NCT06825195

Brief Summary

This study aims to evaluate the force used by fibromyalgia patients during a task compared to healthy volunteers and to evaluate its relationship with fatigue seen in these patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2024

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 11, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 13, 2025

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 14, 2025

Completed
Last Updated

June 26, 2025

Status Verified

November 1, 2024

Enrollment Period

Same day

First QC Date

February 10, 2025

Last Update Submit

June 25, 2025

Conditions

Keywords

FibromiyalgiaMuscle StrengthFatigue

Outcome Measures

Primary Outcomes (3)

  • minimum pinch force

    minimum fingertip pinch force required to hold a constant weight

    November 2024- January 2025

  • maximum pinch force

    maximum fingertip pinch force required to hold a constant weight

    November 2024- January 2025

  • % Minimum/maksimum pinch force

    percentage of minimum holding force to maximum holding force

    November 2024- January 2025

Secondary Outcomes (1)

  • isokinetik muscle strength

    November 2024- January 2025

Study Arms (2)

Fibromiyalgia

Fibromiyalgia Patients

Other: isokinetic muscle strength measurementOther: Minimum pinch force measurement

Healthy Control

Healthy control group

Other: isokinetic muscle strength measurementOther: Minimum pinch force measurement

Interventions

Wrist isokinetic eccentric flexor and extensor peak Torque and fatigue will be measured at the angular velocity of 180°/s

FibromiyalgiaHealthy Control

the minimum fingertip pinch force required to hold a constant weight will be measured

FibromiyalgiaHealthy Control

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Female patients with fibromyalgia diagnosis and no accompanying rheumatological disease

You may qualify if:

  • Female patients diagnosed with fibromyalgia between the ages of 18-70

You may not qualify if:

  • Those whose treatment has been changed in the last month
  • Those with shoulder, elbow, wrist and hand diseases that may cause pain in the dominant upper extremity
  • Those with carpal or cubital tunnel syndrome
  • Those with a history of orthopedic surgery in the dominant extremity
  • Those with uncontrolled metabolic disease
  • Those with B12 deficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prof. Dr. Cemil Taşçıoğlu Şehir Hastanesi

Istanbul, Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

FibromyalgiaFatigue

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Medical doctor

Study Record Dates

First Submitted

February 10, 2025

First Posted

February 13, 2025

Study Start

November 11, 2024

Primary Completion

November 11, 2024

Study Completion

March 14, 2025

Last Updated

June 26, 2025

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations