Acupuncture and Pain Processing

Not Applicable

Completed

• Conditions: Fibromyalgia
• Interventions: Procedure: Acupuncture

• Registration Number: NCT01270607
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-04-14
• Primary Completion: 2010-12
• Study First Submitted QC: 2011-01-04
• Study First Posted: 2011-01-05
• Study Completion: 2012-08
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-22
• Last Update Posted: 2013-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Acupuncture	Acupuncture	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States