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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05332418
Other study ID # P.T. REC/012/003565
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 15, 2022
Est. completion date June 30, 2022

Study information

Verified date May 2022
Source October 6 University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

PURPOSE: to investigate effect of electromagnetic field therapy on neck pain and proprioception in cervical radiculopathy patients BACKGROUND: Cervical radiculopathy is a clinical condition resulting from compression of cervical nerve roots Pulsed electromagnetic field (PEMF) therapy is an easy, non-invasive, safe, and relatively new treatment method that is used with growing interest in physical and rehabilitation medicine. Historically, the benefits from magnetotherapy have been reported for patients with musculoskeletal and neurological disorders


Description:

Thirty four patients with cervical radiculopathy The patients will randomly be divided into two equal groups; the control group which received the selected exercise program and the study group received the same exercise training program in addition to electromagnetic field therapy, three times per week for four weeks. The evaluation methods by Visual analogue scale for pain (VAS-P), cervical joint position error test (JPET), Neck disability index , and Cervical range of motion (CROM) goniometer device measurements


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date June 30, 2022
Est. primary completion date April 30, 2022
Accepts healthy volunteers No
Gender All
Age group 30 Years to 45 Years
Eligibility Inclusion Criteria: 1. Age ranging from 30:45 2. Cervical radiculopathy due to disc prolapse (C5-C6) (C6-C7) mild to moderate or disc prolapse according to magnetic resonance image (MRI). 3. With mild to moderate cervical disability according to neck disability index 4. Body mass index (18.5 to 29.9) Kg/m2. Exclusion Criteria: 1. Cervical myelopathy. 2. Patients with previous cervical surgery. 3. Inflammatory diseases such as rheumatoid arthritis or ankylosing spondylitis 4. Any other musculoskeletal disorders of the spine or upper extremity.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
selected exercise program
therapeutic ultrasound, Static neck exercise, Educational postural correction, and Home neck exercise program for patient
Device:
Electromagenetic Field therapy
Magnetotherapy application the device will be adjusted around the neck and shoulder area at low frequency (50 Hz), with intensity of 2.5 MT, field shape and applicator type rectangular csl60/csp60) , and the application time (10 minutes)

Locations

Country Name City State
Egypt Lama Saad El-Din Mahmoud Al Jizah Select State

Sponsors (1)

Lead Sponsor Collaborator
October 6 University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Visual analogue scale for pain (VAS-P) is a method for measuring the intensity of pain on a horizontal straight line of fixed length (10 cm), as the left end of the line showed the greatest pain score & the right end showed the least pain scores, then the patient was asked to put a mark, on the line according to his/her pain sensation, with a higher score representing the higher level of pain 4 weeks
Primary cervical proprioception using cervical joint position error test (JPET) The subject will be instructed to perform an active head rotation to one side, after which returns back to the neutral or starting head position.
The test will be performed in a 3 trials in each direction: right, left rotations , extension and flexion.
4 weeks
Primary Neck disability index includes 10 items as follows: Pain Intensity, Personal Care, Lifting, Reading, Headaches, Concentration, Work, Driving, Sleeping, and Recreation, with a score (0:5) for every point. The maximum score is 50, with the interpretation scoring (no disability = 0: 4, mild disability 5:14, moderate disability 15:24, severe disability 25: 34 and complete disability above 34 4 weeks
Primary Cervical range of motion (CROM) goniometer device The CROM is an inclinometers system with a gravitational reference that is suitable for evaluating the active cervical spine movements in different direction 4 weeks
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