Clinical trial: Sinew Acupuncture for Knee Osteoarthritis (NCT03099317)

Eligibility criteria:
Inclusion Criteria:

          -  Hong Kong permanent residents aged on or above 50, both male and female;

          -  meet the Clinical Classification Criteria for Osteoarthritis of the Knee by history,
             physical examination and radiographic findings (recommended by the American College of
             Rheumatology): history and physical examination: pain in the knee and one of the
             following (1. Over 50 years of age; 2. Less than 30 minutes of morning stiffness; 3.
             Crepitus on active motion and osteophytes) and radio graphical findings (Kellgren and
             Lawrence Grades 2-4):

          -  with unilateral knee pain or bilateral knee pain;

          -  in chronic stage (pain of at least 6 month's duration);

          -  with rated knee pain >40 mm on a visual analog scale (VAS; 0 to 100 mm) within 7 days;

          -  with X-ray or other radiographic reports are preferable (not necessary);

          -  who volunteer to participate and sign the consent form;

          -  able to write and read Chinese.

        Exclusion Criteria:

          -  Patients who are unable to walk;

          -  with serious infection of knee;

          -  with suspected tears of ligaments, menisci or acute inflammation of synovial capsule;

          -  with trauma, ligament damage, fracture, or surgery on the knee(s) within 6 months, as
             the cause of pain or functional problems (history of knee replacement will be
             excluded);

          -  with history of local tumor/malignancy at knee;

          -  with physical or laboratory findings indicating infection, presence of autoimmune
             disease or inflammatory arthritis;

          -  with knee pain caused by radiculopathy / herniation of intervertebral disc;

          -  with end-stage of diseases and other suspected severe conditions such as deep vein
             thrombosis of the lower limb, edema related to cancer or cancer treatment, severe
             blood coagulation disorders, uncontrolled systemic arterial hypertension and severe
             diabetes;

          -  with history of prolotherapy, with injections of hyaluronic acid or cortisone within 3
             months;

          -  received acupuncture, electro-acupuncture, Tui-na therapy, massage, physiotherapy for
             8 weeks prior to the trial;

          -  with more severe pain in other regions;

          -  have severe mental disorders;

          -  oversensitive to needles;

          -  insensitive to pain due to advanced diabetes, neuropathy or using strong painkillers;

          -  fail to be complaint with the treatment protocol.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 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