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

NCT05581186 | Completed

• 1 other identifier: NECKPEMF2022
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Neck Pain; Musculoskeletal Diseases; Chronic Neck Pain; Cervical Disc Disease

Keywords

Pulse Electromagnetic Field Therapy; Chronic neck pain; Cervical Disc Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 6th week

Secondary Outcomes (6)

• Change from baseline quality of life (short form 36 (SF-36)) at 3rd and 6th weeks

  up to 6th week

• Change from baseline range of motion of cervical spine measurements with goniometer at 3rd and 6th weeks

  up to 6th week

• Change from baseline Neck Dısabılıty Index (NDI) at 3rd and 6th weeks

  up to 6th week

• Change from baseline Pressure pain threshold measurement with an algometer at 3rd and 6th weeks

  up to 6th week

• Change from baseline In the global evaluation of the patient at 3rd and 6th weeks

  up to 6th week

Study Arms (3)

PEMT + exercise

ACTIVE COMPARATOR

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.

Other: Pulse electromagnetic field therapy

Sham PEMT + exercise

SHAM COMPARATOR

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.

Other: Sham pulse electromagnetic field therapy

Exercise only

OTHER

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

Other: Therapeutic Exercise

Interventions

Pulse electromagnetic field therapy 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.

PEMT + exercise

Sham pulse electromagnetic field therapy 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.

Sham PEMT + exercise

Therapeutic Exercise 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.

Exercise only

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Afyonkarahisar Health Sciences University: lead

Study Sites (1)

Nur Doğanlar

Afyonkarahisar, 03200, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 19565156 BACKGROUND

• 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.

  PMID: 19132780 BACKGROUND

• 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.

  PMID: 32760890 BACKGROUND

• 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.

  PMID: 15986086 BACKGROUND

• 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.

  PMID: 31385489 BACKGROUND

MeSH Terms

Conditions

Neck Pain; Musculoskeletal Diseases

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical research assistant

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: October 14, 2022
• Study Start: August 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)