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NCT Number: NCT06799091

Effect Of Neuromodulation In Patient With Fibromyalgia Syndrome

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.

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Key information

Age range

20 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of physical therapy laps at cairo university

Giza, 12612, Egypt

Location status: Recruiting

Location contact

Ashraf Ahmed, Assistant professor

CONTACT

[email protected]

0111462073

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Cortisol level

    Time frame: Six weeks after begining of intervention

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

Secondary outcomes

  1. Fibromyalgia impact questionaire

    Time frame: Six weeks after begining of intervention

    Changes of quality of life from baseline to six weeks after begining of intervention

Study contacts

Contact information is provided by the study sponsor or research team.

Ashraf Ahmed, Assistant professor

CONTACT

[email protected]

0111462073

Rowida Abd Elgleel, Lecturer

CONTACT

[email protected]

01152322678

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Effect Of Neuromodulation on Pain and Quality of Life In Patient With Fibromyalgia Syndrome

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 29, 2025
Registry last updated
Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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