Cervical SpondylosisNCT05734924
Magnetic Therapy and Cervical Stabilization Exercises in Cervical Spondylosis
A study testing low Frequency High Intensity magnetic therapy in people with Cervical Spondylosis, run by Delta University for Science and Technology.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 45 years
- Conditions the study is for
- Cervical Spondylosis
- What is being tested?
- low Frequency High Intensity magnetic therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Feb 2023to Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Neurologic disease (e.g. multiple sclerosis, Parkinson's disease, syringomyelia).
- Congenital anomalies involving cervical spine.
- Diabetes mellitus.
- Vestibular system impairments.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cervical Spondylosis
- Being tested
- low Frequency High Intensity magnetic therapy
- Keywords
- Cervical Spondylosis - magnetic therapy
- Medical subject headings
- Spondylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low Frequency High Intensity magnetic therapyDevice
low Frequency High Intensity magnetic therapy with frequency 50 Hz and high intensity 60mT
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Device: low Frequency High Intensity magnetic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: Baseline
Secondary outcomes (2)
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
Measured: 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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study startFeb 2023 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical SpondylosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Delta University for Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alzahraa Fekry Morshed, Delta University for Science and Technology
- Investigators
- Al zahraa F Morshed, MSC, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05734924
- Sponsor's protocol ID
- P.T.REC/012/003846
- Status last verified
- Feb 2023
- First submitted
- 9 Feb 2023
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 28946516
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adding Low Frequancy High Intensty Magnetic Therapy to Cervical Stabilization Exercises in Cervical Spondylosis
- ClinicalTrials.gov ID
- NCT05734924
- Acronym / sponsor ID
- P.T.REC/012/003846
- Conditions
- Cervical Spondylosis
- Keywords
- Cervical Spondylosis - magnetic therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Delta University for Science and TechnologyUniversity, hospital or other
- Study start
- Feb 2023 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 21 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| study group | Active comparator | Device: low Frequency High Intensity magnetic therapyThe 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 |
| control group | Sham comparator | Device: low Frequency High Intensity magnetic therapyThe 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. |
Who may qualify
- Ages
- 30 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- The following patients will be excluded from the study patients with:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low Frequency High Intensity magnetic therapylow Frequency High Intensity magnetic therapy with frequency 50 Hz and high intensity 60mT | Device | control group, study group |
Primary outcome
Assessment of Endurance of deep neck flexor muscle by the stabilizer
Time frame: 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 .
2 secondary outcomes
Assessment of pain pressure threshold (PPT) assessment by using pressure algometer
Time frame: Baseline
Assessment of pain and function using Neck disability index (NDI):
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Background: PubMed 28946516Akkan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Al zahraa F Morshed, MSC principal investigator
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing low Frequency High Intensity magnetic therapy in people with Cervical Spondylosis, run by Delta University for Science and Technology.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Al zahraa F Morshed, MSC (01002308754, zahraamorshed@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Endurance of deep neck flexor muscle by the stabilizer (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05734924, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.