Effects of Pulsed Electromagnetic Field on 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.
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.|
- 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).
- 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).
- 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.
|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)|
Chronic musculoskeletal pain
Chronic musculoskeletal pain - treated with electromagnetic field Chronic musculoskeletal pain - placebo
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01944917
|Department of Complementary Medicine, Sheba Medical Center||Recruiting|
|Tel Hashomer, Israel, 52621|
|Contact: Dorit Gamus, MD 035303956 firstname.lastname@example.org|
|Principal Investigator: Dorit Gamus, MD|