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Completed

NCT Number: NCT00070824

Functional Brain Imaging - Acupuncture and Osteoarthritis

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4283, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acupuncture

Procedure

Primary outcomes

  1. SPECT Cerebral Bloodflow

    Time frame: 24 hours

Secondary outcomes

  1. 0-10 Numeric Rating Scale for Pain Intensity

    Time frame: 1 hour

Sponsors and collaborators

Lead sponsor

National Center for Complementary and Integrative Health (NCCIH)

Nih

Collaborators

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

Registry information

Important dates

Study start
2004
Study completion
2007
First posted
Oct 13, 2003
Registry last updated
Sep 10, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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