Osteoarthritis
Conditions
Keywords
Acupuncture, SPECT, f-MRI, Functional brain imaging, RCT
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.
Interventions
PROCEDUREacupuncture
Sponsors
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute of Neurological Disorders and Stroke (NINDS)
National Center for Complementary and Integrative Health (NCCIH)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SPECT Cerebral Bloodflow | 24 hours |
Secondary
| Measure | Time frame |
|---|---|
| 0-10 Numeric Rating Scale for Pain Intensity | 1 hour |
Countries
United States
Outcome results
None listed