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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05291377
Other study ID # P.T/BAS/1/2022/10
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 12, 2022
Est. completion date March 24, 2023

Study information

Verified date April 2023
Source Kafrelsheikh University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date March 24, 2023
Est. primary completion date March 24, 2023
Accepts healthy volunteers
Gender All
Age group 30 Years to 55 Years
Eligibility Inclusion Criteria: - Complaining from pain - Able to read and write Exclusion Criteria: - no anomalies

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Egypt Faculty of physical therapy, Kafrelsheik university Cairo

Sponsors (1)

Lead Sponsor Collaborator
Kafrelsheikh University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Correlation between neck disability and emg signals using logistic regression, we can get this outcome 2 weeks
Primary Correlation between neck disability and range of motion using logistic regression, we can get this outcome 2 weeks
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