Effect Of Neuromodulation In Patient With Fibromyalgia Syndrome

NCT ID: NCT06799091

Last Updated: 2025-01-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2025-03-15

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.

Detailed 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.

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control group

Group Type: PLACEBO_COMPARATOR

Low frequency TENS

Intervention Type: 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.

Low fequency TENS

Group Type: ACTIVE_COMPARATOR

Low frequency TENS

Intervention Type: 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.

Interventions

Low frequency TENS

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Rowida Abd Elgleel Sayed Abd Elgleel

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of physical therapy laps at cairo university

Giza, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Rowida Abd Elgleel, Lecturer

Role: CONTACT

rowidaabdelglel@cu.edu.eg

01152322678

Ashraf Ahmed, Assistant professor

Role: CONTACT

Ashraf.darwesh@cu.edu.eg

0111462073

Facility Contacts

Ashraf Ahmed, Assistant professor

Role: primary

Ashraf.darwesh@cu.edu.eg

0111462073

Other Identifiers

Effect of neuromodulation

Identifier Type: -

Identifier Source: org_study_id