Functional Brain Imaging - Acupuncture and Osteoarthritis

Sponsor

National Center for Complementary and Integrative Health (NCCIH) (NIH)

Overall Status

Completed

CT.gov ID

NCT00070824

Collaborator

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

Enrollment

Location

Arms

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis	Procedure: acupuncture	Phase 2/Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Functional Brain Imaging - Acupuncture and Osteoarthritis

Study Start Date :

Jan 1, 2004

Actual Study Completion Date :

Apr 1, 2007

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: B

Patients with osteoarthritis pain at rest

Procedure: acupuncture

Experimental: A

Normal Subjects without pain

Procedure: acupuncture

Outcome Measures

Primary Outcome Measures

SPECT Cerebral Bloodflow [24 hours]

Secondary Outcome Measures

0-10 Numeric Rating Scale for Pain Intensity [1 hour]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.