Acupuncture and Pain Processing

NCT ID: NCT01270607

Last Updated: 2013-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2012-08-31

Brief Summary

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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

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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.

Conditions

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Fibromyalgia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Acupuncture

Group Type EXPERIMENTAL

Acupuncture

Intervention Type PROCEDURE

Treatment given twice per week for 4 weeks

Interventions

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Acupuncture

Treatment given twice per week for 4 weeks

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Sean Mackey

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sean Mackey

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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SU-04132010-5662

Identifier Type: -

Identifier Source: org_study_id

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