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NCT Number: NCT06539793

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

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.

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Key information

Conditions

Fibromyalgia Syndrome Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

25 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Al Ryada University for Science and Technology

Sadat, Menoufia, Egypt

Location status: Recruiting

Location contact

Ahmed Alshimy, PHD

CONTACT

[email protected]

0201115116030

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

aerobic exercises

Other

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

Transcutaneous Electrical Nerve Stimulation

Other

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 outcomes

  1. Pain Numeric Pain Rating Scale

    Time frame: 4 weeks

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

  2. Biochemical analysis

    Time frame: 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.

  3. Fibromyalgia Impact Questionnaire

    Time frame: 4 weeks

    Assess functional outcome

  4. Pressure Pain Thresholds

    Time frame: 4 weeks

    Assess pain sensitivity through pressure algometer

Sponsors and collaborators

Lead sponsor

Ahmed Alshimy

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 6, 2024
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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