NCT06896487

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 26, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 6, 2025

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

March 20, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 26, 2025

Completed
Last Updated

March 26, 2025

Status Verified

March 1, 2025

Enrollment Period

6 months

First QC Date

March 20, 2025

Last Update Submit

March 20, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Upper Extremity Reaction Time

    Week of enrollment and end of the treatment at 6th weeks and 12 th weeks

  • Cervical Proprioception

    Week of enrollment and end of the treatment at 6th weeks and 12 th weeks

Secondary Outcomes (9)

  • Range of Motion Assessment

    Week of enrollment and end of the treatment at 6th weeks and 12 th weeks

  • Neck Pain and Disability Index

    Week of enrollment and end of the treatment at 6th weeks and 12 th weeks

  • Neck Disability Index

    Week of enrollment and end of the treatment at 6th weeks and 12 th weeks

  • Pain Assessment

    Week of enrollment and end of the treatment at 6th weeks and 12 th weeks

  • DASH Upper extremity Function Scale

    Week of enrollment and end of the treatment at 6th weeks and 12 th weeks

  • +4 more secondary outcomes

Study Arms (3)

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.

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.

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.

Interventions

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.

Surface EMG Bofeedback Muscle and Relaxation Training

The conventional rehabilitation group of this study received ultrasound, TENS and hot pack application 3 days a week for 6 weeks.

Conventional Rehabilitation Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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,

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dokuz Eylül üniversitesi

Izmir, Balcova, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Relaxation Therapy

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Pervin Yeşiloğlu, Research Assisstant

    Yuzuncu Yil University

    PRINCIPAL INVESTIGATOR
  • Ayşe M Tat, Assoc. Prof.

    Yuzuncu Yil University

    STUDY CHAIR
  • Murat Toprak, Assoc. Prof.

    Van Yüzüncü Yıl Üniversitesi Tıp Fakültesi

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

March 20, 2025

First Posted

March 26, 2025

Study Start

July 26, 2024

Primary Completion

January 10, 2025

Study Completion

March 6, 2025

Last Updated

March 26, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations