an identifiable history of mechanical loading associated with epicondylitis. The self-report scale contains 10 items, each scored from 0 to 4, yielding a total score of 0 to 40. Higher scores indicate greater obsessive-compulsive symptom severity. Participants rate symptoms experienced during the preceding week. The questionnaire will be completed by participants and scored by a psychiatrist unaware of group membership. Scores will be used to assess symptoms, not to establish a diagnosis of obsessive-compulsive disorder.
Measured: At enrollment (single study visit)
Secondary outcomes (1)
37-Item Turkish Maudsley Obsessional Compulsive Inventory Total Score
The total score will be compared between participants with and without an identifiable history of mechanical loading associated with epicondylitis. The 37-item Turkish self-report inventory uses true/false responses and yields a total score from 0 to 37. Higher scores indicate more obsessive-compulsive symptoms. Participants will complete the questionnaire once, and a psychiatrist unaware of group membership will score it. The score will not be used to establish a diagnosis of obsessive-compulsive disorder.
Measured: At enrollment (single study visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start2 Nov 2026 (estimated)
- Primary completion2 May 2027 (estimated)
- Study completion2 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral EpicondylitisStudies 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
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fatih Turkmensoy
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Fatih Turkmensoy, Bursa Yuksek Ihtisas Training and Research Hospital
- Investigators
- Fatih Turkmensoy, MD, Principal investigator, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07906379
- Sponsor's protocol ID
- 2024-TBEK 2026/09-19
- Status last verified
- Oct 2026
- First submitted
- 24 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Obsessive-Compulsive Disorder in Patients With Medial and/or Lateral Elbow Epicondylitis
- ClinicalTrials.gov ID
- NCT07906379
- Acronym / sponsor ID
- 2024-TBEK 2026/09-19
- Keywords
- Elbow Epicondylitis, Mechanical Loading, Yale-Brown Obsessive Compulsive Scale, Maudsley Obsessional Compulsive Inventory
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Fatih TurkmensoyOther government
- Study start
- 2 Nov 2026 (estimated)
- Primary completion
- 2 May 2027 (estimated)
- Study completion
- 2 May 2027 (estimated)
- First posted
- 30 Oct 2026 (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 study will compare obsessive-compulsive symptoms in adults with medial and/or lateral elbow epicondylitis (pain and tenderness on the inner and/or outer side of the elbow).
The study will include 90 participants in two groups of 45. One group will have no identifiable history of mechanical loading associated with their elbow condition. The other group will have a history of activities that place repeated strain on the elbow, such as manual work, sports, or caregiving. Group assignment will be based on medical history and clinical assessment, rather than random allocation.
Each participant will complete the Turkish self-report Yale-Brown Obsessive Compulsive Scale and the 37-item Turkish Maudsley Obsessional Compulsive Inventory once, at the study visit. The main outcome will be the Yale-Brown total score. The Maudsley total score will be a secondary outcome.
The study will assess symptoms, not establish a diagnosis of obsessive-compulsive disorder. No treatment will be assigned as part of the study, and no follow-up visits are planned.
Detailed description
This single-center observational study will recruit eligible, consenting adults consecutively until each group includes 45 participants. Data collection will take place over approximately six months, with each participant assessed at a single visit.
Clinical diagnosis of lateral epicondylitis will be based on tenderness elicited by palpation over the origin of the extensor carpi radialis brevis at the lateral epicondyle. Medial epicondylitis will be diagnosed by tenderness elicited by palpation over the medial epicondyle. Participants may have medial, lateral, or both forms of epicondylitis. Imaging confirmation and a minimum symptom duration will not be required.
The presence or absence of a history of mechanical loading associated with epicondylitis will be determined from the participant's history and clinical assessment, without a predefined duration or frequency threshold.
Participants will complete both questionnaires themselves. A psychiatrist who is unaware of group membership will score the coded questionnaires. Participant identity and group information will be maintained separately from the questionnaires and will be accessible only to the principal investigator.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epicondylitis Without Identifiable Mechanical Loading | – | –Adults with clinically diagnosed medial and/or lateral elbow epicondylitis and no identifiable history of associated mechanical loading, based on participant history and clinical assessment. This group will include 45 participants. Each participant will complete the Turkish self-report Yale-Brown Obsessive Compulsive Scale and the 37-item Turkish Maudsley Obsessional Compulsive Inventory once at enrollment. |
| Epicondylitis With Identifiable Mechanical Loading | – | –Adults with clinically diagnosed medial and/or lateral elbow epicondylitis and an identifiable history of associated mechanical loading from activities such as manual work, sports, or caregiving, based on participant history and clinical assessment. This group will include 45 participants. Each participant will complete the Turkish self-report Yale-Brown Obsessive Compulsive Scale and the 37-item Turkish Maudsley Obsessional Compulsive Inventory once at enrollment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 18 years or older presenting to the Orthopaedics and Traumatology outpatient clinic at Bursa Yuksek Ihtisas Training and Research Hospital with clinically diagnosed medial and/or lateral elbow epicondylitis. Eligible patients who provide written informed consent will be enrolled consecutively until each group includes 45 participants. Groups will be defined by the presence or absence of an identifiable history of associated mechanical loading, based on participant history and clinical assessment.
Key inclusion criteria (6 listed)
- Age 18 years or older.
- Clinically diagnosed medial and/or lateral elbow epicondylitis, based on tenderness on palpation over the medial epicondyle and/or the origin of the extensor carpi radialis brevis at the lateral epicondyle.
- Provision of written informed consent before study assessments.
- For the group without identifiable mechanical loading: no identifiable history of activities associated with mechanical loading of the affected elbow, based on participant history and clinical assessment.
- For the group with identifiable mechanical loading: a history of associated mechanical loading through activities such as manual work, sports, or caregiving, based on participant history and clinical assessment.
Key exclusion criteria (6 listed)
- History of elbow trauma.
- History of humerus, radius, or ulna fracture in the affected upper extremity.
- Known psychiatric disorder, including obsessive-compulsive disorder.
- Receipt of psychiatric treatment within the preceding six months.
- Diabetes mellitus.
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
Turkish Self-Report Yale-Brown Obsessive Compulsive Scale Total Score
Time frame: At enrollment (single study visit)
The total score will be compared between participants with and without an identifiable history of mechanical loading associated with epicondylitis. The self-report scale contains 10 items, each scored from 0 to 4, yielding a total score of 0 to 40. Higher scores indicate greater obsessive-compulsive symptom severity. Participants rate symptoms experienced during the preceding week. The questionnaire will be completed by participants and scored by a psychiatrist unaware of group membership. Scores will be used to assess symptoms, not to establish a diagnosis of obsessive-compulsive disorder.
1 secondary outcome
37-Item Turkish Maudsley Obsessional Compulsive Inventory Total Score
Time frame: At enrollment (single study visit)
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 2 Nov 2026.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data with other researchers.
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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.
Fatih Turkmensoy, MD principal investigator
Bursa Yuksek Ihtisas Training and Research Hospital
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 Lateral Epicondylitis and Medial Epicondylitis, run by Fatih Turkmensoy 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: opening soon, as of the sponsor's last update on 2 Nov 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?
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 Fatih Turkmensoy, MD (+905057960708, turkmensoyfatih@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Turkish Self-Report Yale-Brown Obsessive Compulsive Scale Total Score (time frame: At enrollment (single study visit)). 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 2 Nov 2026.