Trial · NCT04402047
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in average overall finger joints pain intensity in the dominant hand over the past 48h from baseline to week 4 | at baseline and week 4 | Pain intensity will be measured using a 0-100 VAS, with 0 indicating no pain and 100 indicating maximal pain. |
| Secondary | Change in average overall finger joints pain intensity in the dominant hand over the past 48h from baseline to weeks 8, 16 | at baseline，week 8 and week 16 | Pain intensity will be measured using a 0-100 VAS, with 0 indicating no pain and 100 indicating maximal pain. |
| Secondary | The proportion of participants achieving at least a 15-point reduction in average overall finger joints pain intensity in the dominant hand from baseline to weeks 4, 8 and 16 | at week 4, week 8 and week 16 | |
| Secondary | Change in Australian Canadian Osteoarthritis Hand Index (AUSCAN) total score, and pain, stiffness and physical function subscales from baseline to weeks 4, 8 and 16 | at baseline，week 4, week 8 and week 16 | 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. |
| Secondary | Change in Functional Index for HOA (FIHOA) from baseline to weeks 4, 8 and 16 | at baseline，week 4, week 8 and week 16 | 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" |
| Secondary | Change in the number of self-reported painful joints and painful joints at digital pressure from baseline to weeks 4, 8 and 16 | at baseline，week 4, week 8 and week 16 | 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. |
| Secondary | Change in the number of swollen joints from baseline to weeks 4, 8 and 16: | at baseline，week 4, week 8 and week 16 | All soft swollen finger joints count (0-30) will be assessed by a trained research nurse at each study visit. |
| Secondary | Change in hand grip strength and pinch strength of the fingers from baseline to weeks 4, 8 and 16: | at baseline，week 4, week 8 and week 16 | Hand grip strength and pinch strength of the fingers of the dominant hand will be tested using a hand dynamometer and a Jamar digital pinch gauge respectively. |
| Secondary | Change in patient global assessment of improvement from baseline to weeks 4, 8 and 16 | at baseline，week 4, week 8 and week 16 | 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) |
| Secondary | The proportion of responder according to the Outcome Measures in Rheumatological Clinical Trials (OMERACT) and Osteoarthritis Research Society International (OARSI) responder criteria at weeks 4，8 and 16 | at week 4, week 8 and week 16 | The OMERACT-OARSI response is defined as an improvement in either pain (0-100 overall finger joints pain) or function (0-36 AUSCAN physical function) with ≥50% (relative) and ≥20/100 (absolute); or if the improvement is ≥20% (relative) and ≥10/100 (absolute) in ≥2 of the following: pain, functioning and patient global assessment of improvement. |
| Secondary | Change in quality of life assessed by the World Health Organization Quality of Life abbreviated version (WHOQOL-BREF) from baseline to weeks 4, 8 and 16 | at baseline，week 4, week 8 and week 16 | 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. |
| Secondary | Self-reported consumption of acetaminophen for hand OA during weeks 1-4 and weeks 5-12 | at weeks 1-4 and weeks 5-12 | The proportion of participants using acetaminophen and the average dosage of acetaminophen used weekly will be calculated and assessed. |
| Other | Participants' expectations for acupuncture at baseline | at baseline | At baseline, participants in the EA group will be asked to answer the following question: "What do you expect from EA treatment to improve your hand OA?" |
| Other | Incidence of adverse events | weeks 1-16 | Any adverse events (AEs) during the whole study, whether reported spontaneously by the participants, or observed by the researcher, will be recorded and categorized as acupuncture-related AEs(e.g., fainting, broken needle, localized hematoma, dizziness, or), the side effect of TDG (e.g., skin irritation/itching, reddening, scaly skin), and non-treatment-related AEs. All AEs will be recorded in detail in the case report form. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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