Functional Brain Imaging - Acupuncture and Osteoarthritis

September 6, 2007 updated by: National Center for Complementary and Integrative Health (NCCIH)
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: B
Patients with osteoarthritis pain at rest
Procedure: acupuncture
Experimental: A
Normal Subjects without pain
Procedure: acupuncture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
SPECT Cerebral Bloodflow
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
0-10 Numeric Rating Scale for Pain Intensity
Time Frame: 1 hour
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Center for Complementary and Integrative Health (NCCIH)

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

October 8, 2003

First Submitted That Met QC Criteria

October 10, 2003

First Posted (Estimate)

October 13, 2003

Study Record Updates

Last Update Posted (Estimate)

September 10, 2007

Last Update Submitted That Met QC Criteria

September 6, 2007

Last Verified

September 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R21AT000960-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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