Fibromyalgia Syndrome
Conditions
Keywords
Fibromyalgia, NEUROMODULATION, Centralization, PAIN BIOMARKERS, FUNCTIONAL OUTCOME
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.
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
Sponsors
Ahmed Alshimy
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
25 Years to 35 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Fibromyalgia Impact Questionnaire | 4 weeks | Assess functional outcome |
| Pressure Pain Thresholds | 4 weeks | Assess pain sensitivity through pressure algometer |
Countries
Egypt
Outcome results
None listed