Neuromuscular Electrical Stimulation in Fibromyalgia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Neuromuscular Electrical Stimulation Group, Control Group.
- Who it may be relevant to
- Registry conditions: Fibromyalgia. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effects of Neuromuscular Electrical Stimulation in Fibromyalgia Patients
Overview
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
- Other 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 exper - Other Control Group
Patients will be taught neck normal joint movement exercises, upper trapezius stretching exercise and posture exercises.
Primary outcome measures
- Pain assessment [Time frame: 1 minute]
Secondary outcome measures (2)
- Disability assessment [Time frame: 2 minutes]
- Sleep quality assessment [Time frame: 2 minutes]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Turkey (Türkiye) · 1 center
- Songul Baglan Yentur — Elâzığ
Identifiers
NCT: NCT06554106 · 2024/10-01