Martin S. Angst
Analgesic and Anti-inflammatory Effects of Electromagnetic Therapy (TMR) in Humans
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
Eelectromagnetic (EM) therapy has been used for centuries to treat various health conditions, but has not been well studied in a scientific and scholarly setting. Studies that have been done suggest EM therapy may be beneficial in accelerating bone growth, treating headache and fibromyalgia pain, and accelerating healing of skin abrasions and chronic skin ulcers. In this study we hope to evaluate the hypothesis that EM therapy, using the TMR device (device that generates magnetic resonance for EM therapy) will reduce: > tissue inflammation as evidenced by decreased pro-inflammatory cytokines and a decrease in skin hyperemia. > pain associated with tissue inflammation as evidenced by decreased release of prostaglandin E2 and an increase in thermal and mechanical pain threshold.
Recruiting Status:
CompletedStanford Recruiting Status:
CompletedCondition(s):
Intervention(s):
- Device: TMR device
Phase:
N/AEligibility
Ages Eligible for Study:
18 years to 65 yearsGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can not participate as controls.Key Inclusion Criteria:
1) Age 18-65
2) Skin type II-IV according to classification of Fitzpatrick
3) Negative pregnancy test (women)
4) Willing and able to sign an informed consent form and HIPAA authorization and to comply with study procedures
Key Exclusion Criteria:
1) Participation in another clinical trial within the last 30 days
2) History of acute or chronic illness that may hinder study procedures or confuse interpretation of the data (e.g. dermatological, neurological, psychiatric or addictive diseases)
3) Clinically significant cardiovascular, pulmonary, hepatic or renal diseases
4) Major bodily injury within 3 month of study participation
5) Surgery within 3 month of study participation
6) Implanted electrical stimulating devices (e.g. pacemaker, spinal cord stimulator)
7) Pregnancy or breast-feeding
8) Intake of prescription drugs with anti/pro-inflammatory action
9) Intake of prescription drugs with anti/pro-analgesic action
10) Inability to abstain from any anti/pro-inflammatory drugs during the 24-hour period preceding a study session
11) Inability to abstain from any anti/pro-analgesic drugs during the 24-hour period preceding a study session
12) Inability to obtain at least 6 hours of sleep during the night preceding a study session
Additional Study Details
Official Title:
Analgesic and Anti-inflammatory Effects of Electromagnetic Therapy (TMR) in HumansAnticipated start date:
5/1/2008Lead Sponsor:
Scientific ImagineticsInvestigator(s):
Study Type:
InterventionalPurpose:
OtherAllocation:
RandomizedMasking:
Double BlindControl:
noneAssignment:
Cross OverEndpoints:
EfficacyPrimary Outcomes:
- TMR treatment's effect on pain as measured by thermal and mechanical pain threshold and release of prostaglandin E2
Secondary Outcomes:
- TMR treatment's effect on inflammation as measured by skin hyperemia and pro-inflammatory cytokin release.
Total Number to be Enrolled:
24Total Number to be Enrolled at Stanford:
24More Information
Secondary ID(s):
- IRB # 13274
- SPO # 41958
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
11/21/2008PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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