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Acupuncture and Pain Processing

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01270607
First Posted: January 5, 2011
Last Update Posted: May 23, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sean Mackey, Stanford University
April 14, 2010
January 5, 2011
May 23, 2013
April 2010
December 2010   (Final data collection date for primary outcome measure)
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) ]
Same as current
Complete list of historical versions of study NCT01270607 on ClinicalTrials.gov Archive Site
  • Change in Fibromyalgia Impact Questionnaire [ Time Frame: Change from first to last study treatment session (6 weeks) ]
  • Change in Brief Pain Inventory [ Time Frame: Change from first to last treatment session (6 weeks) ]
Same as current
Not Provided
Not Provided
 
Acupuncture and Pain Processing
Acupuncture and Pain Processing
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.
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.
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Fibromyalgia
Procedure: Acupuncture
Treatment given twice per week for 4 weeks
Experimental: Acupuncture
Intervention: Procedure: Acupuncture
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
August 2012
December 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01270607
SU-04132010-5662
Not Provided
Not Provided
Not Provided
Sean Mackey, Stanford University
Stanford University
Not Provided
Principal Investigator: Sean Mackey Stanford University
Stanford University
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP