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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cervical Lordosis
• Intervention / Treatment: Device: Denneroll cervical traction orthodontic

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shima Zadeh; Phone Number: +971503077039; Email: Szadeh@sharjah.ac.ae
• Study Contact Backup: Name: Ibrahim Mostafa Abuamr; Email: iabuamr@sharjah.ac.ae

Study Locations

• United Arab Emirates
  • Sharjah, United Arab Emirates, 0000
    • University of Sharjah
    • Contact: Ibrahim Mostafa Abuamr, professor; Email: iabuamr@sharjah.ac.ae
    • Sub-Investigator: Shima Zadeh, Research Assistant
    • Principal Investigator: Ibrahim Mostafa Abuamr, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Denneroll Group; The participants will be instructed to lie flat on their back on the ground with their legs extended and arms by their sides and gently folded across their stomach. The subject will place the Denneroll on the ground and the examiner positions the apex of the Denneroll. The apex of the Denneroll orthotic will be placed in one of three regions based on lateral cervical radiographic displacements.	Device: Denneroll cervical traction orthodontic; 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.
Other: Wait List; This group will receive the same posture correction program after all data will be collected.	Device: Denneroll cervical traction orthodontic; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cervical Sagittal Alignment Radiographs	The change of cervical lordosis from the absolute rotatory angle C2-7.	Baseline (pre-treatment), week 10 (upon completion) and after 6 months
Cervical Sagittal Alignment Radiographs	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.	Baseline (pre-treatment), week 10 (upon completion) and after 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate Variability (HRV) physiological parameter	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.	Baseline (pre-treatment), week 10 (upon completion) and after 6 months
Corticomuscular Coherence	The change in the ratio between Muscle activity through Electromyography (EMG) and brain waves through Electroencephalograph (EEG)	Baseline (pre-treatment), week 10 (upon completion) and after 6 months

Collaborators and Investigators

• Sponsor: University of Sharjah

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: March 1, 2024
• First Submitted That Met QC Criteria: March 14, 2024
• First Posted (Actual): March 21, 2024

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Athlete; Electroencephalography; Heart Rate; Cervical Lordosis
• Additional Relevant MeSH Terms: Nutrition Disorders; Musculoskeletal Diseases; Deficiency Diseases; Malnutrition; Spinal Diseases; Bone Diseases; Spinal Curvatures; Lordosis; Swayback
• Other Study ID Numbers: HR-EEG-CSAR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to make individual participant data (IPD) available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No