NCT06600464

Brief 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, 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.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 31, 2024

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

3 months

First QC Date

September 14, 2024

Last Update Submit

September 16, 2024

Conditions

Keywords

osteoarthrosisultrasoundthenar muscles

Outcome Measures

Primary Outcomes (3)

  • 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.

    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)

    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).

    1 day

Study Arms (2)

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: UltrasoundOther: Assessment of Muscle Strength in Both HandsOther: Assessment of Pain Threshold

Group 2

In the healthy control group, subjects were matched based on age and hand dominance

Diagnostic Test: UltrasoundOther: Assessment of Muscle Strength in Both HandsOther: Assessment of Pain Threshold

Interventions

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.

Group 1Group 2

Muscle strength in both hands was evaluated using grip strength measured with a dynamometer (Jamar Hydraulic Hand Dynamometer, Nottinghamshire, UK)

Group 1Group 2

Pressure pain threshold (PPT) for painful and non-painful finger joints was assessed using a hand-held algometer

Group 1Group 2

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gulcan Ozturk

Istanbul, Atasehir, 34752, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

  • Pickrell BB, Eberlin KR. Thumb Basal Joint Arthritis. Clin Plast Surg. 2019 Jul;46(3):407-413. doi: 10.1016/j.cps.2019.02.010.

Related Links

MeSH Terms

Conditions

Osteoarthritis

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2024

First Posted

September 19, 2024

Study Start

August 31, 2024

Primary Completion

November 30, 2024

Study Completion

December 31, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Locations