Acupuncture for Inflammatory Pain and Central Sensitization - A Pilot Study

NCT ID: NCT01945190

Last Updated: 2013-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2013-10-31

Brief Summary

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.

Conditions

Pain; Inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

True before sham 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.

Group Type: EXPERIMENTAL

Electroacupuncture

Intervention Type: DEVICE

Sham before true 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.

Group Type: EXPERIMENTAL

Electroacupuncture

Intervention Type: DEVICE

Interventions

Electroacupuncture

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Stanford University

OTHER

Sponsor Role: collaborator

University of Vermont

OTHER

Sponsor Role: lead

Responsible Party

Nicholas Phillips

MD Candidate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nicholas Phillips, BS, BA, MTOM

Role: PRINCIPAL_INVESTIGATOR

University of Vermont

Helene Langevin, MD

Role: STUDY_DIRECTOR

University of Vermont

Locations

Stanford University

Stanford, California, United States

Countries

United States

Other Identifiers

28064

Identifier Type: OTHER

Identifier Source: secondary_id

14-079

Identifier Type: -

Identifier Source: org_study_id