Clinical trial NCT01944917: Effects of Pulsed Electromagnetic Field on Autonomic Function in Patients With Chronic Musculoskeletal Pain
Official title: Pilot Study to Investigate Autonomic Function in Patients With Chronic Musculoskeletal Pain.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Musculo-skeletal Pain
Keywords: Electromagnetic field
VAS score
Heart Rate Variability
Lead sponsor: Aerotel Ltd
Sponsor class: INDUSTRY
Collaborators: name: Sheba Medical Center
First posted: 2013-09-18
Enrollment: 40
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: Inclusion Criteria:

* Chronic musculoskeletal pain

Exclusion Criteria:

* Implantable defibrillator
* Implantable pacemaker
* Active cancer
* Pregnancy

Primary outcomes:
measure: Reduced heart rate variability measures associated with sympathetic activity
timeFrame: By the end of the experiment: following 20 minutes of PEMF exposure.
Secondary outcomes:
measure: Reduced VAS score
timeFrame: Immediately at the end of the experiment: following 20 minutes of PEMF exposure.
Other outcomes:
measure: No change in patients tolerability to the electromagnetic field
timeFrame: Immediately at the end of the exposure: following 20 minutes of PEMF exposure.
Locations:
city: Tel Hashomer
country: Israel
facility: Department of Complementary Medicine, Sheba Medical Center
Study officials:
References:
citation: 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. doi: 10.1007/s00421-007-0520-x. Epub 2007 Aug 3.