ELECTROMAGNETIC FIELD ON NECK PAIN AND PROPRIOCEPTION IN CERVICAL RADICULOPATHY

EFFECT OF ELECTROMAGNETIC FIELD THERAPY ON NECK PAIN AND PROPRIOCEPTION IN CERVICAL RADICULOPATHY PATIENTS

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

Study Overview

• Status: Recruiting
• Conditions: Cervical Radiculopathy
• Intervention / Treatment: Other: selected exercise program; Device: Electromagenetic Field therapy

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

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Select State
    • Al Jīzah, Select State, Egypt, 0020
      • Recruiting
      • Lama Saad El-Din Mahmoud
      • Contact: Lama Saad El-Din ED Mahmoud, PHD; Phone Number: 01157592636; Email: lamaelsedawyy@hotmail.com
      • Contact: Lama Saad ED Mahmoud, phd; Phone Number: 01157592636; Email: lamaelsedawyy@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: study group; the study group received the same exercise training program in addition to electromagnetic field therapy, three times per week for four weeks	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)
EXPERIMENTAL: control group; the control group which received the selected exercise program	Other: selected exercise program; therapeutic ultrasound, Static neck exercise, Educational postural correction, and Home neck exercise program for patient

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: October 6 University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 15, 2022
• Primary Completion (ACTUAL): April 30, 2022
• Study Completion (ANTICIPATED): June 30, 2022

Study Registration Dates

• First Submitted: April 11, 2022
• First Submitted That Met QC Criteria: April 11, 2022
• First Posted (ACTUAL): April 18, 2022

Study Record Updates

• Last Update Posted (ACTUAL): May 31, 2022
• Last Update Submitted That Met QC Criteria: May 27, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neck Pain; Radiculopathy
• Other Study ID Numbers: P.T. REC/012/003565

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No