FibromyalgiaNCT05372432
Hand Dominance in Fibromyalgia
An observational study of Fibromyalgia, run by Ufuk University at 1 site in Turkey (Türkiye).
Trial summary
Evaluating laterality changes in different psychiatric and neurodevelopmental diseases has recently been one of the popular perspectives of laterality studies. There are studies reporting changes in functional and structural hemispheric asymmetries in some neurodevelopmental and psychiatric diseases, and thus… Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Handgrip strengths measurements with Jamar-type hand dynamometer and, tip pinch strengths measurements with pinchmeter and The Nine Hole Peg Test
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Mar 2021to 5 Sep 2021
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: This cross-sectional study included 40 fibromyalgia patients aged 20-50 years, meeting the American College of Rheumatology (ACR) 2016 Fibromyalgia Diagnostic Criteria, and 40 healthy volunteers in the same age range as the control group.
Who may be able to join
- This study included 40 fibromyalgia patients aged 20-50 years, meeting the American College of Rheumatology (ACR) 2016 Fibromyalgia Diagnostic Criteria.
Who cannot join
- Exclusion criteria were defined as being younger than 20 years of age, older than 50 years of age, having systemic, inflammatory, degenerative, and neurological diseases that may lead to loss of hand and finger grip strength and dexterity, and a history of hand surgery or trauma in the last three months.
Trial locations and contacts
1 site in 1 country.
About this study
Evaluating laterality changes in different psychiatric and neurodevelopmental diseases has recently been one of the popular perspectives of laterality studies. There are studies reporting changes in functional and structural hemispheric asymmetries in some neurodevelopmental and psychiatric diseases, and thus relations with atypical lateralization patterns or handedness. There is no study in the literature evaluating brain lateralization or handedness in fibromyalgia. The aim of our study is to evaluate the relationship between handedness, which is an indicator of brain lateralization, and fibromyalgia disease severity and functional outcomes related to fibromyalgia in patients with fibromyalgia. This cross-sectional study included 40 fibromyalgia patients aged 20-50 years, meeting the American College of Rheumatology 2016 Fibromyalgia Diagnostic Criteria, and 40 healthy volunteers in the same age range as the control group. Information about the age, gender, height, weight, and comorbidities of the participants included in the study were recorded. In addition, information about the duration of fibromyalgia diagnosis and pharmacological and non-pharmacological treatments for fibromyalgia were also recorded in the patient group.
Handgrip strengths with Jamar-type hand dynamometer, tip pinch strengths with pinch meter, and hand dexterities with the Nine-Hole Peg Test were evaluated for both hands of all participants. The Edinburgh Handedness Inventory, Beck Depression Inventory, and Beck Anxiety Inventory were administered to all participants. In addition, the American College of Rheumatology 2016 Fibromyalgia Diagnostic Criteria was questioned in the patient group, and the Revised Fibromyalgia Impact Questionnaire was applied.
- Conditions
- Fibromyalgia
- Being tested
- Handgrip strengths measurements with Jamar-type hand dynamometer and, tip pinch strengths measurements with pinchmeter, The Nine Hole Peg Test
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Handgrip strengths measurements with Jamar-type hand dynamometer and, tip pinch strengths measurements with pinchmeterOther
The handgrip strength and tip pinch strength of the participants were measured using the Jamar-type hand dynamometer and pinch meter available in our clinic. The handgrip strengths were measured with shoulders in adduction and neutral rotation, elbows in 90 degrees flexion, and forearms and wrists in a neutral position, while the tip pinch strengths were measured by squeezing a pinch meter between the thumb and index finger. Participants took a deep breath and then applied gripping force with maximal force while exhaling. In the analysis, the average of the three measurements made with an interval of five minutes was taken as the basis for the analysis.
The Nine Hole Peg TestOther
This test was used to evaluate the hand dexterity of the participants. This test consists of a square area and nine holes in this area, nine cylinders suitable for these holes, and a storage box. Participants quickly took the nine cylinders from the storage box and placed them in the holes, and after placing all the cylinders, they put the cylinders back in the storage box one by one. In the evaluation of the test, the time elapsed during these operations was measured in seconds with a chronometer, and shorter times were considered to indicate better hand dexterity.
What is being measured
The primary outcome is the main question the study is designed to answer.
The handgrip and tip pinch strengths
The handgrip strength and tip pinch strength of the participants were measured using the Jamar-type hand dynamometer and pinch meter available in our clinic. In the analysis, the average of the three measurements made with an interval of five minutes was taken as the basis for the analysis.
Measured: 6 months
The Nine Hole Peg Test
This test was used to evaluate the hand dexterity of the participants. This test consists of a square area and nine holes in this area, nine cylinders suitable for these holes, and a storage box. Participants quickly took the nine cylinders from the storage box and placed them in the holes, and after placing all the cylinders, they put the cylinders back in the storage box one by one. The shorter test times were considered to indicate better hand dexterity.
Measured: 6 months
The Edinburgh Handedness Inventory
It is a questionnaire developed by Oldfield in 1971 to evaluate handedness. This inventory questions individuals' hand use in 10 different activities of daily living (writing, drawing, throwing, using scissors, brushing teeth, using a knife, using a spoon, using a broom, lighting a match, opening a box). In the inventory, there are two boxes for each activity questioning the use of the right and left hand. Only the right or left hand is always used for the specified activity; if the other hand is not used at all, both boxes for the used hand are checked. Generally, if the right or left hand is used for the specified activity, one of the boxes for the used hand is checked. If the specified activity is performed using both hands, one of the boxes on both the right and the left is checked. Right, and left-hand scores are calculated by counting the boxes checked for right and left-hand use.
Measured: 6 months
Secondary outcomes (4)
Beck Depression Inventory
This scale evaluates the level and severity of depressive symptoms. The scale consists of 21 questions in a 4-point Likert structure, where each question is scored between 0 and 3. Higher scores indicate higher levels of depression.
Measured: 6 months
Beck Anxiety Inventory
This scale determines the frequency of anxiety symptoms experienced by individuals. The scale consists of 21 questions in a 4-point Likert structure, where each question is scored between 0 and 3. Higher scores indicate more severe anxiety.
Measured: 6 months
The American College of Rheumatology 2016 Fibromyalgia Diagnostic Criteria
It is a set of diagnostic criteria developed for the diagnosis of fibromyalgia and created as a result of the revision of previously used diagnostic criteria. It consists of two parts, the widespread pain index (WPI) and the symptom severity scale (SSS). In the evaluation of the Fibromyalgia Severity Scale (FSS), WPI and SSS scores are collected. The total score ranges from 12 to 31. A higher score indicates greater disease severity. WPI ≥7 and SSS score ≥5, or WPI=4-6 and SSS score ≥9 suggest a diagnosis of fibromyalgia.
Measured: 6 months
The Revised Fibromyalgia Impact Questionnaire
This questionnaire evaluates functional limitations and disability due to fibromyalgia. The questionnaire, which consists of 21 questions in total, consists of three parts: function, overall impact, and symptoms. The answers to each question are marked on a scale from 0 to 10. The total score is calculated by summing the results by dividing the score of the first section by three, the score of the second section by one, and the score of the third section by two. Higher scores indicate a more fibromyalgia-related disability.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start5 Mar 2021
- Primary completion5 Sep 2021
- Study completion5 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ufuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elzem Bolkan Günaydın, Ufuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05372432
- Sponsor's protocol ID
- 2021-04-05
- Status last verified
- May 2022
- First submitted
- 8 May 2022
- Last updated
- 12 May 2022
- 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 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hand Dominance in Fibromyalgia
- ClinicalTrials.gov ID
- NCT05372432
- Acronym / sponsor ID
- 2021-04-05
- Conditions
- Fibromyalgia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ufuk UniversityUniversity, hospital or other
- Study start
- 5 Mar 2021 (actual)
- Primary completion
- 5 Sep 2021 (actual)
- Study completion
- 5 Sep 2021 (actual)
- First posted
- 12 May 2022 (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.
Evaluating laterality changes in different psychiatric and neurodevelopmental diseases has recently been one of the popular perspectives of laterality studies. There are studies reporting changes in functional and structural hemispheric asymmetries in some neurodevelopmental and psychiatric diseases, and thus relations with atypical lateralization patterns or handedness. There is no study in the literature evaluating brain lateralization or handedness in fibromyalgia. The aim of our study is to evaluate the relationship between handedness, which is an indicator of brain lateralization, and fibromyalgia disease severity and functional outcomes related to fibromyalgia in patients with fibromyalgia. This cross-sectional study included 40 fibromyalgia patients aged 20-50 years, meeting the American College of Rheumatology 2016 Fibromyalgia Diagnostic Criteria, and 40 healthy volunteers in the same age range as the control group. Information about the age, gender, height, weight, and comorbidities of the participants included in the study were recorded. In addition, information about the duration of fibromyalgia diagnosis and pharmacological and non-pharmacological treatments for fibromyalgia were also recorded in the patient group.
Handgrip strengths with Jamar-type hand dynamometer, tip pinch strengths with pinch meter, and hand dexterities with the Nine-Hole Peg Test were evaluated for both hands of all participants. The Edinburgh Handedness Inventory, Beck Depression Inventory, and Beck Anxiety Inventory were administered to all participants. In addition, the American College of Rheumatology 2016 Fibromyalgia Diagnostic Criteria was questioned in the patient group, and the Revised Fibromyalgia Impact Questionnaire was applied.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This cross-sectional study included 40 fibromyalgia patients aged 20-50 years, meeting the American College of Rheumatology (ACR) 2016 Fibromyalgia Diagnostic Criteria, and 40 healthy volunteers in the same age range as the control group.
Key inclusion criteria (1 listed)
- This study included 40 fibromyalgia patients aged 20-50 years, meeting the American College of Rheumatology (ACR) 2016 Fibromyalgia Diagnostic Criteria.
Key exclusion criteria (1 listed)
- Exclusion criteria were defined as being younger than 20 years of age, older than 50 years of age, having systemic, inflammatory, degenerative, and neurological diseases that may lead to loss of hand and finger grip strength and dexterity, and a history of hand surgery or trauma in the last three months.
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 |
|---|---|---|
| Handgrip strengths measurements with Jamar-type hand dynamometer and, tip pinch strengths measurements with pinchmeterThe handgrip strength and tip pinch strength of the participants were measured using the Jamar-type hand dynamometer and pinch meter available in our clinic. The handgrip strengths were measured with shoulders in adduction and neutral rotation, elbows in 90 degrees flexion, and forearms and wrists in a neutral position, while the tip pinch strengths were measured by squeezing a pinch meter between the thumb and index finger. Participants took a deep breath and then applied gripping force with maximal force while exhaling. In the analysis, the average of the three measurements made with an interval of five minutes was taken as the basis for the analysis. | Other | – |
| The Nine Hole Peg TestThis test was used to evaluate the hand dexterity of the participants. This test consists of a square area and nine holes in this area, nine cylinders suitable for these holes, and a storage box. Participants quickly took the nine cylinders from the storage box and placed them in the holes, and after placing all the cylinders, they put the cylinders back in the storage box one by one. In the evaluation of the test, the time elapsed during these operations was measured in seconds with a chronometer, and shorter times were considered to indicate better hand dexterity. | Other | – |
Primary outcome
The handgrip and tip pinch strengths
Time frame: 6 months
The handgrip strength and tip pinch strength of the participants were measured using the Jamar-type hand dynamometer and pinch meter available in our clinic. In the analysis, the average of the three measurements made with an interval of five minutes was taken as the basis for the analysis.
The Nine Hole Peg Test
Time frame: 6 months
This test was used to evaluate the hand dexterity of the participants. This test consists of a square area and nine holes in this area, nine cylinders suitable for these holes, and a storage box. Participants quickly took the nine cylinders from the storage box and placed them in the holes, and after placing all the cylinders, they put the cylinders back in the storage box one by one. The shorter test times were considered to indicate better hand dexterity.
The Edinburgh Handedness Inventory
Time frame: 6 months
It is a questionnaire developed by Oldfield in 1971 to evaluate handedness. This inventory questions individuals' hand use in 10 different activities of daily living (writing, drawing, throwing, using scissors, brushing teeth, using a knife, using a spoon, using a broom, lighting a match, opening a box). In the inventory, there are two boxes for each activity questioning the use of the right and left hand. Only the right or left hand is always used for the specified activity; if the other hand is not used at all, both boxes for the used hand are checked. Generally, if the right or left hand is used for the specified activity, one of the boxes for the used hand is checked. If the specified activity is performed using both hands, one of the boxes on both the right and the left is checked. Right, and left-hand scores are calculated by counting the boxes checked for right and left-hand use.
4 secondary outcomes
Beck Depression Inventory
Time frame: 6 months
Beck Anxiety Inventory
Time frame: 6 months
The American College of Rheumatology 2016 Fibromyalgia Diagnostic Criteria
Time frame: 6 months
The Revised Fibromyalgia Impact Questionnaire
Time frame: 6 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 12 May 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Fibromyalgia, run by Ufuk 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 1 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 12 May 2022. 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?
The handgrip and tip pinch strengths (time frame: 6 months). The study lists 3 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 12 May 2022.