NCT01270607

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

April 14, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 5, 2011

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

May 23, 2013

Status Verified

May 1, 2013

Enrollment Period

8 months

First QC Date

April 14, 2010

Last Update Submit

May 22, 2013

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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 Arms (1)

Acupuncture

EXPERIMENTAL
Procedure: Acupuncture

Interventions

AcupuncturePROCEDURE

Treatment given twice per week for 4 weeks

Acupuncture

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-50
  • Fibromyalgia patient OR healthy control
  • No current opioid use
  • Patients: must have had Fibromyalgia for 6 months or longer

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Fibromyalgia

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Sean Mackey

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 14, 2010

First Posted

January 5, 2011

Study Start

April 1, 2010

Primary Completion

December 1, 2010

Study Completion

August 1, 2012

Last Updated

May 23, 2013

Record last verified: 2013-05

Locations

US(1)