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

Primary Purpose

Neck Pain, Musculoskeletal Diseases, Chronic Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Pulse electromagnetic field therapy
Sham pulse electromagnetic field therapy
Therapeutic Exercise
Sponsored by
Afyonkarahisar Health Sciences University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Neck Pain focused on measuring Pulse Electromagnetic Field Therapy, Chronic neck pain, Cervical Disc Disease

Eligibility Criteria

20 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nur Doğanlar

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Sham Comparator

Other

Arm Label

PEMT + exercise

Sham PEMT + exercise

Exercise only

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

Change from baseline visual analog scale (VAS) neck and arm pain at 3rd and 6th week
Pain intensity was measured with visual analogue scale for pain (0-10 mm; 0 means no pain, 10 means severe pain) which is used to measure musculoskeletal pain with very good reliability and validity.

Secondary Outcome Measures

Change from baseline quality of life (short form 36 (SF-36)) at 3rd and 6th weeks
This is a self-administered scale, which is widely used to measure the quality of life. It was developed to measure the quality of life in patients who have physical illnesses; however, it can also be successfully used in healthy individuals and patients who have psychiatric diseases. SF-36 includes 36 items and surveys eight domains of health, such as physical functionality, physical role limitations, pain, general health, vitality, social functionality, emotional role limitations, and mental health. Total score was between 0 ( disability) and 100 (no disability). Every subgroup of the questionnaire has a score scale between 0 and 100. Every increase in the subgroup of SF-36 questionnaire, which is a positive scoring system, indicates increase in quality of life related to health.
Change from baseline range of motion of cervical spine measurements with goniometer at 3rd and 6th weeks
Cervical flexion, extension ,lateral flexion ,rotations(goniometric measurement results in units of degrees).
Change from baseline Neck Dısabılıty Index (NDI) at 3rd and 6th weeks
The Neck Disability Index (NDI) is designed to measure neck-specific disability. The questionnaire has 10 items concerning pain and activities of daily living including personal care, lifting, reading, headaches, concentration, work status, driving, sleeping and recreation. Each question measures from 0 to 5, the total score out of 100 is calculated.
Change from baseline Pressure pain threshold measurement with an algometer at 3rd and 6th weeks
The algometer is a useful tool for determining pressure pain threshold measurements. Pressure pain threshold is defined as the minimum force applied to elicit pain. A digital pressure algometer (Baseline, push-pull, force gauce Algometer, USA) will be used for measurements. The most painful point in the cervical region will be determined by sitting all patients in their most comfortable position for measurement. Three measurements will be made at an angle of 90 to this point, repeated at 1-minute intervals, and the average of these three measurements will be taken and this value will be recorded as the mean pressure pain threshold in kg/cm2. During the measurement, the value at the first moment when the patient feels pain will be taken as a basis.
Change from baseline In the global evaluation of the patient at 3rd and 6th weeks
"Very bad" is written on the end corresponding to the numerical value of "0 cm" and "very good" is written on the end corresponding to the numerical value of "10 cm".
Change from baseline In the doctor's global evaluation at 3rd and 6th weeks
"Very bad" is written on the end corresponding to the numerical value of "0 cm" and "very good" is written on the end corresponding to the numerical value of "10 cm".

Full Information

First Posted
October 12, 2022
Last Updated
September 20, 2023
Sponsor
Afyonkarahisar Health Sciences University
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1. Study Identification

Unique Protocol Identification Number
NCT05581186
Brief Title
Efficacy of Pulse Electromagnetic Field Therapy (PEMF) in Patients With Nonspecific Chronic Neck Pain
Official Title
Efficacy of Pulse Electromagnetic Field Therapy (PEMF) in Patients With Nonspecific Chronic Neck Pain: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
September 1, 2023 (Actual)
Study Completion Date
September 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Afyonkarahisar Health Sciences University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain, Musculoskeletal Diseases, Chronic Neck Pain, Cervical Disc Disease
Keywords
Pulse Electromagnetic Field Therapy, Chronic neck pain, Cervical Disc Disease

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PEMT + exercise
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sham PEMT + exercise
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Exercise only
Arm Type
Other
Arm Description
Exercise program was applied in five sessions a week for three weeks, with a total of 15 sessions a day with the physiotherapist.
Intervention Type
Other
Intervention Name(s)
Pulse electromagnetic field therapy
Intervention Description
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
Intervention Name(s)
Sham pulse electromagnetic field therapy
Intervention Description
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
Intervention Name(s)
Therapeutic Exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline visual analog scale (VAS) neck and arm pain at 3rd and 6th week
Description
Pain intensity was measured with visual analogue scale for pain (0-10 mm; 0 means no pain, 10 means severe pain) which is used to measure musculoskeletal pain with very good reliability and validity.
Time Frame
up to 6th week
Secondary Outcome Measure Information:
Title
Change from baseline quality of life (short form 36 (SF-36)) at 3rd and 6th weeks
Description
This is a self-administered scale, which is widely used to measure the quality of life. It was developed to measure the quality of life in patients who have physical illnesses; however, it can also be successfully used in healthy individuals and patients who have psychiatric diseases. SF-36 includes 36 items and surveys eight domains of health, such as physical functionality, physical role limitations, pain, general health, vitality, social functionality, emotional role limitations, and mental health. Total score was between 0 ( disability) and 100 (no disability). Every subgroup of the questionnaire has a score scale between 0 and 100. Every increase in the subgroup of SF-36 questionnaire, which is a positive scoring system, indicates increase in quality of life related to health.
Time Frame
up to 6th week
Title
Change from baseline range of motion of cervical spine measurements with goniometer at 3rd and 6th weeks
Description
Cervical flexion, extension ,lateral flexion ,rotations(goniometric measurement results in units of degrees).
Time Frame
up to 6th week
Title
Change from baseline Neck Dısabılıty Index (NDI) at 3rd and 6th weeks
Description
The Neck Disability Index (NDI) is designed to measure neck-specific disability. The questionnaire has 10 items concerning pain and activities of daily living including personal care, lifting, reading, headaches, concentration, work status, driving, sleeping and recreation. Each question measures from 0 to 5, the total score out of 100 is calculated.
Time Frame
up to 6th week
Title
Change from baseline Pressure pain threshold measurement with an algometer at 3rd and 6th weeks
Description
The algometer is a useful tool for determining pressure pain threshold measurements. Pressure pain threshold is defined as the minimum force applied to elicit pain. A digital pressure algometer (Baseline, push-pull, force gauce Algometer, USA) will be used for measurements. The most painful point in the cervical region will be determined by sitting all patients in their most comfortable position for measurement. Three measurements will be made at an angle of 90 to this point, repeated at 1-minute intervals, and the average of these three measurements will be taken and this value will be recorded as the mean pressure pain threshold in kg/cm2. During the measurement, the value at the first moment when the patient feels pain will be taken as a basis.
Time Frame
up to 6th week
Title
Change from baseline In the global evaluation of the patient at 3rd and 6th weeks
Description
"Very bad" is written on the end corresponding to the numerical value of "0 cm" and "very good" is written on the end corresponding to the numerical value of "10 cm".
Time Frame
up to 6th week
Title
Change from baseline In the doctor's global evaluation at 3rd and 6th weeks
Description
"Very bad" is written on the end corresponding to the numerical value of "0 cm" and "very good" is written on the end corresponding to the numerical value of "10 cm".
Time Frame
up to 6th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Neck pain for at least 3 months in the 20-55 age range Diagnosed with nonspecific chronic neck pain by examination, history and imaging methods Exclusion Criteria: Pregnancy Inflammatory rheumatologic diseases Malignity Having a cardiac pacemaker Previous surgery related to the cervical spine Having bleeding diathesis Having a body implant with an electronic or battery system Neck pain due to neurological and vascular diseases Having neurological diseases Having received physical therapy and rehabilitation for the cervical area in the last 6 months Acute infections
Facility Information:
Facility Name
Nur Doğanlar
City
Afyonkarahisar
ZIP/Postal Code
03200
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19565156
Citation
Dusunceli Y, Ozturk C, Atamaz F, Hepguler S, Durmaz B. Efficacy of neck stabilization exercises for neck pain: a randomized controlled study. J Rehabil Med. 2009 Jul;41(8):626-31. doi: 10.2340/16501977-0392.
Results Reference
background
PubMed Identifier
19132780
Citation
Griffiths C, Dziedzic K, Waterfield J, Sim J. Effectiveness of specific neck stabilization exercises or a general neck exercise program for chronic neck disorders: a randomized controlled trial. J Rheumatol. 2009 Feb;36(2):390-7. doi: 10.3899/jrheum.080376.
Results Reference
background
PubMed Identifier
32760890
Citation
Karakas M, Gok H. Effectiveness of pulsed electromagnetic field therapy on pain, functional status, and quality of life in patients with chronic non-specific neck pain: A prospective, randomized-controlled study. Turk J Phys Med Rehabil. 2020 May 18;66(2):140-146. doi: 10.5606/tftrd.2020.5169. eCollection 2020 Jun.
Results Reference
background
PubMed Identifier
15986086
Citation
Sutbeyaz ST, Sezer N, Koseoglu BF. The effect of pulsed electromagnetic fields in the treatment of cervical osteoarthritis: a randomized, double-blind, sham-controlled trial. Rheumatol Int. 2006 Feb;26(4):320-4. doi: 10.1007/s00296-005-0600-3. Epub 2005 Jun 29.
Results Reference
background
PubMed Identifier
31385489
Citation
Hattapoglu E, Batmaz I, Dilek B, Karakoc M, Em S, Cevik R. Efficiency of pulsed electromagnetic fields on pain, disability, anxiety, depression, and quality of life in patients with cervical disc herniation: a randomized controlled study. Turk J Med Sci. 2019 Aug 8;49(4):1095-1101. doi: 10.3906/sag-1901-65.
Results Reference
background

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

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