Acupuncture vs Sham Acupuncture for Hand Osteoarthritis

Participants that meet at least one of the following criteria are considered as responders: 1) at least a 50% decrease and change from baseline≥20 in VAS score; 2) at least a 50% decrease and change from baseline≥20 in Australian Canadian Osteoarthritis Hand Index (AUSCAN); 3) at least a 20% decrease and change from baseline≥10 in at least two measurements of VAS score, AUSCAN and global assessment.

Participants that meet at least one of the following criteria are considered as responders: 1) at least a 50% decrease and change from baseline≥20 in VAS score; 2) at least a 50% decrease and change from baseline≥20 in Australian Canadian Osteoarthritis Hand Index (AUSCAN); 3) at least a 20% decrease and change from baseline≥10 in at least two measurements of VAS score, AUSCAN and global assessment.

Pain intensity will be measured using a 0-100 VAS, with 0 indicating no pain and 100 indicating maximal pain.

Pain intensity will be measured using a 0-100 VAS, with 0 indicating no pain and 100 indicating maximal pain.

Pain intensity will be measured using a 0-100 VAS, with 0 indicating no pain and 100 indicating maximal pain.

The AUSCAN index contains a 15-item scale referring to hand pain (5 items), stiffness (1 item), and function (9 items) during the preceding 48 hours, which is valid, reliable and responsive in patients with hand OA. All items are scaled on a 0-100 VAS (0=none to 100= very severe), with higher scores indicating more severe symptoms/function.

The FIHOA is a patient-reported hand function questionnaire, comprising 10 items with a four-point Likert scale, in which 0 represents "possible without difficulty", 1 indicates "possible with slight difficulty", 2 represents "possible with important difficulty" and 3 indicates "impossible".

All finger joints will be reported spontaneously for the presence of pain by the participants, and examined by a trained research nurse for the presence of pain at digital pressure.

All soft swollen finger joints count (0-30) will be assessed by a trained research nurse at each study visit.

Hand grip strength of the fingers of the dominant hand will be tested using a hand dynamometer.

Hand pinch strength of the fingers of the dominant hand will be tested using a Jamar digital pinch gauge respectively.

The patients will be asked to respond to the question 'Considering all the ways your hand OA affects you, how have you been during the last 48 h?' on a self-administered 0-100 VAS (0, worst possible, to 100, best possible, in 10-point increments).

The WHOQOL-BREF is a 26-item self-report questionnaire rated on a 5-point Likert-type scale with four domains of QOL: physical (seven items), psychological (six items), social (three items), and environment (eight items), plus 2 items representing the general QOL. The four domain scores are scaled in a positive direction with higher scores indicating a higher quality of life.

At baseline, participants in both groups will be asked to answer the following question: "What do you expect from EA treatment to improve your hand OA?"

All participants will be told before allocation that insertion is deeper in group A (traditional acupuncture) and shallower in group B (modern acupuncture). After treatments finished, they will be asked "Do you think you were in group A (traditional acupuncture) in the past weeks?", the answers are "Yes", "No" or "Unclear".

The proportion of participants using acetaminophen, and the frequency and total dosage of acetaminophen used will be calculated and assessed.

Any acupuncture-associated adverse event (AE) such as dizziness, palpitations, local hematomas, or infection, and any other AE irrelevant to acupuncture, will be carefully documented.