Magnetic Therapy Versus Exercise Therapy in Old Patients With Chronic Mechanical Neck Pain

NCT05600647 | Completed DMC

• 1 other identifier: PGS-2020-03-082
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Mechanical Neck Pain

Keywords

Neck Pain; Magnetic therapy; Exercise; Elderly; Proprioception; Balance

Outcome Measures

Primary Outcomes (4)

• Visual analogue scale (VAS)

  Every patient was asked to but a mark on the VAS line which represents his/her level of neck pain intensity from 0 to 10.It is a 10 cm drawn line. Where 0 represents no pain and 10 is the maximum pain level. The patient will be asked to but a mark on the line which represents his/her level of pain.

  4 weeks

• Tinetti balance assessment

  consists of 2 parts: balance (9 items) and gait (8 items) with a total score of 28. The test started with the patient sitting on armless chair then asked to stand up. The next step, then the assessor nudged the patient sternum to check the balance with the patient eyes opened and then closed then the patient turned around 360 degrees and lastly sat down. The next part was to test the gait to assess the dynamic balance. The patient had to walk about five meters on an even walkway in his usual walking pattern while the assessor assess the steps length, height, symmetry, and continuity and straightness of the trunk. 24 is a low risk of falls, 19 to 23 is a moderate risk and 18 and less is a high risk of falls.

  4 weeks

• Single-leg stance time (SLST)

  Every patient was asked to stand on the preferred leg for a maximum of 90 seconds with the arms on the sides. The elevated leg should not touch the other one. The test was performed with eyes opened first then repeated with eyes closed. The time was recorded with a stopwatch.with eyes open and closed will be used for static postural balance.The participant will stand on the preferred leg for a maximum of 90 seconds with the arms on the sides. The test will be performed with eyes opened first then with eyes closed. Time is recorded by a stopwatch.

  4 weeks

• Timed Up and Go

  Every patient was asked to stand up from an armchair, walk for three meters (marked on the floor), and turn around the mark, go back and sit down again. Time was measured in seconds with a stopwatch.the patient will be asked to stand up from an armchair, walks for 3 meters (marked on the floor), and turns back and sits again. Time is measured in seconds with a stopwatch.

  4 weeks

Secondary Outcomes (4)

• Neck Disability Index

  4 weeks

• Cervical range of motion (CROM)

  4 weeks

• cervical joint position sense error test (JPSE)

  4 weeks

• Quality of life questionnaire SF-36

  4 weeks

Study Arms (2)

Electromagnetic Field therapy with an exercise program

EXPERIMENTAL

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

Device: Electromagnetic Field therapy with an exercise program

exercise program

ACTIVE COMPARATOR

Every patients will practice the exercise training program alone. the program included postural correction, strengthening exercises, stretching, proprioception and balance training

Other: exercise program

Interventions

Electromagnetic Field therapy with an exercise program DEVICE

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

Also known as: BEMER 3000

Electromagnetic Field therapy with an exercise program

exercise program OTHER

the exercise program included postural correction, strengthening exercises, stretching, proprioception and balance training

exercise program

Eligibility Criteria

• Age: 56 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Imam Abdulrahman Bin Faisal University: lead

Study Sites (1)

Imam abdulrahman bin faisal university

Dammam, Saudi Arabia

Location

MeSH Terms

Conditions

Neck Pain; Motor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessment will be done by an independent assessor who will be blinded to the aim of the study and the patient's group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 5, 2022
• First Posted: October 31, 2022
• Study Start: October 21, 2020
• Primary Completion: February 28, 2021
• Study Completion: May 28, 2022
• Last Updated: October 31, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)