- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06896487
The Effect of Superficial EMG Biofeedback Training on Muscle Activation, Proprioception, Reaction Time and Upper Extremity Functions in Patients with Chronic Neck Pain: a Single-Blind Randomized Controlled Trial
The EFFECT of SUPERFICIAL EMG BIOFEEDBACK TRAINING on MUSCLE ACTIVATION, PROPRIOCEPTION, REACTION TIME and UPPER EXTREMITY FUNCTIONS in PATIENTS with CHRONIC NECK PAIN: a SINGLE-BLIND RANDOMIZED CONTROLLED TRIAL
Musculoskeletal disorders are among the health problems that most distract individuals from work life in both developed and developing countries. According to the 2019 Global Burden of Disease Study, when evaluated in terms of burden of disease, life expectancy with disability and rehabilitation needs, low back and neck pain are at the top of this category. According to the Health Research Report published by the Turkish Statistical Institute (TurkStat) in 2019, musculoskeletal disorders in the neck region are more common in women and were determined as the musculoskeletal disorder with the highest increase by 12.9% between 2016 and 2019.
It has been reported that in approximately half of individuals with neck pain, this pain recurs and becomes chronic. Factors such as sedentary lifestyle, history of low back pain, being female, anxiety disorders, sleep problems and smoking are thought to contribute to the chronicization of pain. Chronic neck pain is defined as pain in the neck region lasting longer than twelve weeks.
Cervical muscle activations have been monitored with EMG studies in the patient population with neck pain from past to present and altered cervical muscle activations have been reported in individuals with neck pain. The main muscle groups in which muscle activation has been monitored with superficial EMG and changes have been found in individuals with neck pain are upper trapezius, sternocelidomastoid, cervical erector spinal muscles and thoracic erector spinal muscles. On the other hand, it is still debated whether these muscle activation changes are the cause or a normal consequence of chronic neck pain.
In recent years, it has been reported in the literature that EMG Biofeedback studies have been included in patients with neck pain, but more studies are needed to determine its superiority to conventional applications. In the light of this information, in our study titled "The Effect of Superficial EMG Biofeedback Training on Muscle Activation, Proprioception, Reaction Time and Upper Extremity Functions in Patients with Chronic Neck Pain; Randomized controlled study", both the effect of EMG Biofeedback muscle training application on the symptoms of patients with neck pain will be investigated and data that will be a reference for future studies in this field will be obtained.
The study in patients with chronic neck pain had two aims. To investigate the effect of EMG Biofeedback relaxation training (upper trapezius muscle) combined with active EMG Biofeedback exercises + routine exercise program on muscle activation, pain, proprioception, reaction time and upper extremity function in patients with neck pain. To compare the effects of EMG Biofeedback training with standard physiotherapy program.
Hypotheses of the study; H0: EMG Biofeedback relaxation training (upper trapezius muscle) combined with active EMG Biofeedback exercises + routine exercise program has no effect on muscle activation, pain, proprioception, reaction time and upper extremity function in patients with neck pain H1: EMG Biofeedback relaxation training (upper trapezius muscle) combined with active EMG Biofeedback exercises + routine exercise program has an effect on muscle activation, pain, proprioception, reaction time and upper extremity function in patients with neck pain.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Balcova
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Izmir, Balcova, Turkey
- Dokuz Eylul Universitesi
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Presentation to the clinic with neck pain for at least 3 months due to at least one of the following causes: facet joint dysfunction, cervical disc lesions, myofascial pain syndrome, cervical spondylosis, mechanical neck pain,
- To be between the ages of 18-65,
- To cooperate with the evaluation parameters to be applied in the study,
- Volunteering to participate in the study,
- Not having received physical therapy for neck pain before,
Exclusion Criteria:
- Over 65 years of age,
- Problems in perceiving verbal commands,
- Having benefited from physiotherapy and/or another treatment method for neck pain within the last 1 year,
- Undergoing any operation related to pathologies of the neck region,
- To have undergone upper extremity surgery,
- Presence of neurological symptoms,
- Presence of comorbidities affecting upper extremity and hand functions (carpal tunnel syndrome, trigger finger, impingement syndrome, thoracic outlet syndrome, lateral and medial epicondylitis, hand osteoarthritis),
- Pregnancy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Surface EMG Bofeedback Muscle and Relaxation Training
Participants in this group were given muscle training and relaxation training for 6 weeks with superficial EMG Biofeedback protocol in addition to home exercise therapy.
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We think that 6 weeks of superficial EMG Biofeedback muscle training and relaxation training given to the participants in this study will improve the patient's upper trapezius activation and voluntary contraction performance.
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Experimental: Conventional Rehabilitation Group
Patients in this study group were enrolled in a conventional therapy program consisting of ultrasound, TENS and hot pack in addition to home exercise therapy.
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The conventional rehabilitation group of this study received ultrasound, TENS and hot pack application 3 days a week for 6 weeks.
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No Intervention: Home Exercise Group
Patients in this group were only told about home exercises and asked to do them 3 days a week.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Upper Extremity Reaction Time
Time Frame: Week of enrollment and end of the treatment at 6th weeks and 12 th weeks
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Week of enrollment and end of the treatment at 6th weeks and 12 th weeks
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Cervical Proprioception
Time Frame: Week of enrollment and end of the treatment at 6th weeks and 12 th weeks
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Week of enrollment and end of the treatment at 6th weeks and 12 th weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Range of Motion Assessment
Time Frame: Week of enrollment and end of the treatment at 6th weeks and 12 th weeks
|
Week of enrollment and end of the treatment at 6th weeks and 12 th weeks
|
|
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Neck Pain and Disability Index
Time Frame: Week of enrollment and end of the treatment at 6th weeks and 12 th weeks
|
Week of enrollment and end of the treatment at 6th weeks and 12 th weeks
|
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Neck Disability Index
Time Frame: Week of enrollment and end of the treatment at 6th weeks and 12 th weeks
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Week of enrollment and end of the treatment at 6th weeks and 12 th weeks
|
|
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Pain Assessment
Time Frame: Week of enrollment and end of the treatment at 6th weeks and 12 th weeks
|
Visual analog scale was used to assess pain.
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Week of enrollment and end of the treatment at 6th weeks and 12 th weeks
|
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DASH Upper extremity Function Scale
Time Frame: Week of enrollment and end of the treatment at 6th weeks and 12 th weeks
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Week of enrollment and end of the treatment at 6th weeks and 12 th weeks
|
|
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Hand Grip Strenght
Time Frame: Week of enrollment and end of the treatment at 6th weeks and 12 th weeks
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Week of enrollment and end of the treatment at 6th weeks and 12 th weeks
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Upper Trapezius EMG Activation
Time Frame: Week of enrollment and end of the treatment at 6th weeks and 12 th weeks
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Week of enrollment and end of the treatment at 6th weeks and 12 th weeks
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SF-36
Time Frame: Week of enrollment and end of the treatment at 6th weeks and 12 th weeks
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Week of enrollment and end of the treatment at 6th weeks and 12 th weeks
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Upper Trapezius MVC on SEMG
Time Frame: Week of enrollment and end of the treatment at 6th weeks and 12 th weeks
|
Week of enrollment and end of the treatment at 6th weeks and 12 th weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Pervin Yeşiloğlu, Research Assisstant, Yuzuncu Yıl University
- Study Chair: Ayşe M Tat, Assoc. Prof., Yuzuncu Yıl University
- Study Chair: Murat Toprak, Assoc. Prof., Van Yüzüncü Yıl Üniversitesi Tıp Fakültesi
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- YYUPY01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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