Chronic Neck PainNCT06896487
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
A study testing Surface EMG Biofeedback Muscle and Relaxation Training and Conventional Rehabilitation in people with Chronic Neck Pain, run by Pervin Yeşiloğlu at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Neck Pain
- What is being tested?
- Surface EMG Biofeedback Muscle and Relaxation Training and Conventional Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Jul 2024to 6 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
- Conditions
- Chronic Neck Pain
- Being tested
- Surface EMG Biofeedback Muscle and Relaxation Training, Conventional Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surface EMG Biofeedback Muscle and Relaxation TrainingOther
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.
Conventional RehabilitationOther
The conventional rehabilitation group of this study received ultrasound, TENS and hot pack application 3 days a week for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Surface EMG Bofeedback Muscle and Relaxation Training | Experimental | 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. Receives: Other: Surface EMG Biofeedback Muscle and Relaxation Training |
| Conventional Rehabilitation Group | Experimental | 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. Receives: Other: Conventional Rehabilitation |
| Home Exercise Group | No intervention | Patients in this group were only told about home exercises and asked to do them 3 days a week. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper Extremity Reaction Time
Measured: Week of enrollment and end of the treatment at 6th weeks and 12 th weeks
Cervical Proprioception
Measured: Week of enrollment and end of the treatment at 6th weeks and 12 th weeks
Secondary outcomes (9)
Range of Motion Assessment
Measured: Week of enrollment and end of the treatment at 6th weeks and 12 th weeks
Neck Pain and Disability Index
Measured: Week of enrollment and end of the treatment at 6th weeks and 12 th weeks
Neck Disability Index
Measured: Week of enrollment and end of the treatment at 6th weeks and 12 th weeks
Pain Assessment
Visual analog scale was used to assess pain.
Measured: Week of enrollment and end of the treatment at 6th weeks and 12 th weeks
DASH Upper extremity Function Scale
Measured: Week of enrollment and end of the treatment at 6th weeks and 12 th weeks
Hand Grip Strenght
Measured: Week of enrollment and end of the treatment at 6th weeks and 12 th weeks
Upper Trapezius EMG Activation
Measured: Week of enrollment and end of the treatment at 6th weeks and 12 th weeks
SF-36
Measured: Week of enrollment and end of the treatment at 6th weeks and 12 th weeks
Upper Trapezius MVC on SEMG
Measured: Week of enrollment and end of the treatment at 6th weeks and 12 th weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start26 Jul 2024
- Primary completion10 Jan 2025
- Study completion6 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pervin Yeşiloğlu
- Sponsor type
- University, hospital or other
- Collaborators
- Dokuz Eylul University
- Responsible party
- Sponsor-investigator, Pervin Yeşiloğlu, Yuzuncu Yil University
- Investigators
- Pervin Yeşiloğlu, Research Assisstant, Principal investigator, Yuzuncu Yil UniversityAyşe M Tat, Assoc. Prof., Study chair, Yuzuncu Yil UniversityMurat Toprak, Assoc. Prof., Study chair, Van Yüzüncü Yıl Üniversitesi Tıp Fakültesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06896487
- Sponsor's protocol ID
- YYUPY01
- Status last verified
- Mar 2025
- First submitted
- 20 Mar 2025
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06896487
- Acronym / sponsor ID
- YYUPY01
- Conditions
- Chronic Neck Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Pervin YeşiloğluUniversity, hospital or other
- Collaborators
- Dokuz Eylul University
- Study start
- 26 Jul 2024 (actual)
- Primary completion
- 10 Jan 2025 (actual)
- Study completion
- 6 Mar 2025 (actual)
- First posted
- 26 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Surface EMG Bofeedback Muscle and Relaxation Training | Experimental | Other: Surface EMG Biofeedback Muscle and Relaxation TrainingParticipants in this group were given muscle training and relaxation training for 6 weeks with superficial EMG Biofeedback protocol in addition to home exercise therapy. |
| Conventional Rehabilitation Group | Experimental | Other: Conventional RehabilitationPatients in this study group were enrolled in a conventional therapy program consisting of ultrasound, TENS and hot pack in addition to home exercise therapy. |
| Home Exercise Group | No intervention | –Patients in this group were only told about home exercises and asked to do them 3 days a week. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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,
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surface EMG Biofeedback Muscle and Relaxation TrainingWe 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. | Other | Surface EMG Bofeedback Muscle and Relaxation Training |
| Conventional RehabilitationThe conventional rehabilitation group of this study received ultrasound, TENS and hot pack application 3 days a week for 6 weeks. | Other | Conventional Rehabilitation Group |
Primary outcome
Upper Extremity Reaction Time
Time frame: Week of enrollment and end of the treatment at 6th weeks and 12 th weeks
Cervical Proprioception
Time frame: Week of enrollment and end of the treatment at 6th weeks and 12 th weeks
9 secondary outcomes
Range of Motion Assessment
Time frame: Week of enrollment and end of the treatment at 6th weeks and 12 th weeks
Neck Pain and Disability Index
Time frame: Week of enrollment and end of the treatment at 6th weeks and 12 th weeks
Neck Disability Index
Time frame: Week of enrollment and end of the treatment at 6th weeks and 12 th weeks
Pain Assessment
Time frame: Week of enrollment and end of the treatment at 6th weeks and 12 th weeks
DASH Upper extremity Function Scale
Time frame: Week of enrollment and end of the treatment at 6th weeks and 12 th weeks
Hand Grip Strenght
Time frame: Week of enrollment and end of the treatment at 6th weeks and 12 th weeks
Upper Trapezius EMG Activation
Time frame: Week of enrollment and end of the treatment at 6th weeks and 12 th weeks
SF-36
Time frame: Week of enrollment and end of the treatment at 6th weeks and 12 th weeks
Upper Trapezius MVC on SEMG
Time frame: Week of enrollment and end of the treatment at 6th weeks and 12 th weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Chronic Neck Pain
Recruiting
Longitudinal Stripping Massage vs. Percussion Device for Neck Pain: Ultrasound Study.
Chronic Neck Pain
RecruitingPhase 2
Phenotype-based Model for Managing Chronic Post-treatment Pain Among Head and Neck Cancer Survivors: a Pilot Study
Chronic Postsurgical Pain, Chronic Post Cancer Surgery Pain
Active, not recruiting
Multimodal Manual Therapy vs. Maitland Mobilization for Chronic Non-Specific Neck Pain
Chronic Neck Pain
Not yet recruiting
Comparison of the Effectiveness of Motor Imagery Exercises and Suboccipital Myofascial Release Techniques in Nonspecific Chronic Neck Pain
Non-specific Chronic Neck Pain
Not yet recruiting
Digital Use, 24-Hour Movement Behaviors, and Myofascial Release in University Students With Neck Pain
Forward Head Posture, Chronic Nonspecific Neck Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pervin Yeşiloğlu, Research Assisstant principal investigator
Yuzuncu Yil University
Ayşe M Tat, Assoc. Prof. study chair
Yuzuncu Yil University
Murat Toprak, Assoc. Prof. study chair
Van Yüzüncü Yıl Üniversitesi Tıp Fakültesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surface EMG Biofeedback Muscle and Relaxation Training and Conventional Rehabilitation in people with Chronic Neck Pain, run by Pervin Yeşiloğlu at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper Extremity Reaction Time (time frame: Week of enrollment and end of the treatment at 6th weeks and 12 th weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.