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

NCT01944917 | Unknown

• 1 other identifier: DGS2013
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Musculo-skeletal Pain

Keywords

Electromagnetic field; VAS score; Heart Rate Variability

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• Reduced VAS score

  Immediately at the end of the experiment: following 20 minutes of PEMF exposure.

Other Outcomes (1)

• No change in patients tolerability to the electromagnetic field

  Immediately at the end of the exposure: following 20 minutes of PEMF exposure.

Study Arms (1)

Chronic musculoskeletal pain

Chronic musculoskeletal pain - treated with electromagnetic field Chronic musculoskeletal pain - placebo

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Chronic musculoskeletal pain

You may not qualify if:

• Implantable defibrillator
• Implantable pacemaker
• Active cancer
• Pregnancy

Sponsors & Collaborators

• Aerotel Ltd: lead
• Sheba Medical Center: collaborator

Study Sites (1)

Department of Complementary Medicine, Sheba Medical Center

Tel Litwinsky, 52621, Israel

RECRUITING

Related Publications (1)

• 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.

  PMID: 17674028 RESULT

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2013
• First Posted: September 18, 2013
• Study Start: August 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: September 18, 2013

Record last verified: 2013-09

Locations

IL (1)