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Functional Brain Imaging - Acupuncture and Osteoarthritis

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
acupuncture
Sponsored by
National Center for Complementary and Integrative Health (NCCIH)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Osteoarthritis focused on measuring Acupuncture, SPECT, f-MRI, Functional brain imaging, RCT

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Hospital of the University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

B

A

Arm Description

Patients with osteoarthritis pain at rest

Normal Subjects without pain

Outcomes

Primary Outcome Measures

SPECT Cerebral Bloodflow

Secondary Outcome Measures

0-10 Numeric Rating Scale for Pain Intensity

Full Information

First Posted
October 8, 2003
Last Updated
September 6, 2007
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)
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1. Study Identification

Unique Protocol Identification Number
NCT00070824
Brief Title
Functional Brain Imaging - Acupuncture and Osteoarthritis
Official Title
Functional Brain Imaging - Acupuncture and Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Name of the 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)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Acupuncture, SPECT, f-MRI, Functional brain imaging, RCT

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
B
Arm Type
Experimental
Arm Description
Patients with osteoarthritis pain at rest
Arm Title
A
Arm Type
Experimental
Arm Description
Normal Subjects without pain
Intervention Type
Procedure
Intervention Name(s)
acupuncture
Primary Outcome Measure Information:
Title
SPECT Cerebral Bloodflow
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
0-10 Numeric Rating Scale for Pain Intensity
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John T. Farrar, MD, MSCE
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4283
Country
United States

12. IPD Sharing Statement

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Functional Brain Imaging - Acupuncture and Osteoarthritis

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