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

Ahmed Alshimy

Status: Enrolling

Conditions: Fibromyalgia Syndrome

Treatments: Other: Transcutaneous electrical nerve stimulation; Other: Aerobic Exercises

Study type: Interventional

Funder types: Other

Identifiers

NCT06539793

P.T.REC/012/005277

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 25 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Study group (A)

Experimental group

Description:

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

Treatment:

Other: Aerobic Exercises

Other: Transcutaneous electrical nerve stimulation

Control group (B)

Experimental group

Description:

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.

Treatment:

Other: Aerobic Exercises