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Functional Brain Imaging - Acupuncture and Osteoarthritis

This study has been completed.

Sponsors and Collaborators: National Center for Complementary and Alternative Medicine (NCCAM)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by: National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier: NCT00070824
  Purpose

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.


Condition Intervention Phase
Osteoarthritis
Procedure: acupuncture
Phase II
Phase III

Genetics Home Reference related topics:   Osteoarthritis  

MedlinePlus related topics:   Acupuncture   Osteoarthritis  

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Diagnostic, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Pharmacodynamics Study
Official Title:   Functional Brain Imaging - Acupuncture and Osteoarthritis

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Primary Outcome Measures:
  • SPECT Cerebral Bloodflow [ Time Frame: 24 hours ]

Secondary Outcome Measures:
  • 0-10 Numeric Rating Scale for Pain Intensity [ Time Frame: 1 hour ]

Enrollment:   16
Study Start Date:   January 2004
Study Completion Date:   April 2007

Arms Assigned Interventions
B: Experimental
Patients with osteoarthritis pain at rest
Procedure: acupuncture
A: Experimental
Normal Subjects without pain
Procedure: 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.

  Eligibility
Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00070824

Locations
United States, Pennsylvania
Hospital of the University of Pennsylvania    
      Philadelphia, Pennsylvania, United States, 19104-4283

Sponsors and Collaborators

Investigators
Principal Investigator:     John T. Farrar, MD, MSCE     University of Pennsylvania    
  More Information

Study ID Numbers:   R21 AT000960-01A1
First Received:   October 8, 2003
Last Updated:   September 6, 2007
ClinicalTrials.gov Identifier:   NCT00070824
Health Authority:   United States: Federal Government;   United States: Institutional Review Board

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
Acupuncture  
SPECT  
f-MRI  
Functional brain imaging  
RCT  

Study placed in the following topic categories:
Osteoarthritis
Joint Diseases
Arthritis
Rheumatic Diseases

Additional relevant MeSH terms:
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on July 03, 2008




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