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Neuromuscular Electrical Stimulation in Fibromyalgia

Effects of Neuromuscular Electrical Stimulation in Fibromyalgia Patients

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06554106
Enrollment
20
Registered
2024-08-15
Start date
2024-08-20
Completion date
2024-10-30
Last updated
2024-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia

Keywords

Fibromyalgia, Neuromuscular Electrical Stimulation, Pain

Brief summary

Fibromyalgia syndrome (FMS) is associated with chronic widespread pain and at least eleven positive tender points out of 18 according to the American College of Rheumatology (ACR) 1990 criteria. Neuromuscular electrical stimulation (NMES) stimulates nerve fibers providing innervation in healthy muscle and muscle fibers in denervated muscle to produce contraction. All patients will be taught neck normal joint motion exercises, upper trapezius stretching exercise and posture exercises. Patients included in the study will be randomly distributed equally between the two groups. In addition to the study group, NMES will be applied to the upper trapezius muscle for 30 minutes 5 days a week for 4 weeks. Pain, disability and sleep quality of all patients will be evaluated.

Detailed description

Fibromyalgia syndrome (FMS) is associated with chronic widespread pain and at least eleven positive tender points out of 18 according to the 1990 criteria of the American College of Rheumatology (ACR) (1). Pain and other symptoms associated with fibromyalgia interfere with daily functions, work and social activities, leading to a decrease in quality of life. Neuromuscular electrical stimulation (NMES) stimulates nerve fibers that provide innervation in healthy muscle and muscle fibers in denervated muscle to produce contraction. Studies on TENS current in patients with FM have shown that pain decreases and functional status improves. However, although muscle weakness has been described in patients with FM, there are no studies on the effects of NMES application. All patients will be taught neck normal joint motion exercises, upper trapezius stretching exercise and posture exercises. Patients included in the study will be randomly distributed equally between the two groups. In addition to the study group, NMES will be applied to the upper trapezius muscle for 30 minutes 5 days a week for 4 weeks. Pain, disability and sleep quality of all patients will be evaluated.

Interventions

All patients will be taught neck normal joint movement exercises, upper trapezius stretching exercise and posture exercises. In addition to the study group, NMES will be applied to the upper trapezius muscle for 30 minutes 5 days a week for 4 weeks. Neuromuscular Electrical Stimulation (NMES) applications will be performed with a Compex 3 (Compex Medical SA, Ecublens, Switzerland) model, portable and programmable electrostimulator unit in rehabilitation mode and under the supervision of an expert physiotherapist experienced in the device and application. The NMES program will be applied with a 4-channel device with a functional stimulation capacity of 120 mA, pulse duration 400 μs and pulse frequency 150 Hz.

OTHERControl Group

Patients will be taught neck normal joint movement exercises, upper trapezius stretching exercise and posture exercises.

Sponsors

Firat University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Patients who were aged between 18-65 years, * Patients who got diagnosed with Fibromyalgia Syndrome

Exclusion criteria

* Patients who had regular exercise habits, malignancy, pregnancy, incorporation * Patients who had changes of medical treatment in last 3 months * Patients who had dysfunction that can prevent physical activity

Design outcomes

Primary

MeasureTime frameDescription
Pain assessment1 minutePain intensity will be evaluated according to VAS. Patients will be asked to mark the pain intensity on a 10 cm line. 0 means no pain and 10 means unbearable pain.

Secondary

MeasureTime frameDescription
Disability assessment2 minutesFibromyalgia Impact Questionnaire will be used. The FIQ consists of 10 items. The first item includes daily activity questions scored on a Likert scale from 0 to 3 (always able to do - never able to do).
Sleep quality assessment2 minutesPittsburg Sleep Quality Index will be used to evaluate sleep quality

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026