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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04819139
Other study ID # 2021-THUMB-1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2021
Est. completion date June 1, 2021

Study information

Verified date June 2021
Source University of Malaga
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In practice, a single test is used to quantify thumb proprioception. Previous studies have found a decrease in joint position sense (JPS) and force sense (FS) in patients diagnosis of thumb carpometacarpal osteoarthritis, but no correlation have been stabilize between JPS, FS and pain intensity perceived by the patient during activity daily life (ADL). The goal of the study is compared joint position error (JPE) with joint force sense error (JFSE) in subjects with carpometacarpal (CMC) joint osteoarthritis and investigated a possible correlation between thumb pain intensity and thumb proprioception in patients with CMC joint OA.


Description:

Forty-five subjects over 18 with thumb CMC joint OA in the dominant hand grade 1-3 according o the Eaton Classification Stage will be evaluated for thumb active joint position sense (JPS) test and Force sense test to measure proprioception function. For measurement of JPS, the subjects will blindfolded and repositioned their thumb to a target position, which will be determined by the examiner previously. For force sense, participants will should reproduce pinch force measure with dynamometer. The severity of pain with activity will be measured according to the visual analog scale (VAS).


Recruitment information / eligibility

Status Completed
Enrollment 62
Est. completion date June 1, 2021
Est. primary completion date April 20, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Over 18 years; Diagnosis of grade I, II or II thumb CMC joint OA in their dominant hand according to the Eaton Classification Stage; A minimum pain rating of 4/10 on the Visual Analogue Scale (VAS) during activities of daily living (ADLs) at the time of the initial evaluation; Ability to read and understand the patient information sheets and exercises Exclusion Criteria: - Neurological disorder affecting the upper limb; Treatment for hand or thumb pain in the same limb in the last 6 months (including injections to the wrist, fingers, or thumb); Fracture or significant hand injury; Previous surgery to the wrist or hand; Hand/finger tenosynovitis; Dupuytren disease; Cognitive impairment that inhibited an understanding of the informed consent and exercise program; Fixed thumb adduction contracture or blindness.

Study Design


Intervention

Other:
Active Excersises
Active thumb exercises
Reeducation ADL
Reeducation in the activities daily life
Joint protection
Used of a thumb orthosis
Proprioception exercises
Specific proprioception exercises

Locations

Country Name City State
Spain Raquel Cantero-Téllez Malaga Málaga

Sponsors (1)

Lead Sponsor Collaborator
University of Malaga

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain intensity Pain intensity will be measured according to the visual analog scale (VAS). The VAS scale is a unidimensional measure of pain intensity and is widely used in adult populations, including those with rheumatic diseases. Sensitivity and reliability of the instrument are well defined including sensitivity to change in pain for patients with chronic inflammatory or degenerative joint pain baseline - 2 days
Secondary JPS For measurement of JPS, the subjects were blindfolded and repositioned their thumb to a target position, which was determined by the examiner previously baseline - 2 days
Secondary FS For force sense, participants should reproduce pinch force measure with dynamometer. baseline- 2 days
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