We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
  Purpose
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.

Condition Intervention
Fibromyalgia Procedure: Acupuncture

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Acupuncture and Pain Processing

Resource links provided by NLM:


Further study details as provided by Sean Mackey, Stanford University:

Primary Outcome Measures:
  • 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 Measures:
  • 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) ]

Enrollment: 10
Study Start Date: April 2010
Study Completion Date: August 2012
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acupuncture Procedure: Acupuncture
Treatment given twice per week for 4 weeks

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01270607


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Sean Mackey Stanford University
  More Information

Additional Information:
Responsible Party: Sean Mackey, Assistant Professor, Stanford University
ClinicalTrials.gov Identifier: NCT01270607     History of Changes
Other Study ID Numbers: SU-04132010-5662
First Submitted: April 14, 2010
First Posted: January 5, 2011
Last Update Posted: May 23, 2013
Last Verified: May 2013

Additional relevant MeSH terms:
Fibromyalgia
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases