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

Not Applicable

Recruiting

• Conditions: Fibromyalgia Syndrome
• Interventions: Other: Aerobic Exercises; Other: Transcutaneous electrical nerve stimulation

• Registration Number: NCT06539793
• Lead Sponsor: Ahmed Alshimy

Brief 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.

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 Timeline

• Study First Submitted: 2024-07-29
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-05
• Last Update Submitted: 2024-08-05
• Study First Posted: 2024-08-06
• Last Update Posted: 2024-08-06
• Study Start: 2024-09-01
• Primary Completion: 2025-04-04
• Study Completion: 2025-07-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 Montreal Cognitive Assessment (MoCA) >26.

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Control group (B)	Aerobic Exercises	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 group (A)	Aerobic Exercises	Patients will receive exercises, and sham Non-Invasive Neuromodulation, 3 sessions per week (one hour for each session) for 4 weeks.
Study group (A)	Transcutaneous electrical nerve stimulation	Patients will receive exercises, and sham Non-Invasive Neuromodulation, 3 sessions per week (one hour for each session) for 4 weeks.

Primary Outcome Measures

Name	Time	Method
Pain Numeric Pain Rating Scale	4 weeks	Assessment of pain intensity (0-no pain, 10-most intense pain)
Biochemical analysis	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.
Pressure Pain Thresholds	4 weeks	Assess pain sensitivity through pressure algometer
Fibromyalgia Impact Questionnaire	4 weeks	Assess functional outcome

Trial Locations

Locations (1)

Al Ryada University for Science and Technology; 🇪🇬 Sadat, Menoufia, Egypt