Acupuncture and Pain Processing

Fibromyalgia Clinical Trial

Official title:

Acupuncture and Pain Processing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01270607
• Other study ID #: SU-04132010-5662
• Status: Completed
• Phase: N/A
• First received: April 14, 2010
• Last updated: May 22, 2013
• Start date: April 2010
• Est. completion date: August 2012

Study information

• Verified date: May 2013
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 2012
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia

Intervention

Procedure:
• Acupuncture
Treatment given twice per week for 4 weeks

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Change in Fibromyalgia Impact Questionnaire		Change from first to last study treatment session (6 weeks)	No
Secondary	Change in Brief Pain Inventory		Change from first to last treatment session (6 weeks)	No