Efficacy of Pulse Electromagnetic Field Therapy (PEMF) in Patients With Nonspecific Chronic Neck Pain

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2023-09-01

Brief Summary

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This investigation aims to investigate the effectiveness of Pulse Electromagnetic Field Therapy (PEMF) on neck pain, cervical range of motion, pressure pain threshold and quality of life in patients with nonspecific chronic neck pain compared to cervical therapeutic exercises.

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Detailed Description

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Neck pain is a common musculoskeletal complaint in society. It is the most common musculoskeletal problem after low back pain. It may regress spontaneously within a few weeks or may become chronic, as in 30% of patients. When it becomes chronic, it can negatively affect the daily life activities of individuals and lead to functional limitations and inadequacies.

Various approaches exist for neck pain in clinical practice. Among them; education of patients on neck pain, ergonomic arrangements, analgesics, non-steroidal anti-inflammatory drugs, muscle relaxants, exercise, physical therapy agents such as transcutaneous electrical stimulation (TENS), superficial and deep heaters, Pulse Electromagnetic Field Therapy (PEMT) , manipulation, mobilization methods, nerve blockages and surgical intervention.

Magnetotherapy is a treatment method based on magnetic field interaction. As a result of pulsed or alternating electromagnetic fields, an electrical current occurs in the tissues. Pulse magnetotherapy has three physical mechanisms known to be effective in living tissue: Magnetic induction, magneto-mechanical effects, and electronic interactions. Effects of magnetic field application are vasodilation, analgesic effect, anti-inflammatory effect, acceleration of healing, antiedematous effect. Magnetotherapy increases the oxygen release of erythrocytes and provides oxygenation of the tissues. This causes a decrease in toxins in the damaged area, an increase in vital nutrients and endorphins. With this physiological change, magnetic energy decreases the pain receptor sensitivity that sends a message to the brain. With this treatment method, pain reduction is achieved, while joint mobility increases. This investigation was designed prospective sham controlled randomized study. Participants were randomized into 3 groups: PEMT + therapeutic exercise, sham PEMT + therapeutic exercise, and only therapeutic exercise. As evaluation parameters, cervical range of motion, Visual Pain Scale (VAS) Neck, Visual Pain Scale (VAS) Neck, SF (Short form) -36 Quality of Life Scale, pressure pain threshold measurement with an algometer, patient global assessment, and physician global assessment will be evaluated with.It was planned that the evaluations were made and recorded by a blinded physician to the groups at the beginning of the treatment, at the end of the treatment and at the 6th week controls.

Conditions

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Neck Pain Musculoskeletal Diseases Chronic Neck Pain Cervical Disc Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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PEMT + exercise

A total of 15 sessions of pulse electromagnetic field therapy using an electromagnetic field device (ASA Pmt Quatro Pro, ASA Srl Via A.Volta 9-36057, Italia),five times a week and once a day for three weeks, were applied to the patients. The patients were then given a daily exercise program once a day by a physiotherapist.

Group Type ACTIVE_COMPARATOR

Pulse electromagnetic field therapy

Intervention Type OTHER

It was applied with an electromagnetic field device (ASA Pmt Quatro Pro, ASA Srl Via A.Volta 9-36057 Italia) at 25 Hz frequency, 30 Gauss, %35 intensity and for 25 minutes. The treatment period was 5 days a week for 3 weeks, in total. It was applied as 15 sessions.

Therapeutic Exercise As a therapeutic exercise program (neck stability exercises); active cervical ROM, cervical isometric and progressive (selfexercise with Thera-Band) strengthening muscles; trapezius, scalene, rhomboid, levator scapular, pectoral, suboccipital muscles stretching exercises, scapular stabilization exercises. It was planned to implement a total of 15 sessions 5 days a week for 3 weeks, for approximately 30 minutes. Exercises will be performed by a trained (at least 5 years experienced) physiotherapist, three times a day, in 3 sets, 10 repetitions.

Sham PEMT + exercise

Sham therapy was applied in five sessions a week for three weeks, with a total of 15 sessions, with no current flowing through the device. This was followed by the exercise programs described above, performed once a day with the physiotherapist.

Group Type SHAM_COMPARATOR

Sham pulse electromagnetic field therapy

Intervention Type OTHER

Sham pulse electromagnetic field therapy was applied five sessions a week for four weeks, for a total of 15 sessions a day, using electromagnetic field device (ASA Pmt Quatro Pro, ASA Srl Via A.Volta 9-36057 Italy) without current flowing through the device.

Therapeutic Exercise As a therapeutic exercise program (neck stability exercises); active cervical ROM, cervical isometric and progressive (selfexercise with Thera-Band) strengthening muscles; trapezius, scalene, rhomboid, levator scapular, pectoral, suboccipital muscles stretching exercises, scapular stabilization exercises. It was planned to implement a total of 15 sessions 5 days a week for 3 weeks, for approximately 30 minutes. Exercises will be performed by a trained (at least 5 years experienced) physiotherapist, three times a day, in 3 sets, 10 repetitions.

Exercise only

Exercise program was applied in five sessions a week for three weeks, with a total of 15 sessions a day with the physiotherapist.

Group Type OTHER

Therapeutic Exercise

Intervention Type OTHER

Therapeutic Exercise As a therapeutic exercise program (neck stability exercises); active cervical ROM, cervical isometric and progressive (selfexercise with Thera-Band) strengthening muscles; trapezius, scalene, rhomboid, levator scapular, pectoral, suboccipital muscles stretching exercises, scapular stabilization exercises. It was planned to implement a total of 15 sessions 5 days a week for 3 weeks, for approximately 30 minutes. Exercises will be performed by a trained (at least 5 years experienced) physiotherapist, three times a day, in 3 sets, 10 repetitions.

Interventions

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Pulse electromagnetic field therapy

It was applied with an electromagnetic field device (ASA Pmt Quatro Pro, ASA Srl Via A.Volta 9-36057 Italia) at 25 Hz frequency, 30 Gauss, %35 intensity and for 25 minutes. The treatment period was 5 days a week for 3 weeks, in total. It was applied as 15 sessions.

Therapeutic Exercise As a therapeutic exercise program (neck stability exercises); active cervical ROM, cervical isometric and progressive (selfexercise with Thera-Band) strengthening muscles; trapezius, scalene, rhomboid, levator scapular, pectoral, suboccipital muscles stretching exercises, scapular stabilization exercises. It was planned to implement a total of 15 sessions 5 days a week for 3 weeks, for approximately 30 minutes. Exercises will be performed by a trained (at least 5 years experienced) physiotherapist, three times a day, in 3 sets, 10 repetitions.

Intervention Type OTHER

Sham pulse electromagnetic field therapy

Sham pulse electromagnetic field therapy was applied five sessions a week for four weeks, for a total of 15 sessions a day, using electromagnetic field device (ASA Pmt Quatro Pro, ASA Srl Via A.Volta 9-36057 Italy) without current flowing through the device.

Therapeutic Exercise As a therapeutic exercise program (neck stability exercises); active cervical ROM, cervical isometric and progressive (selfexercise with Thera-Band) strengthening muscles; trapezius, scalene, rhomboid, levator scapular, pectoral, suboccipital muscles stretching exercises, scapular stabilization exercises. It was planned to implement a total of 15 sessions 5 days a week for 3 weeks, for approximately 30 minutes. Exercises will be performed by a trained (at least 5 years experienced) physiotherapist, three times a day, in 3 sets, 10 repetitions.

Intervention Type OTHER

Therapeutic Exercise

Therapeutic Exercise As a therapeutic exercise program (neck stability exercises); active cervical ROM, cervical isometric and progressive (selfexercise with Thera-Band) strengthening muscles; trapezius, scalene, rhomboid, levator scapular, pectoral, suboccipital muscles stretching exercises, scapular stabilization exercises. It was planned to implement a total of 15 sessions 5 days a week for 3 weeks, for approximately 30 minutes. Exercises will be performed by a trained (at least 5 years experienced) physiotherapist, three times a day, in 3 sets, 10 repetitions.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Neck pain for at least 3 months in the 20-55 age range
2. Diagnosed with nonspecific chronic neck pain by examination, history and imaging methods

Exclusion Criteria

1. Pregnancy
2. Inflammatory rheumatologic diseases
3. Malignity
4. Having a cardiac pacemaker
5. Previous surgery related to the cervical spine
6. Having bleeding diathesis
7. Having a body implant with an electronic or battery system
8. Neck pain due to neurological and vascular diseases
9. Having neurological diseases
10. Having received physical therapy and rehabilitation for the cervical area in the last 6 months
11. Acute infections

Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No