search
Back to results

Magnetic Therapy and Cervical Stabilization Exercises in Cervical Spondylosis

Primary Purpose

Cervical Spondylosis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
low Frequency High Intensity magnetic therapy
Sponsored by
Delta University for Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Spondylosis focused on measuring Cervical Spondylosis - magnetic therapy

Eligibility Criteria

30 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Sham Comparator

    Arm Label

    study group

    control group

    Arm Description

    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

    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.

    Outcomes

    Primary Outcome Measures

    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 .

    Secondary Outcome Measures

    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
    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

    Full Information

    First Posted
    February 9, 2023
    Last Updated
    February 9, 2023
    Sponsor
    Delta University for Science and Technology
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05734924
    Brief Title
    Magnetic Therapy and Cervical Stabilization Exercises in Cervical Spondylosis
    Official Title
    Adding Low Frequancy High Intensty Magnetic Therapy to Cervical Stabilization Exercises in Cervical Spondylosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 2023 (Anticipated)
    Primary Completion Date
    June 2023 (Anticipated)
    Study Completion Date
    July 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Delta University for Science and Technology

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cervical Spondylosis
    Keywords
    Cervical Spondylosis - magnetic therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    The selected patients will be randomly assigned into two equal groups study group (GI), and control group (GII). The study group (GI) will receive low Frequency High Intensity magnetic therapy in addition to cervical stabilization exercise protocol . The control group (GII) will receive sham magnetic therapy in addition to, cervical stabilization exercise protocol.
    Masking
    Participant
    Masking Description
    The patients in control group will receive sham magnetic therapy in addition to, cervical stabilization exercise protocol.
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    study group
    Arm Type
    Active Comparator
    Arm Description
    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
    Arm Title
    control group
    Arm Type
    Sham Comparator
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    low Frequency High Intensity magnetic therapy
    Intervention Description
    low Frequency High Intensity magnetic therapy with frequency 50 Hz and high intensity 60mT
    Primary Outcome Measure Information:
    Title
    Assessment of Endurance of deep neck flexor muscle by the stabilizer
    Description
    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 .
    Time Frame
    Baseline
    Secondary Outcome Measure Information:
    Title
    Assessment of pain pressure threshold (PPT) assessment by using pressure algometer
    Description
    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
    Time Frame
    Baseline
    Title
    Assessment of pain and function using Neck disability index (NDI):
    Description
    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
    Time Frame
    Baseline

    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: 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Al zahraa F Morshed, MSC
    Phone
    01002308754
    Email
    zahraamorshed@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Al zahraa F Morshed, MSC
    Organizational Affiliation
    Cairo University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    28946516
    Citation
    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.
    Results Reference
    background

    Learn more about this trial

    Magnetic Therapy and Cervical Stabilization Exercises in Cervical Spondylosis

    We'll reach out to this number within 24 hrs