Neuromuscular Electrical Stimulation in Fibromyalgia

Not Applicable

Recruiting

• Conditions: Fibromyalgia
• Interventions: Other: Neuromuscular Electrical Stimulation Group; Other: Control Group

• Registration Number: NCT06554106
• Lead Sponsor: Firat University

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.

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-13
• Study First Submitted QC: 2024-08-13
• Last Update Submitted: 2024-08-13
• Study First Posted: 2024-08-15
• Last Update Posted: 2024-08-15
• Study Start: 2024-08-20
• Primary Completion: 2024-10-20
• Study Completion: 2024-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neuromuscular Electrical Stimulation Group	Neuromuscular Electrical Stimulation Group	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.
Control group	Control Group	Patients will be taught neck normal joint movement exercises, upper trapezius stretching exercise and posture exercises.

Primary Outcome Measures

Name	Time	Method
Pain assessment	1 minute	Pain 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 Outcome Measures

Name	Time	Method
Sleep quality assessment	2 minutes	Pittsburg Sleep Quality Index will be used to evaluate sleep quality
Disability assessment	2 minutes	Fibromyalgia 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).

Trial Locations

Locations (1)

Songul Baglan Yentur; 🇹🇷 Elazığ, Turkey