Magnetic Therapy and Cervical Stabilization Exercises in Cervical Spondylosis

Adding Low Frequancy High Intensty Magnetic Therapy to Cervical Stabilization Exercises in Cervical Spondylosis

The purposes of this study are to Investigate adding low frequency high intensity magnetic therapy to cervical stabilization exercises on pain intensity, function, ROM, cervical endurance, and cervical proprioception errors in patients with cervical spondylosis.

Study Overview

• Status: Not yet recruiting
• Conditions: Cervical Spondylosis
• Intervention / Treatment: Device: low Frequency High Intensity magnetic therapy

Detailed Description

Cervical spondylosis is a chronic degenerative process of the cervical spine. Pain in the neck and/or arms, neck stiffness, and headaches are the usual symptoms of cervical spondylosis . Low frequency high intensity magnetic therapy causes short term immediate effect in the relieve pain and improve function in patients with cervical spondylosis . Cervical stabilization causes decrease in neck pain and neck disability as well as a significant increase in cervical muscle endurance and cervical range of motion after the intervention. It also demonstrates a more ideal upper body posture and improved cervical proprioception. In the present study, therefore, we aimed to investigate adding low frequency high intensity magnetic therapy to CSE on management of cervical spondylosis. This study will be a benefit in the physical therapy field and may guide rehabilitation programs of physical therapy towards better results through decreasing time needed to perform activity of daily living, decreasing dependency and making patient an active member in society.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Al zahraa F Morshed, MSC; Phone Number: 01002308754; Email: zahraamorshed@gmail.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:

• Eighty Cervical spondylosis patients from both sexes will be participated in this study.
• The patients' ages will be ranged from 30-45 years to prevent aging process.
• X-ray evidence of cervical spondylosis (osteophyte formation, intervertebral disc height narrowing and vertebral end-plate sclerosis) .
• The presence of chronic neck pain (more than 3 months).
• Limited mobility in the cervical spine.

Exclusion Criteria:

• The following patients will be excluded from the study patients with:

  • History of cervical injury of trauma.
  • Cervical myelopathy.
  • Inflammatory arthritis involving cervical spine.
  • Tumor or infection involving cervical spine.
  • Vertebrobasilar artery insufficiency.
  • Neurologic disease (e.g. multiple sclerosis, Parkinson's disease, syringomyelia).
  • Congenital anomalies involving cervical spine.
  • Diabetes mellitus.
  • Vestibular system impairments.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: study group; The patient in this group will received low Frequency High Intensity magnetic therapy with frequency 50 Hz and high intensity 60mT for 30 minutes /session, treatment will be conducted for 3times/week for five weeks combined with cervical stabilization exercise protocol	Device: low Frequency High Intensity magnetic therapy; low Frequency High Intensity magnetic therapy with frequency 50 Hz and high intensity 60mT
Sham Comparator: control group; The patient in this group will sham magnetic therapy in addition to, cervical stabilization exercise protocol; treatment will conduct for 3 times/ week for five weeks.	Device: low Frequency High Intensity magnetic therapy; low Frequency High Intensity magnetic therapy with frequency 50 Hz and high intensity 60mT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Endurance of deep neck flexor muscle by the stabilizer	Neck muscles endurance test will assess using the stabilizer. Subjects laid hook-lying position on a therapy table with a neutral neck position where their head and neck will be lined up and straight. The pressure sensor of the stabilizer will placed underneath the neck. Subjects will instructed to nod their head gently as if saying 'yes' without using the neck motions which may substitute the sternocleidomastoid muscle so that the pressure sensor will measured 2 mmHg above baseline. The testing will ranged from 20 mmHg to 30 mmHg and the pressure should maintain for the 10 seconds in each 2 mmHg without resting in muscle endurance test. Record the number of times a subject will hold the pressure level .	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of pain pressure threshold (PPT) assessment by using pressure algometer	A PPT measurement will be obtained in the same order for all patients. The pressure will applied with 0.785 cm2 rubber tip at tolerable level of the patient at the site of measurement. The measurement will be at the mid-belly of upper fiber of trapezius muscles at both sides. The tip of the algometer will position on this specific point. By pushing the algometer, the force will applied to the mid belly of trapezius gradually will increased. The patients will not allowed to see the algometer display in any moment, and, as soon as the volunteers experience a painful sensation, they say "stop", the algometer will immediately release and the force (in Kpa) will read from the display. A PPT will measure three times per patient on each site and the average will be calculated and will be used for analysis	Baseline
Assessment of pain and function using Neck disability index (NDI):	The NDI will be scored as a raw score or doubled and expressed as a percent . Each section will be scored on a 0 to 5 rating scale, in which zero means 'No pain' and 5 means 'Worst imaginable pain'. Points will sum to a total score. The test can be interpreted as a raw score, with a maximum score of 50, or as a percentage. 0 points or 0% means : no activity limitations , 50 points or 100% means complete activity limitation. A higher score indicates more patient-rated disability	Baseline

Collaborators and Investigators

• Sponsor: Delta University for Science and Technology
• Investigators: Principal Investigator: Al zahraa F Morshed, MSC, Cairo University

Publications and helpful links

General Publications

• Akkan H, Gelecek N. The effect of stabilization exercise training on pain and functional status in patients with cervical radiculopathy. J Back Musculoskelet Rehabil. 2018;31(2):247-252. doi: 10.3233/BMR-169583.

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2023
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: February 9, 2023
• First Submitted That Met QC Criteria: February 9, 2023
• First Posted (Estimate): February 20, 2023

Study Record Updates

• Last Update Posted (Estimate): February 20, 2023
• Last Update Submitted That Met QC Criteria: February 9, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Cervical Spondylosis - magnetic therapy
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spondylosis
• Other Study ID Numbers: P.T.REC/012/003846

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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