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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01944917
Enrollment
40
Registered
2013-09-18
Start date
2013-08-31
Completion date
2014-06-30
Last updated
2013-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Musculo-skeletal Pain

Keywords

Electromagnetic field, VAS score, Heart Rate Variability

Brief summary

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

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.

Interventions

None listed

Sponsors

Sheba Medical Center
CollaboratorOTHER_GOV
Aerotel Ltd
Lead SponsorINDUSTRY

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Chronic musculoskeletal pain

Exclusion criteria

* Implantable defibrillator * Implantable pacemaker * Active cancer * Pregnancy

Design outcomes

Primary

MeasureTime frameDescription
Reduced heart rate variability measures associated with sympathetic activityBy 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).

Secondary

MeasureTime frameDescription
Reduced VAS scoreImmediately 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).

Other

MeasureTime frameDescription
No change in patients tolerability to the electromagnetic fieldImmediately 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.

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026