- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04540809
The Effect of Psoriatic Arthritis on the Functions of the Hand
September 4, 2020 updated by: Burcu Talu, Inonu University
Effect of Psoriatic Arthritis on the Strength, Proprioception, Skill, Coordination, and Functional Condition of the Hand
This study was planned to evaluate the effect of psoriatic arthritis on the strength, proprioception, skill, coordination, and functional condition of the hand and to determine the correlate disease activity with these parameters.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Psoriatic arthritis (PsA) is a chronic, progressive, inflammatory arthritis that occurs as a condition associated with patients with psoriasis and may result in permanent joint damage and an increased risk of mortality.
Synovial membrane inflammation characterized by increased vascularization and immune cell infiltration is an important feature of psoriatic arthritis.
This inflamed synovial microenvironment leads to the formation of synovial pannus, entheseal inflammation, and joint damage.
Although PsA is generally thought of as a benign arthropathy, structural damage has been shown with the progression of the disease, along with joint inflammation.As a result of the researches, it has been stated that tissue biomechanical stress and microtraumas that lead to the activation of abnormal natural immune responses in psoriatic arthritis can trigger joint inflammation.
In parallel, inflammation is expected to be more common in peripheral joints, which are known to be more exposed to microtrauma.
Studies have reported that hand joint involvement is frequently seen in patients with PsA and is an important cause of loss of function and that erosions in hand joints are associated with statistically significant loss of hand strength.
Theoretically, either the mechanical effect of the fluid in the acute joint effusion or the components of the inflammatory fluid and the changing capsular compliance after chronic effusion and has been reported that problems may occur in proprioception due to causes such as pain, trauma, and fatigue.
However, pain, decreased joint ROM and grip strength, muscle weakness, and hand deformities can affect hand fine hand skills and function.
The hypothesis of this study is that supporting the clinical condition of the participants with parameters related to general hand function will be effective in predicting disease progression and disability.
Accordingly, the aim of the researchers is to evaluate the effect of PsA on the grip and pinch strength of the hand, proprioception, skill, coordination and functional status, and to determine the relationship of disease activity with these parameters.
Study Type
Observational
Enrollment (Actual)
56
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Malatya, Turkey
- İnönü University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Individuals and healthy controls diagnosed with PsA according to the classification criteria for PsA (Classification Criteria for Psoriatic Arthritis, CASPAR).
Description
Inclusion Criteria:
- Individuals between the ages of 18-65
Exclusion Criteria:
- Neurological diseases that caused sequelae at hand, upper extremity surgeries, neuropathies, traumas, and history of nerve damage
- Psychiatric disorders,
- Reluctance to continue evaluation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Psoriatic arthritis group (PsAG)
The evaluation was made using dynamometer, goniometer, mobile application, and Purdue pegboard test.
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Disease Activity Score 28 was used to determine the disease activity of patients with PsA.
Grip strength was measured with the help of Baseline Digital Hand Dynamometer®.
Pinch strength was measured with Baseline Hydraulic Pinch Gauge®.
Wrist proprioception was assessed by measuring the joint position sensation using a goniometer by actively repeating the target angle predetermined by the researcher (30 ° for flexion and extension, 15 ° for ulnar deviation, 10 ° for radial deviation.
Finger skills were assessed using a mobile application called Ball Tap©.
The application included the fastest contact of the participants to the balls coming from different parts of the screen for 30 seconds.
Two hand coordination and skills were evaluated using the Purdue Pegboard test.
The Michigan Hand Outcomes Questionnaire was used for functional evaluation of the hand, and the Health Assessment Questionnaire was used to assess the general functional condition and health-related quality of life.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Handgrip strength
Time Frame: 3 months
|
Handgrip was measured with the Baseline Digital Hand Dynamometer 135 KG®.
The results were recorded as Kg.
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3 months
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Pinch strength
Time Frame: 3 months
|
Pinch strength was measured with the Baseline Hydraulic Compaction Meter 45 KG®.
The results were recorded as Kg.
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3 months
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Wrist proprioception
Time Frame: 3 months
|
Wrist proprioception was assessed by measuring joint position sense with a goniometer.
Error average of 3 repetitions in each movement axis was recorded.
Low scores indicate a better functional status.
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3 months
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Finger skills
Time Frame: 3 months
|
Finger skills were recorded as points at the end of 30 seconds with the mobile application.
Higher scores indicate better functional status.
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3 months
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Both hand skill and coordination
Time Frame: 3 months
|
Both hand skill and coordination were evaluated using the Purdue Pegboard test.
It consists of 4 parts.
These; right and left hand, both hands, and assembly.
Higher scores indicate better function.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease activity
Time Frame: 3 months
|
DAS28 is a measurement method that determines the disease activity by using the number of painful and swollen joints, ESR (erythrocyte sedimentation rate) or C-reactive protein values in the first hour, and a 100 mm visual analog scale for general evaluation.
ESR was used in this study.
Higher scores indicate higher disease activity.
|
3 months
|
Michigan Hand Outcomes Questionnaire
Time Frame: 3 months
|
The MHQ is a self-report measure that assesses the function of hand (s) and / or wrist (s).
The MHQ contains six distinct scales including overall hand function, activities of daily living, pain, work performance, aesthetics and subject satisfaction with hand function.
Each question is scored on a scale of 1-5.
High score in total scores indicates high satisfaction.
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3 months
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Health Assessment Questionnaire
Time Frame: 3 months
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It is a questionnaire consisting of 8 subtitles evaluating daily life activities.
Each question ranges from zero (no functional impairment) to three (task disabling).
Points between 0-60 are received.Lower scores indicate better conditions.
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3 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 15, 2019
Primary Completion (Actual)
July 1, 2019
Study Completion (Actual)
July 15, 2019
Study Registration Dates
First Submitted
August 28, 2020
First Submitted That Met QC Criteria
September 4, 2020
First Posted (Actual)
September 7, 2020
Study Record Updates
Last Update Posted (Actual)
September 7, 2020
Last Update Submitted That Met QC Criteria
September 4, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019 / 7-21
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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