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.