Clinical trial: A Pilot Trial of Acupuncture for Knee Osteoarthritis With Differential Functional Status of Acupoints (NCT03008668)

Eligibility criteria:
Inclusion Criteria:

          -  Eligible patients are those aged 40 years or older who are diagnosed with KOA and have
             signed the informed consent.

          -  The diagnosis of KOA will follow the diagnostic criteria according to the Chinese
             Guidelines for the Medical Management of Osteoarthritis:

          -  refractory knee pain for most days in the last month;

          -  joint space narrowing, sclerosis or cystic change in subchondral bone (as indicated by
             X-ray);

          -  laboratory examinations of arthritis: clear and viscous synovial fluid (≥2 times) and
             white blood cell count < 2000/mm3;

          -  age 40 years or older;

          -  morning stiffness continues less than 30 minutes;

          -  bone sound exists when joints was taking flexion and/or extension. A person is
             confirmed to be diagnosed with KOA if meeting the either of the three criteria set: (1
             and 2), or (1,3 and 5), or (1,4,5 and 6).

        Exclusion Criteria:

        Patients will be excluded if they:

          -  Can not adhere to the study protocol in the future 6 months;

          -  Are diagnosed with conditions leading to skeletal disorders, such as tuberculosis,
             tumors or rheumatism of knee/bone joint, rheumatoid arthritis;

          -  Have sprain or other trauma;

          -  Are unable to walk properly due to foot deformity or pain;

          -  Are present with mental disorders;

          -  Have comorbidities including severe cardiovascular disease, liver or kidney
             impairment, immunodeficiency, diabetes mellitus or blood disorder;

          -  Females who are pregnant or lactating;

          -  Were using physiotherapy treatments for osteoarthritis knee pain;

          -  Had used intra-articular injection of glucocorticoid or viscosupplementation in the
             past 6 months;

          -  Received knee-replacement surgery;

          -  Were participating or had participated in the other clinical trials.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.


Patient description (medical language): A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes.  The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief.  Past medical history is notable for hypertension and hypercholesteremia.  Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints.

Patient description (patient's own words): I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints.

Does the patient match the trial criteria? Entailment