Magnetic Therapy and Cervical Stabilization Exercises in Cervical Spondylosis

Sponsor
Delta University for Science and Technology (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05734924
Collaborator
(none)
80
2
4.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: low Frequency High Intensity magnetic therapy
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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:
Single (Participant)
Masking Description:
The patients in control group will receive sham magnetic therapy in addition to, cervical stabilization exercise protocol.
Primary Purpose:
Treatment
Official Title:
Adding Low Frequancy High Intensty Magnetic Therapy to Cervical Stabilization Exercises in Cervical Spondylosis
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Assessment of Endurance of deep neck flexor muscle by the stabilizer [Baseline]

    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

  1. Assessment of pain pressure threshold (PPT) assessment by using pressure algometer [Baseline]

    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

  2. Assessment of pain and function using Neck disability index (NDI): [Baseline]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Delta University for Science and Technology

Investigators

  • Principal Investigator: Al zahraa F Morshed, MSC, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Alzahraa Fekry Morshed, Assistant Lecturer, Delta University for Science and Technology
ClinicalTrials.gov Identifier:
NCT05734924
Other Study ID Numbers:
  • P.T.REC/012/003846
First Posted:
Feb 21, 2023
Last Update Posted:
Feb 21, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Alzahraa Fekry Morshed, Assistant Lecturer, Delta University for Science and Technology
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 21, 2023