An interventional study of Denneroll cervical traction orthodontic in Cervical Lordosis, sponsored by University of Sharjah. Not yet recruiting at 1 site in United Arab Emirates. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-30.
Sponsored by University of Sharjah · Not applicable, Interventional, and Treatment
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:
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.
30 studies on the registry are indexed under Lordosis; 5 are open to participants now.
This study's planned enrollment of 80 is above the median of 50 across 15 interventional studies indexed under Lordosis.
Browse Lordosis studies →University of Sharjah is the lead sponsor of 42 studies on the registry; 17 are open to participants now.
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Exclusion Criteria:
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
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.
Cervical Sagittal Alignment Radiographs
The change of cervical lordosis from the absolute rotatory angle C2-7.
Time frame: 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.
Time frame: Baseline (pre-treatment), week 10 (upon completion) and after 6 months
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.
Time frame: 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)
Time frame: Baseline (pre-treatment), week 10 (upon completion) and after 6 months
Plan to share: No — No plan to make individual participant data (IPD) available to other researchers.
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This study is not yet recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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University of Sharjah