Clinical trial: Electromoxibustion and Knee Health Education for Knee Osteoarthritis in Older Adults (NCT04034394)

Eligibility criteria:
Inclusion Criteria:

          1. ethnic Chinese;

          2. aged 60 years or above;

          3. ability to comprehend Chinese;

          4. fulfilling any 3 of the following criteria: i. morning stiffness </= 30 min; ii.
             crepitus on active joint motion; iii. bone tenderness; iv. bone enlargement; or v. no
             palpable joint warmth (This classification yielded 84% sensitivity and 89% specificity
             for OA knee diagnosis (Altman et al., 1986);

          5. having knee pain for at least 3 months;

          6. Knee pain ≥4 on a Likert pain scale from 1-10; and

          7. willing to provide informed consent.

        Exclusion Criteria:

          1. medical diagnoses or conditions that preclude individuals from active participation
             (e.g. dementia, post-stroke syndrome, alcohol or drug abuse);

          2. knee pain related to other conditions (cancer, fracture, rheumatoid arthritis,
             rheumatism) as screened according to the red flags for further investigation or
             referral in the National Clinical Guideline Centre 2014 Guidelines for Osteoarthritis
             of the knee (National Clinical Guideline Centre, 2014);

          3. presence of skin lesions or infections at the treatment sites;

          4. ever had knee replacement surgery or knee joint implant; and

          5. ever received moxibustion, electromoxibustion or steroid injection for knee pain over
             the past 6 months; Further investigation or referral, either at the screening or
             during the study, will be made when necessary.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 60 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