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Acupuncture for Inflammatory Pain and Central Sensitization - A Pilot Study

Primary Purpose

Pain, Inflammation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Electroacupuncture
Sponsored by
University of Vermont
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Stanford University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

True before sham electroacupuncture

Sham before true electroacupuncture

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

Full Information

First Posted
September 4, 2013
Last Updated
October 15, 2013
Sponsor
University of Vermont
Collaborators
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT01945190
Brief Title
Acupuncture for Inflammatory Pain and Central Sensitization - A Pilot Study
Official Title
Acupuncture for Inflammatory Pain and Central Sensitization - A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Vermont
Collaborators
Stanford University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Inflammation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
True before sham electroacupuncture
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham before true electroacupuncture
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Electroacupuncture
Primary Outcome Measure Information:
Title
Erythema as measured by Laser Doppler
Description
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
Title
Heat pain threshold (deg C)
Description
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
Title
Analgesia to temporal summation of heat pain
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicholas Phillips, BS, BA, MTOM
Organizational Affiliation
University of Vermont
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Helene Langevin, MD
Organizational Affiliation
University of Vermont
Official's Role
Study Director
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94304
Country
United States

12. IPD Sharing Statement

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Acupuncture for Inflammatory Pain and Central Sensitization - A Pilot Study

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