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Acupuncture and Pain Processing

Primary Purpose

Fibromyalgia

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

About this trial

This is an interventional treatment trial for Fibromyalgia

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Age 18-50
  2. Fibromyalgia patient OR healthy control
  3. No current opioid use
  4. Patients: must have had Fibromyalgia for 6 months or longer

Exclusion Criteria:

  1. Inflammatory disorder (lupus, rheumatoid arthritis)
  2. Current untreated depression
  3. Active infection
  4. Healthy controls: pain disorder or major medical condition that in the discretion of the investigator interfere with the validity of the study
  5. Heart disease or use of a cardiac pacemaker

Sites / Locations

  • Stanford University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Acupuncture

Arm Description

Outcomes

Primary Outcome Measures

Pain rating to Temporal Summation and Diffuse Noxious Inhibitory Control (DNIC) as measured by a visual analogue scale

Secondary Outcome Measures

Change in Fibromyalgia Impact Questionnaire
Change in Brief Pain Inventory

Full Information

First Posted
April 14, 2010
Last Updated
May 22, 2013
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT01270607
Brief Title
Acupuncture and Pain Processing
Official Title
Acupuncture and Pain Processing
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to test the hypothesis that acupuncture will reduce Fibromyalgia pain, via alterations in the processing of pain in the central nervous system.
Detailed Description
Patients and healthy controls will be enrolled in the study for a total of 6 weeks. This includes a screening and baseline visit, 8 acupuncture treatments (2 per week for 4 weeks), and a follow-up visit and treatment 1 week after completion of the study treatment sessions. To determine the effects of acupuncture on pain, patients and healthy controls will undergo psychophysical pain testing at four points throughout the study: Baseline (appointment 1), post-treatment 1 (appointment2), post treatment 8 (appointment 9), and at the final follow-up session (1 week from last treatment - appointment 10).Participants will also fill out a brief report on pain, sleep, and functioning on a palm pilot. This is expected to take less than 2 minutes per day and will occur throughout the 6 week study period.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Acupuncture
Intervention Description
Treatment given twice per week for 4 weeks
Primary Outcome Measure Information:
Title
Pain rating to Temporal Summation and Diffuse Noxious Inhibitory Control (DNIC) as measured by a visual analogue scale
Time Frame
Measured at last study acupuncture session (6 weeks post enrollment)
Secondary Outcome Measure Information:
Title
Change in Fibromyalgia Impact Questionnaire
Time Frame
Change from first to last study treatment session (6 weeks)
Title
Change in Brief Pain Inventory
Time Frame
Change from first to last treatment session (6 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 18-50 Fibromyalgia patient OR healthy control No current opioid use Patients: must have had Fibromyalgia for 6 months or longer Exclusion Criteria: Inflammatory disorder (lupus, rheumatoid arthritis) Current untreated depression Active infection Healthy controls: pain disorder or major medical condition that in the discretion of the investigator interfere with the validity of the study Heart disease or use of a cardiac pacemaker
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sean Mackey
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Links:
URL
http://snapl.stanford.edu/acupuncture
Description
Study website

Learn more about this trial

Acupuncture and Pain Processing

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