Clinical trial: Electroacupuncture vs Topical Diclofenac Sodium Gel for Patients With Hand Osteoarthritis (NCT04402047)

Eligibility criteria:
Inclusion Criteria:

          1. History of hand OA for at least 3 months before enrolment and use of a NASID for ≥ 1
             episode of pain;

          2. Reported an average possible overall finger joints pain intensity in the dominant hand
             over the past 48 hours of at least 40mm according to a 100-mm visual analog scale
             (VAS) after 1-week wash-out period of previous OA medications(Patients applying NSAIDs
             at the screening had to have an increase in pain in the dominant hand of ≥ 20 mm
             during washout);

          3. Posterior-anterior radiographs had to show Kellgren-Lawrence grade 1, 2, or 3 changes
             in symptomatic joints;

          4. Rheumatoid factor and anticyclonic citrullinated peptide were negative in all eligible
             participants to exclude inflammatory arthritis;

          5. Ability to comply with the study protocol, understand the medical information forms as
             well as having signed informed consent.

        Exclusion Criteria:

          1. History or current evidence of secondary OA(due to causes other than a solely
             degenerative joint disease) or symptomatic OA at additional locations besides the
             hand(s) requiring treatment, or any painful syndrome of the upper limb which may
             interfere with evaluation of hand pain;

          2. History of inflammatory arthritis(e.g., rheumatoid arthritis (RA), psoriatic
             arthritis), hemochromatosis, metabolic, or neuropathic arthropathies;

          3. History of trauma, dislocation or operation to the hand or arm in the previous 3
             months;

          4. Hand pain and stiffness due to tissue scarring or tendinitis;

          5. Skin damage or serious skin disorders in the hands;

          6. Intake of antidepressants, anticonvulsants, vascular or narcotics during the 10 days
             prior to beginning the study;

          7. Oral, intramuscular, intra-articular or intravenous corticosteroids, or hyaluronic
             acid injection within 3 months preceding enrollment;

          8. Serious uncontrolled medical conditions such as cancer, uncontrolled cardiovascular
             disorder, severe hepatic/renal insufficiency or coagulation disorder;

          9. Known allergy, contraindication or intolerance to diclofenac, acetaminophen, or gel
             components;

         10. Known phobic to acupuncture or received acupuncture treatment within 4 weeks prior to
             enrollment.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years

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