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Clinical Trials/NCT01270607
NCT01270607
Completed
Not Applicable

Acupuncture and Pain Processing

Stanford University1 site in 1 country10 target enrollmentApril 2010
ConditionsFibromyalgia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fibromyalgia
Sponsor
Stanford University
Enrollment
10
Locations
1
Primary Endpoint
Pain rating to Temporal Summation and Diffuse Noxious Inhibitory Control (DNIC) as measured by a visual analogue scale
Status
Completed
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2010
End Date
August 2012
Last Updated
12 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sean Mackey

Assistant Professor

Stanford University

Eligibility Criteria

Inclusion Criteria

  • 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

Outcomes

Primary Outcomes

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 Outcomes

  • Change in Fibromyalgia Impact Questionnaire(Change from first to last study treatment session (6 weeks))
  • Change in Brief Pain Inventory(Change from first to last treatment session (6 weeks))

Study Sites (1)

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