Health TrialsbyHealthPanel

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

ConditionFibromyalgia Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-35
SponsorAhmed Alshimy

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Factorial

Treatments tested in this trial

  • Aerobic Exercises

    Other intervention

    Treadmill 20 minutes including 5 minutes warm up and 5 minutes cool.

  • Transcutaneous electrical nerve stimulation

    Other intervention

    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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Study group (A)Experimental treatment 2 interventions
Group B: Control group (B)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Pain Numeric Pain Rating Scale

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

Time frame
4 weeks
2

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
3

Fibromyalgia Impact Questionnaire

Assess functional outcome

Time frame
4 weeks
4

Pressure Pain Thresholds

Assess pain sensitivity through pressure algometer

Time frame
4 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ahmed Alshimy

Lead sponsor

AlRyada University for Science & Technology

Sponsor institution

Source ClinicalTrials.gov
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