Functional Brain Imaging - Acupuncture and Osteoarthritis

This study has been completed.

First Received: October 8, 2003 Last Updated: September 6, 2007 History of Changes

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)
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

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

Resource links provided by NLM:

MedlinePlus related topics: Acupuncture Osteoarthritis

U.S. FDA Resources

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

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)

Investigators

Principal Investigator:

John T. Farrar, MD, MSCE

University of Pennsylvania

More Information

No publications provided

Study ID Numbers:	R21 AT000960-01A1
Study First Received:	October 8, 2003
Last Updated:	September 6, 2007
ClinicalTrials.gov Identifier:	NCT00070824 History of Changes
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

Additional relevant MeSH terms:

Musculoskeletal Diseases
Osteoarthritis
Joint Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 25, 2009