Psoriatic Arthropathy HandNCT04540809
The Effect of Psoriatic Arthritis on the Functions of the Hand
An observational study of Psoriatic Arthropathy Hand and Psoriatic Arthritis, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Psoriatic Arthropathy Hand, Psoriatic Arthritis
- What is being tested?
- Assessment of strength, proprioception, skill and coordination of the hand
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2019to 15 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Individuals and healthy controls diagnosed with PsA according to the classification criteria for PsA (Classification Criteria for Psoriatic Arthritis, CASPAR).
Who may be able to join
- Individuals between the ages of 18-65
Who cannot join
- Neurological diseases that caused sequelae at hand, upper extremity surgeries, neuropathies, traumas, and history of nerve damage
- Psychiatric disorders,
- Reluctance to continue evaluation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Psoriatic Arthropathy Hand, Psoriatic Arthritis
- Being tested
- Assessment of strength, proprioception, skill and coordination of the hand
- Keywords
- Psoriatic Arthritis, Pathogenesis, Disease activity, Hand
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of strength, proprioception, skill and coordination of the handOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Psoriatic arthritis group (PsAG) | The evaluation was made using dynamometer, goniometer, mobile application, and Purdue pegboard test. Receives: Other: Assessment of strength, proprioception, skill and coordination of the hand |
What is being measured
The primary outcome is the main question the study is designed to answer.
Handgrip strength
Handgrip was measured with the Baseline Digital Hand Dynamometer 135 KG®. The results were recorded as Kg.
Measured: 3 months
Pinch strength
Pinch strength was measured with the Baseline Hydraulic Compaction Meter 45 KG®. The results were recorded as Kg.
Measured: 3 months
Wrist proprioception
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.
Measured: 3 months
Finger skills
Finger skills were recorded as points at the end of 30 seconds with the mobile application. Higher scores indicate better functional status.
Measured: 3 months
Both hand skill and coordination
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.
Measured: 3 months
Secondary outcomes (3)
Disease activity
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.
Measured: 3 months
Michigan Hand Outcomes Questionnaire
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.
Measured: 3 months
Health Assessment Questionnaire
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2020
- Study start15 Apr 2019
- Primary completion1 Jul 2019
- Study completion15 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriatic Arthropathy HandStudies of the same condition, open and under way.
- More trials run by Inonu 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
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burcu Talu, Inonu University
- Investigators
- Burcu TALU, Principal investigator, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04540809
- Sponsor's protocol ID
- 2019 / 7-21
- Status last verified
- Sep 2020
- First submitted
- 28 Aug 2020
- Last updated
- 7 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Psoriatic Arthritis on the Strength, Proprioception, Skill, Coordination, and Functional Condition of the Hand
- ClinicalTrials.gov ID
- NCT04540809
- Acronym / sponsor ID
- 2019 / 7-21
- Conditions
- Psoriatic Arthropathy Hand, Psoriatic Arthritis
- Keywords
- Psoriatic Arthritis, Pathogenesis, Disease activity, Hand
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 15 Jul 2019 (actual)
- First posted
- 7 Sep 2020 (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 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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psoriatic arthritis group (PsAG) | – | Other: Assessment of strength, proprioception, skill and coordination of the handThe evaluation was made using dynamometer, goniometer, mobile application, and Purdue pegboard test. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals and healthy controls diagnosed with PsA according to the classification criteria for PsA (Classification Criteria for Psoriatic Arthritis, CASPAR).
Key inclusion criteria (1 listed)
- Individuals between the ages of 18-65
Key exclusion criteria (3 listed)
- Neurological diseases that caused sequelae at hand, upper extremity surgeries, neuropathies, traumas, and history of nerve damage
- Psychiatric disorders,
- Reluctance to continue evaluation
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 |
|---|---|---|
| Assessment of strength, proprioception, skill and coordination of the handDisease 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. | Other | Psoriatic arthritis group (PsAG) |
Primary outcome
Handgrip strength
Time frame: 3 months
Handgrip was measured with the Baseline Digital Hand Dynamometer 135 KG®. The results were recorded as Kg.
Pinch strength
Time frame: 3 months
Pinch strength was measured with the Baseline Hydraulic Compaction Meter 45 KG®. The results were recorded as Kg.
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.
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.
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 secondary outcomes
Disease activity
Time frame: 3 months
Michigan Hand Outcomes Questionnaire
Time frame: 3 months
Health Assessment Questionnaire
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2020.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
Burcu TALU principal investigator
Inonu University
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 Psoriatic Arthropathy Hand and Psoriatic Arthritis, run by Inonu 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 1 inclusion and 3 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: finished, as of the sponsor's last update on 7 Sep 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Handgrip strength (time frame: 3 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Sep 2020.