Clinical trial NCT05581186: 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
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Musculoskeletal Diseases
Chronic Neck Pain
Cervical Disc Disease
Keywords: Pulse Electromagnetic Field Therapy
Chronic neck pain
Cervical Disc Disease
Lead sponsor: Afyonkarahisar Health Sciences University
Sponsor class: OTHER
First posted: 2022-10-14
Enrollment: 75
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline visual analog scale (VAS) neck and arm pain at 3rd and 6th week
timeFrame: up to 6th week
Secondary outcomes:
measure: Change from baseline quality of life (short form 36 (SF-36)) at 3rd and 6th weeks
timeFrame: up to 6th week
measure: Change from baseline range of motion of cervical spine measurements with goniometer at 3rd and 6th weeks
timeFrame: up to 6th week
measure: Change from baseline Neck Dısabılıty Index (NDI) at 3rd and 6th weeks
timeFrame: up to 6th week
measure: Change from baseline Pressure pain threshold measurement with an algometer at 3rd and 6th weeks
timeFrame: up to 6th week
measure: Change from baseline In the global evaluation of the patient at 3rd and 6th weeks
timeFrame: up to 6th week
measure: Change from baseline In the doctor's global evaluation at 3rd and 6th weeks
timeFrame: up to 6th week
Other outcomes:
Locations:
city: Afyonkarahisar
country: Turkey
facility: Nur Doğanlar
Study officials:
References:
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.
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.
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.
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.
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.