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NCT Number: NCT06323746

Exploring Heart Rate Variability, EEG Pattern, and Corticomuscular Coherence After Cervical Sagittal Alignment Restoration

The goal of this Randomized clinical trial is to learn about how fixing neck curvature and head posture right away affects heart rate, brainwaves, and muscle coordination in college athletes. The main question it aims to answer:

- Whether forward head posture (FHP) may play a crucial role in affecting heart rate variability, brainwaves, and muscle coordination.

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Key information

Conditions

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Sharjah

Sharjah city, 0000, United Arab Emirates

Location contact

Ibrahim Mostafa Abuamr, Professor

PRINCIPAL_INVESTIGATOR

Ibrahim Mostafa Abuamr, professor

CONTACT

[email protected]

Shima Zadeh, Research Assistant

SUB_INVESTIGATOR

About this study

Background: Restoring normal cervical spine alignment has emerged as one of the most important clinical outcomes in healthcare. However, the question of whether cervical biomechanical dysfunction manifesting as forward head posture (FHP) may play a crucial role in affecting heart rate variability, as an indicator of the autonomic nervous system, electroencephalography (EEG) pattern, as indictor for brain waves, and corticomuscular coherence, as an indicator of the functional connection between the cortex and muscles during continuous muscle contractions among collegiate athletes has not been answered yet.

Objective: To investigate the immediate and long-term effects of cervical lordosis restoration and forward head correction using the Denneroll™ on heart rate variability, EEG pattern, and corticomuscular coherence among collegiate athletes.

Methods: Eighty asymptomatic subjects with a definite hypolordotic cervical spine and FHP will be randomly assigned to an experimental group or a control group. The experimental group will receive the Denneroll™ cervical traction while the control group will be considered as a wait list to start the intervention after completion of the experimental group. Interventions will be applied 3 times per week for a period of 10 weeks. Changes in heart rate variability, EEG pattern and corticomuscular coherence will be assessed at three-time intervals: at baseline, after 10 weeks of intervention, and at 6-months follow up with no further interventions.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Anterior head translation (AHT) >15 mm
  • Absolute rotatory angle C2 to C7 is <25°
  • Athletic student

Exclusion criteria

  • Inflammatory joint disease or other systemic pathologies
  • Prior history of overt injury and surgery relating to the musculoskeletal system, or disorder related to the spine and extremities
  • Musculoskeletal pain in the previous three months.

Treatment and study plan

Denneroll cervical traction orthodontic

Device

The duration of each session will start at approximately three minutes and increase by one minute per session until reaching the goal of 20 minutes per session. The intervention will be repeated three times per week for 10 weeks in the supervised setting.

Primary outcomes

  1. Cervical Sagittal Alignment Radiographs

    Time frame: Baseline (pre-treatment), week 10 (upon completion) and after 6 months

    The change of cervical lordosis from the absolute rotatory angle C2-7.

  2. Cervical Sagittal Alignment Radiographs

    Time frame: Baseline (pre-treatment), week 10 (upon completion) and after 6 months

    The amount of the change in the anterior head translation from the horizontal offset of the posterior superior body corner of C2 relative to the vertical line.

Secondary outcomes

  1. Heart rate Variability (HRV) physiological parameter

    Time frame: Baseline (pre-treatment), week 10 (upon completion) and after 6 months

    The change in Heart rate through Electrocardiographic recordings (ECG) will be monitored using a Nexus-10 physiologic monitoring system. Recordings will be made simultaneously through three separate channels. The ground electrode will be placed below the left clavicle, the cathode (-) below the right clavicle and the anode (+) will be placed on the third rib, in line with the ground.

    HRV time parameter will be calculated from respiratory rate (RR) intervals (Standard deviation of the normal to normal intervals (SDNN), Root-mean-square of the successive normal sinus RR interval difference (RMSSD) and the percentage of absolute differences between successive normal RR intervals that exceed 50 ms (pNN50)).

    HRV frequency domain variable will include total power, high frequency (HF) and low frequency (LF) power (measured in ms2) and LF:HF ratio were derived from spectral analysis of successive R-R intervals.

  2. Corticomuscular Coherence

    Time frame: Baseline (pre-treatment), week 10 (upon completion) and after 6 months

    The change in the ratio between Muscle activity through Electromyography (EMG) and brain waves through Electroencephalograph (EEG)

Study contacts

Contact information is provided by the study sponsor or research team.

Ibrahim Mostafa Abuamr

CONTACT

[email protected]

Shima Zadeh

CONTACT

[email protected]

+971503077039

Sponsors and collaborators

Lead sponsor

University of Sharjah

Other

Registry information

Official study title

Exploring Heart Rate Variability, EEG Pattern, and Corticomuscular Coherence After Cervical Sagittal Alignment Restoration: A Randomized Controlled Trial Investigation

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 21, 2024
Registry last updated
May 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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