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Functional Brain Imaging - Acupuncture and Osteoarthritis

NCT ID: NCT00070824

Last Updated: 2007-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2007-04-30

Brief Summary

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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

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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.

Conditions

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Osteoarthritis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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B

Patients with osteoarthritis pain at rest

Group Type EXPERIMENTAL

acupuncture

Intervention Type PROCEDURE

A

Normal Subjects without pain

Group Type EXPERIMENTAL

acupuncture

Intervention Type PROCEDURE

Interventions

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acupuncture

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role collaborator

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role lead

Principal Investigators

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John T. Farrar, MD, MSCE

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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R21AT000960-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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