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Functional Brain Imaging - Acupuncture and Osteoarthritis

This study has been completed.
Information provided by National Center for Complementary and Alternative Medicine (NCCAM)

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Descriptive Information Fields
Brief Title  Functional Brain Imaging - Acupuncture and Osteoarthritis
Official Title  Functional Brain Imaging - Acupuncture and Osteoarthritis
Brief Summary

The goal of this study is to use single photon emission computed tomography (SPECT) and functional magnetic resonance imaging (f-MRI) of the brain to study the response of both normal participants and participants with Osteoarthritis (OA) of the knee to acupuncture.

Detailed Description

Recent experimental studies in both animal and humans have begun to demonstrate some measurable physiologic effects that are associated with acupuncture, suggesting the possibility of a neurophysiologic explanation. In addition, brain research continues to uncover a complex set of endogenous neurologic control systems, such that it has become clear that the brain plays a major role in the modulation of pain perception and control. If acupuncture can be demonstrated to have a consistent effect on specific areas of the brain, it will become possible to explore the potential efficacy of acupuncture based on measurable neurophysiologic responses.

Study Phase Phase II, Phase III
Study Type  Interventional
Study Design  Diagnostic, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Pharmacodynamics Study
Primary Outcome Measure  SPECT Cerebral Bloodflow [ Time Frame: 24 hours ]
Secondary Outcome Measure  0-10 Numeric Rating Scale for Pain Intensity [ Time Frame: 1 hour ]
Condition  Osteoarthritis
Intervention  Procedure: acupuncture
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  16
Start Date  January 2004
Completion Date April 2007
Eligibility Criteria 

Inclusion criteria:

  • Seen in an outpatient clinical setting
  • Have active knee OA of >6 months including Kellgren x-ray changes >2 from an x-ray report <12 months old or new x-ray interpretation
  • Moderate unilateral only pain (average >4/10 on a 0-10 likert scale) for more than 5 out of 7 days
  • Have the capacity to understand the requirements of the study and complete the baseline studies in a reasonable time frame, as determined by the interviewer

Exclusion criteria:

  • Having had acupuncture before (must be acupuncture naïve)
  • Any history of claustrophobia that could affect the subject's ability to tolerate the f-MRI study
  • Hip or ankle disease by history or exam severe enough to cause pain >2/10 daily
  • Bleeding disorder or current use of warfarin or heparin by patient history
  • Other primary causes of chronic knee pain, per the referring physician, including chondromalacia patella, torn meniscus or ligament injury.
Gender Both
Ages 40 Years and older
Accepts Healthy Volunteers Yes
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00070824
Organization ID R21 AT000960-01A1
Secondary IDs ††
Study Sponsor  National Center for Complementary and Alternative Medicine (NCCAM)
Collaborators †† National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators 
Principal Investigator:     John T. Farrar, MD, MSCE     University of Pennsylvania    
Information Provided By National Center for Complementary and Alternative Medicine (NCCAM)
Verification Date September 2007
First Received Date  October 8, 2003
Last Updated Date September 6, 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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