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Clinical Trials/NCT06554106
NCT06554106
Recruiting
Not Applicable

Effects of Neuromuscular Electrical Stimulation in Fibromyalgia Patients

Firat University1 site in 1 country20 target enrollmentAugust 20, 2024
ConditionsFibromyalgia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fibromyalgia
Sponsor
Firat University
Enrollment
20
Locations
1
Primary Endpoint
Pain assessment
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 20, 2024
End Date
October 30, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Firat University
Responsible Party
Principal Investigator
Principal Investigator

Songül Bağlan Yentür

Firat University

Firat University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Pain assessment

Time Frame: 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 Outcomes

  • Sleep quality assessment(2 minutes)
  • Disability assessment(2 minutes)

Study Sites (1)

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