Back to resultsELECTROMAGNETIC FIELD ON NECK PAIN AND PROPRIOCEPTION IN CERVICAL RADICULOPATHY
Primary Purpose
Cervical Radiculopathy
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
selected exercise program
Electromagenetic Field therapy
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Radiculopathy
Eligibility Criteria
Inclusion Criteria:
- Age ranging from 30:45
- Cervical radiculopathy due to disc prolapse (C5-C6) (C6-C7) mild to moderate or disc prolapse according to magnetic resonance image (MRI).
- With mild to moderate cervical disability according to neck disability index
- Body mass index (18.5 to 29.9) Kg/m2.
Exclusion Criteria:
- Cervical myelopathy.
- Patients with previous cervical surgery.
- Inflammatory diseases such as rheumatoid arthritis or ankylosing spondylitis
- Any other musculoskeletal disorders of the spine or upper extremity.
Sites / Locations
- Lama Saad El-Din MahmoudRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
study group
control group
Arm Description
the study group received the same exercise training program in addition to electromagnetic field therapy, three times per week for four weeks
the control group which received the selected exercise program
Outcomes
Primary Outcome Measures
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
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.
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
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05332418
Brief Title
ELECTROMAGNETIC FIELD ON NECK PAIN AND PROPRIOCEPTION IN CERVICAL RADICULOPATHY
Official Title
EFFECT OF ELECTROMAGNETIC FIELD THERAPY ON NECK PAIN AND PROPRIOCEPTION IN CERVICAL RADICULOPATHY PATIENTS
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 15, 2022 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
October 6 University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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
Detailed 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Radiculopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
study group
Arm Type
Experimental
Arm Description
the study group received the same exercise training program in addition to electromagnetic field therapy, three times per week for four weeks
Arm Title
control group
Arm Type
Experimental
Arm Description
the control group which received the selected exercise program
Intervention Type
Other
Intervention Name(s)
selected exercise program
Intervention Description
therapeutic ultrasound, Static neck exercise, Educational postural correction, and Home neck exercise program for patient
Intervention Type
Device
Intervention Name(s)
Electromagenetic Field therapy
Intervention Description
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)
Primary Outcome Measure Information:
Title
Visual analogue scale for pain (VAS-P)
Description
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
Time Frame
4 weeks
Title
cervical proprioception using cervical joint position error test (JPET)
Description
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.
Time Frame
4 weeks
Title
Neck disability index
Description
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
Time Frame
4 weeks
Title
Cervical range of motion (CROM) goniometer device
Description
The CROM is an inclinometers system with a gravitational reference that is suitable for evaluating the active cervical spine movements in different direction
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ranging from 30:45
Cervical radiculopathy due to disc prolapse (C5-C6) (C6-C7) mild to moderate or disc prolapse according to magnetic resonance image (MRI).
With mild to moderate cervical disability according to neck disability index
Body mass index (18.5 to 29.9) Kg/m2.
Exclusion Criteria:
Cervical myelopathy.
Patients with previous cervical surgery.
Inflammatory diseases such as rheumatoid arthritis or ankylosing spondylitis
Any other musculoskeletal disorders of the spine or upper extremity.
Facility Information:
Facility Name
Lama Saad El-Din Mahmoud
City
Al Jīzah
State/Province
Select State
ZIP/Postal Code
0020
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lama Saad El-Din ED Mahmoud, PHD
Phone
01157592636
Email
lamaelsedawyy@hotmail.com
First Name & Middle Initial & Last Name & Degree
Lama Saad ED Mahmoud, phd
Phone
01157592636
Email
lamaelsedawyy@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
ELECTROMAGNETIC FIELD ON NECK PAIN AND PROPRIOCEPTION IN CERVICAL RADICULOPATHY
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