NCT06778681

Brief Summary

The goal of this study is to test whether cortical motor neuron dysfunction plays a role in the pathogenesis of fatigue in fibromyalgia patients. The main questions it aims to answer are: Do fibromyalgia patients have lower v-wave compared to healthy subjects? Does cheering affect V-wave in fibromyalgia patients more than healthy subjects? Researchers will compare the V-waves of fibromyalgia patients with those of healthy subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2024

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

April 18, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 16, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2025

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2025

Completed
Last Updated

November 20, 2025

Status Verified

November 1, 2025

Enrollment Period

1.1 years

First QC Date

January 12, 2025

Last Update Submit

November 19, 2025

Conditions

Fibromyalgia

Keywords

FatigueFibromyalgiaCortical motor neuron dysfunctionV-Wave

Outcome Measures

Primary Outcomes (1)

  • V-wave

    Subjects will be asked to perform voluntary foot plantar flexion. During 3rd, 20th, 40th, and 60th seconds v-wave will be measured. During the 60th second of voluntary foot plantar flexion subjects will be cheered to increase their flexion strength. V-wave/H-max ratio and V-wave amplitude changes during cheer will be compared between healthy and fibromyalgia subjects. A low ratio or amplitude will be interpreted in favor of fatigue.

    On the day of testing

Secondary Outcomes (3)

  • Fatigue severity scale

    On the day of testing

  • Grip strength

    On the day of testing

  • 4m walking speed

    On the day of testing

Study Arms (2)

Fibromyalgia

EXPERIMENTAL

Subjects with diagnosed fibromyalgia will be in this arm. Subjects will have their grip strength and 4-meter walking speed measured and will be asked to fill the fatigue severity scale. Subjects will be tested for v-wave during voluntary foot plantarflexion.

Other: Cheer

Healthy

EXPERIMENTAL

Healthy subjects will be in this arm. Subjects will have their grip strength and 4-meter walking speed measured and will be asked to score the fatigue severity scale. Subjects will be tested for v-wave during voluntary foot plantarflexion.

Other: Cheer

Interventions

CheerOTHER

During voluntary muscle contraction subjects will be cheered with verbal encouragement ("push, push, push") and clapping.

FibromyalgiaHealthy

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosed with fibromyalgia according to acr 2016 criteria(for fibromyalgia group)
  • Being healthy(for control group)
  • years old
  • Volunteering
  • Being female
  • Right hand dominant

You may not qualify if:

  • Presence of scars, dermatitis, or similar conditions on the skin where surface EMG electrodes will be placed.
  • Diseases causing muscle and nerve dysfunction: myopathies, polyneuropathy, radiculopathy, peripheral nerve lesions such as entrapment neuropathies; central nervous system disorders such as stroke, amyotrophic lateral sclerosis, multiple sclerosis, and parkinsonism.
  • Hypertension and cardiac arrhythmias.
  • Other diseases with fatigue symptoms: cardiopulmonary diseases, hypothyroidism, polymyalgia rheumatica, major depression, bipolar disorder, chronic fatigue syndrome.
  • Epilepsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Physical Medicine Rehabilitation Training & Research Hospital

Istanbul, Bahçelievler, 34186, 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
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Doctor

Study Record Dates

First Submitted

January 12, 2025

First Posted

January 16, 2025

Study Start

April 18, 2024

Primary Completion

May 15, 2025

Study Completion

June 10, 2025

Last Updated

November 20, 2025

Record last verified: 2025-11

Locations

TU(1)