An interventional study of Neuromuscular Electrical Stimulation Group and Control Group in Fibromyalgia, sponsored by Firat University. Recruiting at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-08-15.
Sponsored by Firat University · Not applicable, Interventional, and Treatment
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.
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.
1,335 studies on the registry are indexed under Fibromyalgia; 265 are open to participants now.
This study's planned enrollment of 20 is below the median of 60 across 1,034 interventional studies indexed under Fibromyalgia.
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Exclusion Criteria:
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
Patients will be taught neck normal joint movement exercises, upper trapezius stretching exercise and posture exercises.
Other: Control 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.
Patients will be taught neck normal joint movement exercises, upper trapezius stretching exercise and posture exercises.
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.
Time frame: 1 minute
Disability assessment
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).
Time frame: 2 minutes
Sleep quality assessment
Pittsburg Sleep Quality Index will be used to evaluate sleep quality
Time frame: 2 minutes
Plan to share: No
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