FibromyalgiaNCT06778681
Mechanism of Fatigue in Fibromyalgia and Cortical Motor Neuron Dysfunction
A study testing Cheer in people with Fibromyalgia, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Cheer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Apr 2024to 10 Jun 2025
- Phase
- Interventional
- 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 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Diagnosed with fibromyalgia according to acr 2016 criteria(for fibromyalgia group)
- Being healthy(for control group)
- 18-60 years old
- Volunteering
- Being female
- Right hand dominant
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Physical Medicine Rehabilitation Training & Research Hospital
Istanbul, Bahçelievler, 34186
About this study
Official title: Is Cortical Motor Neuron Dysfunction the Underlying Mechanism of Fatigue in Fibromyalgia?
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.
Read the detailed description
All volunteers will first undergo the Fatigue Severity Scale (FSS) assessment, grip strength measurement, and a 4-meter walking speed test. Subsequently, V-wave recordings will be performed.
EMG and Force Data Acquisition
Surface EMG from the soleus muscle and force sensor data will be collected at a 2 kHz sampling rate using a data acquisition system (CED 3601 Power 1401 MKII digital-to-analogue converter and CED 1902 Quad System MKIII amplifier). Data analyses will be performed using Spike2 version 7.20 software.
Maximal plantar flexion will be performed against a force platform equipped with a force sensor (FC2231-0000-0100-L Compression Load Sensor, France) mounted on a wall and connected to a data acquisition device. Participants will be fixed to the examination table using a pelvic strap to prevent cranial movement during the contraction. This setup will allow real-time recording of muscle force during the 1-minute isometric contraction.
V-Wave Measurement Procedure
The procedure involves positioning participants prone on an examination table. Two self-adhesive Ag/AgCl surface electrodes (KENDALL® Coviden, Massachusetts, USA) will be placed on the belly of the left lateral soleus muscle with a 4 cm inter-electrode distance. A grounding electrode will be placed over the malleolus.
Before attaching the electrodes, any hair on the skin will be shaved, and the skin will be cleaned with alcohol wipes to remove surface oils. An ECG gel will be applied to increase skin conductivity.
For the V-wave measurement:
A cathode electrode (1 cm diameter round electrode) will be positioned over the tibial nerve in the left popliteal fossa, and an anode electrode (10x10 cm) will be placed over the suprapatellar area.
Stimulation will be delivered using a constant-current stimulator [model DS7A, Digitimer Ltd, Hertfordshire, UK] with monophasic rectangular current pulses of 1 ms duration.
The current intensity will start at 5 mA and incrementally increase. The intensity required to achieve the recruitment curve of the H-reflex and the maximum M-response (Mmax) will be determined. Supramaximal stimulation at 1.2 times the Mmax intensity will be applied to record the V-wave response.
Recording of V-Wave Responses
A one-minute fatigue protocol will be applied to see the effect of Cheer on fatigue. For this purpose, V responses will be recorded during maximum voluntary plantar flexion maintained for 60 seconds. Four V-wave responses will be recorded during the 3rd, 20th, 40th and 60th seconds of contraction. Before 60th second measurement, maximal voluntary contraction will be accompanied by verbal encouragement ("push, push, push") and clapping. Supramaximal stimulation will be given during specified times to measure v-wave.
Sample size calculation
For the V-wave measurements, repeated measures analysis of variance (ANOVA) will be used to analyze the four measurements within the two groups. Assuming a medium effect size (partial eta squared = 0.06), an alpha error level of 0.05, and a power of 0.95, the minimum required sample size was calculated to be 18 participants per group, resulting in a total of 36 participants.
The sample size calculation was performed using G*Power software version 3.1.9.4 (Franz Faul, University of Kiel, Germany).
Statistical Analysis
The normality of data distribution will be assessed using the Shapiro-Wilk test. Continuous numerical variables will be summarized as mean and standard deviation, while categorical variables will be presented as frequencies (percentages).
If the data follow a normal distribution, V-wave amplitudes will be compared using repeated measures analysis of variance (ANOVA). In cases where the analysis yields a p-value < 0.05, post-hoc pairwise comparisons will be conducted to identify differences in V-wave responses obtained during different stimulations.
If the data does not follow a normal distribution, within-group comparisons will be performed using the Friedman test and Wilcoxon test, while between-group comparisons will be performed using the Mann-Whitney U test. Post-hoc pairwise comparisons will be evaluated with Bonferroni-adjusted p-values, where a corrected p-value < 0.05 will be considered statistically significant.
All analyses will be conducted using SPSS software version 18.0.
- Conditions
- Fibromyalgia
- Being tested
- Cheer
- Keywords
- Fatigue, Fibromyalgia, Cortical motor neuron dysfunction, V-Wave
- Medical subject headings
- Fibromyalgia, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CheerOther
During voluntary muscle contraction subjects will be cheered with verbal encouragement ("push, push, push") and clapping.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Cheer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: On the day of testing
Secondary outcomes (3)
Fatigue severity scale
Subjects will be asked to fill in the fatigue severity scale before the study. Fatigue severity scale is scored between 1 and 7, with higher scores indicating greater fatigue.
Measured: On the day of testing
Grip strength
Subjects will have their grip strength measured using a Jamar hand dynamometer. Results will be recorded in kilograms-force.
Measured: On the day of testing
4m walking speed
Subjects will be asked to walk a 4-meter distance at a normal pace. They will be timed with a chronometer and walking speed will be calculated in meters/second.
Measured: On the day of testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start18 Apr 2024
- Primary completion15 May 2025
- Study completion10 Jun 2025
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Fuat Orhun Alayoglu, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06778681
- Sponsor's protocol ID
- 2023/438
- Status last verified
- Nov 2025
- First submitted
- 12 Jan 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Cortical Motor Neuron Dysfunction the Underlying Mechanism of Fatigue in Fibromyalgia?
- ClinicalTrials.gov ID
- NCT06778681
- Acronym / sponsor ID
- 2023/438
- Conditions
- Fibromyalgia
- Keywords
- Fatigue, Fibromyalgia, Cortical motor neuron dysfunction, V-Wave
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 18 Apr 2024 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 10 Jun 2025 (actual)
- First posted
- 16 Jan 2025 (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.
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.
Detailed description
All volunteers will first undergo the Fatigue Severity Scale (FSS) assessment, grip strength measurement, and a 4-meter walking speed test. Subsequently, V-wave recordings will be performed.
EMG and Force Data Acquisition
Surface EMG from the soleus muscle and force sensor data will be collected at a 2 kHz sampling rate using a data acquisition system (CED 3601 Power 1401 MKII digital-to-analogue converter and CED 1902 Quad System MKIII amplifier). Data analyses will be performed using Spike2 version 7.20 software.
Maximal plantar flexion will be performed against a force platform equipped with a force sensor (FC2231-0000-0100-L Compression Load Sensor, France) mounted on a wall and connected to a data acquisition device. Participants will be fixed to the examination table using a pelvic strap to prevent cranial movement during the contraction. This setup will allow real-time recording of muscle force during the 1-minute isometric contraction.
V-Wave Measurement Procedure
The procedure involves positioning participants prone on an examination table. Two self-adhesive Ag/AgCl surface electrodes (KENDALL® Coviden, Massachusetts, USA) will be placed on the belly of the left lateral soleus muscle with a 4 cm inter-electrode distance. A grounding electrode will be placed over the malleolus.
Before attaching the electrodes, any hair on the skin will be shaved, and the skin will be cleaned with alcohol wipes to remove surface oils. An ECG gel will be applied to increase skin conductivity.
For the V-wave measurement:
A cathode electrode (1 cm diameter round electrode) will be positioned over the tibial nerve in the left popliteal fossa, and an anode electrode (10x10 cm) will be placed over the suprapatellar area.
Stimulation will be delivered using a constant-current stimulator [model DS7A, Digitimer Ltd, Hertfordshire, UK] with monophasic rectangular current pulses of 1 ms duration.
The current intensity will start at 5 mA and incrementally increase. The intensity required to achieve the recruitment curve of the H-reflex and the maximum M-response (Mmax) will be determined. Supramaximal stimulation at 1.2 times the Mmax intensity will be applied to record the V-wave response.
Recording of V-Wave Responses
A one-minute fatigue protocol will be applied to see the effect of Cheer on fatigue. For this purpose, V responses will be recorded during maximum voluntary plantar flexion maintained for 60 seconds. Four V-wave responses will be recorded during the 3rd, 20th, 40th and 60th seconds of contraction. Before 60th second measurement, maximal voluntary contraction will be accompanied by verbal encouragement ("push, push, push") and clapping. Supramaximal stimulation will be given during specified times to measure v-wave.
Sample size calculation
For the V-wave measurements, repeated measures analysis of variance (ANOVA) will be used to analyze the four measurements within the two groups. Assuming a medium effect size (partial eta squared = 0.06), an alpha error level of 0.05, and a power of 0.95, the minimum required sample size was calculated to be 18 participants per group, resulting in a total of 36 participants.
The sample size calculation was performed using G*Power software version 3.1.9.4 (Franz Faul, University of Kiel, Germany).
Statistical Analysis
The normality of data distribution will be assessed using the Shapiro-Wilk test. Continuous numerical variables will be summarized as mean and standard deviation, while categorical variables will be presented as frequencies (percentages).
If the data follow a normal distribution, V-wave amplitudes will be compared using repeated measures analysis of variance (ANOVA). In cases where the analysis yields a p-value < 0.05, post-hoc pairwise comparisons will be conducted to identify differences in V-wave responses obtained during different stimulations.
If the data does not follow a normal distribution, within-group comparisons will be performed using the Friedman test and Wilcoxon test, while between-group comparisons will be performed using the Mann-Whitney U test. Post-hoc pairwise comparisons will be evaluated with Bonferroni-adjusted p-values, where a corrected p-value < 0.05 will be considered statistically significant.
All analyses will be conducted using SPSS software version 18.0.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fibromyalgia | Experimental | Other: CheerSubjects 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. |
| Healthy | Experimental | Other: CheerHealthy 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Diagnosed with fibromyalgia according to acr 2016 criteria(for fibromyalgia group)
- Being healthy(for control group)
- 18-60 years old
- Volunteering
- Being female
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| CheerDuring voluntary muscle contraction subjects will be cheered with verbal encouragement ("push, push, push") and clapping. | Other | Fibromyalgia, Healthy |
Primary outcome
V-wave
Time frame: On the day of testing
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.
3 secondary outcomes
Fatigue severity scale
Time frame: On the day of testing
Grip strength
Time frame: On the day of testing
4m walking speed
Time frame: On the day of testing
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 20 Nov 2025.
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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?
A study testing Cheer in people with Fibromyalgia, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital 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 6 inclusion and 5 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 20 Nov 2025. 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?
V-wave (time frame: On the day of testing). 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 20 Nov 2025; AzTrials last refreshed its copy on 8 Nov 2026.