Functional Brain Imaging - Acupuncture and Osteoarthritis

This study has been completed.
Sponsor:
Collaborators:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00070824
First received: October 8, 2003
Last updated: September 6, 2007
Last verified: September 2007
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Functional Brain Imaging - Acupuncture and Osteoarthritis

Resource links provided by NLM:


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
Experimental: B
Patients with osteoarthritis pain at rest
Procedure: acupuncture
Experimental: A
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: John T. Farrar, MD, MSCE University of Pennsylvania
  More Information

No publications provided

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

ClinicalTrials.gov processed this record on August 19, 2014