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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Neck Pain
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
Collaborators: name: Dokuz Eylul University
First posted: 2025-03-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Upper Extremity Reaction Time
timeFrame: Week of enrollment and end of the treatment at 6th weeks and 12 th weeks
measure: Cervical Proprioception
timeFrame: Week of enrollment and end of the treatment at 6th weeks and 12 th weeks
Secondary outcomes:
measure: Range of Motion Assessment
timeFrame: Week of enrollment and end of the treatment at 6th weeks and 12 th weeks
measure: Neck Pain and Disability Index
timeFrame: Week of enrollment and end of the treatment at 6th weeks and 12 th weeks
measure: Neck Disability Index
timeFrame: Week of enrollment and end of the treatment at 6th weeks and 12 th weeks
measure: Pain Assessment
timeFrame: Week of enrollment and end of the treatment at 6th weeks and 12 th weeks
measure: DASH Upper extremity Function Scale
timeFrame: Week of enrollment and end of the treatment at 6th weeks and 12 th weeks
measure: Hand Grip Strenght
timeFrame: Week of enrollment and end of the treatment at 6th weeks and 12 th weeks
measure: Upper Trapezius EMG Activation
timeFrame: Week of enrollment and end of the treatment at 6th weeks and 12 th weeks
measure: SF-36
timeFrame: Week of enrollment and end of the treatment at 6th weeks and 12 th weeks
measure: Upper Trapezius MVC on SEMG
timeFrame: Week of enrollment and end of the treatment at 6th weeks and 12 th weeks
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Dokuz Eylül üniversitesi
state: Balcova
Study officials:
affiliation: Yuzuncu Yıl University
name: Pervin Yeşiloğlu, Research Assisstant
role: PRINCIPAL_INVESTIGATOR
affiliation: Yuzuncu Yıl University
name: Ayşe M Tat, Assoc. Prof.
role: STUDY_CHAIR
affiliation: Van Yüzüncü Yıl Üniversitesi Tıp Fakültesi
name: Murat Toprak, Assoc. Prof.
role: STUDY_CHAIR
References: