Hand Dominance in Fibromyalgia

May 8, 2022 updated by: Elzem Bolkan Günaydın, Ufuk University

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 Overview

Study Type

Observational

Enrollment (Actual)

80

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

    • Çankaya
      • Ankara, Çankaya, Turkey, 06520
        • Ufuk University

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

20 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • This study included 40 fibromyalgia patients aged 20-50 years, meeting the American College of Rheumatology (ACR) 2016 Fibromyalgia Diagnostic Criteria.

Exclusion Criteria:

  • 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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months
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.
6 months
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Beck Depression Inventory
Time Frame: 6 months
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.
6 months
Beck Anxiety Inventory
Time Frame: 6 months
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.
6 months
The American College of Rheumatology 2016 Fibromyalgia Diagnostic Criteria
Time Frame: 6 months
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.
6 months
The Revised Fibromyalgia Impact Questionnaire
Time Frame: 6 months
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.
6 months

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)

March 5, 2021

Primary Completion (ACTUAL)

September 5, 2021

Study Completion (ACTUAL)

September 5, 2021

Study Registration Dates

First Submitted

May 8, 2022

First Submitted That Met QC Criteria

May 8, 2022

First Posted (ACTUAL)

May 12, 2022

Study Record Updates

Last Update Posted (ACTUAL)

May 12, 2022

Last Update Submitted That Met QC Criteria

May 8, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

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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