Chronic Musculo-skeletal Pain Clinical Trial
Official title:
Pilot Study to Investigate Autonomic Function in Patients With Chronic Musculoskeletal Pain.
| Verified date | September 2013 |
| Source | Aerotel Ltd |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Israel: Ministry of Health |
| Study type | Observational [Patient Registry] |
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.
| Status | Recruiting |
| Enrollment | 40 |
| Est. completion date | June 2014 |
| Est. primary completion date | June 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 35 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - Chronic musculoskeletal pain Exclusion Criteria: - Implantable defibrillator - Implantable pacemaker - Active cancer - Pregnancy |
Observational Model: Case Control, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Israel | Department of Complementary Medicine, Sheba Medical Center | Tel Hashomer |
| Lead Sponsor | Collaborator |
|---|---|
| Aerotel Ltd | Sheba Medical Center |
Israel,
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. Epub 2007 Aug 3. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | No change in patients tolerability to the electromagnetic field | 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. | No |
| Primary | Reduced heart rate variability measures associated with sympathetic activity | 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. | No |
| Secondary | Reduced VAS score | 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. | No |