Neuromuscular Electrical Stimulation in Fibromyalgia

NCT06554106 | Recruiting

• 1 other identifier: 2024/10-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

Fibromyalgia; Neuromuscular Electrical Stimulation; Pain

Outcome Measures

Primary Outcomes (1)

• Pain assessment

  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.

  1 minute

Secondary Outcomes (2)

• Disability assessment

  2 minutes

• Sleep quality assessment

  2 minutes

Study Arms (2)

Neuromuscular Electrical Stimulation Group

EXPERIMENTAL

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.

Other: Neuromuscular Electrical Stimulation Group

Control group

EXPERIMENTAL

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

Other: Control Group

Interventions

Neuromuscular Electrical Stimulation Group OTHER

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.

Neuromuscular Electrical Stimulation Group

Control Group OTHER

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

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Firat University: lead

Study Sites (1)

Songul Baglan Yentur

Elâzığ, 23100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Fibromyalgia; Pain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

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

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: August 15, 2024
• Study Start: August 20, 2024
• Primary Completion: October 20, 2024
• Study Completion: October 30, 2024
• Last Updated: August 15, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)