Magnetic Therapy Versus Exercise Therapy in Old Patients With Chronic Mechanical Neck Pain
NCT ID: NCT05600647
Last Updated: 2022-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
51 participants
INTERVENTIONAL
2020-10-21
2022-05-28
Brief Summary
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All participants will receive three sessions every week for four weeks. The primary outcomes are pain (Visual Analogue Scale VAS) and balance (Single leg stance time test SLST, Tinetti balance assessment, and Timed Up and Go TUG). The secondary outcomes are the Neck Disability Index (NDI), cervical range of motion (CROM), cervical joint position sense error (JPSE), and quality of life QOL SF-36 questionnaire. Measurements will be taken before the first session, after two weeks, and after the last session.
Detailed Description
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Evaluate effects of pulsed electromagnetic field therapy along with exercise versus exercise therapy alone on neck pain, proprioception, balance, QOL, and functions in elderly patients with chronic MNP.
Procedure Design of the study: Randomized clinical trial RCT. Subjects: 50 patients (male and female) will be recruited from two physiotherapy departments in Saudi Arabia according to the inclusion and exclusion criteria. Their age will be 56 and above years. The included participants will be equally randomized into one of two groups: Group-I: 25 patients will practice the exercise program in addition to receiving a pulsed electromagnetic field therapy (experimental arm). Group-II: 25 patients will practice the exercise program (control arm)\_ Randomization is blocking randomization and will be taken by the main researcher using a random number generator by a computer program software http://mahmoodsaghaei.tripod.com/Softwares/randalloc.html#Generate. Allocation will be done by an independent person who is not involved in the study using concealed opaque envelopes.
Confidentiality: All participants' data will be saved in a personal computer locked with a password. All questionnaire papers will be kept with the primary researcher in a locker.
Patient's rights: All recruited patients will sign a consent form before their participation and they will be informed that the collected data might be published.
The recruited patients will be randomized into two groups:
Group-I: 25 male and female patients will practice the exercise program and PEMF using a Bio-Electro-Magnetic-Energy-Regulation (BEMER) device.
Group-II: 25 male and female patients will practice the exercise program. The BEMER has a weak, pulsed magnetic field. The magnetic field is generated through a mattress that is connected to the device. The device will be manually set on 50-60 Hz, intensity of 35 microtesla, for 20 minutes while the participant lying on the mattress in a supine position.
NB: Each patient in each group will receive three sessions per week for four weeks. Total number of sessions is 12 sessions. Received any newly prescribed pain medications such as anti-inflammatory or opioids will not be allowed for all participants to prevent their effects on the study results. The assessment will be repeated by the same blinded assessor after two weeks and after finishing the last session. All the measurements will be recorded in a table. In addition, the same assessment tools will be used for all patients in all the physiotherapy departments where the study will be conducted.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Electromagnetic Field therapy with an exercise program
The magnetic field is generated through a mattress that is connected to the device. The maximum program, program 4, for 20 minutes with an intensity of 35 microtesla (level 10) and 50-60 Hz. Every patient is lying on the mattress in a supine position. In addition to exercise training program included postural correction strengthening exercises, stretching, proprioception and balance training
Electromagnetic Field therapy with an exercise program
1. The magnetic field is generated through a mattress that is connected to the device. The maximum program, program 4, for 20 minutes with an intensity of 35 microtesla (level 10) and 50-60 Hz. the patient was lying on the mattress in a supine position.
2. the exercise program included postural correction strengthening exercises, stretching, proprioception and balance training
exercise program
Every patients will practice the exercise training program alone. the program included postural correction, strengthening exercises, stretching, proprioception and balance training
exercise program
the exercise program included postural correction, strengthening exercises, stretching, proprioception and balance training
Interventions
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Electromagnetic Field therapy with an exercise program
1. The magnetic field is generated through a mattress that is connected to the device. The maximum program, program 4, for 20 minutes with an intensity of 35 microtesla (level 10) and 50-60 Hz. the patient was lying on the mattress in a supine position.
2. the exercise program included postural correction strengthening exercises, stretching, proprioception and balance training
exercise program
the exercise program included postural correction, strengthening exercises, stretching, proprioception and balance training
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* pain at rest or with movement that is felt in the neck, shoulders, and between scapulas on VAS scale at least 3/10.
* did not have any physical therapy interventions in the last five weeks.
Exclusion Criteria
* previous cervical spine surgeries.
* implemented cardiac pacemakers or any other electrical devices.
* vestibular system dysfunction or internal ear problems.
* corticosteroid injection in the last 12 weeks before participation.
* lower limb pain or condition that prevents the participant from performing the standing balance assessment.
56 Years
ALL
No
Sponsors
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Imam Abdulrahman Bin Faisal University
OTHER
Responsible Party
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Randa Mohammed Almasri
Principal investigator
Locations
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Imam abdulrahman bin faisal university
Dammam, , Saudi Arabia
Countries
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Other Identifiers
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PGS-2020-03-082
Identifier Type: -
Identifier Source: org_study_id