Trapeziometacarpal OsteoarthritisNCT07447323
Thumb Proprioception in Trapeziometacarpal Osteoarthritis
An observational study of Trapeziometacarpal Osteoarthritis, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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. To compare these measurements between people with thumb base osteoarthritis and healthy people. 2. Read more about this study
- Who is it for?
- Ages 25 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Trapeziometacarpal Osteoarthritis
- What is being tested?
- Thumb Proprioception Assessment
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Oct 2025to May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 25 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
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- 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)
Who cannot join
- 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)
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- 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
- -Exclusion criteria identical to the TMC OA group
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hacettepe University
Ankara, Ankara, 06100
Çiğdem Ayhan Kuru, PT, PhD
Merve Sümeyye Yılmaz, PT
About this study
Official title: Investigation of Thumb Proprioception in Trapeziometacarpal Joint Osteoarthritis
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:
Read more
- To compare these measurements between people with thumb base osteoarthritis and healthy people.
- To find out whether this ability changes from milder to more advanced levels of osteoarthritis.
- 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.
This is an observational study. No treatment is given. Participants complete thumb measurements and several tests/questionnaires.
Read the detailed description
This study aims to quantitatively evaluate thumb proprioception in individuals diagnosed with trapeziometacarpal (TMC) joint osteoarthritis (OA) and to compare the findings with healthy individuals. As a secondary aim, potential determinants that may influence proprioceptive function of the thumb joints will be examined systematically. In this context, relationships between thumb proprioception and participants' demographic characteristics (age, sex, body weight, occupational characteristics, and OA severity), motor functions (muscle strength of opponens pollicis, first dorsal interosseous, abductor pollicis brevis/longus, and flexor pollicis brevis/longus, as well as fine motor performance), sensory functions (pain, light touch/pressure sensation, and vibration sensation), and emotional status (fear of movement, anxiety, and depression) will be investigated. In addition, whether proprioceptive measures differ across radiographic severity levels will be evaluated within the TMC OA group.
The study is conducted using a cross-sectional case-control design. Individuals with TMC OA are compared with an healthy control group. In the TMC OA group, disease severity is classified based on radiographs according to the Eaton-Littler classification (Stages 1-4).
Thumb proprioception is assessed using two main outcomes: (1) joint position sense (JPS) error values for the TMC, metacarpophalangeal (MCP), and interphalangeal (IP) joints, and (2) pinch aperture proprioception error values. To evaluate the repeatability of pinch aperture proprioception measurement in individuals with TMC OA, an intra-rater test-retest approach is used; the same test is administered to 30 participants by the same assessor within one week.
Sample size is planned to support the primary hypothesis. For the primary group comparisons, at least 20 participants per group are targeted. To enable planned subgroup analyses by OA severity, the study aims to include 20 individuals for each Eaton-Littler stage (Stages 1-4) in the TMC OA group (total 80 individuals with TMC OA) and 20 healthy controls, resulting in a total target sample size of 100 participants.
Statistical analyses will be performed using SPSS for Windows version 22.0. Continuous variables will be reported as mean ± standard deviation or median (interquartile range), and categorical variables as frequency and percentage. Depending on data distribution, parametric or non-parametric methods will be used. Proprioceptive outcomes will be compared between the TMC OA group and the age-matched healthy control group using appropriate two-group comparison tests. Planned subgroup comparisons across radiographic severity levels (Eaton-Littler Stages 1-4) will be conducted within the TMC OA group. Associations between proprioceptive outcomes and demographic, motor, sensory, and emotional factors will be examined using correlation analyses and, where appropriate, multiple regression models. Statistical significance will be set at two-sided p < 0.05, and effect sizes will be reported where applicable.
Ethics approval was obtained from the Hacettepe University Faculty of Physical Therapy and Rehabilitation Research Ethics Committee (Session date: 23 Oct 2025; Session number: 2025/22; Decision number: FTREK25/112; validity: 23 Oct 2025-23 Oct 2027). All participants received verbal and written information about the purpose and scope of the study, the assessments to be performed, potential discomfort, and their right to withdraw at any time without providing a reason; written informed consent was obtained prior to assessments. A safety approach was adopted such that measurements were discontinued if a participant reported discomfort during assessment. To ensure confidentiality, all participants were assigned a unique study code, and identifying information was stored separately from measurement data. Analyses were conducted using de-identified datasets. Data were stored in password-protected digital files, and any paper forms were kept in a locked cabinet with access restricted to the research team.
- Conditions
- Trapeziometacarpal Osteoarthritis
- Being tested
- Thumb Proprioception Assessment
- Keywords
- Thumb proprioception, Joint position sense, Pinch aperture proprioception, Trapeziometacarpal joint, Pain, Proprioception, Carpometacarpal, Proprioception*, Thumb*, Carpometacarpal Joints*, Humans
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thumb Proprioception AssessmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Thumb Proprioception Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (single assessment at study visit)
Secondary outcomes (22)
Joint Mobility
Joint mobility of the thumb was assessed by measuring active range of motion (ROM) of the trapeziometacarpal (TMC), metacarpophalangeal (MCP), and interphalangeal (IP) joints using a standard goniometer. For the TMC joint, abduction, adduction, flexion, extension, and opposition were evaluated. Flexion and extension ROM of the MCP and IP joints were also measured. All joint mobility values were recorded in degrees, with higher values indicating greater joint mobility.
Measured: Baseline (single assessment at study visit)
Opposition
Thumb opposition was additionally evaluated using the Kapandji opposition score, which grades the maximal opposition achieved by the thumb pulp on a 10-point scale. A score of 1 corresponds to contact with the radial side of the proximal phalanx of the index finger, whereas a score of 10 corresponds to contact with the distal palmar crease of the little finger.
Measured: Baseline (single assessment at study visit)
Re-Opposition
Thumb re-opposition (reposition ability) was assessed as the minimal contact point reached during return from maximal opposition, recorded using the Kapandji opposition scale (0-10).
Measured: Baseline (single assessment at study visit)
Hypermobility
Generalized joint hypermobility was assessed using the Beighton Hypermobility Score. This nine-item scoring system evaluates joint laxity at multiple anatomical sites, yielding a total score ranging from 0 to 9. Higher scores indicate greater joint laxity, and individuals with a score of 4 or higher were classified as hypermobile.
Measured: Baseline (single assessment at study visit)
Thumb/Hand Muscle Strength (Manual Muscle Testing)
Motor function of the thumb and hand was evaluated by assessing manual muscle strength and grip and pinch strength. Manual muscle testing was performed to evaluate the strength of the opponens pollicis, abductor pollicis brevis and longus, first dorsal interosseous, and flexor pollicis brevis and longus muscles. Muscle strength was graded according to the Lovett scale and the Medical Research Council (MRC) classification, with higher scores indicating greater muscle strength.
Measured: Baseline (single assessment at study visit)
Hand Grip Strength
Hand grip strength will be assessed in the standardized position recommended by the American Society of Hand Therapists: seated, with the arm adducted and in neutral rotation, elbow flexed to 90°, forearm in mid-rotation, and wrist in neutral position. A Jamar hand dynamometer (Jamar; JLW Instruments, Chicago, IL) will be used to measure standard grip strength. The dynamometer handle will be set at the second position, and participants will be instructed to maintain the testing position and squeeze maximally. Three trials will be performed, and the mean value will be recorded in kilograms-force.
Measured: Baseline (single assessment at study visit)
Lateral Pinch Strength
Lateral pinch strength will be assessed in the standardized position recommended by the American Society of Hand Therapists: seated, with the arm adducted and in neutral rotation, elbow flexed to 90°, forearm in mid-rotation, and wrist in neutral position. A pinch gauge (Pro Med Products, Atlanta, GA) will be used. Participants will be instructed to squeeze the pinch gauge maximally between the thumb pulp and the lateral aspect of the index finger while maintaining the testing position. Three trials will be performed, and the mean value will be recorded in kilograms-force.
Measured: Baseline (single assessment at study visit)
Tripod Pinch Strength
Tripod pinch strength will be assessed in the standardized position recommended by the American Society of Hand Therapists: seated, with the arm adducted and in neutral rotation, elbow flexed to 90°, forearm in mid-rotation, and wrist in neutral position. A pinch gauge (Pro Med Products, Atlanta, GA) will be used. Participants will be instructed to squeeze the pinch gauge maximally between the thumb, index finger, and middle finger while maintaining the testing position. Three trials will be performed, and the mean value will be recorded in kilograms-force.
Measured: Baseline (single assessment at study visit)
Tip Pinch Strength
Tip pinch strength will be assessed in the standardized position recommended by the American Society of Hand Therapists: seated, with the arm adducted and in neutral rotation, elbow flexed to 90°, forearm in mid-rotation, and wrist in neutral position. A pinch gauge (Pro Med Products, Atlanta, GA) will be used. Participants will be instructed to squeeze the pinch gauge maximally between the thumb pulp and the index finger pulp while maintaining the testing position. Three trials will be performed, and the mean value will be recorded in kilograms-force.
Measured: Baseline (single assessment at study visit)
Pain Intensity at Rest (VAS)
Pain intensity at rest was evaluated using the Visual Analog Scale (VAS), scored from 0 (no pain) to 10 (worst imaginable pain), with higher scores representing greater pain intensity.
Measured: Baseline (single assessment at study visit)
Pain Intensity During Activity (VAS)
Pain intensity during activity was evaluated using the Visual Analog Scale (VAS), scored from 0 (no pain) to 10 (worst imaginable pain), with higher scores representing greater pain intensity.
Measured: Baseline (single assessment at study visit)
Pain Frequency/Occurrence (Alnot Classification)
Pain frequency and occurrence were classified using the Alnot classification according to the conditions under which pain occurs (0 = no pain, 1 = pain during intense exertion, 2 = pain during daily activities, 3 = spontaneous intermittent pain, 4 = continuous pain).
Measured: Baseline (single assessment at study visit)
Light Touch/Pressure Sensation (Semmes-Weinstein Monofilament test)
Light touch and pressure sensation were assessed using the Semmes-Weinstein Monofilament (SWM) test (Baseline® Tactile™ Monofilament - 20-piece set). Sensory threshold was determined using graded nylon monofilaments, with a threshold value of 2.83 mg/cm² considered normal. Perception of monofilaments greater than 2.83 in any of the first three digits was interpreted as sensory impairment. Sensory performance was recorded based on the smallest monofilament perceived, with higher values indicating reduced cutaneous sensitivity.
Measured: Baseline (single assessment at study visit)
Vibration Sense (128 Hz tuning fork)
Vibration sense was evaluated using a 128 Hz tuning fork applied to the radial styloid. The duration of perceived vibration was recorded in seconds, and values of 8 seconds or less were considered indicative of impaired vibration sense. Longer perception times reflected better vibration sensitivity.
Measured: Baseline (single assessment at study visit)
Hand Grip-Related Functional Performance Score (5 Grasp Patterns)
Grip function was assessed across five commonly described grasp patterns in daily activities: power grip, key pinch, pinch grip, cylindrical grip, and precision grip. Functional difficulty for each grasp type was rated using a three-level Likert-type scale, with scores of 4 indicating no or mild difficulty, 2 indicating moderate difficulty, and 0 indicating severe difficulty or inability to perform the task. The total score ranged from 0 to 20, with lower scores reflecting poorer hand function. Individuals with a total score of 16 or less were classified as having moderate to poor hand function, defined by the inability to perform at least one grasp type and difficulty in at least two grasp patterns.
Measured: Baseline (single assessment at study visit)
Manual Dexterity and Functional Sensory Performance (Moberg Pick-Up Test)
Functional sensory performance and manual dexterity were assessed using the Moberg Pick-Up Test. The test evaluates the ability to manipulate small objects using tactile input and fine motor control. Performance was quantified as the time required to complete the task, recorded in seconds. Mean completion time across repeated trials was used for analysis, with longer times indicating reduced functional performance.
Measured: Baseline (single assessment at study visit)
Thumb-Specific Disability (Thumb Disability Index [TDX])
Thumb-specific functional disability was assessed using the Thumb Disability Index (TDX), a patient-reported outcome measure consisting of 20 items across three domains: thumb-related functional activities, pain, and satisfaction with the affected thumb. Total and subscale scores were calculated and transformed to a 0-100 scale, where higher scores indicate greater functional limitation. TDX scores were not calculated when more than 10% of items were left unanswered.
Measured: Baseline (single assessment at study visit)
Upper Extremity Disability (QuickDASH)
Overall upper extremity function was evaluated using the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire. This 11-item self-reported measure assesses symptoms and functional limitations related to upper extremity use. Total scores range from 0 to 100, with higher scores indicating greater disability. The Turkish version of the QuickDASH has demonstrated established validity and reliability.
Measured: Baseline (single assessment at study visit)
Emotional Distress (Hospital Anxiety and Depression Scale [HADS])
Emotional status was assessed using the Hospital Anxiety and Depression Scale (HADS). The HADS is a 14-item self-report questionnaire consisting of two subscales that assess symptoms of anxiety (7 items) and depression (7 items). Each item is scored on a 4-point Likert scale ranging from 0 to 3, yielding subscale scores between 0 and 21. Higher scores indicate greater emotional distress. Scores of 0-7 are considered within the normal range, scores of 8-10 indicate possible emotional disturbance, and scores of 11 or higher suggest clinically relevant anxiety or depression. The HADS is intended as a screening tool rather than a diagnostic instrument and reflects emotional status over the previous week.
Measured: Baseline (single assessment at study visit)
Fear of Movement (Tampa Scale of Kinesiophobia [TSK])
Fear of movement was evaluated using the Tampa Scale of Kinesiophobia (TSK). The TSK is a 17-item Likert-type questionnaire designed to assess fear of movement and re-injury associated with pain. Each item is scored from 1 (strongly disagree) to 4 (strongly agree), resulting in a total score ranging from 17 to 68. Four items are reverse scored, and higher total scores indicate greater levels of kinesiophobia. A total score above 37 is commonly used to indicate a high level of fear of movement. The Turkish version of the TSK has demonstrated acceptable validity and test-retest reliability.
Measured: Baseline (single assessment at study visit)
Passive Positional Stability of Thumb Joints During Pinch (No Load)
Thumb joint positional awareness during pinch will be assessed in a quiet room under a passive (no-load) condition. The trapeziometacarpal (TMC), metacarpophalangeal (MCP), and interphalangeal (IP) joints will be evaluated. The examiner passively sets Kapandji position 3 (TMC and MCP 30° flexion; IP 20°), participants encode the position for approximately 30 seconds, and then reproduce the posture with eyes closed. Joint angles are measured with a manual goniometer (degrees). A practice trial precedes testing; each measure is taken 3 times and averaged, with 2-minute rest between trials.
Measured: Baseline (single assessment at study visit)
Active Load-Bearing Positional Stability of Thumb Joints During Pinch
Thumb joint positional awareness during pinch will be assessed in a quiet room under an active load-bearing condition. The trapeziometacarpal (TMC), metacarpophalangeal (MCP), and interphalangeal (IP) joints will be evaluated. The same target posture (Kapandji position 3: TMC and MCP 30° flexion; IP 20°) is set and encoded, then reproduced with eyes closed during maximal voluntary pinch on a pinch dynamometer. Joint angles are measured with a manual goniometer (degrees). A practice trial precedes testing; each measure is taken 3 times and averaged, with 2-minute rest between trials.
Measured: Baseline (single assessment at study visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start23 Oct 2025
- Primary completionMar 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Trapeziometacarpal OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cigdem Ayhan, Hacettepe University
- Investigators
- Çiğdem Ayhan Kuru, PT, PhD, Principal investigator, Faculty of Physiotherapy and Rehabilitation, Department of Orthopedic Physiotherapy and Rehabilitation, Hacettepe University, Ankara, TurkeyMerve Sümeyye Yılmaz, PT, Study director, Faculty of Physiotherapy and Rehabilitation, Department of Orthopedic Physiotherapy and Rehabilitation, Hacettepe University, Ankara, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07447323
- Sponsor's protocol ID
- FTREK25/112
- Status last verified
- Feb 2026
- First submitted
- 23 Feb 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 41500919Kennedy 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.
PubMed 27146653Yahya 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.
PubMed 31586215Yahya 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.
PubMed 29765192Ouegnin 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.
PubMed 30871959Seok 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.
PubMed 32501842Ludwig 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.
PubMed 26649261Gehrmann 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.
PubMed 20807622Poole 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.
PubMed 10855745
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Thumb Proprioception in Trapeziometacarpal Joint Osteoarthritis
- ClinicalTrials.gov ID
- NCT07447323
- Acronym / sponsor ID
- FTREK25/112
- Conditions
- Trapeziometacarpal Osteoarthritis
- Keywords
- Thumb proprioception, Joint position sense, Pinch aperture proprioception, Trapeziometacarpal joint, Pain, Proprioception, Carpometacarpal, Proprioception*
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 23 Oct 2025 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 3 Mar 2026 (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.
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:
- To compare these measurements between people with thumb base osteoarthritis and healthy people.
- To find out whether this ability changes from milder to more advanced levels of osteoarthritis.
- 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.
This is an observational study. No treatment is given. Participants complete thumb measurements and several tests/questionnaires.
Detailed description
This study aims to quantitatively evaluate thumb proprioception in individuals diagnosed with trapeziometacarpal (TMC) joint osteoarthritis (OA) and to compare the findings with healthy individuals. As a secondary aim, potential determinants that may influence proprioceptive function of the thumb joints will be examined systematically. In this context, relationships between thumb proprioception and participants' demographic characteristics (age, sex, body weight, occupational characteristics, and OA severity), motor functions (muscle strength of opponens pollicis, first dorsal interosseous, abductor pollicis brevis/longus, and flexor pollicis brevis/longus, as well as fine motor performance), sensory functions (pain, light touch/pressure sensation, and vibration sensation), and emotional status (fear of movement, anxiety, and depression) will be investigated. In addition, whether proprioceptive measures differ across radiographic severity levels will be evaluated within the TMC OA group.
The study is conducted using a cross-sectional case-control design. Individuals with TMC OA are compared with an healthy control group. In the TMC OA group, disease severity is classified based on radiographs according to the Eaton-Littler classification (Stages 1-4).
Thumb proprioception is assessed using two main outcomes: (1) joint position sense (JPS) error values for the TMC, metacarpophalangeal (MCP), and interphalangeal (IP) joints, and (2) pinch aperture proprioception error values. To evaluate the repeatability of pinch aperture proprioception measurement in individuals with TMC OA, an intra-rater test-retest approach is used; the same test is administered to 30 participants by the same assessor within one week.
Sample size is planned to support the primary hypothesis. For the primary group comparisons, at least 20 participants per group are targeted. To enable planned subgroup analyses by OA severity, the study aims to include 20 individuals for each Eaton-Littler stage (Stages 1-4) in the TMC OA group (total 80 individuals with TMC OA) and 20 healthy controls, resulting in a total target sample size of 100 participants.
Statistical analyses will be performed using SPSS for Windows version 22.0. Continuous variables will be reported as mean ± standard deviation or median (interquartile range), and categorical variables as frequency and percentage. Depending on data distribution, parametric or non-parametric methods will be used. Proprioceptive outcomes will be compared between the TMC OA group and the age-matched healthy control group using appropriate two-group comparison tests. Planned subgroup comparisons across radiographic severity levels (Eaton-Littler Stages 1-4) will be conducted within the TMC OA group. Associations between proprioceptive outcomes and demographic, motor, sensory, and emotional factors will be examined using correlation analyses and, where appropriate, multiple regression models. Statistical significance will be set at two-sided p < 0.05, and effect sizes will be reported where applicable.
Ethics approval was obtained from the Hacettepe University Faculty of Physical Therapy and Rehabilitation Research Ethics Committee (Session date: 23 Oct 2025; Session number: 2025/22; Decision number: FTREK25/112; validity: 23 Oct 2025-23 Oct 2027). All participants received verbal and written information about the purpose and scope of the study, the assessments to be performed, potential discomfort, and their right to withdraw at any time without providing a reason; written informed consent was obtained prior to assessments. A safety approach was adopted such that measurements were discontinued if a participant reported discomfort during assessment. To ensure confidentiality, all participants were assigned a unique study code, and identifying information was stored separately from measurement data. Analyses were conducted using de-identified datasets. Data were stored in password-protected digital files, and any paper forms were kept in a locked cabinet with access restricted to the research team.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TMC OA Group (Eaton-Littler Stages I-IV) | – | Other: Thumb Proprioception AssessmentIndividuals 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. |
| Healthy Control Group | – | Other: Thumb Proprioception AssessmentHealthy 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. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
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 |
|---|---|---|
| Thumb Proprioception AssessmentThis 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. | Other | Healthy Control Group, TMC OA Group (Eaton-Littler Stages I-IV) |
Primary outcome
Joint Position Sense (JPS)
Time frame: Baseline (single assessment at study visit)
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.
Pinch Aperture Proprioception
Time frame: Baseline (single assessment at study visit)
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.
22 secondary outcomes
Joint Mobility
Time frame: Baseline (single assessment at study visit)
Opposition
Time frame: Baseline (single assessment at study visit)
Re-Opposition
Time frame: Baseline (single assessment at study visit)
Hypermobility
Time frame: Baseline (single assessment at study visit)
Thumb/Hand Muscle Strength (Manual Muscle Testing)
Time frame: Baseline (single assessment at study visit)
Hand Grip Strength
Time frame: Baseline (single assessment at study visit)
Lateral Pinch Strength
Time frame: Baseline (single assessment at study visit)
Tripod Pinch Strength
Time frame: Baseline (single assessment at study visit)
Tip Pinch Strength
Time frame: Baseline (single assessment at study visit)
Pain Intensity at Rest (VAS)
Time frame: Baseline (single assessment at study visit)
Pain Intensity During Activity (VAS)
Time frame: Baseline (single assessment at study visit)
Pain Frequency/Occurrence (Alnot Classification)
Time frame: Baseline (single assessment at study visit)
Light Touch/Pressure Sensation (Semmes-Weinstein Monofilament test)
Time frame: Baseline (single assessment at study visit)
Vibration Sense (128 Hz tuning fork)
Time frame: Baseline (single assessment at study visit)
Hand Grip-Related Functional Performance Score (5 Grasp Patterns)
Time frame: Baseline (single assessment at study visit)
Manual Dexterity and Functional Sensory Performance (Moberg Pick-Up Test)
Time frame: Baseline (single assessment at study visit)
Thumb-Specific Disability (Thumb Disability Index [TDX])
Time frame: Baseline (single assessment at study visit)
Upper Extremity Disability (QuickDASH)
Time frame: Baseline (single assessment at study visit)
Emotional Distress (Hospital Anxiety and Depression Scale [HADS])
Time frame: Baseline (single assessment at study visit)
Fear of Movement (Tampa Scale of Kinesiophobia [TSK])
Time frame: Baseline (single assessment at study visit)
Passive Positional Stability of Thumb Joints During Pinch (No Load)
Time frame: Baseline (single assessment at study visit)
Active Load-Bearing Positional Stability of Thumb Joints During Pinch
Time frame: Baseline (single assessment at study visit)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Background: PubMed 41500919Ulusoy 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.
- Background: PubMed 27146653Kennedy 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.
- Background: PubMed 31586215Yahya 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.
- Background: PubMed 29765192Yahya 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.
- Background: PubMed 30871959Ouegnin 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.
- Background: PubMed 32501842Seok 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.
- Background: PubMed 26649261Ludwig 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.
- Background: PubMed 20807622Gehrmann 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.
- Background: PubMed 10855745Poole 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.
- Individual participant dataSharing planned: No. 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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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.
Çiğdem Ayhan Kuru, PT, PhD principal investigator
Faculty of Physiotherapy and Rehabilitation, Department of Orthopedic Physiotherapy and Rehabilitation, Hacettepe University, Ankara, Turkey
Merve Sümeyye Yılmaz, PT study director
Faculty of Physiotherapy and Rehabilitation, Department of Orthopedic Physiotherapy and Rehabilitation, Hacettepe University, Ankara, Turkey
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 Trapeziometacarpal Osteoarthritis, run by Hacettepe University 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 13 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 3 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Merve Sümeyye Yılmaz, PT (+90 507 843 82 69, mervesumeyyeyilmaz@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Joint Position Sense (JPS) (time frame: Baseline (single assessment at study visit)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07447323, which also lists 9 linked publications.
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 3 Mar 2026.