Effects of Pulsed Electromagnetic Field on Autonomic Function in Patients With Chronic Musculoskeletal Pain

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Aerotel Ltd
Sponsor:
Collaborator:
Sheba Medical Center
Information provided by (Responsible Party):
Aerotel Ltd
ClinicalTrials.gov Identifier:
NCT01944917
First received: August 25, 2013
Last updated: September 15, 2013
Last verified: September 2013
  Purpose

Previously it has been demonstrated that exposing the heart to electromagnetic field during exercise stress test improves the recovery following the stress test. This is explained by the effect of the electromagnetic field on the sympathetic activity of the heart. In the present study we would like to further investigate the effects of electromagnetic field on autonomic nervous system function in patients with chronic musculoskeletal pain that usually have high sympathetic activity. Each patient will be exposed to 20 minutes of electromagnetic field during which the autonomic nervous system function will be measured. In addition, patient tolerability to the exposed magnetic field will be investigated. We assume that short exposure to electromagnetic field would result in decreased sympathetic activity and therefore, on the long run, could be suggested as a therapeutic tool for such patients.


Condition
Chronic Musculo-skeletal Pain

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Pilot Study to Investigate Autonomic Function in Patients With Chronic Musculoskeletal Pain.

Resource links provided by NLM:


Further study details as provided by Aerotel Ltd:

Primary Outcome Measures:
  • Reduced heart rate variability measures associated with sympathetic activity [ Time Frame: By the end of the experiment: following 20 minutes of PEMF exposure. ] [ Designated as safety issue: No ]
    Heart rate variability will be measured at baseline, prior to exposure to PEMF, and continuously for 20 minutes during exposure to PEMF, and 5 minute thereafter, after removal of the PEMF. Changes in heart rate variability (increase in high frequency and decrease in low frequency spectra) between exposure to PEMF and baseline will be evaluated. We hypothesize that heart rate variability measures reflecting sympathetic activity (low frequency spectra) will be reduced during exposure to PEMF with consequence increase in parasympathetic autonomic activity (high frequency spectra).


Secondary Outcome Measures:
  • Reduced VAS score [ Time Frame: Immediately at the end of the experiment: following 20 minutes of PEMF exposure. ] [ Designated as safety issue: No ]
    Since VAS is visual analogue scale pain score that reflects sympathetic activity we expect to monitor a reduced score following exposure to PEMF, which should be in correlation with increased parasympathetic activity (as measured by heart rate variability measures).


Other Outcome Measures:
  • No change in patients tolerability to the electromagnetic field [ Time Frame: Immediately at the end of the exposure: following 20 minutes of PEMF exposure. ] [ Designated as safety issue: No ]
    As a secondary outcome we would like to assess patients tolerability to 20 minutes exposure to PEMF. We do not expect any change in tolerability score due to the exposure to PEMF.


Estimated Enrollment: 40
Study Start Date: August 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Chronic musculoskeletal pain
Chronic musculoskeletal pain - treated with electromagnetic field Chronic musculoskeletal pain - placebo

Detailed Description:

Adult patients suffering from chronic muscoloskeletal pain will be recruited to this study during their weekly visits to the Department for Complementary Medicine at Sheba Medical Center. Patient will be exposed to 20 minutes of weak intensity and low frequency electromagnetic field while seated, during which heart rate variability measures will be recorded. In addition, patient tolerability to the exposed electromagnetic field will be investigated, including VAS score (pain score). This is a double blind placebo-control study by which neither the patients nor the physicians know which treatment is given to the patients. The study code will be open only at the end of the trial.

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients suffering from musculoskeletal pain visiting weekly the Department for Complementary Medicine at Sheba Medical Center will be recruited to this study.

Criteria

Inclusion Criteria:

  • Chronic musculoskeletal pain

Exclusion Criteria:

  • Implantable defibrillator
  • Implantable pacemaker
  • Active cancer
  • Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01944917

Locations
Israel
Department of Complementary Medicine, Sheba Medical Center Recruiting
Tel Hashomer, Israel, 52621
Contact: Dorit Gamus, MD    035303956    dorit.gamus@sheba.health.gov.il   
Principal Investigator: Dorit Gamus, MD         
Sponsors and Collaborators
Aerotel Ltd
Sheba Medical Center
  More Information

Publications:
Responsible Party: Aerotel Ltd
ClinicalTrials.gov Identifier: NCT01944917     History of Changes
Other Study ID Numbers: DGS2013
Study First Received: August 25, 2013
Last Updated: September 15, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Aerotel Ltd:
Electromagnetic field
VAS score
Heart Rate Variability

Additional relevant MeSH terms:
Musculoskeletal Pain
Muscular Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Nervous System Diseases

ClinicalTrials.gov processed this record on September 16, 2014