Fibromyalgia SyndromeNCT06539793
Effect of Neuromodulation on Pain Biomarkers and Functional Outcome in Patients With Fibromyalgia Syndrome
A study testing Aerobic Exercises and Transcutaneous electrical nerve stimulation in people with Fibromyalgia Syndrome, run by Ahmed Alshimy at 1 site in Egypt.
Trial summary
Fibromyalgia is the third most common musculoskeletal condition in terms of prevalence, after lumbar pain and osteoarthritis. Its prevalence is around 2-4 % and is more frequent in women than in men; the prevalence is highest in age the range of 40-60 years. Read more about this study
- Who is it for?
- Ages 25 to 35 years
- Conditions the study is for
- Fibromyalgia Syndrome
- What is being tested?
- Aerobic Exercises and Transcutaneous electrical nerve stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2024to 3 Jul 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 25 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients fibromyalgia from both genders.
- The duration of fibromyalgia is more than 6 month (all patients with history of cervical or lumbar pain) and following diagnosis of FM using the 2016 revised FM criteria, on the basis of the ACR-2010 criteria.
- Their ages will be ranged from 25-35 years old.
- They will be medically stable and have sufficient cognitive abilities that enable them to understand and follow instruction according to Montreal Cognitive Assessment (MoCA) >26.
Who cannot join
- Other Neurological diseases as stroke , multiple sclerosis, Parkinson's disease and motor neuron disease
- Pacemaker
- Spinal fusion-cervical or lumbar
- Metal implants in the spine
- Pregnancy
- Epilepsy
Show all 11Show fewer
- Severe psychiatric disorder or alcohol and drug abuse.
- Unstable medical condition which could compromise the participant's welfare or confound the study results.
- Uncontrolled blood pressure or diabetes
- Visual or auditory problems.
- Active inflammatory conditions
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Al Ryada University for Science and Technology
Sadat, Menoufia
Ahmed Alshimy, PHD, 0201115116030, ahmed.alshimy@rst.edu.eg
About this study
Fibromyalgia is the third most common musculoskeletal condition in terms of prevalence, after lumbar pain and osteoarthritis. Its prevalence is around 2-4 % and is more frequent in women than in men; the prevalence is highest in age the range of 40-60 years.
Read the detailed description
Group A (Control Group): Patients will receive exercises, and sham Non-Invasive Neuromodulation, 3 sessions per week (one hour for each session) for 4 weeks.
Group B (Study Group): Patients will receive exercises as in group (A) in addition to Non-Invasive Neuromodulation 3 sessions per week (one hour for each session) for 4 weeks.
- Conditions
- Fibromyalgia Syndrome
- Being tested
- Aerobic Exercises, Transcutaneous electrical nerve stimulation
- Keywords
- Fibromyalgia, NEUROMODULATION, Centralization, PAIN BIOMARKERS, FUNCTIONAL OUTCOME
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic ExercisesOther
Treadmill 20 minutes including 5 minutes warm up and 5 minutes cool.
Transcutaneous electrical nerve stimulationOther
will be applied for all patients, which uses an asymmetrical biphasic alternating current in the continuous mode (pulse duration 100 µs, low frequency). TENS intensity will increase slowly, and patients will be instructed to indicate sensory threshold (ST); then, the intensity are going to increase until the sensation perceived as "strong but comfortable" (SC1). The duration will be for 30 minutes, 3times/ week for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Study group (A) | Experimental | Patients will receive exercises, and sham Non-Invasive Neuromodulation, 3 sessions per week (one hour for each session) for 4 weeks. Receives: Other: Aerobic Exercises; Other: Transcutaneous electrical nerve stimulation |
| Control group (B) | Experimental | Patients will receive exercises as in group (A) in addition to Non-Invasive Neuromodulation 3 sessions per week (one hour for each session) for 4 weeks. Receives: Other: Aerobic Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Numeric Pain Rating Scale
Assessment of pain intensity (0-no pain, 10-most intense pain)
Measured: 4 weeks
Biochemical analysis
Assessment of pain intensity through the change of blood cortisol level, plasma cytokine level, antinuclear antibody (ANA) level. Blood samples will be taken between the hours of 08:00-09:00 in the morning. Two blood samples will be taken from the patients before and after treatment.
Measured: 4 weeks
Fibromyalgia Impact Questionnaire
Assess functional outcome
Measured: 4 weeks
Pressure Pain Thresholds
Assess pain sensitivity through pressure algometer
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start1 Sep 2024 (estimated)
- Primary completion4 Apr 2025 (estimated)
- Study completion3 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibromyalgia SyndromeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahmed Alshimy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmed Alshimy, AlRyada University for Science & Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06539793
- Sponsor's protocol ID
- P.T.REC/012/005277
- Status last verified
- Aug 2024
- First submitted
- 29 Jul 2024
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Neuromodulation on Pain Biomarkers and Functional Outcome in Patients With Fibromyalgia Syndrome
- ClinicalTrials.gov ID
- NCT06539793
- Acronym / sponsor ID
- P.T.REC/012/005277
- Conditions
- Fibromyalgia Syndrome
- Keywords
- Fibromyalgia, NEUROMODULATION, Centralization, PAIN BIOMARKERS, FUNCTIONAL OUTCOME
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ahmed AlshimyUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 4 Apr 2025 (estimated)
- Study completion
- 3 Jul 2025 (estimated)
- First posted
- 6 Aug 2024 (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.
Fibromyalgia is the third most common musculoskeletal condition in terms of prevalence, after lumbar pain and osteoarthritis. Its prevalence is around 2-4 % and is more frequent in women than in men; the prevalence is highest in age the range of 40-60 years.
Detailed description
Group A (Control Group): Patients will receive exercises, and sham Non-Invasive Neuromodulation, 3 sessions per week (one hour for each session) for 4 weeks.
Group B (Study Group): Patients will receive exercises as in group (A) in addition to Non-Invasive Neuromodulation 3 sessions per week (one hour for each session) for 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group (A) | Experimental | Other: Aerobic Exercises, Other: Transcutaneous electrical nerve stimulationPatients will receive exercises, and sham Non-Invasive Neuromodulation, 3 sessions per week (one hour for each session) for 4 weeks. |
| Control group (B) | Experimental | Other: Aerobic ExercisesPatients will receive exercises as in group (A) in addition to Non-Invasive Neuromodulation 3 sessions per week (one hour for each session) for 4 weeks. |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients fibromyalgia from both genders.
- The duration of fibromyalgia is more than 6 month (all patients with history of cervical or lumbar pain) and following diagnosis of FM using the 2016 revised FM criteria, on the basis of the ACR-2010 criteria.
- Their ages will be ranged from 25-35 years old.
- They will be medically stable and have sufficient cognitive abilities that enable them to understand and follow instruction according to Montreal Cognitive Assessment (MoCA) >26.
Key exclusion criteria (11 listed)
- Other Neurological diseases as stroke , multiple sclerosis, Parkinson's disease and motor neuron disease
- Pacemaker
- Spinal fusion-cervical or lumbar
- Metal implants in the spine
- Pregnancy
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 |
|---|---|---|
| Aerobic ExercisesTreadmill 20 minutes including 5 minutes warm up and 5 minutes cool. | Other | Control group (B), Study group (A) |
| Transcutaneous electrical nerve stimulationwill be applied for all patients, which uses an asymmetrical biphasic alternating current in the continuous mode (pulse duration 100 µs, low frequency). TENS intensity will increase slowly, and patients will be instructed to indicate sensory threshold (ST); then, the intensity are going to increase until the sensation perceived as "strong but comfortable" (SC1). The duration will be for 30 minutes, 3times/ week for 4 weeks | Other | Study group (A) |
Primary outcome
Pain Numeric Pain Rating Scale
Time frame: 4 weeks
Assessment of pain intensity (0-no pain, 10-most intense pain)
Biochemical analysis
Time frame: 4 weeks
Assessment of pain intensity through the change of blood cortisol level, plasma cytokine level, antinuclear antibody (ANA) level. Blood samples will be taken between the hours of 08:00-09:00 in the morning. Two blood samples will be taken from the patients before and after treatment.
Fibromyalgia Impact Questionnaire
Time frame: 4 weeks
Assess functional outcome
Pressure Pain Thresholds
Time frame: 4 weeks
Assess pain sensitivity through pressure algometer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Fibromyalgia Syndrome
Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
Fibromyalgia
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Recruiting
Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia
Fibromyalgia Syndrome
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercises and Transcutaneous electrical nerve stimulation in people with Fibromyalgia Syndrome, run by Ahmed Alshimy at 1 site in Egypt.
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 4 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 6 Aug 2024. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Numeric Pain Rating Scale (time frame: 4 weeks). The study lists 4 primary outcomes in all. 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 6 Aug 2024.