Acupuncture and Pain Processing

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sean Mackey, Stanford University
ClinicalTrials.gov Identifier:
NCT01270607
First received: April 14, 2010
Last updated: May 22, 2013
Last verified: May 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Acupuncture and Pain Processing

Resource links provided by NLM:


Further study details as provided by 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Fibromyalgia Impact Questionnaire [ Time Frame: Change from first to last study treatment session (6 weeks) ] [ Designated as safety issue: No ]
  • Change in Brief Pain Inventory [ Time Frame: Change from first to last treatment session (6 weeks) ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Sean Mackey, Assistant Professor, Stanford University
ClinicalTrials.gov Identifier: NCT01270607     History of Changes
Other Study ID Numbers: SU-04132010-5662
Study First Received: April 14, 2010
Last Updated: May 22, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 22, 2014