Cervical RadiculopathyNCT05332418
ELECTROMAGNETIC FIELD ON NECK PAIN AND PROPRIOCEPTION IN CERVICAL RADICULOPATHY
A study testing selected exercise program and Electromagenetic Field therapy in people with Cervical Radiculopathy, run by October 6 University at 1 site in Egypt.
Trial summary
PURPOSE: to investigate effect of electromagnetic field therapy on neck pain and proprioception in cervical radiculopathy patients BACKGROUND: Cervical radiculopathy is a clinical condition resulting from compression of cervical nerve roots Pulsed electromagnetic field (PEMF) therapy is an easy, non-invasive, safe… Read more about this study
- Who is it for?
- Ages 30 to 45 years
- Conditions the study is for
- Cervical Radiculopathy
- What is being tested?
- selected exercise program and Electromagenetic Field therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2022to 30 Jun 2022
- 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
- Age ranging from 30:45
- Cervical radiculopathy due to disc prolapse (C5-C6) (C6-C7) mild to moderate or disc prolapse according to magnetic resonance image (MRI).
- With mild to moderate cervical disability according to neck disability index
- Body mass index (18.5 to 29.9) Kg/m2.
Who cannot join
- Cervical myelopathy.
- Patients with previous cervical surgery.
- Inflammatory diseases such as rheumatoid arthritis or ankylosing spondylitis
- Any other musculoskeletal disorders of the spine or upper extremity.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Lama Saad El-Din Mahmoud
Al Jīzah, Select State, 0020
Lama Saad El-Din ED Mahmoud, PHD, 01157592636, lamaelsedawyy@hotmail.com
Lama Saad ED Mahmoud, phd, 01157592636, lamaelsedawyy@hotmail.com
About this study
Official title: EFFECT OF ELECTROMAGNETIC FIELD THERAPY ON NECK PAIN AND PROPRIOCEPTION IN CERVICAL RADICULOPATHY PATIENTS
PURPOSE:
to investigate effect of electromagnetic field therapy on neck pain and proprioception in cervical radiculopathy patients
BACKGROUND: Cervical radiculopathy is a clinical condition resulting from compression of cervical nerve roots Pulsed electromagnetic field (PEMF) therapy is an easy, non-invasive, safe, and relatively new treatment method that is used with growing interest in physical and rehabilitation medicine. Historically, the benefits from magnetotherapy have been reported for patients with musculoskeletal and neurological disorders
Read the detailed description
Thirty four patients with cervical radiculopathy The patients will randomly be divided into two equal groups; the control group which received the selected exercise program and the study group received the same exercise training program in addition to electromagnetic field therapy, three times per week for four weeks. The evaluation methods by Visual analogue scale for pain (VAS-P), cervical joint position error test (JPET), Neck disability index , and Cervical range of motion (CROM) goniometer device measurements
- Conditions
- Cervical Radiculopathy
- Being tested
- selected exercise program, Electromagenetic Field therapy
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
selected exercise programOther
therapeutic ultrasound, Static neck exercise, Educational postural correction, and Home neck exercise program for patient
Electromagenetic Field therapyDevice
Magnetotherapy application the device will be adjusted around the neck and shoulder area at low frequency (50 Hz), with intensity of 2.5 MT, field shape and applicator type rectangular csl60/csp60) , and the application time (10 minutes)
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | the study group received the same exercise training program in addition to electromagnetic field therapy, three times per week for four weeks Receives: Other: selected exercise program; Device: Electromagenetic Field therapy |
| control group | Experimental | the control group which received the selected exercise program Receives: Other: selected exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale for pain (VAS-P)
is a method for measuring the intensity of pain on a horizontal straight line of fixed length (10 cm), as the left end of the line showed the greatest pain score \& the right end showed the least pain scores, then the patient was asked to put a mark, on the line according to his/her pain sensation, with a higher score representing the higher level of pain
Measured: 4 weeks
cervical proprioception using cervical joint position error test (JPET)
- The subject will be instructed to perform an active head rotation to one side, after which returns back to the neutral or starting head position.
- The test will be performed in a 3 trials in each direction: right, left rotations , extension and flexion.
Measured: 4 weeks
Neck disability index
includes 10 items as follows: Pain Intensity, Personal Care, Lifting, Reading, Headaches, Concentration, Work, Driving, Sleeping, and Recreation, with a score (0:5) for every point. The maximum score is 50, with the interpretation scoring (no disability = 0: 4, mild disability 5:14, moderate disability 15:24, severe disability 25: 34 and complete disability above 34
Measured: 4 weeks
Cervical range of motion (CROM) goniometer device
The CROM is an inclinometers system with a gravitational reference that is suitable for evaluating the active cervical spine movements in different direction
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2022
- Study start15 Jan 2022
- Primary completion30 Apr 2022
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical RadiculopathyStudies 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 control group which received the selected exercise program and the study group received the same exercise training program in addition to electromagnetic field therapy, three times per week for four weeks.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lama Saad El-Din Mahmoud, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05332418
- Sponsor's protocol ID
- P.T. REC/012/003565
- Status last verified
- May 2022
- First submitted
- 11 Apr 2022
- Last updated
- 31 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF ELECTROMAGNETIC FIELD THERAPY ON NECK PAIN AND PROPRIOCEPTION IN CERVICAL RADICULOPATHY PATIENTS
- ClinicalTrials.gov ID
- NCT05332418
- Acronym / sponsor ID
- P.T. REC/012/003565
- Conditions
- Cervical Radiculopathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 18 Apr 2022 (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.
PURPOSE:
to investigate effect of electromagnetic field therapy on neck pain and proprioception in cervical radiculopathy patients
BACKGROUND: Cervical radiculopathy is a clinical condition resulting from compression of cervical nerve roots Pulsed electromagnetic field (PEMF) therapy is an easy, non-invasive, safe, and relatively new treatment method that is used with growing interest in physical and rehabilitation medicine. Historically, the benefits from magnetotherapy have been reported for patients with musculoskeletal and neurological disorders
Detailed description
Thirty four patients with cervical radiculopathy The patients will randomly be divided into two equal groups; the control group which received the selected exercise program and the study group received the same exercise training program in addition to electromagnetic field therapy, three times per week for four weeks. The evaluation methods by Visual analogue scale for pain (VAS-P), cervical joint position error test (JPET), Neck disability index , and Cervical range of motion (CROM) goniometer device measurements
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- the control group which received the selected exercise program and the study group received the same exercise training program in addition to electromagnetic field therapy, three times per week for four weeks.
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Other: selected exercise program, Device: Electromagenetic Field therapythe study group received the same exercise training program in addition to electromagnetic field therapy, three times per week for four weeks |
| control group | Experimental | Other: selected exercise programthe control group which received the selected exercise program |
Who may qualify
- Ages
- 30 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age ranging from 30:45
- Cervical radiculopathy due to disc prolapse (C5-C6) (C6-C7) mild to moderate or disc prolapse according to magnetic resonance image (MRI).
- With mild to moderate cervical disability according to neck disability index
- Body mass index (18.5 to 29.9) Kg/m2.
Key exclusion criteria (4 listed)
- Cervical myelopathy.
- Patients with previous cervical surgery.
- Inflammatory diseases such as rheumatoid arthritis or ankylosing spondylitis
- Any other musculoskeletal disorders of the spine or upper extremity.
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 |
|---|---|---|
| selected exercise programtherapeutic ultrasound, Static neck exercise, Educational postural correction, and Home neck exercise program for patient | Other | control group, study group |
| Electromagenetic Field therapyMagnetotherapy application the device will be adjusted around the neck and shoulder area at low frequency (50 Hz), with intensity of 2.5 MT, field shape and applicator type rectangular csl60/csp60) , and the application time (10 minutes) | Device | study group |
Primary outcome
Visual analogue scale for pain (VAS-P)
Time frame: 4 weeks
is a method for measuring the intensity of pain on a horizontal straight line of fixed length (10 cm), as the left end of the line showed the greatest pain score \& the right end showed the least pain scores, then the patient was asked to put a mark, on the line according to his/her pain sensation, with a higher score representing the higher level of pain
cervical proprioception using cervical joint position error test (JPET)
Time frame: 4 weeks
* The subject will be instructed to perform an active head rotation to one side, after which returns back to the neutral or starting head position. * The test will be performed in a 3 trials in each direction: right, left rotations , extension and flexion.
Neck disability index
Time frame: 4 weeks
includes 10 items as follows: Pain Intensity, Personal Care, Lifting, Reading, Headaches, Concentration, Work, Driving, Sleeping, and Recreation, with a score (0:5) for every point. The maximum score is 50, with the interpretation scoring (no disability = 0: 4, mild disability 5:14, moderate disability 15:24, severe disability 25: 34 and complete disability above 34
Cervical range of motion (CROM) goniometer device
Time frame: 4 weeks
The CROM is an inclinometers system with a gravitational reference that is suitable for evaluating the active cervical spine movements in different direction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing selected exercise program and Electromagenetic Field therapy in people with Cervical Radiculopathy, run by October 6 University at 1 site in Egypt.
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 4 inclusion and 4 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 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale for pain (VAS-P) (time frame: 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 May 2022.