Clinical trial NCT06323746: Exploring Heart Rate Variability, EEG Pattern, and Corticomuscular Coherence After Cervical Sagittal Alignment Restoration
Official title: Exploring Heart Rate Variability, EEG Pattern, and Corticomuscular Coherence After Cervical Sagittal Alignment Restoration: A Randomized Controlled Trial Investigation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cervical Lordosis
Keywords: Cervical Lordosis
Athlete
Electroencephalography
Heart Rate
Lead sponsor: University of Sharjah
Sponsor class: OTHER
First posted: 2024-03-21
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cervical Sagittal Alignment Radiographs
timeFrame: Baseline (pre-treatment), week 10 (upon completion) and after 6 months
measure: Cervical Sagittal Alignment Radiographs
timeFrame: Baseline (pre-treatment), week 10 (upon completion) and after 6 months
Secondary outcomes:
measure: Heart rate Variability (HRV) physiological parameter
timeFrame: Baseline (pre-treatment), week 10 (upon completion) and after 6 months
measure: Corticomuscular Coherence
timeFrame: Baseline (pre-treatment), week 10 (upon completion) and after 6 months
Other outcomes:
Locations:
city: Sharjah
country: United Arab Emirates
facility: University of Sharjah
Study officials:
References: