NCT06730698

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2024

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

December 10, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 12, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2025

Completed
Last Updated

March 26, 2025

Status Verified

March 1, 2025

Enrollment Period

1 month

First QC Date

December 9, 2024

Last Update Submit

March 22, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    0 day

Secondary Outcomes (3)

  • Grip Strength

    0 day

  • Pinch Strength

    0 day

  • Pain Level (VAS)

    0 day

Study Arms (2)

Early stage osteoarthritis

Early stage osteoarthritis according to Eaton-Litter classification (stage 1 and 2)

Other: No intervention

Advanced stage osteoarthritis

Advanced stage osteoarthritis according to Eaton-Litter classification (stage 3 and 4)

Other: No intervention

Interventions

No intervention

Advanced stage osteoarthritisEarly stage osteoarthritis

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beylikdüzü State Hospital

Istanbul, Beylikdüzü, 34147, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Büşra Şirin Ahısha

    Beylikdüzü State Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

December 9, 2024

First Posted

December 12, 2024

Study Start

December 10, 2024

Primary Completion

January 20, 2025

Study Completion

January 20, 2025

Last Updated

March 26, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations