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

NCT ID: NCT01944917

Last Updated: 2013-09-18

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

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Musculo-skeletal Pain

Keywords

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Electromagnetic field VAS score Heart Rate Variability

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Chronic musculoskeletal pain

Chronic musculoskeletal pain - treated with electromagnetic field Chronic musculoskeletal pain - placebo

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Chronic musculoskeletal pain

Exclusion Criteria

* Implantable defibrillator
* Implantable pacemaker
* Active cancer
* Pregnancy
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role collaborator

Aerotel Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Complementary Medicine, Sheba Medical Center

Tel Litwinsky, , Israel

Site Status RECRUITING

Countries

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Israel

Facility Contacts

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Dorit Gamus, MD

Role: primary

References

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Grote V, Lackner H, Kelz C, Trapp M, Aichinger F, Puff H, Moser M. Short-term effects of pulsed electromagnetic fields after physical exercise are dependent on autonomic tone before exposure. Eur J Appl Physiol. 2007 Nov;101(4):495-502. doi: 10.1007/s00421-007-0520-x. Epub 2007 Aug 3.

Reference Type RESULT
PMID: 17674028 (View on PubMed)

Other Identifiers

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DGS2013

Identifier Type: -

Identifier Source: org_study_id