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

NCT06539793 | Recruiting

• 1 other identifier: P.T.REC/012/005277
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia Syndrome

Keywords

Fibromyalgia; NEUROMODULATION; Centralization; PAIN BIOMARKERS; FUNCTIONAL OUTCOME

Outcome Measures

Primary Outcomes (4)

• Pain Numeric Pain Rating Scale

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

  4 weeks

• 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.

  4 weeks

• Fibromyalgia Impact Questionnaire

  Assess functional outcome

  4 weeks

• Pressure Pain Thresholds

  Assess pain sensitivity through pressure algometer

  4 weeks

Study Arms (2)

Study group (A)

EXPERIMENTAL

Patients will receive exercises, and sham Non-Invasive Neuromodulation, 3 sessions per week (one hour for each session) for 4 weeks.

Other: Aerobic Exercises; Other: Transcutaneous electrical nerve stimulation

Control group (B)

EXPERIMENTAL

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.

Other: Aerobic Exercises

Interventions

Aerobic Exercises OTHER

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

Control group (B); Study group (A)

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

Study group (A)

Eligibility Criteria

• Age: 25 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ahmed Alshimy: lead

Study Sites (1)

Al Ryada University for Science and Technology

Sadat, Menoufia, Egypt

RECRUITING

MeSH Terms

Conditions

Fibromyalgia

Interventions

Exercise; Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer and Consultant in Physical Therapy at Department of Neurology and it's Surgery. Faculty of Physical Therapy Al Ryada University for Science and Technology, Egypt

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 6, 2024
• Study Start: September 1, 2024
• Primary Completion: April 4, 2025
• Study Completion: July 3, 2025
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)