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

September 15, 2013 updated by: Aerotel Ltd

Pilot Study to Investigate Autonomic Function in Patients With Chronic Musculoskeletal Pain.

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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel Hashomer, Israel, 52621
        • Recruiting
        • Department of Complementary Medicine, Sheba Medical Center
        • Contact:
        • Principal Investigator:
          • Dorit Gamus, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

  • Chronic musculoskeletal pain

Exclusion Criteria:

  • Implantable defibrillator
  • Implantable pacemaker
  • Active cancer
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Chronic musculoskeletal pain
Chronic musculoskeletal pain - treated with electromagnetic field Chronic musculoskeletal pain - placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduced heart rate variability measures associated with sympathetic activity
Time Frame: By the end of the experiment: following 20 minutes of PEMF exposure.
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).
By the end of the experiment: following 20 minutes of PEMF exposure.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduced VAS score
Time Frame: Immediately at the end of the experiment: following 20 minutes of PEMF exposure.
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).
Immediately at the end of the experiment: following 20 minutes of PEMF exposure.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
No change in patients tolerability to the electromagnetic field
Time Frame: Immediately at the end of the exposure: following 20 minutes of PEMF exposure.
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.
Immediately at the end of the exposure: following 20 minutes of PEMF exposure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aerotel Ltd

Collaborators

Sheba Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Anticipated)

June 1, 2014

Study Completion (Anticipated)

June 1, 2014

Study Registration Dates

First Submitted

August 25, 2013

First Submitted That Met QC Criteria

September 15, 2013

First Posted (Estimate)

September 18, 2013

Study Record Updates

Last Update Posted (Estimate)

September 18, 2013

Last Update Submitted That Met QC Criteria

September 15, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DGS2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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