Psoriatic ArthritisNCT04553302
Comparison of Hand Functions and Wrist Proprioception in Patients With and Without Psoriatic Arthritis
An observational study of Psoriatic Arthritis, run by Melissa Köprülüoğlu at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to assess hand functions and wrist joint position sense in patients with and without PsA. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psoriatic Arthritis
- What is being tested?
- This study does not contain any intervention.
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2019to 30 Aug 2020
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 54 participants * 18 of them PsA * 18 of them RA * 18 of them asymptomatic healthy group
Who may be able to join
- to be diagnosed according to CASPAR or ACR/ EULAR 2010 criteria for patient groups
- taking regular medication for patient groups,
- have complaints related to hand / wrist joints for patients groups,
- have no complaints related to upper extremity for asymptomatic healthy group.
- have any rheumatologic disease and OA diagnosed according to traditional criteria
Who cannot join
- finger infection and / or finger amputation,
- using orthoses,
- to report a diagnosis of neurological disease,
- to report a history of trauma or surgery involving the upper extremity,
- to report a psychiatric and / or cognitive problem
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Izmir Katip Celebi University Ataturk Research and Training Hospital
Izmir, Izmir/ Cigli
About this study
The purpose of this study is to assess hand functions and wrist joint position sense in patients with and without PsA.
Read the detailed description
In this study, 54 patients (18 of them RA, 18 of them PsA and, 18 of them asymptomatic healthy group) were included. The patient group was selected from the patients who came to the Izmir Katip Celebi University Ataturk Training and Research Hospital Rheumatology Outpatient Clinic for routine control.
Participants were matched according to age and gender. It was recorded demographic and clinical data.
Grip and pinch strengths were evaluated within the scope of hand function evaluation. Wrist joint position sense was evaluated along with hand functions.
- Conditions
- Psoriatic Arthritis
- Being tested
- This study does not contain any intervention.
- Keywords
- Psoriatic Arthritis, Hand Function, Wrist Proprioception.
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This study does not contain any intervention.Other
This study does not contain any intervention.
| Study group | Role | What they receive |
|---|---|---|
| Psoriatic Arthritis | Patients diagnosed with PsA according to CASPAR criteria by the rheumatologist were included. Receives: Other: This study does not contain any intervention. | |
| Rheumatoid Arthritis | Patients diagnosed with RA according to ACR / EULAR 2010 criteria by the rheumatologist were included. Receives: Other: This study does not contain any intervention. | |
| Asymptomatic Healthy Group | Participants had any neurological and/or rheumatological diseases, no complaints about the upper extremity. Participants diagnosed with OA according to traditional clinical criteria were excluded from the study. Receives: Other: This study does not contain any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grip Strength
Grip strenght was examined using a hand dynamometer (Lafayette Proffessional Hand Held Dynamometer, USA).
Measured: Data collection will continue until September 2019. Data analysis and report preparation will be completed by August 2020.
Secondary outcomes (5)
Two-Point Pinch Strength
It was evaluated by pinchmeter (Lafayette,USA).
Measured: Data collection will continue until September 2019. Data analysis and report preparation will be completed by August 2020.
Three-Point Pinch Strength
It was evaluated by pinchmeter (Lafayette,USA).
Measured: Data collection will continue until September 2019. Data analysis and report preparation will be completed by August 2020.
Lateral Pinch Strength
It was evaluated by pinchmeter (Lafayette,USA).
Measured: Data collection will continue until September 2019. Data analysis and report preparation will be completed by August 2020.
DASH score
The DASH score provides information about the general functionality of the upper extremity and especially activities of hand.
Measured: Data collection will continue until September 2019. Data analysis and report preparation will be completed by August 2020.
Wrist Joint Position Sense
Wrist joint position sense was evaluated by goniometric re-position error test ( in 30◦ wrist extansion, 3 repeat ).
Measured: Data collection will continue until September 2019. Data analysis and report preparation will be completed by August 2020.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study start1 Oct 2019
- Primary completion1 Jun 2020
- Study completion30 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Psoriatic ArthritisStudies of the same condition, open and under way.
- 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
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melissa Köprülüoğlu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Melissa Köprülüoğlu, Izmir Katip Celebi University
- Investigators
- İlknur NAZ GÜRŞAN, PhD, Principal investigator, İzmir Katip Celebi University, Faculty of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04553302
- Sponsor's protocol ID
- Izmir Katip Celebi University
- Status last verified
- Sep 2020
- First submitted
- 5 Sep 2020
- Last updated
- 22 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
INNES, E. V. Handgrip strength testing: a review of the literature. Australian Occupational Therapy Journal, 1999, 46.3: 120-140.
Mathiowetz V, Weber K, Volland G, Kashman N. Reliability and validity of grip and pinch strength evaluations. J Hand Surg Am. 1984 Mar;9(2):222-6. doi: 10.1016/s0363-5023(84)80146-x.
PubMed 6715829Hudak PL, Amadio PC, Bombardier C. Development of an upper extremity outcome measure: the DASH (disabilities of the arm, shoulder and hand) [corrected]. The Upper Extremity Collaborative Group (UECG). Am J Ind Med. 1996 Jun;29(6):602-8. doi: 10.1002/(SICI)1097-0274(199606)29:63.0.CO;2-L.
PubMed 8773720Navsarikar A, Gladman DD, Husted JA, Cook RJ. Validity assessment of the disabilities of arm, shoulder, and hand questionnaire (DASH) for patients with psoriatic arthritis. J Rheumatol. 1999 Oct;26(10):2191-4.
PubMed 10529138Feced Olmos CM, Alvarez-Calderon O, Hervas Marin D, Ivorra Cortes J, Pujol Marco C, Roman Ivorra JA. Relationship between structural damage with loss of strength and functional disability in psoriatic arthritis patients. Clin Biomech (Bristol). 2019 Aug;68:169-174. doi: 10.1016/j.clinbiomech.2019.06.009. Epub 2019 Jun 11.
PubMed 31220740
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Hand Functions and Wrist Proprioception in Patients With and Without Psoriatic Arthritis
- ClinicalTrials.gov ID
- NCT04553302
- Acronym / sponsor ID
- Izmir Katip Celebi University
- Conditions
- Psoriatic Arthritis
- Keywords
- Psoriatic Arthritis, Hand Function, Wrist Proprioception.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Melissa KöprülüoğluUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 30 Aug 2020 (actual)
- First posted
- 17 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.
The purpose of this study is to assess hand functions and wrist joint position sense in patients with and without PsA.
Detailed description
In this study, 54 patients (18 of them RA, 18 of them PsA and, 18 of them asymptomatic healthy group) were included. The patient group was selected from the patients who came to the Izmir Katip Celebi University Ataturk Training and Research Hospital Rheumatology Outpatient Clinic for routine control.
Participants were matched according to age and gender. It was recorded demographic and clinical data.
Grip and pinch strengths were evaluated within the scope of hand function evaluation. Wrist joint position sense was evaluated along with hand functions.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Psoriatic Arthritis | – | Other: This study does not contain any intervention.Patients diagnosed with PsA according to CASPAR criteria by the rheumatologist were included. |
| Rheumatoid Arthritis | – | Other: This study does not contain any intervention.Patients diagnosed with RA according to ACR / EULAR 2010 criteria by the rheumatologist were included. |
| Asymptomatic Healthy Group | – | Other: This study does not contain any intervention.Participants had any neurological and/or rheumatological diseases, no complaints about the upper extremity. Participants diagnosed with OA according to traditional clinical criteria were excluded from the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 54 participants * 18 of them PsA * 18 of them RA * 18 of them asymptomatic healthy group
Key inclusion criteria (5 listed)
- to be diagnosed according to CASPAR or ACR/ EULAR 2010 criteria for patient groups
- taking regular medication for patient groups,
- have complaints related to hand / wrist joints for patients groups,
- have no complaints related to upper extremity for asymptomatic healthy group.
- have any rheumatologic disease and OA diagnosed according to traditional criteria
Key exclusion criteria (5 listed)
- finger infection and / or finger amputation,
- using orthoses,
- to report a diagnosis of neurological disease,
- to report a history of trauma or surgery involving the upper extremity,
- to report a psychiatric and / or cognitive problem
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 |
|---|---|---|
| This study does not contain any intervention.This study does not contain any intervention. | Other | Asymptomatic Healthy Group, Psoriatic Arthritis, Rheumatoid Arthritis |
Primary outcome
Grip Strength
Time frame: Data collection will continue until September 2019. Data analysis and report preparation will be completed by August 2020.
Grip strenght was examined using a hand dynamometer (Lafayette Proffessional Hand Held Dynamometer, USA).
5 secondary outcomes
Two-Point Pinch Strength
Time frame: Data collection will continue until September 2019. Data analysis and report preparation will be completed by August 2020.
Three-Point Pinch Strength
Time frame: Data collection will continue until September 2019. Data analysis and report preparation will be completed by August 2020.
Lateral Pinch Strength
Time frame: Data collection will continue until September 2019. Data analysis and report preparation will be completed by August 2020.
DASH score
Time frame: Data collection will continue until September 2019. Data analysis and report preparation will be completed by August 2020.
Wrist Joint Position Sense
Time frame: Data collection will continue until September 2019. Data analysis and report preparation will be completed by August 2020.
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 22 Sep 2020.
- BackgroundINNES, E. V. Handgrip strength testing: a review of the literature. Australian Occupational Therapy Journal, 1999, 46.3: 120-140.
- Background: PubMed 6715829Mathiowetz V, Weber K, Volland G, Kashman N. Reliability and validity of grip and pinch strength evaluations. J Hand Surg Am. 1984 Mar;9(2):222-6. doi: 10.1016/s0363-5023(84)80146-x.
- Background: PubMed 8773720Hudak PL, Amadio PC, Bombardier C. Development of an upper extremity outcome measure: the DASH (disabilities of the arm, shoulder and hand) [corrected]. The Upper Extremity Collaborative Group (UECG). Am J Ind Med. 1996 Jun;29(6):602-8. doi: 10.1002/(SICI)1097-0274(199606)29:63.0.CO;2-L.
- Background: PubMed 10529138Navsarikar A, Gladman DD, Husted JA, Cook RJ. Validity assessment of the disabilities of arm, shoulder, and hand questionnaire (DASH) for patients with psoriatic arthritis. J Rheumatol. 1999 Oct;26(10):2191-4.
- Background: PubMed 31220740Feced Olmos CM, Alvarez-Calderon O, Hervas Marin D, Ivorra Cortes J, Pujol Marco C, Roman Ivorra JA. Relationship between structural damage with loss of strength and functional disability in psoriatic arthritis patients. Clin Biomech (Bristol). 2019 Aug;68:169-174. doi: 10.1016/j.clinbiomech.2019.06.009. Epub 2019 Jun 11.
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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. This study is not recruiting at the moment.
İlknur NAZ GÜRŞAN, PhD principal investigator
İzmir Katip Celebi University, Faculty of Health Sciences
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 Arthritis, run by Melissa Köprülüoğlu 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 5 inclusion and 5 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 22 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?
Grip Strength (time frame: Data collection will continue until September 2019. Data analysis and report preparation will be completed by August 2020.). 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 NCT04553302, which also lists 5 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 22 Sep 2020.