Neck PainNCT05291377
ML for Neck Disability Using Muscle and Joint
An observational study of Neck Pain and Disability Physical, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
conduct machine learning models to identify different aspects that can give us an impression about the disability in patients with neck pain. By using 17 different classifier and regressor models. to identify disability from emg, pain, ROM and curve measurements Read more about this study
- Who is it for?
- Ages 30 to 55 years
- Conditions the study is for
- Neck Pain, Disability Physical
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Aug 2022to 24 Mar 2023
- How long will I take part?
- 1 Week
- 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 30 to 55 years
- All sexes
- Adult
Study population: neck pain patients that scored at least 3 on VAS and experienced the pain for more than 3 months
Who may be able to join
- Complaining from pain
- Able to read and write
Who cannot join
- no anomalies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Machine Learning Models for Identifying Disability in Neck Pain Patients Using Muscle and Joint Parameters
conduct machine learning models to identify different aspects that can give us an impression about the disability in patients with neck pain.
By using 17 different classifier and regressor models. to identify disability from emg, pain, ROM and curve measurements
Read the detailed description
ninety patients from both sexes suffering from mechanical neck dysfunction were participated in this study.
Patients were participated in the study if they fulfilled the following criteria
- Ninety patients from both sexes with their ages ranged from 20-35 years old.
- Subjects Referred from orthopedic consultant with chronic mechanical neck pain (<3months duration)
- The neck disability index is above 15, a minimal score to reflect the presence of at least a mild neck pain disorder
- cervical lordotic curve less than 34°
- Subjects whose dull aching pain increased by sustained posture, neck movement, palpation of cervical musculatur
- Agreements of patients.
Exclusion criteria:
- Cervical disc problems or cervical spondylosis.
- History of previous neck trauma or head injuries.
- Ankylosing spondylitis
- Acute inflammation, contracture or surgery affecting cervical spine.
- Current participation in supervised physical therapy for neck pain.
- Any skin disease or injury that may affect technique.
- Osteoporotic and rheumatic arthritic patients.
- Positive skin sensitivity test to kinesiotape.
- Unhealed wounds or scars at the treated area
- Visual or auditory problems Pain intensity was measured by the VAS. The patients were asked to mark on the line of VAS to the point that they felt the pain. Then the score was determined by measuring from the left end of the line to the point that the patient marked It was measured by The NDI which is a 10-item questionnaire consist of pain intensity, personal care, lifting, reading, headache, concentration, work, driving, sleeping and recreation. The subject was instructed to circle one of the six options which describes the severity of each item (0-5)55.Then the marks were counted and divided by 50 or 45 if one section was missing with total score ranging from 0 (no pain or disability) to 50 (severe pain and disability) 57. Then was multiplied by 100 for the percentage (score/ 50) x 100=---% points88. A score of 10-28% is considered mild disability, 30-48% is moderate, 50-68% is sever and 72% or more is complete
Activation pattern of the examined ms was recorded and analyzed using electromyography as follow:
Skin preparation67 After history taking and physical examination, subjects were allowed to rest for 10 minutes for acclimatization. During this period each subject was prepared for the experimental set as follow;
- The site of the electrode placement had been shaved when needed
- The skin was cleaned with alcohol with a piece of cotton to reduce skin impedance at the site of recorded muscle and at the site of the reference electrode
Electrodes positions10:
The electrodes sites were located on each subject's dominant side as follows:
levator scapulae:was centered lateral to the C3-4 spinous process between the posterior margin of the sternocleidomastoid and the anterior margins of the upper trapezius Upper trapezius: 2 cm lateral to the midpoint of a line drawn between C7 spinous process and the posterolateral acromion Reference electrode: was situated over the C7 spinous process. The sites of electrodes placement were determined using a marker and a tape measurement and confirmed through palpation and manual resistance.
- Conditions
- Neck Pain, Disability Physical
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
| Study group | Role | What they receive |
|---|---|---|
| high disbility group | Group scored more than half of the score of the neck disability index | |
| low disability group | Group scored less than half of the score of the neck disability index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between neck disability and emg signals
using logistic regression, we can get this outcome
Measured: 2 weeks
Correlation between neck disability and range of motion
using logistic regression, we can get this outcome
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start12 Aug 2022
- Primary completion24 Mar 2023
- Study completion24 Mar 2023
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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Ali Mohammed Torad, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05291377
- Sponsor's protocol ID
- P.T/BAS/1/2022/10
- Status last verified
- Apr 2023
- First submitted
- 10 Mar 2022
- Last updated
- 24 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: the researcher intend to share the code of the analysis with the globe to increase body of knowledge
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Machine Learning Models for Identifying Disability in Neck Pain Patients Using Muscle and Joint Parameters
- ClinicalTrials.gov ID
- NCT05291377
- Acronym / sponsor ID
- P.T/BAS/1/2022/10
- Conditions
- Neck Pain, Disability Physical
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 12 Aug 2022 (actual)
- Primary completion
- 24 Mar 2023 (actual)
- Study completion
- 24 Mar 2023 (actual)
- First posted
- 22 Mar 2022 (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.
conduct machine learning models to identify different aspects that can give us an impression about the disability in patients with neck pain.
By using 17 different classifier and regressor models. to identify disability from emg, pain, ROM and curve measurements
Detailed description
ninety patients from both sexes suffering from mechanical neck dysfunction were participated in this study.
Patients were participated in the study if they fulfilled the following criteria
- Ninety patients from both sexes with their ages ranged from 20-35 years old.
- Subjects Referred from orthopedic consultant with chronic mechanical neck pain (<3months duration)
- The neck disability index is above 15, a minimal score to reflect the presence of at least a mild neck pain disorder
- cervical lordotic curve less than 34°
- Subjects whose dull aching pain increased by sustained posture, neck movement, palpation of cervical musculatur
- Agreements of patients.
Exclusion criteria:
- Cervical disc problems or cervical spondylosis.
- History of previous neck trauma or head injuries.
- Ankylosing spondylitis
- Acute inflammation, contracture or surgery affecting cervical spine.
- Current participation in supervised physical therapy for neck pain.
- Any skin disease or injury that may affect technique.
- Osteoporotic and rheumatic arthritic patients.
- Positive skin sensitivity test to kinesiotape.
- Unhealed wounds or scars at the treated area
- Visual or auditory problems Pain intensity was measured by the VAS. The patients were asked to mark on the line of VAS to the point that they felt the pain. Then the score was determined by measuring from the left end of the line to the point that the patient marked It was measured by The NDI which is a 10-item questionnaire consist of pain intensity, personal care, lifting, reading, headache, concentration, work, driving, sleeping and recreation. The subject was instructed to circle one of the six options which describes the severity of each item (0-5)55.Then the marks were counted and divided by 50 or 45 if one section was missing with total score ranging from 0 (no pain or disability) to 50 (severe pain and disability) 57. Then was multiplied by 100 for the percentage (score/ 50) x 100=---% points88. A score of 10-28% is considered mild disability, 30-48% is moderate, 50-68% is sever and 72% or more is complete
Activation pattern of the examined ms was recorded and analyzed using electromyography as follow:
Skin preparation67 After history taking and physical examination, subjects were allowed to rest for 10 minutes for acclimatization. During this period each subject was prepared for the experimental set as follow;
- The site of the electrode placement had been shaved when needed
- The skin was cleaned with alcohol with a piece of cotton to reduce skin impedance at the site of recorded muscle and at the site of the reference electrode
Electrodes positions10:
The electrodes sites were located on each subject's dominant side as follows:
levator scapulae:was centered lateral to the C3-4 spinous process between the posterior margin of the sternocleidomastoid and the anterior margins of the upper trapezius Upper trapezius: 2 cm lateral to the midpoint of a line drawn between C7 spinous process and the posterolateral acromion Reference electrode: was situated over the C7 spinous process. The sites of electrodes placement were determined using a marker and a tape measurement and confirmed through palpation and manual resistance.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Week
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high disbility group | – | –Group scored more than half of the score of the neck disability index |
| low disability group | – | –Group scored less than half of the score of the neck disability index |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Age groups
- Adult
- Study population
- neck pain patients that scored at least 3 on VAS and experienced the pain for more than 3 months
Key inclusion criteria (2 listed)
- Complaining from pain
- Able to read and write
Key exclusion criteria (1 listed)
- no anomalies
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 |
|---|---|---|
| Other | high disbility group, low disability group |
Primary outcome
Correlation between neck disability and emg signals
Time frame: 2 weeks
using logistic regression, we can get this outcome
Correlation between neck disability and range of motion
Time frame: 2 weeks
using logistic regression, we can get this outcome
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2023.
- Individual participant dataSharing planned: Yes. the researcher intend to share the code of the analysis with the globe to increase body of knowledge
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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 Disability Physical, run by Kafrelsheikh University 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 24 Apr 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Correlation between neck disability and emg signals (time frame: 2 weeks). 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 24 Apr 2023.