Neck PainNCT06301217
Are Axioscapular Muscles Activity and Cervical Curvature Associated With Disability in Neck Pain
An observational study of Neck Pain and Electromyohgraph, run by Delta University for Science and Technology at 1 site in Egypt.
Trial summary
Despite the important role of axioscapular muscles electromyography and cervical posture as outcomes for the management of chronic neck non specific pain , there is gab of evidence that highlight their association to the commonly used neck disability index. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Neck Pain, Electromyohgraph
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 17 Dec 2023to 20 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Study population: patients with chronic nonspecific neck pain lasting longer than three months
Who may be able to join
- chronic nonspecific neck pain
- age between 20 and 40 years,
- either sex
- symptoms lasting longer than three months
Who cannot join
- Pregnancy
- Spinal surgeries
- spinal deformities
- visual or auditory issues
- ongoing physical or medical treatment for cervical or low back pain
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Delta university for science and technology
Gamasa, Dakahlia Governorate, 7731168
About this study
Official title: Are Axioscapular Muscles Activity and Cervical Curvature Associated With Disability in Patients With Chronic Nonspecific Neck Pain? - A Cross Sectional Exploratory Study
Despite the important role of axioscapular muscles electromyography and cervical posture as outcomes for the management of chronic neck non specific pain , there is gab of evidence that highlight their association to the commonly used neck disability index. The quest to improve outcomes for individuals suffering from chronic nonspecific neck pain is underscored by the need to identify key prognostic variables that can guide clinical decision-making and intervention strategies. This study seeks to bridge the gap in research by examining the association between neck disability index score, cervical sagittal curvature, and axioscapular muscles electromyography in forms of both trapezius and levator scapula root mean squares to indicate muscular activities and median frequencies to indicate muscular fatigue.
- Conditions
- Neck Pain, Electromyohgraph
- Being tested
- There is no intervention
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There is no interventionOther
There is no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck disability
Neck disability will be measured using the neck disability index. It is a 10-item questionnaire. The patient will be asked to respond by selecting the checkbox next to each statement that most accurately reflect him/her.
Measured: at the enrollment
Curvature angle of the cervical spine
A flexible ruler (ati, FC-700R, Taiwan) will be used to measure the cervical spine curve. To calculate the angle, the patient's elbows will be resting on the armrest directly below the acromion as the patient sat in a chair with his feet flat on the floor, and the ruler will firmly press against the patient's upright cervical spine between the occiput and the seventh cervical spinous process. A mathematical equation will be used: angle (Q)
=arc tan (2b / a). whereas: a, Length between the two endpoints of the cervical curve; b, Length of the perpendicular from the midpoint of line a to the curve
Measured: at the enrollment
root-mean-square value (RMS) of Surface electromyography for both upper trapezius and levator scapula
electromyography (MyoSystemTM 1400A, Noraxon Inc, 15770 N) will be used to measure:
- the maximum voluntary isometric contraction of both upper trapezius and levator scapula for 3 trials.
- Writing task electromyography amplitude for 15 minutes, a semistatic load, after the MVIC evaluation
Finally, root-mean-square value (%) of both upper trapezius and levator scapula will be calculated as : Writing task electromyography amplitude divided by the average of the three maximum voluntary isometric contraction trials.
Measured: at the enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start17 Dec 2023
- Primary completion10 Mar 2024 (estimated)
- Study completion20 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Delta University for Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Mohamed Ali Elabd, Delta University for Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06301217
- Sponsor's protocol ID
- NO: PT. BU. EC. 7
- Status last verified
- Mar 2024
- First submitted
- 3 Mar 2024
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Personal preference
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are Axioscapular Muscles Activity and Cervical Curvature Associated With Disability in Patients With Chronic Nonspecific Neck Pain? - A Cross Sectional Exploratory Study
- ClinicalTrials.gov ID
- NCT06301217
- Acronym / sponsor ID
- NO: PT. BU. EC. 7
- Conditions
- Neck Pain, Electromyohgraph
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Delta University for Science and TechnologyUniversity, hospital or other
- Study start
- 17 Dec 2023 (actual)
- Primary completion
- 10 Mar 2024 (estimated)
- Study completion
- 20 Mar 2024 (estimated)
- First posted
- 8 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.
Despite the important role of axioscapular muscles electromyography and cervical posture as outcomes for the management of chronic neck non specific pain , there is gab of evidence that highlight their association to the commonly used neck disability index. The quest to improve outcomes for individuals suffering from chronic nonspecific neck pain is underscored by the need to identify key prognostic variables that can guide clinical decision-making and intervention strategies. This study seeks to bridge the gap in research by examining the association between neck disability index score, cervical sagittal curvature, and axioscapular muscles electromyography in forms of both trapezius and levator scapula root mean squares to indicate muscular activities and median frequencies to indicate muscular fatigue.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- patients with chronic nonspecific neck pain lasting longer than three months
Key inclusion criteria (4 listed)
- chronic nonspecific neck pain
- age between 20 and 40 years,
- either sex
- symptoms lasting longer than three months
Key exclusion criteria (5 listed)
- Pregnancy
- Spinal surgeries
- spinal deformities
- visual or auditory issues
- ongoing physical or medical treatment for cervical or low back pain
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 |
|---|---|---|
| There is no interventionThere is no intervention | Other | – |
Primary outcome
Neck disability
Time frame: at the enrollment
Neck disability will be measured using the neck disability index. It is a 10-item questionnaire. The patient will be asked to respond by selecting the checkbox next to each statement that most accurately reflect him/her.
Curvature angle of the cervical spine
Time frame: at the enrollment
A flexible ruler (ati, FC-700R, Taiwan) will be used to measure the cervical spine curve. To calculate the angle, the patient's elbows will be resting on the armrest directly below the acromion as the patient sat in a chair with his feet flat on the floor, and the ruler will firmly press against the patient's upright cervical spine between the occiput and the seventh cervical spinous process. A mathematical equation will be used: angle (Q) =arc tan (2b / a). whereas: a, Length between the two endpoints of the cervical curve; b, Length of the perpendicular from the midpoint of line a to the curve
root-mean-square value (RMS) of Surface electromyography for both upper trapezius and levator scapula
Time frame: at the enrollment
electromyography (MyoSystemTM 1400A, Noraxon Inc, 15770 N) will be used to measure: * the maximum voluntary isometric contraction of both upper trapezius and levator scapula for 3 trials. * Writing task electromyography amplitude for 15 minutes, a semistatic load, after the MVIC evaluation Finally, root-mean-square value (%) of both upper trapezius and levator scapula will be calculated as : Writing task electromyography amplitude divided by the average of the three maximum voluntary isometric contraction trials.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Individual participant dataSharing planned: No. Personal preference
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neck Pain and Electromyohgraph, run by Delta University for Science and Technology at 1 site in Egypt.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 8 Mar 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neck disability (time frame: at the enrollment). The study lists 3 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 8 Mar 2024.