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

Ahmed Alshimy40 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Fibromyalgia Syndrome

Interventions

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

Eligibility

Sex: ALLMin age: 25 YearsMax age: 35 Years

Medical Language ↔ Plain English

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

Locations (1)

Al Ryada University for Science and Technology

Sadat, Menoufia, Egypt

RECRUITING

Outcomes

Primary Outcomes

Pain Numeric Pain Rating Scale

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

Time frame: 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.

Time frame: 4 weeks

Fibromyalgia Impact Questionnaire

Assess functional outcome

Time frame: 4 weeks

Pressure Pain Thresholds

Assess pain sensitivity through pressure algometer

Time frame: 4 weeks

Data from ClinicalTrials.gov

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