Hypermobility Syndrome (Disorder)NCT06918613
Ultrasonographic Evaluation of the Effects of Different Wrist Positions on the Median Nerve in Patients With Generalized Joint Hypermobility
An observational study of Hypermobility Syndrome (Disorder) and Ultrasonography, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to evaluate the effects of different wrist positions (neutral, flexion, extension, and ulnar deviation) on median nerve morphology in patients with generalized joint hypermobility (GJH) using ultrasonography and to compare them with healthy controls. Read more about this study
- Who is it for?
- Ages 15 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypermobility Syndrome (Disorder), Ultrasonography, Median Nerve
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2024to 28 Jun 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 15 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Subjects who met the criteria were selected from those who presented to Istanbul Physical Medicine Rehabilitation Training and Research Hospital.
Who may be able to join
- 15-45 years of age
- Female gender
- Diagnosed with GJH according to the hypermobility spectrum disorders definition
- Patients who agree to participate in the study and provide written consent
Who cannot join
- Having wrist pain
- Inability to complete full range of motion in the wrist joint
- Patients diagnosed with carpal tunnel syndrome
- Anatomical abnormalities (bifid median nerve, aberrant persistent median artery, Martin-Gruber or other anastomoses)
- History of trauma, operation, fracture, or steroid injection of the hand/wrist
- History of known rheumatological, hereditary, genetic disease, or connective tissue disease other than GJH
Show all 12Show fewer
- Having neurological disease affecting hand functions (cervical radiculopathy, peripheral nerve lesion, polyneuropathy, cerebrovascular event, etc.)
- Patients with history of regular steroid or non-steroid use, receiving oral glucosamine/hyaluronate supplementation
- Those with systemic diseases (inflammatory joint diseases, diabetes mellitus, acromegaly, hypothyroidism, kidney failure, etc.)
- Having a body mass index (BMI) of 30 or above, or history of morbid obesity
- Being pregnant or in lactation period
- Presence of malignancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Istanbul, Bahçelievler, 34158
About this study
The aim of this study was to evaluate the effects of different wrist positions (neutral, flexion, extension, and ulnar deviation) on median nerve morphology in patients with generalized joint hypermobility (GJH) using ultrasonography and to compare them with healthy controls.
The investigators' hypothesis is that the deformability of the median nerve in response to active maximal wrist flexion, extension, or ulnar deviation may be increased in patients with GJH
Read the detailed description
This prospective cross-sectional study will include 18 female patients diagnosed with GJH (Beighton score ≥5) and 18 healthy volunteers with similar age, gender, and body mass index. Both wrists of all participants (total of 72 wrists) will be evaluated using ultrasonography. Images of the median nerve will be obtained in neutral position, active maximal flexion, extension, and ulnar deviation. The cross-sectional area and perimeter of the median nerve will be measured in each position, and circularity will be calculated. Deformation ratios will be determined.
Ultrasonographic Evaluation
Ultrasonographic evaluation was performed using a Mindray DC-7 ultrasound device. The ultrasonographic imaging of participants was performed while the shoulder was in neutral position with the forearm resting on a fixed surface in supination, and with the patient sitting in a chair facing the doctor. Images were obtained from both median nerves of the participants. A linear probe was used for imaging the median nerve. The proximal carpal tunnel was defined as the area between the pisiform and scaphoid tubercle; these two anatomical structures were palpated in the palm and easily identified on ultrasound by their hyperechoic surface and strong posterior acoustic shadowing characteristics. The linear probe was placed along the pisiform and scaphoid bones, the probe was kept perpendicular to the median nerve to prevent anisotropic artifact, and the median nerve was visualized in the proximal carpal tunnel.
The wrists of the participants were imaged for the median nerve in the following positions:
Neutral position (fingers in extension) Active maximal flexion position Active maximal ulnar deviation position Active maximal extension position
During position changes, the probe was kept stable and its position was checked before capturing the image. Images were recorded via the ultrasound device.
To test the consistency of ultrasound measurements, imaging of 10 individuals was performed twice with a one-day interval. Measurements were taken and compared. Intraclass correlation coefficient and intra-observer error values were calculated.
Ultrasound Image Analysis
The "ImageJ" program was used to calculate the perimeter and area of the median nerve. The measurement scale in the ultrasound images was proportioned to the number of pixels on the computer screen. Measurements were repeated 3 times and the average of the values was taken.
The circularity formula was defined. A circularity value of 1 indicates that the drawn polygon is a perfect circle; a value less than 1 indicates a deviation from a circle (for example, an oval or irregularly shaped polygon).
To evaluate the deformability of the median nerve, area, perimeter, and circularity deformation ratios were calculated. The deformation ratio was defined as the normalization of the value in different positions with the value in the neutral position. A deformation ratio close to 1 indicates that the ratio in different positions is very similar to the neutral position. The more the deformation ratio deviates from 1, the greater the difference between parameter measurements in neutral and other positions.
Statistical Analysis
The conformity of the variables in the study to normal distribution was evaluated using the Shapiro-Wilk test. Mean±Standard Deviation and Median (Minimum-Maximum) values were used to display the descriptive statistics of the variables.
For comparing Area, Perimeter, Circularity, Area Deformation Ratio, Perimeter Deformation Ratio, and Circularity Deformation Ratio values according to Patient-Control grouping, Independent Samples T-test was used for parameters showing normal distribution, and Mann-Whitney U test was used for parameters not showing normal distribution.
In examining the relationships between Beighton score, age, height, weight, BMI values and Area, Perimeter, Circularity, Area Deformation Ratio, Perimeter Deformation Ratio, Circularity Deformation Ratio values, Pearson correlation analysis was used for parameters conforming to normal distribution, and Spearman non-parametric correlation coefficient was provided for examining relationships between parameters not conforming to normal distribution.
IBM SPSS Statistics 21.0 (IBM Corp. Released 2012. IBM SPSS Statistics for Windows, Version 21.0. Armonk, NY: IBM Corp.) and MS-Excel 2007 programs were used for statistical analyses and calculations. Statistical significance level was accepted as p<0.05.
- Keywords
- Generalized Joint Hypermobility, Median Nerve, Ultrasonography, Wrist Positions, Neural Mobility
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 |
|---|---|---|
| Generalized Joint Hypermobility | Subjects in this group are diagnosed with Generalized joint hypermobility. Asymptomatic ( no arthralgia, subluxation, pain etc.) subjects with Beighton score 5 or more are included in this group. Full wrist range of motion is required. Ultrasonography of median nerve in proximal carpal tunnel will be done in different wrist positions. | |
| Healthy | This group consists of healthy volunteers. Full wrist range of motion is required. Beighton scores must be 4 or lower. Ultrasonography of median nerve in proximal carpal tunnel will be done in different wrist positions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area deformation ratio
To evaluate the deformability of the median nerve, deformation ratios for area (mm²), perimeter (mm), and circularity ( Circularity = 4π (Area / Perimeter²) ) is calculated. The deformation ratio is defined as the measurement in the final position divided by the corresponding measurement in the initial position.
Measured: On the day one of testing
Perimeter deformation ratio
To evaluate the deformability of the median nerve, deformation ratios for area (mm²), perimeter (mm), and circularity ( Circularity = 4π (Area / Perimeter²) ) is calculated. The deformation ratio is defined as the measurement in the final position divided by the corresponding measurement in the initial position.
Measured: On the day one of testing
Circularity deformation ratio
To evaluate the deformability of the median nerve, deformation ratios for area (mm²), perimeter (mm), and circularity ( Circularity = 4π (Area / Perimeter²) ) is calculated. The deformation ratio is defined as the measurement in the final position divided by the corresponding measurement in the initial position.
Measured: On the day one of testing
Secondary outcomes (7)
Area
Ultrasonograpic images of median nerve obtained in different wrist positions. The cross-sectional area (mm²) and perimeter (mm) of the median nerve were measured in each position, and circularity (4π (Area / Perimeter²)) was calculated.
Measured: On the day one of testing
Perimeter
Ultrasonograpic images of median nerve obtained in different wrist positions. The cross-sectional area (mm²) and perimeter (mm) of the median nerve were measured in each position, and circularity (4π (Area / Perimeter²)) was calculated.
Measured: On the day one of testing
Circularity
Ultrasonograpic images of median nerve obtained in different wrist positions. The cross-sectional area (mm²) and perimeter (mm) of the median nerve were measured in each position, and circularity (4π (Area / Perimeter²)) was calculated.
Measured: On the day one of testing
Beighton Score
Correlation between Beighton Score, Height (cm), Weight (kg), BMI (kg/m²) and ultrasonographic measurements is investigated
Measured: On the day one of testing
Height
Correlation between Beighton Score, Height (cm), Weight (kg), BMI (kg/m²) and ultrasonographic measurements is investigated
Measured: On the day one of testing
Weight
Correlation between Beighton Score, Height (cm), Weight (kg), BMI (kg/m²) and ultrasonographic measurements is investigated
Measured: On the day one of testing
BMI correlation
Correlation between Beighton Score, Height (cm), Weight (kg), BMI (kg/m²) and ultrasonographic measurements is investigated
Measured: On the day one of testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start1 Feb 2024
- Primary completion15 May 2025
- Study completion28 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hypermobility Syndrome (Disorder)Studies 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, İsmet Alkım Özkan, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06918613
- Sponsor's protocol ID
- IstPRMTRH1A
- Status last verified
- Nov 2025
- First submitted
- 1 Apr 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Castori M, Tinkle B, Levy H, Grahame R, Malfait F, Hakim A. A framework for the classification of joint hypermobility and related conditions. Am J Med Genet C Semin Med Genet. 2017 Mar;175(1):148-157. doi: 10.1002/ajmg.c.31539. Epub 2017 Feb 1.
PubMed 28145606Aktas I, Ofluoglu D, Albay T. The relationship between benign joint hypermobility syndrome and carpal tunnel syndrome. Clin Rheumatol. 2008 Oct;27(10):1283-7. doi: 10.1007/s10067-008-0909-x. Epub 2008 Jun 5.
PubMed 18528726Wang Y, Filius A, Zhao C, Passe SM, Thoreson AR, An KN, Amadio PC. Altered median nerve deformation and transverse displacement during wrist movement in patients with carpal tunnel syndrome. Acad Radiol. 2014 Apr;21(4):472-80. doi: 10.1016/j.acra.2013.12.012.
PubMed 24594417
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic Evaluation of the Effects of Different Wrist Positions on the Median Nerve in Patients With Generalized Joint Hypermobility
- ClinicalTrials.gov ID
- NCT06918613
- Acronym / sponsor ID
- IstPRMTRH1A
- Keywords
- Generalized Joint Hypermobility, Median Nerve, Ultrasonography, Wrist Positions, Neural Mobility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 28 Jun 2025 (actual)
- First posted
- 9 Apr 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.
The aim of this study was to evaluate the effects of different wrist positions (neutral, flexion, extension, and ulnar deviation) on median nerve morphology in patients with generalized joint hypermobility (GJH) using ultrasonography and to compare them with healthy controls.
The investigators' hypothesis is that the deformability of the median nerve in response to active maximal wrist flexion, extension, or ulnar deviation may be increased in patients with GJH
Detailed description
This prospective cross-sectional study will include 18 female patients diagnosed with GJH (Beighton score ≥5) and 18 healthy volunteers with similar age, gender, and body mass index. Both wrists of all participants (total of 72 wrists) will be evaluated using ultrasonography. Images of the median nerve will be obtained in neutral position, active maximal flexion, extension, and ulnar deviation. The cross-sectional area and perimeter of the median nerve will be measured in each position, and circularity will be calculated. Deformation ratios will be determined.
Ultrasonographic Evaluation
Ultrasonographic evaluation was performed using a Mindray DC-7 ultrasound device. The ultrasonographic imaging of participants was performed while the shoulder was in neutral position with the forearm resting on a fixed surface in supination, and with the patient sitting in a chair facing the doctor. Images were obtained from both median nerves of the participants. A linear probe was used for imaging the median nerve. The proximal carpal tunnel was defined as the area between the pisiform and scaphoid tubercle; these two anatomical structures were palpated in the palm and easily identified on ultrasound by their hyperechoic surface and strong posterior acoustic shadowing characteristics. The linear probe was placed along the pisiform and scaphoid bones, the probe was kept perpendicular to the median nerve to prevent anisotropic artifact, and the median nerve was visualized in the proximal carpal tunnel.
The wrists of the participants were imaged for the median nerve in the following positions:
Neutral position (fingers in extension) Active maximal flexion position Active maximal ulnar deviation position Active maximal extension position
During position changes, the probe was kept stable and its position was checked before capturing the image. Images were recorded via the ultrasound device.
To test the consistency of ultrasound measurements, imaging of 10 individuals was performed twice with a one-day interval. Measurements were taken and compared. Intraclass correlation coefficient and intra-observer error values were calculated.
Ultrasound Image Analysis
The "ImageJ" program was used to calculate the perimeter and area of the median nerve. The measurement scale in the ultrasound images was proportioned to the number of pixels on the computer screen. Measurements were repeated 3 times and the average of the values was taken.
The circularity formula was defined. A circularity value of 1 indicates that the drawn polygon is a perfect circle; a value less than 1 indicates a deviation from a circle (for example, an oval or irregularly shaped polygon).
To evaluate the deformability of the median nerve, area, perimeter, and circularity deformation ratios were calculated. The deformation ratio was defined as the normalization of the value in different positions with the value in the neutral position. A deformation ratio close to 1 indicates that the ratio in different positions is very similar to the neutral position. The more the deformation ratio deviates from 1, the greater the difference between parameter measurements in neutral and other positions.
Statistical Analysis
The conformity of the variables in the study to normal distribution was evaluated using the Shapiro-Wilk test. Mean±Standard Deviation and Median (Minimum-Maximum) values were used to display the descriptive statistics of the variables.
For comparing Area, Perimeter, Circularity, Area Deformation Ratio, Perimeter Deformation Ratio, and Circularity Deformation Ratio values according to Patient-Control grouping, Independent Samples T-test was used for parameters showing normal distribution, and Mann-Whitney U test was used for parameters not showing normal distribution.
In examining the relationships between Beighton score, age, height, weight, BMI values and Area, Perimeter, Circularity, Area Deformation Ratio, Perimeter Deformation Ratio, Circularity Deformation Ratio values, Pearson correlation analysis was used for parameters conforming to normal distribution, and Spearman non-parametric correlation coefficient was provided for examining relationships between parameters not conforming to normal distribution.
IBM SPSS Statistics 21.0 (IBM Corp. Released 2012. IBM SPSS Statistics for Windows, Version 21.0. Armonk, NY: IBM Corp.) and MS-Excel 2007 programs were used for statistical analyses and calculations. Statistical significance level was accepted as p<0.05.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Generalized Joint Hypermobility | – | –Subjects in this group are diagnosed with Generalized joint hypermobility. Asymptomatic ( no arthralgia, subluxation, pain etc.) subjects with Beighton score 5 or more are included in this group. Full wrist range of motion is required. Ultrasonography of median nerve in proximal carpal tunnel will be done in different wrist positions. |
| Healthy | – | –This group consists of healthy volunteers. Full wrist range of motion is required. Beighton scores must be 4 or lower. Ultrasonography of median nerve in proximal carpal tunnel will be done in different wrist positions. |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Subjects who met the criteria were selected from those who presented to Istanbul Physical Medicine Rehabilitation Training and Research Hospital.
Key inclusion criteria (4 listed)
- 15-45 years of age
- Female gender
- Diagnosed with GJH according to the hypermobility spectrum disorders definition
- Patients who agree to participate in the study and provide written consent
Key exclusion criteria (12 listed)
- Having wrist pain
- Inability to complete full range of motion in the wrist joint
- Patients diagnosed with carpal tunnel syndrome
- Anatomical abnormalities (bifid median nerve, aberrant persistent median artery, Martin-Gruber or other anastomoses)
- History of trauma, operation, fracture, or steroid injection of the hand/wrist
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
Area deformation ratio
Time frame: On the day one of testing
To evaluate the deformability of the median nerve, deformation ratios for area (mm²), perimeter (mm), and circularity ( Circularity = 4π (Area / Perimeter²) ) is calculated. The deformation ratio is defined as the measurement in the final position divided by the corresponding measurement in the initial position.
Perimeter deformation ratio
Time frame: On the day one of testing
To evaluate the deformability of the median nerve, deformation ratios for area (mm²), perimeter (mm), and circularity ( Circularity = 4π (Area / Perimeter²) ) is calculated. The deformation ratio is defined as the measurement in the final position divided by the corresponding measurement in the initial position.
Circularity deformation ratio
Time frame: On the day one of testing
To evaluate the deformability of the median nerve, deformation ratios for area (mm²), perimeter (mm), and circularity ( Circularity = 4π (Area / Perimeter²) ) is calculated. The deformation ratio is defined as the measurement in the final position divided by the corresponding measurement in the initial position.
7 secondary outcomes
Area
Time frame: On the day one of testing
Perimeter
Time frame: On the day one of testing
Circularity
Time frame: On the day one of testing
Beighton Score
Time frame: On the day one of testing
Height
Time frame: On the day one of testing
Weight
Time frame: On the day one of testing
BMI correlation
Time frame: On the day one of testing
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 20 Nov 2025.
- Results publication: PubMed 28145606Castori M, Tinkle B, Levy H, Grahame R, Malfait F, Hakim A. A framework for the classification of joint hypermobility and related conditions. Am J Med Genet C Semin Med Genet. 2017 Mar;175(1):148-157. doi: 10.1002/ajmg.c.31539. Epub 2017 Feb 1.
- Results publication: PubMed 18528726Aktas I, Ofluoglu D, Albay T. The relationship between benign joint hypermobility syndrome and carpal tunnel syndrome. Clin Rheumatol. 2008 Oct;27(10):1283-7. doi: 10.1007/s10067-008-0909-x. Epub 2008 Jun 5.
- Results publication: PubMed 24594417Wang Y, Filius A, Zhao C, Passe SM, Thoreson AR, An KN, Amadio PC. Altered median nerve deformation and transverse displacement during wrist movement in patients with carpal tunnel syndrome. Acad Radiol. 2014 Apr;21(4):472-80. doi: 10.1016/j.acra.2013.12.012.
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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 Hypermobility Syndrome (Disorder) and Ultrasonography, run by Istanbul Physical Medicine Rehabilitation Training and Research 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 4 inclusion and 12 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 20 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 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?
Area deformation ratio (time frame: On the day one of testing). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06918613, which also lists 3 linked publications.
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 20 Nov 2025.