Hypermobility, JointNCT07044986
Ultrasonographic Evaluation of the Ulnar Nerve in Individuals With and Without Generalized Joint Hypermobility
An observational study of Hypermobility, Joint, run by Beylikduzu State Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study will include 30 individuals diagnosed with Generalized Joint Hypermobility (GJH) based on the Beighton score and 30 healthy controls without GJH. Participants will undergo Tinel's test and the flexion-compression test. The presence of ulnar nerve-related symptoms such as pain and numbness will be recorded. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypermobility, Joint
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2025to 1 Aug 2025
- How long will I take part?
- 1 Day
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: hypermobility and healthy controls
Who may be able to join
- Aged between 18 and 40 years
- A Beighton score of 4 or higher (indicative of Generalized Joint Hypermobility)
- Willingness to participate in the study
Who cannot join
- Being under 18 or over 40 years of age
- History of surgery or fracture in the elbow region
- Presence of active infection at the measurement site
- Presence of congenital anomaly in the upper extremity
- History of surgery involving neural structures in the upper extremity
- Presence of malignancy
- Pregnancy
- Presence of cognitive or psychiatric disorders
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
Beylikdüzü State Hospital
Istanbul, Beylikdüzü, 34147
About this study
This study will include 30 individuals diagnosed with Generalized Joint Hypermobility (GJH) based on the Beighton score and 30 healthy controls without GJH. Participants will undergo Tinel's test and the flexion-compression test. The presence of ulnar nerve-related symptoms such as pain and numbness will be recorded. Ultrasonographic evaluation of the ulnar nerve will be performed at the level of the medial epicondyle, as well as 2 cm proximal and distal to it. Cross-sectional area and diameter of the ulnar nerve will be measured at each site, repeated three times, and the average will be used. Additionally, ulnar nerve mobility during elbow flexion and extension will be assessed. The nerve will be classified as stable if it remains within the cubital tunnel, subluxated if it moves to the level of the epicondyle, and dislocated if it shifts anterior to the medial epicondyle.
- Conditions
- Hypermobility, Joint
- Being tested
- no intervention
- Medical subject headings
- Joint Instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| hypermobility | patients with generalized joint hypermobility snyndrome Receives: Other: no intervention | |
| Control group | healthy control Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ulnar nerve cross-sectional area (CSA) at the medial epicondyle
CSA measurement provides insight into nerve thickening, which may indicate entrapment or irritation.
Measured: 0 day
Ulnar nerve cross-sectional area (CSA) at the 2 cm proximal of medial epicondyle
CSA measurement provides insight into nerve thickening, which may indicate entrapment or irritation.
Measured: 0 day
Ulnar nerve cross-sectional area (CSA) at the 2 cm distal of medial epicondyle
CSA measurement provides insight into nerve thickening, which may indicate entrapment or irritation.
Measured: 0 day
Ulnar nerve diameter
Ulnar nerve diameter with ultrasonography
Measured: 0 day
Ulnar nerve mobility classification during elbow flexion (stable/subluxated/dislocated)
Dynamic USG evaluation allows visualization of nerve movement and instability during joint motion.
Measured: 0 day
Secondary outcomes (1)
Presence of ulnar nerve-related symptoms:
Symptom inquiry helps correlate clinical complaints with sonographic findings.
Measured: 0 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start1 Jul 2025 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypermobility, JointStudies 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
- 60 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Beylikduzu State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Busra Sirin, Beylikduzu State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07044986
- Sponsor's protocol ID
- BeylikduzuStateH21
- Status last verified
- Jun 2025
- First submitted
- 22 Jun 2025
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic Evaluation of the Ulnar Nerve in Individuals With and Without Generalized Joint Hypermobility
- ClinicalTrials.gov ID
- NCT07044986
- Acronym / sponsor ID
- BeylikduzuStateH21
- Conditions
- Hypermobility, Joint
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Beylikduzu State HospitalUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 1 Jul 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 study will include 30 individuals diagnosed with Generalized Joint Hypermobility (GJH) based on the Beighton score and 30 healthy controls without GJH. Participants will undergo Tinel's test and the flexion-compression test. The presence of ulnar nerve-related symptoms such as pain and numbness will be recorded. Ultrasonographic evaluation of the ulnar nerve will be performed at the level of the medial epicondyle, as well as 2 cm proximal and distal to it. Cross-sectional area and diameter of the ulnar nerve will be measured at each site, repeated three times, and the average will be used. Additionally, ulnar nerve mobility during elbow flexion and extension will be assessed. The nerve will be classified as stable if it remains within the cubital tunnel, subluxated if it moves to the level of the epicondyle, and dislocated if it shifts anterior to the medial epicondyle.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hypermobility | – | Other: no interventionpatients with generalized joint hypermobility snyndrome |
| Control group | – | Other: no interventionhealthy control |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- hypermobility and healthy controls
Key inclusion criteria (3 listed)
- Aged between 18 and 40 years
- A Beighton score of 4 or higher (indicative of Generalized Joint Hypermobility)
- Willingness to participate in the study
Key exclusion criteria (8 listed)
- Being under 18 or over 40 years of age
- History of surgery or fracture in the elbow region
- Presence of active infection at the measurement site
- Presence of congenital anomaly in the upper extremity
- History of surgery involving neural structures in the upper extremity
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 |
|---|---|---|
| no interventionno intervention | Other | Control group, hypermobility |
Primary outcome
Ulnar nerve cross-sectional area (CSA) at the medial epicondyle
Time frame: 0 day
CSA measurement provides insight into nerve thickening, which may indicate entrapment or irritation.
Ulnar nerve cross-sectional area (CSA) at the 2 cm proximal of medial epicondyle
Time frame: 0 day
CSA measurement provides insight into nerve thickening, which may indicate entrapment or irritation.
Ulnar nerve cross-sectional area (CSA) at the 2 cm distal of medial epicondyle
Time frame: 0 day
CSA measurement provides insight into nerve thickening, which may indicate entrapment or irritation.
Ulnar nerve diameter
Time frame: 0 day
Ulnar nerve diameter with ultrasonography
Ulnar nerve mobility classification during elbow flexion (stable/subluxated/dislocated)
Time frame: 0 day
Dynamic USG evaluation allows visualization of nerve movement and instability during joint motion.
1 secondary outcome
Presence of ulnar nerve-related symptoms:
Time frame: 0 day
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 1 Jul 2025.
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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.
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 Hypermobility, Joint, run by Beylikduzu State Hospital 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 3 inclusion and 8 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 1 Jul 2025. 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?
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?
Ulnar nerve cross-sectional area (CSA) at the medial epicondyle (time frame: 0 day). The study lists 5 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 1 Jul 2025.