NCT07447323

Brief Summary

This study looks at people who have osteoarthritis at the base of the thumb. It examines how well the thumb can sense its position and movement. The study has three goals:

  1. 1.To compare these measurements between people with thumb base osteoarthritis and healthy people.
  2. 2.To find out whether this ability changes from milder to more advanced levels of osteoarthritis.
  3. 3.To explore whether this ability is related to factors such as basic personal characteristics, thumb/hand muscle strength and hand use, pain and touch sensation, and emotional factors like fear of movement, anxiety, and depression.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
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

October 23, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2026

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

March 3, 2026

Status Verified

February 1, 2026

Enrollment Period

4 months

First QC Date

February 23, 2026

Last Update Submit

February 26, 2026

Conditions

Keywords

Thumb proprioceptionJoint position sensePinch aperture proprioceptionTrapeziometacarpal jointPainProprioceptionCarpometacarpalProprioception*Thumb*Carpometacarpal Joints*Humans

Outcome Measures

Primary Outcomes (2)

  • Joint Position Sense (JPS)

    Thumb JPS was assessed using a joint position reproduction test at the TMC, metacarpophalangeal (MCP), and interphalangeal (IP) joints using a standard universal goniometer. Target positions were: TMC abduction at 20°, 30°, and 40°, TMC adduction at 20° and 30°; MCP flexion at 20°; and IP flexion at 20°. Each target was tested three times. JPS performance was quantified as the angular error between the target angle and the actively reproduced angle, summarized as the mean error across the three trials (degrees), with higher values indicating poorer proprioception.

    Baseline (single assessment at study visit)

  • Pinch Aperture Proprioception

    Pinch aperture proprioception was assessed using a pinch aperture reproduction test with a custom-built modified goniometer-based device with reported validity and reliability. The device included circular fingertip pads to standardize thumb-index placement. Two target apertures (15° and 30°) were tested, selected to represent functional pinch apertures for common objects, such as a large medication container (approximately 3.5 cm diameter) and a standard drinking glass (approximately 7 cm diameter), respectively. For each target, three trials were performed, and angular error was computed as the difference between target and actively reproduced aperture; the mean error across trials was used (degrees), with higher values indicating greater impairment. Bidirectional testing (30°→15° and 15°→30°) was performed as described in the protocol.

    Baseline (single assessment at study visit)

Secondary Outcomes (22)

  • Joint Mobility

    Baseline (single assessment at study visit)

  • Opposition

    Baseline (single assessment at study visit)

  • Re-Opposition

    Baseline (single assessment at study visit)

  • Hypermobility

    Baseline (single assessment at study visit)

  • Thumb/Hand Muscle Strength (Manual Muscle Testing)

    Baseline (single assessment at study visit)

  • +17 more secondary outcomes

Study Arms (2)

TMC OA Group (Eaton-Littler Stages I-IV)

Individuals diagnosed with trapeziometacarpal (TMC) joint osteoarthritis. Disease stage will be determined on radiographs using the Eaton-Littler classification (Stages I-IV). Thumb proprioception will be quantified using joint position sense measurements at the TMC, MCP, and IP joints and a pinch aperture proprioception task (error measures). We will also examine potential determinants of thumb proprioceptive function, including demographic characteristics, motor function, sensory function, and emotional status. To evaluate intra-rater repeatability of the pinch aperture proprioception measure, the same assessor will repeat the test within one week in a subgroup of 30 participants.

Other: Thumb Proprioception Assessment

Healthy Control Group

Healthy individuals enrolled as a comparison group. Thumb proprioception will be assessed using joint position sense measurements at the TMC, MCP, and IP joints and a pinch aperture proprioception task (error measures), and results will be compared with those of the TMC osteoarthritis group.

Other: Thumb Proprioception Assessment

Interventions

This is an observational study. All participants undergo a standardized thumb proprioception assessment performed by the same assessor. Proprioception is evaluated using (1) joint position sense error at the thumb trapeziometacarpal, metacarpophalangeal, and interphalangeal joints, and (2) pinch aperture proprioception error. No therapeutic intervention is delivered; assessments are for measurement purposes only.

Healthy Control GroupTMC OA Group (Eaton-Littler Stages I-IV)

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults aged 25-75 years with trapeziometacarpal (TMC) osteoarthritis and healthy controls will be included in this cross-sectional case-control study. The TMC OA group will be radiographically classified according to the Eaton-Littler staging system (Stages I-IV). The target sample is 100 participants in the OA group (20 per stage) and 20 healthy controls. Participants will be recruited from the Faculty of Physiotherapy and Rehabilitation, Department of Orthopedic Physiotherapy and Rehabilitation, Hacettepe University (Ankara, Turkey). All participants will undergo standardized assessments of thumb proprioception and related clinical measures.

You may qualify if:

  • Voluntary participation
  • Radiographic Eaton-Littler stage I-IV confirmed by an orthopedic specialist
  • Symptom duration ≥6 months
  • Age 25-75 years
  • Pain intensity ≥4/10 on the Visual Analog Scale (VAS) during daily activities at assessment
  • Ability to actively perform ≥40° palmar abduction
  • Adequate cognitive capacity to understand and perform study procedures (for participants aged ≥65 years: Montreal Cognitive Assessment \[MoCA\] score ≥21)
  • Voluntary participation
  • No thumb pain
  • Age 25-75 years
  • No clinical signs of TMC OA
  • Negative provocation tests
  • Adequate cognitive capacity to understand and perform study procedures (for participants aged ≥65 years: MoCA score ≥21)

You may not qualify if:

  • Inability to abduct the thumb beyond 40° due to severe pain/deformity (especially advanced stage III-IV)
  • Acute trauma or prior surgery of the hand/wrist
  • Conservative treatment for hand/thumb pain in the same extremity within the previous 6 months
  • Current use of anti-inflammatory medication
  • Peripheral nerve disorders affecting proprioception (e.g., carpal tunnel syndrome, dorsal radial nerve irritation, cervical radiculopathy, double crush syndrome)
  • Concomitant upper-extremity musculoskeletal disorders (e.g., trigger finger, De Quervain's disease)
  • Generalized joint hypermobility (Beighton score ≥4)
  • Neuromuscular, systemic peripheral neuropathic, autoimmune, rheumatic, or infectious diseases
  • Active malignancy
  • Neurological conditions affecting pain perception
  • Visual impairment
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Ankara, 06100, Turkey (Türkiye)

RECRUITING

Related Publications (9)

  • Ulusoy T, Ayhan Kuru C. Predictive factors affecting functional outcomes following conservative treatment in trapeziometacarpal osteoarthritis: A systematic review. J Hand Ther. 2026 Jan 6:S0894-1130(25)00200-5. doi: 10.1016/j.jht.2025.12.002. Online ahead of print.

    PMID: 41500919BACKGROUND
  • Kennedy CD, Manske MC, Huang JI. Classifications in Brief: The Eaton-Littler Classification of Thumb Carpometacarpal Joint Arthrosis. Clin Orthop Relat Res. 2016 Dec;474(12):2729-2733. doi: 10.1007/s11999-016-4864-6. Epub 2016 May 4. No abstract available.

    PMID: 27146653BACKGROUND
  • Yahya A, Kluding P, Pasnoor M, Wick J, Liu W, Dos Santos M. The impact of diabetic peripheral neuropathy on pinch proprioception. Exp Brain Res. 2019 Dec;237(12):3165-3174. doi: 10.1007/s00221-019-05663-3. Epub 2019 Oct 4.

    PMID: 31586215BACKGROUND
  • Yahya A, von Behren T, Levine S, Dos Santos M. Pinch aperture proprioception: reliability and feasibility study. J Phys Ther Sci. 2018 May;30(5):734-740. doi: 10.1589/jpts.30.734. Epub 2018 May 8.

    PMID: 29765192BACKGROUND
  • Ouegnin A, Valdes K. Joint position sense impairments in older adults with carpometacarpal osteoarthritis: A descriptive comparative study. J Hand Ther. 2020 Oct-Dec;33(4):547-552. doi: 10.1016/j.jht.2019.01.006. Epub 2019 Mar 11.

    PMID: 30871959BACKGROUND
  • Seok HS, Lee KH, Lee Y, Bae KJ, Kim J, Gong HS. Is Thumb Proprioception Decreased in Patients With Trapeziometacarpal Joint Osteoarthritis? Ann Plast Surg. 2020 Oct;85(4):379-383. doi: 10.1097/SAP.0000000000002422.

    PMID: 32501842BACKGROUND
  • Ludwig CA, Mobargha N, Okogbaa J, Hagert E, Ladd AL. Altered Innervation Pattern in Ligaments of Patients with Basal Thumb Arthritis. J Wrist Surg. 2015 Nov;4(4):284-91. doi: 10.1055/s-0035-1564982.

    PMID: 26649261BACKGROUND
  • Gehrmann SV, Tang J, Li ZM, Goitz RJ, Windolf J, Kaufmann RA. Motion deficit of the thumb in CMC joint arthritis. J Hand Surg Am. 2010 Sep;35(9):1449-53. doi: 10.1016/j.jhsa.2010.05.026.

    PMID: 20807622BACKGROUND
  • Poole JU, Pellegrini VD Jr. Arthritis of the thumb basal joint complex. J Hand Ther. 2000 Apr-Jun;13(2):91-107. doi: 10.1016/s0894-1130(00)80034-4.

    PMID: 10855745BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Çiğdem Ayhan Kuru, PT, PhD

    Faculty of Physiotherapy and Rehabilitation, Department of Orthopedic Physiotherapy and Rehabilitation, Hacettepe University, Ankara, Turkey

    PRINCIPAL INVESTIGATOR
  • Merve Sümeyye Yılmaz, PT

    Faculty of Physiotherapy and Rehabilitation, Department of Orthopedic Physiotherapy and Rehabilitation, Hacettepe University, Ankara, Turkey

    STUDY DIRECTOR

Central Study Contacts

Merve Sümeyye Yılmaz, PT

CONTACT

Çiğdem Ayhan Kuru, PT, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 23, 2026

First Posted

March 3, 2026

Study Start

October 23, 2025

Primary Completion

March 1, 2026

Study Completion

May 1, 2026

Last Updated

March 3, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared. The dataset contains potentially identifiable clinical information, and participant consent/ethics approval does not include public IPD sharing. Only aggregated, de-identified summary results will be reported.

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