An interventional study of Electroacupuncture in Pain and Inflammation, sponsored by University of Vermont. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-10-17.
Sponsored by University of Vermont · Not applicable, Interventional, and Basic science
Acupuncture is used extensively by patients worldwide for a variety of illnesses. While research is beginning to show effectiveness in clinical pain, the mechanisms underlying how these effects are evoked are poorly understood. Experimental models in healthy human volunteers can more closely control the variables of acupuncture needling and begin to separate out the relative contribution of specific components of needling and needle stimulation. By examining acupuncture's effects on experimental inflammatory models with well-characterized physiologic mechanisms, hypotheses can begin to be generated regarding how acupuncture produces its clinical effects. We propose to establish a model which could be used as a template to examine the individual components contributing to acupuncture's clinical effects on inflammation and pain. We hypothesize that acupuncture will have analgesic and anti-inflammatory effects on a ultraviolet B induced cutaneous lesion as well as a model of heat pain testing which activates central sensitization.
Twenty healthy human volunteers will participate in a crossover study with active acupuncture and sham acupuncture interventions. They will be tested for their minimal erythemal dose (MED) to ultraviolet B exposure. An experimental lesion at 3x MED will be administered on the lower leg. Background information will be collected which could affect individuals' sensitivity to pain such as anxiety and depression, as well as their expectations regarding acupuncture treatment.
The following day they will return for the first experimental day. A measurement with Laser Doppler will quantify the inflammation in the ultraviolet B lesion. Heat pain testing will be performed using a computer controlled thermode both on and off the ultraviolet B lesion. On-lesion testing will be for heat pain threshold. Off-lesion testing will examine temporal summation of heat pain.
Next, a licensed acupuncturist will perform either true electroacupuncture or sham electroacupuncture in the region adjacent to the ultraviolet B lesion. Participants are blinded to the intervention, as is the examiner collecting data. Afterwards, Laser Doppler and heat pain testing will be repeated. The difference between pre-acupuncture and post-acupuncture measurements will represent the acupuncture -induced analgesic and anti-inflammatory effects.
Participants will return for another ultraviolet B exposure adjacent to the first, and will receive whichever sham or true acupuncture intervention was not performed on the first study day.
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This study's enrollment of 15 is below the median of 50 across 2,436 interventional studies indexed under Inflammation.
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Exclusion Criteria:
Crossover design, individuals randomized to receive either true or sham acupuncture in first study day, and on the second study day whichever intervention was not administered on the first study day.
Device: Electroacupuncture
Crossover design, individuals randomized to receive either true or sham acupuncture in first study day, and on the second study day whichever intervention was not administered on the first study day.
Device: Electroacupuncture
Erythema as measured by Laser Doppler
Participants are studied in two separate sessions each contained within one day, and each lasting approximately 3 hours. Participants' pre-acupuncture treatment data are compared to post-acupuncture data to assess effect of acupuncture
Time frame: within one day
Heat pain threshold (deg C)
Participants are studied in two separate sessions each contained within one day, and each lasting approximately 3 hours. Participants' pre-acupuncture treatment data are compared to post-acupuncture data to assess effect of acupuncture
Time frame: within one day
Analgesia to temporal summation of heat pain
Temporal summation of pain is an increased magnitude of response to repetitive stimulus administration. Participants are studied in two separate sessions each contained within one day, and each lasting approximately 3 hours. Participants' pre-acupuncture treatment data are compared to post-acupuncture data to assess effect of acupuncture
Time frame: within one day
This study is completed, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.
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University of Vermont