Cervical LordosisNCT06323746
Exploring Heart Rate Variability, EEG Pattern, and Corticomuscular Coherence After Cervical Sagittal Alignment Restoration
A study testing Denneroll cervical traction orthodontic in people with Cervical Lordosis, run by University of Sharjah at 1 site in United Arab Emirates.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Cervical Lordosis
- What is being tested?
- Denneroll cervical traction orthodontic
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- May 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Anterior head translation (AHT) >15 mm
- Absolute rotatory angle C2 to C7 is <25°
- Athletic student
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ibrahim Mostafa Abuamr contact
United Arab Emirates1 site
University of Sharjah
Sharjah city, 0000
Ibrahim Mostafa Abuamr, professor, iabuamr@sharjah.ac.ae
Shima Zadeh, Research Assistant
About this study
Official title: 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.
Read the 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.
- Conditions
- Cervical Lordosis
- Being tested
- Denneroll cervical traction orthodontic
- Keywords
- Cervical Lordosis, Athlete, Electroencephalography, Heart Rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Denneroll cervical traction orthodonticDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Denneroll Group | Experimental | 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. Receives: Device: Denneroll cervical traction orthodontic |
| Wait List | Other | This group will receive the same posture correction program after all data will be collected. Receives: Device: Denneroll cervical traction orthodontic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervical Sagittal Alignment Radiographs
The change of cervical lordosis from the absolute rotatory angle C2-7.
Measured: 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.
Measured: Baseline (pre-treatment), week 10 (upon completion) and after 6 months
Secondary outcomes (2)
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.
Measured: 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)
Measured: Baseline (pre-treatment), week 10 (upon completion) and after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study startMay 2024 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical LordosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sharjah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahim Moustafa, University of Sharjah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06323746
- Sponsor's protocol ID
- HR-EEG-CSAR
- Status last verified
- May 2024
- First submitted
- 1 Mar 2024
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to make individual participant data (IPD) available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Heart Rate Variability, EEG Pattern, and Corticomuscular Coherence After Cervical Sagittal Alignment Restoration: A Randomized Controlled Trial Investigation
- ClinicalTrials.gov ID
- NCT06323746
- Acronym / sponsor ID
- HR-EEG-CSAR
- Conditions
- Cervical Lordosis
- Keywords
- Cervical Lordosis, Athlete, Electroencephalography, Heart Rate
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of SharjahUniversity, hospital or other
- Study start
- May 2024 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Denneroll Group | Experimental | Device: Denneroll cervical traction orthodonticThe 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. |
| Wait List | Other | Device: Denneroll cervical traction orthodonticThis group will receive the same posture correction program after all data will be collected. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Anterior head translation (AHT) >15 mm
- Absolute rotatory angle C2 to C7 is <25°
- Athletic student
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Denneroll cervical traction orthodonticThe 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. | Device | Denneroll Group, Wait List |
Primary outcome
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.
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.
2 secondary outcomes
Heart rate Variability (HRV) physiological parameter
Time frame: Baseline (pre-treatment), week 10 (upon completion) and after 6 months
Corticomuscular Coherence
Time frame: Baseline (pre-treatment), week 10 (upon completion) and after 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- Individual participant dataSharing planned: No. No plan to make individual participant data (IPD) available to other researchers.
Related trials for Cervical Lordosis
RecruitingObservational study
Changes in Cervical Posture, Cervical Function, and Neck Pain After Sleeve Gastrectomy
Morbid Obesity Requiring Bariatric Surgery, Neck Pain Musculoskeletal
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ibrahim Mostafa Abuamr contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Denneroll cervical traction orthodontic in people with Cervical Lordosis, run by University of Sharjah at 1 site in United Arab Emirates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shima Zadeh (+971503077039, Szadeh@sharjah.ac.ae), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cervical Sagittal Alignment Radiographs (time frame: Baseline (pre-treatment), week 10 (upon completion) and after 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2024.