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.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Procedure: Acupuncture

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acupuncture	Procedure: Acupuncture; Treatment given twice per week for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pain rating to Temporal Summation and Diffuse Noxious Inhibitory Control (DNIC) as measured by a visual analogue scale	Measured at last study acupuncture session (6 weeks post enrollment)

Secondary Outcome Measures

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Sean Mackey, Stanford University

Publications and helpful links

Helpful Links

• Study website

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: April 14, 2010
• First Submitted That Met QC Criteria: January 4, 2011
• First Posted (Estimate): January 5, 2011

Study Record Updates

• Last Update Posted (Estimate): May 23, 2013
• Last Update Submitted That Met QC Criteria: May 22, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia
• Other Study ID Numbers: SU-04132010-5662