Effect Of Neuromodulation In Patient With Fibromyalgia Syndrome

Last updated: January 23, 2025
Sponsor: Cairo University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Fibromyalgia

Treatment

Low frequency TENS

Clinical Study ID

NCT06799091
Effect of neuromodulation
  • Ages 20-45
  • Female

Study Summary

This study was designed to examine the efficacy of Neuromodulation therapy By using transcutanous electric nerve stimulation( TENS) in Patients With FMS and to provide preliminary evidence regarding its effects on pain ,anxiety and QOL by objectively measuring Cortisol level in FMS patients.

Eligibility Criteria

Inclusion

Inclusion Criteria:

women between 20-45 years old, (ii) diagnoses according to the 2016 American College of Rheumatology criteria for fibromyalgia [1]

  • Symptoms have been present at a similar level for at least three months (iii)Absence of other disorders that causes similar symptoms: systemic lupuserethromatosis (SLE), rheumatoid arthritis (RA) and Lyme disease based on laboratoryinvestigations (erythrocyte sedimentation rate (ESR), Anti anti-cyclic citrullinatedpeptide (Anti CCP), antinuclear antibody (ANA) and Rheumatoid factor (RF)).

Exclusion

Exclusion Criteria:

  • any medical, neurological, or psychiatric illness, use of strong opioids or otherpainkillers except paracetamol and/or ibuprofen, benzodiazepine, illicit drug oralcohol use, recent use of cannabis, pregnancy, breast feeding, and the presence ofpain syndromes other than FM.

Presence of other autoimmune disorders e.g.: rheumatoid arthritis and systemic lupus erethromatosus

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: Low frequency TENS
Phase:
Study Start date:
January 01, 2023
Estimated Completion Date:
March 15, 2025

Study Description

Forty female patients with FM ( age : 20- 45 Years ) participated in the study after suing the consent form . Participants were randomly allocated assigned into 2 equal groups ( control group [ G1 ] and low TENS group [G2 ] ) . Group 1 received selected programs of Physiotherapy including Aerobic exercise and placebo low TENS. Group 2 received low frequency TENS (10 Hz).All participants were assessed for cortisol and pain level by using visual analogues scale Also participants were assessed for QOL by FIBROMYALGIA IMPACT QUESTIONNAIRE (FIQR) . treatment was done 3 sessions per weeks for successive 6 weeks pre and post assessment for all valuable were Done.

Connect with a study center

  • Faculty of physical therapy laps at cairo university

    Giza, 12612
    Egypt

    Active - Recruiting

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