NCT06918613

Brief 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. 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2024

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 9, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2025

Completed
Last Updated

November 20, 2025

Status Verified

November 1, 2025

Enrollment Period

1.3 years

First QC Date

April 1, 2025

Last Update Submit

November 19, 2025

Conditions

Keywords

Generalized Joint HypermobilityMedian NerveUltrasonographyWrist PositionsNeural Mobility

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    On the day one of testing

Secondary Outcomes (7)

  • Area

    On the day one of testing

  • Perimeter

    On the day one of testing

  • Circularity

    On the day one of testing

  • Beighton Score

    On the day one of testing

  • Height

    On the day one of testing

  • +2 more secondary outcomes

Study Arms (2)

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.

Eligibility Criteria

Age15 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Subjects who met the criteria were selected from those who presented to Istanbul Physical Medicine Rehabilitation Training and Research Hospital.

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Istanbul, Bahçelievler, 34158, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

  • Aktas 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.

  • Wang 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.

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 1, 2025

First Posted

April 9, 2025

Study Start

February 1, 2024

Primary Completion

May 15, 2025

Study Completion

June 28, 2025

Last Updated

November 20, 2025

Record last verified: 2025-11

Locations