Effect Of Neuromodulation In Patient With Fibromyalgia Syndrome

NCT06799091 | Recruiting DMC

• 1 other identifier: Effect of neuromodulation
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (1)

• Cortisol level

  Changes in pain from baseline to six weeks after begining of intervention

  Six weeks after begining of intervention

Secondary Outcomes (1)

• Fibromyalgia impact questionaire

  Six weeks after begining of intervention

Study Arms (2)

Control group

PLACEBO COMPARATOR

Device: Low frequency TENS

Low fequency TENS

ACTIVE COMPARATOR

Device: Low frequency TENS

Interventions

Low frequency TENS DEVICE

Low TENS group participated in twelve sessions of electrical stimulation with low frequency (TENS, 10 Hz/200 μs) was applied with self-adhesive electrodes (size 9 × 5 cm,), in the paravertebral ganglionar region (from T1 to L2). The sessions took place at the same time of the day, lasted 30 min, in an acclimatized room (23 °C) and the intensity of the current was delivered at sensory-level intensity, adjusted every 5 min by the sensory threshold, during the 30 min as tolerated by each subject, but without motor contraction or pain reported by the subject.

Control group; Low fequency TENS

Eligibility Criteria

• Age: 20 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)).

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of physical therapy laps at cairo university

Giza, 12612, Egypt

RECRUITING

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Rowida Abd Elgleel, Lecturer

CONTACT

01152322678; rowidaabdelglel@cu.edu.eg

Ashraf Ahmed, Assistant professor

CONTACT

0111462073; Ashraf.darwesh@cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: January 29, 2025
• Study Start: January 1, 2023
• Primary Completion: March 1, 2025
• Study Completion: March 15, 2025
• Last Updated: January 29, 2025

Record last verified: 2025-01

Locations

EG (1)