Clinical trial NCT05600647: Magnetic Therapy Versus Exercise Therapy in Old Patients With Chronic Mechanical Neck Pain
Official title: Effectiveness of Magnetic Therapy With Exercise Versus Exercise Therapy in Old Patients With Chronic Mechanical Neck Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Mechanical Neck Pain
Keywords: Neck Pain
Magnetic therapy
Exercise
Elderly
Proprioception
Balance
Lead sponsor: Imam Abdulrahman Bin Faisal University
Sponsor class: OTHER
First posted: 2022-10-31
Enrollment: 51
Sex: ALL
Minimum age (years): 56
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: the control group will receive the exercise program and the experimental group will receive the same exercise training program in addition to electromagnetic field therapy, three times per week for four weeks.
Primary purpose: TREATMENT

Brief summary: Mechanical neck pain (MNP) is a common condition that affects all aging groups. MNP has a huge physical, psychological and economic impact. The aim of this study is to evaluate the effects of magnetic therapy (MT) with exercise versus exercise therapy on neck pain, proprioception, balance, and function in older patients with chronic MNP. Materials \& Method: 50 male and female patients with chronic MNP, their ages will range from 56 years and above. They will be allocated from different physiotherapy departments. Eligible participants will be equally randomized into two groups. Group-I: 25 patients will practice the exercise training program in addition to receiving pulsed electromagnetic field therapy (PEMF) (experimental arm). Group-II: 25 patients will practice the exercise program.

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: The aim of the study is to:

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.

Eligibility criteria: Inclusion Criteria:

* chronic mechanical neck pain for \> 3 months.
* 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:

* cognitive impairment, rheumatic disease, infected joints, uncontrolled cardiovascular or pulmonary diseases, neurological conditions or nerve pathology, radicular symptoms, or malignancy.
* 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.

Primary outcomes:
measure: Visual analogue scale (VAS)
timeFrame: 4 weeks
measure: Tinetti balance assessment
timeFrame: 4 weeks
measure: Single-leg stance time (SLST)
timeFrame: 4 weeks
measure: Timed Up and Go
timeFrame: 4 weeks
Secondary outcomes:
measure: Neck Disability Index
timeFrame: 4 weeks
measure: Cervical range of motion (CROM)
timeFrame: 4 weeks
measure: cervical joint position sense error test (JPSE)
timeFrame: 4 weeks
measure: Quality of life questionnaire SF-36
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Dammam
country: Saudi Arabia
facility: Imam abdulrahman bin faisal university
Study officials:
References: