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Completed

NCT Number: NCT01270607

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.

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Acupuncture

Procedure

Treatment given twice per week for 4 weeks

Primary outcomes

  1. Pain rating to Temporal Summation and Diffuse Noxious Inhibitory Control (DNIC) as measured by a visual analogue scale

    Time frame: Measured at last study acupuncture session (6 weeks post enrollment)

Secondary outcomes

  1. Change in Fibromyalgia Impact Questionnaire

    Time frame: Change from first to last study treatment session (6 weeks)

  2. Change in Brief Pain Inventory

    Time frame: Change from first to last treatment session (6 weeks)

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2010
Primary completion
2010
Study completion
2012
First posted
Jan 5, 2011
Registry last updated
May 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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