Functional Brain Imaging - Acupuncture and Osteoarthritis - Tabular View

Tracking Information

First Received Date ^ICMJE

October 8, 2003

Last Updated Date

September 6, 2007

Start Date ^ICMJE

January 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

SPECT Cerebral Bloodflow [ Time Frame: 24 hours ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00070824 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Functional Brain Imaging - Acupuncture and Osteoarthritis

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Design ^ICMJE

Diagnostic, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Pharmacodynamics Study

Condition ^ICMJE

Osteoarthritis

Intervention ^ICMJE

Procedure: acupuncture

Study Arms / Comparison Groups

Experimental: Patients with osteoarthritis pain at rest
Experimental: Normal Subjects without pain

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

April 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

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 ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00070824

Responsible Party

Study ID Numbers ^ICMJE

R21 AT000960-01A1

Study Sponsor ^ICMJE

National Center for Complementary and Alternative Medicine (NCCAM)

Collaborators ^ICMJE

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute of Neurological Disorders and Stroke (NINDS)

Investigators ^ICMJE

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

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP