OsteoarthritisNCT06730698
Thumb Muscle Thickness and Strength in CMC Osteoarthritis
An observational study of Osteoarthritis, run by Beylikduzu State Hospital at 1 site in Turkey (Türkiye).
Trial summary
A total of 34 patients aged between 50-80 years, diagnosed with first carpometacarpal joint osteoarthritis based on hand radiographs taken within the last 3 months, will be included in the study from the Physical Therapy and Rehabilitation outpatient clinic. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Osteoarthritis
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Dec 2024to 20 Jan 2025
- How long will I take part?
- 1 Day
- 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 50 to 80 years
- All sexes
- Adult, Older adult
Study population: The study population includes patients aged 50-80 years with first carpometacarpal joint osteoarthritis, classified into early and advanced stages based on radiographs, excluding those with confounding medical or cognitive conditions.
Who may be able to join
- Patients aged 50-80 years.
- Diagnosed with first carpometacarpal joint osteoarthritis.
- Presence of a hand radiograph taken within the last 3 months.
- Volunteered to participate in the study.
Who cannot join
- Refusal to participate in the study.
- Use of medications that may suppress osteoarthritis flares.
- Presence of rheumatologic diseases causing peripheral joint involvement.
- History of fractures or surgeries involving the first carpometacarpal joint.
- Presence of psychiatric disorders.
- Presence of cognitive impairments that could hinder understanding or performance of study-related tasks.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Beylikdüzü State Hospital
Istanbul, Beylikdüzü, 34147
About this study
Official title: Ultrasonographic Measurement of Thumb Muscle Thickness and Evaluation of Pinch and Grip Strength in First Carpometacarpal Joint Osteoarthritis: A Comparison of Early and Advanced Stages
A total of 34 patients aged between 50-80 years, diagnosed with first carpometacarpal joint osteoarthritis based on hand radiographs taken within the last 3 months, will be included in the study from the Physical Therapy and Rehabilitation outpatient clinic. Sociodemographic data such as age, gender, height, weight, and BMI will be recorded. Based on their current radiographs, patients will be classified into two groups according to the Eaton-Littler classification: Stage 1-2 (early stage) and Stage 3-4 (advanced stage). Pain levels will be assessed using the Visual Analog Scale (VAS). Hand grip strength will be evaluated with a Jamar hand dynamometer, and pinch grip strength will be assessed with a Jamar pinch meter. The thicknesses of the abductor pollicis brevis, first dorsal interosseous, and opponens pollicis muscles will be measured using ultrasound. All assessments will be performed separately for the dominant and non-dominant hands.
- Conditions
- Osteoarthritis
- Being tested
- No intervention
- Medical subject headings
- Osteoarthritis
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 |
|---|---|---|
| Early stage osteoarthritis | Early stage osteoarthritis according to Eaton-Litter classification (stage 1 and 2) Receives: Other: No intervention | |
| Advanced stage osteoarthritis | Advanced stage osteoarthritis according to Eaton-Litter classification (stage 3 and 4) Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thumb Muscle Thickness (Ultrasound)
Measurement of the thickness of three thumb muscles-abductor pollicis brevis, first dorsal interosseous, and opponens pollicis-using ultrasonography. These measurements will help determine muscle atrophy or hypertrophy related to disease severity and stage
Measured: 0 day
Secondary outcomes (3)
Grip Strength
Assessed using a Jamar hand dynamometer. This measure evaluates overall hand strength, which is often impaired in advanced stages of carpometacarpal joint osteoarthritis.
Measured: 0 day
Pinch Strength
Assessed using a Jamar pinch meter. This measure evaluates the strength of the thumb-index finger pinch, a critical function for fine motor activities. It is particularly relevant to functional limitations seen in osteoarthritis.
Measured: 0 day
Pain Level (VAS)
Pain intensity will be measured using the Visual Analog Scale (VAS). Patients will mark their perceived pain level on a 10 cm scale, providing a quantitative measure of pain severity in both early and advanced stages.
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 posted12 Dec 2024
- Study start10 Dec 2024
- Primary completion20 Jan 2025
- Study completion20 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 34 participants (actual)
- 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
- Investigators
- Büşra Şirin Ahısha, Principal investigator, Beylikdüzü State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06730698
- Sponsor's protocol ID
- BeylikduzuStateH11
- Status last verified
- Mar 2025
- First submitted
- 9 Dec 2024
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic Measurement of Thumb Muscle Thickness and Evaluation of Pinch and Grip Strength in First Carpometacarpal Joint Osteoarthritis: A Comparison of Early and Advanced Stages
- ClinicalTrials.gov ID
- NCT06730698
- Acronym / sponsor ID
- BeylikduzuStateH11
- Conditions
- Osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Beylikduzu State HospitalUniversity, hospital or other
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- 20 Jan 2025 (actual)
- Study completion
- 20 Jan 2025 (actual)
- First posted
- 12 Dec 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.
A total of 34 patients aged between 50-80 years, diagnosed with first carpometacarpal joint osteoarthritis based on hand radiographs taken within the last 3 months, will be included in the study from the Physical Therapy and Rehabilitation outpatient clinic. Sociodemographic data such as age, gender, height, weight, and BMI will be recorded. Based on their current radiographs, patients will be classified into two groups according to the Eaton-Littler classification: Stage 1-2 (early stage) and Stage 3-4 (advanced stage). Pain levels will be assessed using the Visual Analog Scale (VAS). Hand grip strength will be evaluated with a Jamar hand dynamometer, and pinch grip strength will be assessed with a Jamar pinch meter. The thicknesses of the abductor pollicis brevis, first dorsal interosseous, and opponens pollicis muscles will be measured using ultrasound. All assessments will be performed separately for the dominant and non-dominant hands.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early stage osteoarthritis | – | Other: No interventionEarly stage osteoarthritis according to Eaton-Litter classification (stage 1 and 2) |
| Advanced stage osteoarthritis | – | Other: No interventionAdvanced stage osteoarthritis according to Eaton-Litter classification (stage 3 and 4) |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population includes patients aged 50-80 years with first carpometacarpal joint osteoarthritis, classified into early and advanced stages based on radiographs, excluding those with confounding medical or cognitive conditions.
Key inclusion criteria (4 listed)
- Patients aged 50-80 years.
- Diagnosed with first carpometacarpal joint osteoarthritis.
- Presence of a hand radiograph taken within the last 3 months.
- Volunteered to participate in the study.
Key exclusion criteria (6 listed)
- Refusal to participate in the study.
- Use of medications that may suppress osteoarthritis flares.
- Presence of rheumatologic diseases causing peripheral joint involvement.
- History of fractures or surgeries involving the first carpometacarpal joint.
- Presence of psychiatric disorders.
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 | Advanced stage osteoarthritis, Early stage osteoarthritis |
Primary outcome
Thumb Muscle Thickness (Ultrasound)
Time frame: 0 day
Measurement of the thickness of three thumb muscles-abductor pollicis brevis, first dorsal interosseous, and opponens pollicis-using ultrasonography. These measurements will help determine muscle atrophy or hypertrophy related to disease severity and stage
3 secondary outcomes
Grip Strength
Time frame: 0 day
Pinch Strength
Time frame: 0 day
Pain Level (VAS)
Time frame: 0 day
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 26 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Osteoarthritis
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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.
Büşra Şirin Ahısha principal investigator
Beylikdüzü State 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 Osteoarthritis, 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 4 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: finished, as of the sponsor's last update on 26 Mar 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?
Thumb Muscle Thickness (Ultrasound) (time frame: 0 day). 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 26 Mar 2025.