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RecruitingNot ApplicableNCT06539793

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

Sponsor

Ahmed Alshimy

Enrollment

40 participants

Start Date

Sep 1, 2024

Study Type

INTERVENTIONAL

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.

Eligibility

Min Age: 25 YearsMax Age: 35 Years

Inclusion Criteria4

  • 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 Criteria11

  • 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

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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

Locations(1)

Al Ryada University for Science and Technology

Sadat, Menoufia, Egypt

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NCT06539793