Effects of Pulsed Electromagnetic Field on Autonomic Function in Patients With Chronic Musculoskeletal Pain
|ClinicalTrials.gov Identifier: NCT01944917|
Recruitment Status : Unknown
Verified September 2013 by Aerotel Ltd.
Recruitment status was: Recruiting
First Posted : September 18, 2013
Last Update Posted : September 18, 2013
|Condition or disease|
|Chronic Musculo-skeletal Pain|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||40 participants|
|Observational Model:||Case Control|
|Target Follow-Up Duration:||1 Day|
|Official Title:||Pilot Study to Investigate Autonomic Function in Patients With Chronic Musculoskeletal Pain.|
|Study Start Date :||August 2013|
|Estimated Primary Completion Date :||June 2014|
|Estimated Study Completion Date :||June 2014|
Chronic musculoskeletal pain
Chronic musculoskeletal pain - treated with electromagnetic field Chronic musculoskeletal pain - placebo
- 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).
- 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).
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01944917
|Department of Complementary Medicine, Sheba Medical Center||Recruiting|
|Tel Hashomer, Israel, 52621|
|Contact: Dorit Gamus, MD 035303956 email@example.com|
|Principal Investigator: Dorit Gamus, MD|