Effect of Neuromodulation on Pain Biomarkers and Functional Outcome in Patients With Fibromyalgia Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Aerobic Exercises, Transcutaneous electrical nerve stimulation.
- Who it may be relevant to
- Registry conditions: Fibromyalgia Syndrome. Basic parameters: 25 years — 35 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
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
- Other Aerobic Exercises
Treadmill 20 minutes including 5 minutes warm up and 5 minutes cool. - Other Transcutaneous 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
Primary outcome measures
- Pain Numeric Pain Rating Scale [Time frame: 4 weeks]
- Biochemical analysis [Time frame: 4 weeks]
- Fibromyalgia Impact Questionnaire [Time frame: 4 weeks]
- Pressure Pain Thresholds [Time frame: 4 weeks]
Eligibility criteria
Inclusion criteria
- Patients fibromyalgia from both genders.
- 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.
- Their ages will be ranged from 25-35 years old.
- 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
- Other Neurological diseases as stroke , multiple sclerosis, Parkinson's disease and motor neuron disease
- Pacemaker
- Spinal fusion-cervical or lumbar
- Metal implants in the spine
- Pregnancy
- Epilepsy
- Severe psychiatric disorder or alcohol and drug abuse.
- Unstable medical condition which could compromise the participant's welfare or confound the study results.
- Uncontrolled blood pressure or diabetes
- Visual or auditory problems.
- Active inflammatory conditions
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Factorial
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Al Ryada University for Science and Technology — Sadat
Identifiers
NCT: NCT06539793 · P.T.REC/012/005277