ClinicalTrials.gg
RecruitingNCT06539793Updated Aug 6, 2024

Effect of Neuromodulation on Pain Biomarkers and Functional Outcome in Patients With Fibromyalgia Syndrome

An interventional study of Aerobic Exercises and Transcutaneous electrical nerve stimulation in Fibromyalgia Syndrome, sponsored by Ahmed Alshimy. Recruiting at 1 site in Egypt. Open to participants aged 25 Years to 35 Years. Per ClinicalTrials.gov, last updated 2024-08-06.

Sponsored by Ahmed Alshimy · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Apr 2025, 1 year 7 months ago, but the record still lists the study as recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
25 Years to 35 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 31 studies in Fibromyalgia with a site in Egypt — 17 open to participants now, 17 under way, none of them phase 3. Fibromyalgia · Egypt.

Planned enrollment
20th of 26
40 · median 60
Started
2024
with 5 others
No phase
24 of 31
12 open now
Primary completion
2025-04
later than 6 of 16 live
Registered
18th of 31
by date
Lead sponsor
1 of 31
Ahmed Alshimy

Among the 31 studies in Fibromyalgia with a site in Egypt, this one is the 20th largest by planned enrollment of the 26 interventional ones that give a count, is one of 6 that started in 2024, is one of 24 with no phase, reaches primary completion later than 6 of the 16 other live ones, and was the 18th registered.

Fibromyalgia

1,243 studies on the registry are indexed under Fibromyalgia; 256 are open to participants now.

This study's planned enrollment of 40 is below the median of 60 across 937 interventional studies indexed under Fibromyalgia.

Browse Fibromyalgia studies →

Open to participants now

17 of the 31 studies in Fibromyalgia with a site in Egypt are open now, in 1 country. Each count lists the studies.

All 17 open studies →

Where they have run

Who these studies take

Of the 160 Fibromyalgia studies recruiting now, 50 (31%) set no upper age limit and 96 (60%) stop at 75 or younger; 14 take children under 18; 35 take healthy volunteers.

This study: 25 Years to 35 Years · all sexes · no healthy volunteers.

The full table on the hub →
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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 31 studies in Fibromyalgia with a site in Egypt, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Fibromyalgia Syndrome

Browse trials for

Keywords

  • Fibromyalgia
  • NEUROMODULATION
  • Centralization
  • PAIN BIOMARKERS
  • FUNCTIONAL OUTCOME
04

Who can participate

Ages eligible
25 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients fibromyalgia from both genders.
  2. 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.
  3. Their ages will be ranged from 25-35 years old.
  4. They will be medically stable and have sufficient cognitive abilities that enable them to understand and follow instruction according to (MoCA) >26.

Exclusion criteria

Exclusion Criteria:

  1. Other Neurological diseases as stroke , multiple sclerosis, Parkinson's disease and motor neuron disease
  2. Pacemaker
  3. Spinal fusion-cervical or lumbar
  4. Metal implants in the spine
  5. Pregnancy
  6. Epilepsy
  7. Severe psychiatric disorder or alcohol and drug abuse.
  8. Unstable medical condition which could compromise the participant's welfare or confound the study results.
  9. Uncontrolled blood pressure or diabetes
  10. Visual or auditory problems.
  11. Active inflammatory conditions
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Double (Participant, Investigator)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Study group (A)

    Patients will receive exercises, and sham Non-Invasive Neuromodulation, 3 sessions per week (one hour for each session) for 4 weeks.

    Other: Aerobic Exercises · Other: Transcutaneous electrical nerve stimulation

  • Experimental
    Control group (B)

    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.

    Other: Aerobic Exercises

Interventions

  • OtherAerobic Exercises

    Treadmill 20 minutes including 5 minutes warm up and 5 minutes cool.

  • OtherTranscutaneous electrical nerve stimulation

    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

06

What researchers measure

Primary outcomes

  1. Pain Numeric Pain Rating Scale

    Assessment of pain intensity (0-no pain, 10-most intense pain)

    Time frame: 4 weeks

  2. 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.

    Time frame: 4 weeks

  3. Fibromyalgia Impact Questionnaire

    Assess functional outcome

    Time frame: 4 weeks

  4. Pressure Pain Thresholds

    Assess pain sensitivity through pressure algometer

    Time frame: 4 weeks

07

Study locations

1 of 1 sites recruiting
  • Al Ryada University for Science and Technology
    Sadat, Menoufia, Egypt
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2024; primary completion for Apr 2025, 7 months later.

Of 436 non-industry interventional studies with no phase under Fibromyalgia, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 31. This study's planned 7 months is below that.

Counting every sponsor, half of 449 studies reached it within 15 months; a quarter within 6 and three quarters within 31.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 29, 2024
First posted
Aug 6, 2024
StartEst.
Sep 1, 2024
Primary completionEst.
Apr 4, 2025
CompletionEst.
Jul 3, 2025
Last update
Aug 6, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06539793
Lead sponsor
Ahmed Alshimy
Responsible party
Ahmed Alshimy (Lecturer and Consultant in Physical Therapy at Department of Neurology and it's Surgery. Faculty of Physical Therapy Al Ryada University for Science and Technology, Egypt, AlRyada University for Science & Technology) — Sponsor-investigator
First posted
Aug 6, 2024
Start date
Sep 1, 2024 (estimated)
Primary completion
Apr 4, 2025 (estimated)
Completion
Jul 3, 2025 (estimated)
Last update
Aug 6, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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