NCT05734924

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2023

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

February 9, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 21, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

February 21, 2023

Status Verified

February 1, 2023

Enrollment Period

4 months

First QC Date

February 9, 2023

Last Update Submit

February 9, 2023

Conditions

Keywords

Cervical Spondylosis - magnetic therapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Assessment of pain pressure threshold (PPT) assessment by using pressure algometer

    Baseline

  • Assessment of pain and function using Neck disability index (NDI):

    Baseline

Study Arms (2)

study group

ACTIVE COMPARATOR

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

control group

SHAM COMPARATOR

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

Interventions

low Frequency High Intensity magnetic therapy with frequency 50 Hz and high intensity 60mT

control groupstudy group

Eligibility Criteria

Age30 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 28946516BACKGROUND

MeSH Terms

Conditions

Spondylosis

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Al zahraa F Morshed, MSC

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Al zahraa F Morshed, MSC

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The patients in control group will receive sham magnetic therapy in addition to, cervical stabilization exercise protocol.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

February 9, 2023

First Posted

February 21, 2023

Study Start

February 1, 2023

Primary Completion

June 1, 2023

Study Completion

July 1, 2023

Last Updated

February 21, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share