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OpenTrials
Completed

NCT Number: NCT01945190

Acupuncture for Inflammatory Pain and Central Sensitization - A Pilot Study

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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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Stanford, California, 94304, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 18-70

Exclusion criteria

  • Clinically relevant systemic diseases such as psychiatric, neurological, and dermatological conditions interfering with the collection and interpretation of study data
  • Chronic or recent use of medication potentially interfering with pain processing (except oral contraceptives)
  • Intake of analgesics within the two days prior to study
  • Participation in other research studies within the previous 30 days
  • Having previously received acupuncture treatments

Treatment and study plan

Electroacupuncture

Device

Primary outcomes

  1. Erythema as measured by Laser Doppler

    Time frame: within one day

    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

  2. Heat pain threshold (deg C)

    Time frame: within one day

    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

  3. Analgesia to temporal summation of heat pain

    Time frame: within one day

    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

Sponsors and collaborators

Lead sponsor

University of Vermont

Other

Collaborators

  • Stanford University

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Sep 18, 2013
Registry last updated
Oct 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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