NCT05372432

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 5, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 8, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 12, 2022

Completed
Last Updated

May 12, 2022

Status Verified

May 1, 2022

Enrollment Period

6 months

First QC Date

May 8, 2022

Last Update Submit

May 8, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    6 months

Secondary Outcomes (4)

  • Beck Depression Inventory

    6 months

  • Beck Anxiety Inventory

    6 months

  • The American College of Rheumatology 2016 Fibromyalgia Diagnostic Criteria

    6 months

  • The Revised Fibromyalgia Impact Questionnaire

    6 months

Interventions

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.

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.

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ufuk University

Ankara, Çankaya, 06520, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer Doctor

Study Record Dates

First Submitted

May 8, 2022

First Posted

May 12, 2022

Study Start

March 5, 2021

Primary Completion

September 5, 2021

Study Completion

September 5, 2021

Last Updated

May 12, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations