Ultrasound Findings of Thumb Muscles in 1st Carpometacarpal Osteoarthritis

September 16, 2024 updated by: Fatih Sultan Mehmet Training and Research Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Atasehir
      • Istanbul, Atasehir, Turkey, 34752
        • Gulcan Ozturk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Postmenopausal women with clinical and/or radiological evidence of 1st CMC OA

Description

Inclusion Criteria:

Postmenopausal women with clinical and/or radiological evidence of 1st CMC OA

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Diagnostic test: 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.
Other: Assessment of Muscle Strength in Both Hands
Muscle strength in both hands was evaluated using grip strength measured with a dynamometer (Jamar Hydraulic Hand Dynamometer, Nottinghamshire, UK)
Other: Assessment of Pain Threshold
Pressure pain threshold (PPT) for painful and non-painful finger joints was assessed using a hand-held algometer
Group 2
In the healthy control group, subjects were matched based on age and hand dominance
Diagnostic test: 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.
Other: Assessment of Muscle Strength in Both Hands
Muscle strength in both hands was evaluated using grip strength measured with a dynamometer (Jamar Hydraulic Hand Dynamometer, Nottinghamshire, UK)
Other: Assessment of Pain Threshold
Pressure pain threshold (PPT) for painful and non-painful finger joints was assessed using a hand-held algometer

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
1 day
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)
1 day
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).
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fatih Sultan Mehmet Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 31, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 14, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 19, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Gulcanozturk1984

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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