OsteoarthrosisNCT06600464
Ultrasound Findings of Thumb Muscles in 1st Carpometacarpal Osteoarthritis
An observational study of Osteoarthrosis and Ultrasound, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Carpometacarpal (CMC) joint osteoarthritis is a disorder that is estimated to affect more than one-third of postmenopausal women, leading to decreased muscle strength, reduced joint range of motion, and pain.The pathogenesis of thumb CMC osteoarthritis involves complex interactions between biomechanical forces… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoarthrosis, Ultrasound
- What is being tested?
- Ultrasound, Assessment of Muscle Strength in Both Hands and Assessment of Pain Threshold
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Aug 2024to 31 Dec 2024
- 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 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Postmenopausal women with clinical and/or radiological evidence of 1st CMC OA
Who may be able to join
- Postmenopausal women with clinical and/or radiological evidence of 1st CMC OA
Who cannot join
- De Quervain\'s tenosynovitis, flexor carpi radialis tendon pathology, and carpal tunnel syndrome, as well as those with hand trauma or hand surgery within the past year, had received steroid and local anesthetic injections into the 1st CMC joint within the last 3 months, or had connective tissue disorders, rheumatologic, or autoimmune diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is There a Relationship Between Ultrasound Findings of Thumb Muscles and Grip Strength in Addition to Pain Threshold in Thumb Carpometacarpal Osteoarthritis
Carpometacarpal (CMC) joint osteoarthritis is a disorder that is estimated to affect more than one-third of postmenopausal women, leading to decreased muscle strength, reduced joint range of motion, and pain.The pathogenesis of thumb CMC osteoarthritis involves complex interactions between biomechanical forces, genetic predisposition, hormonal changes, repetitive microtrauma, and aging. An important factor in the progression of carpometacarpal osteoarthritis is the loss of joint stability provided by the surrounding muscles (2). The common methods for diagnosing thumb CMC OA is plain radiographs and clinical examinations. However, radiographs are unable to assess the role of surrounding structures, including muscles and ligaments.
Ultrasound is a cost-effective, radiation-free, and easily applicable imaging method.
Read the detailed description
In this cross-sectional study, patients with various stages of 1st carpometacarpal (CMC) joint osteoarthritis (OA) were assessed using standard radiographs based on the Modified Eaton Litter classification. Postmenopausal women with clinical and/or radiological evidence of 1st CMC OA will be included (Group 1). In the healthy control group, subjects will be matched based on age and hand dominance (Group 2). Demographic information including age, sex, height, weight, body mass index (BMI, kg/m²), dominant hand, and symptom duration (in months) will recorded. Pain levels will be assessed using the Visual Analogue Scale (VAS).The thickness of the thenar eminence muscles (longitudinal thickness of the first dorsal interosseous muscle (FDI), abductor pollicis brevis (APB), and opponens pollicis (OPP)) was measured using musculoskeletal ultrasound. Muscle strength in both hands will be evaluated using grip strength measured with a dynamometer . Pressure pain threshold (PPT) for painful and non-painful finger joints will be assessed using a hand-held algometer
- Conditions
- Osteoarthrosis, Ultrasound
- Being tested
- Ultrasound, Assessment of Muscle Strength in Both Hands, Assessment of Pain Threshold
- Keywords
- osteoarthrosis, ultrasound, thenar muscles
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDiagnostic test
The thickness of the thenar eminence muscles (longitudinal thickness of the first dorsal interosseous muscle (FDI), abductor pollicis brevis (APB), and opponens pollicis (OPP)) was measured using musculoskeletal ultrasound.
Assessment of Muscle Strength in Both HandsOther
Muscle strength in both hands was evaluated using grip strength measured with a dynamometer (Jamar Hydraulic Hand Dynamometer, Nottinghamshire, UK)
Assessment of Pain ThresholdOther
Pressure pain threshold (PPT) for painful and non-painful finger joints was assessed using a hand-held algometer
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients with various stages of 1st carpometacarpal (CMC) joint osteoarthritis (OA) were assessed using standard radiographs based on the Modified Eaton Litter classification Receives: Diagnostic Test: Ultrasound; Other: Assessment of Muscle Strength in Both Hands; Other: Assessment of Pain Threshold | |
| Group 2 | In the healthy control group, subjects were matched based on age and hand dominance Receives: Diagnostic Test: Ultrasound; Other: Assessment of Muscle Strength in Both Hands; Other: Assessment of Pain Threshold |
What is being measured
The primary outcome is the main question the study is designed to answer.
ultrasound
The thickness of the thenar eminence muscles (longitudinal thickness of the first dorsal interosseous muscle (FDI), abductor pollicis brevis (APB), and opponens pollicis (OPP)) was measured using musculoskeletal ultrasound.
Measured: 1 day
Assessment of Muscle Strength in Both Hands
Participants were seated in a standardized position with their elbows flexed at 90°. Muscle strength in both hands was evaluated using grip strength measured with a dynamometer (Jamar Hydraulic Hand Dynamometer, Nottinghamshire, UK)
Measured: 1 day
Assessment of Pain Threshold
Pressure pain threshold (PPT) for painful and non-painful finger joints was assessed using a hand-held algometer (FPIX25, with a 1 cm² flat rubber probe).
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start31 Aug 2024
- Primary completion30 Nov 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OsteoarthrosisStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06600464
- Sponsor's protocol ID
- Gulcanozturk1984
- Status last verified
- Sep 2024
- First submitted
- 14 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mohseny B, Nijhuis TH, Hundepool CA, Janssen WG, Selles RW, Coert JH. Ultrasonographic quantification of intrinsic hand muscle cross-sectional area; reliability and validity for predicting muscle strength. Arch Phys Med Rehabil. 2015 May;96(5):845-53. doi: 10.1016/j.apmr.2014.11.014. Epub 2014 Dec 4.
PubMed 25482051Pickrell BB, Eberlin KR. Thumb Basal Joint Arthritis. Clin Plast Surg. 2019 Jul;46(3):407-413. doi: 10.1016/j.cps.2019.02.010.
PubMed 31103085
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is There a Relationship Between Ultrasound Findings of Thumb Muscles and Grip Strength in Addition to Pain Threshold in Thumb Carpometacarpal Osteoarthritis
- ClinicalTrials.gov ID
- NCT06600464
- Acronym / sponsor ID
- Gulcanozturk1984
- Conditions
- Osteoarthrosis, Ultrasound
- Keywords
- osteoarthrosis, ultrasound, thenar muscles
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- 31 Aug 2024 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 19 Sep 2024 (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.
Carpometacarpal (CMC) joint osteoarthritis is a disorder that is estimated to affect more than one-third of postmenopausal women, leading to decreased muscle strength, reduced joint range of motion, and pain.The pathogenesis of thumb CMC osteoarthritis involves complex interactions between biomechanical forces, genetic predisposition, hormonal changes, repetitive microtrauma, and aging. An important factor in the progression of carpometacarpal osteoarthritis is the loss of joint stability provided by the surrounding muscles (2). The common methods for diagnosing thumb CMC OA is plain radiographs and clinical examinations. However, radiographs are unable to assess the role of surrounding structures, including muscles and ligaments.
Ultrasound is a cost-effective, radiation-free, and easily applicable imaging method.
Detailed description
In this cross-sectional study, patients with various stages of 1st carpometacarpal (CMC) joint osteoarthritis (OA) were assessed using standard radiographs based on the Modified Eaton Litter classification. Postmenopausal women with clinical and/or radiological evidence of 1st CMC OA will be included (Group 1). In the healthy control group, subjects will be matched based on age and hand dominance (Group 2). Demographic information including age, sex, height, weight, body mass index (BMI, kg/m²), dominant hand, and symptom duration (in months) will recorded. Pain levels will be assessed using the Visual Analogue Scale (VAS).The thickness of the thenar eminence muscles (longitudinal thickness of the first dorsal interosseous muscle (FDI), abductor pollicis brevis (APB), and opponens pollicis (OPP)) was measured using musculoskeletal ultrasound. Muscle strength in both hands will be evaluated using grip strength measured with a dynamometer . Pressure pain threshold (PPT) for painful and non-painful finger joints will be assessed using a hand-held algometer
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Diagnostic Test: Ultrasound, Other: Assessment of Muscle Strength in Both Hands, Other: Assessment of Pain ThresholdPatients with various stages of 1st carpometacarpal (CMC) joint osteoarthritis (OA) were assessed using standard radiographs based on the Modified Eaton Litter classification |
| Group 2 | – | Diagnostic Test: Ultrasound, Other: Assessment of Muscle Strength in Both Hands, Other: Assessment of Pain ThresholdIn the healthy control group, subjects were matched based on age and hand dominance |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Postmenopausal women with clinical and/or radiological evidence of 1st CMC OA
Key inclusion criteria (1 listed)
- Postmenopausal women with clinical and/or radiological evidence of 1st CMC OA
Key exclusion criteria (1 listed)
- De Quervain\'s tenosynovitis, flexor carpi radialis tendon pathology, and carpal tunnel syndrome, as well as those with hand trauma or hand surgery within the past year, had received steroid and local anesthetic injections into the 1st CMC joint within the last 3 months, or had connective tissue disorders, rheumatologic, or autoimmune diseases
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 |
|---|---|---|
| UltrasoundThe thickness of the thenar eminence muscles (longitudinal thickness of the first dorsal interosseous muscle (FDI), abductor pollicis brevis (APB), and opponens pollicis (OPP)) was measured using musculoskeletal ultrasound. | Diagnostic test | Group 1, Group 2 |
| Assessment of Muscle Strength in Both HandsMuscle strength in both hands was evaluated using grip strength measured with a dynamometer (Jamar Hydraulic Hand Dynamometer, Nottinghamshire, UK) | Other | Group 1, Group 2 |
| Assessment of Pain ThresholdPressure pain threshold (PPT) for painful and non-painful finger joints was assessed using a hand-held algometer | Other | Group 1, Group 2 |
Primary outcome
ultrasound
Time frame: 1 day
The thickness of the thenar eminence muscles (longitudinal thickness of the first dorsal interosseous muscle (FDI), abductor pollicis brevis (APB), and opponens pollicis (OPP)) was measured using musculoskeletal ultrasound.
Assessment of Muscle Strength in Both Hands
Time frame: 1 day
Participants were seated in a standardized position with their elbows flexed at 90°. Muscle strength in both hands was evaluated using grip strength measured with a dynamometer (Jamar Hydraulic Hand Dynamometer, Nottinghamshire, UK)
Assessment of Pain Threshold
Time frame: 1 day
Pressure pain threshold (PPT) for painful and non-painful finger joints was assessed using a hand-held algometer (FPIX25, with a 1 cm² flat rubber probe).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Results publication: PubMed 25482051Mohseny B, Nijhuis TH, Hundepool CA, Janssen WG, Selles RW, Coert JH. Ultrasonographic quantification of intrinsic hand muscle cross-sectional area; reliability and validity for predicting muscle strength. Arch Phys Med Rehabil. 2015 May;96(5):845-53. doi: 10.1016/j.apmr.2014.11.014. Epub 2014 Dec 4.
- Results publication: PubMed 31103085Pickrell BB, Eberlin KR. Thumb Basal Joint Arthritis. Clin Plast Surg. 2019 Jul;46(3):407-413. doi: 10.1016/j.cps.2019.02.010.
- Pickrell BB, Eberlin KR. Thumb Basal Joint Arthritis.Link provided by the sponsor.
- Ultrasonographic quantification of intrinsic hand muscle cross-sectional area; reliability and validity for predicting muscle strengthLink provided by the sponsor.
- 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 Osteoarthrosis and Ultrasound, run by Fatih Sultan Mehmet 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. 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?
Results are not available in the source record.
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?
ultrasound (time frame: 1 day). 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 NCT06600464, which also lists 2 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 19 Sep 2024.