- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04819139
Position Sense, Force Control and Pain Intensity in Basal Thumb Osteoarthritis
Interaction Between Position Sense, Force Control and Pain Intensity in Basal Thumb Osteoarthritis. A Cross-sectional Study.
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Málaga
-
Malaga, Málaga, Spain, 29012
- Raquel Cantero-Téllez
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Thumb exercises +orthosis
Participants will be instructed to perform daily exercises grouped in 3 sets of 10 repetitions in the absence of pain for 4 weeks. If the patient experienced pain, the number of repetitions dropped sequentially until the exercise was performed pain free. Exercises consisted of active - resistive exercises for the first dorsal interosseous (FDI) muscle, manual distraction of the CMC joint and relaxation of the adductor thumb muscle. Each participant will also engaged in a one month re-education/joint protection program for thumb use during ADL's and completed a weekly record sheet for monitoring purposes. In addiction, they will received a "thumb whale" orthosis to wear at night and during ADL's as needed for pain. |
Active thumb exercises
Reeducation in the activities daily life
Used of a thumb orthosis
|
|
Experimental: Thumb exercises +orthosis+ proprioceptive program exercises
Participants will be instructed to perform daily exercises grouped in 3 sets of 10 repetitions in the absence of pain for 4 weeks. If the patient experienced pain, the number of repetitions dropped sequentially until the exercise was performed pain free. Exercises consisted of active - resistive exercises for the first dorsal interosseous (FDI) muscle, manual distraction of the CMC joint and relaxation of the adductor thumb muscle. Each participant will also engaged in a one month re-education/joint protection program for thumb use during ADL's and completed a weekly record sheet for monitoring purposes. In addiction, they will received a "thumb whale" orthosis to wear at night and during ADL's as needed for pain. In addiction, patients will received a proprioceptive program exercises using also a online program with a laptop. |
Active thumb exercises
Reeducation in the activities daily life
Used of a thumb orthosis
Specific proprioception exercises
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain intensity
Time Frame: baseline - 2 days
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
JPS
Time Frame: baseline - 2 days
|
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
|
|
FS
Time Frame: baseline- 2 days
|
For force sense, participants should reproduce pinch force measure with dynamometer.
|
baseline- 2 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-THUMB-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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