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Effect Of Neuromodulation In Patient With Fibromyalgia Syndrome

Cairo University (CU) logo

Cairo University (CU)

Status

Enrolling

Conditions

Fibromyalgia

Treatments

Device: Low frequency TENS

Study type

Interventional

Funder types

Other

Identifiers

NCT06799091
Effect of neuromodulation

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

Female

Ages

20 to 45 years old

Volunteers

No Healthy Volunteers

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 lupus erethromatosis (SLE), rheumatoid arthritis (RA) and Lyme disease based on laboratory investigations (erythrocyte sedimentation rate (ESR), Anti anti-cyclic citrullinated peptide (Anti CCP), antinuclear antibody (ANA) and Rheumatoid factor (RF)).

Exclusion criteria

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

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 2 patient groups, including a placebo group

Control group
Placebo Comparator group
Treatment:
Device: Low frequency TENS
Low fequency TENS
Active Comparator group
Treatment:
Device: Low frequency TENS

Trial contacts and locations

1

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Central trial contact

Rowida Abd Elgleel, Lecturer; Ashraf Ahmed, Assistant professor

Data sourced from clinicaltrials.gov

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