Thermographic evaluation of acupoints in lower limb region of individuals with osteoarthritis: A cross-sectional case-control study protocol.

PURPOSE: Acupuncture has been widely used in the treatment of knee osteoarthritis (KOA), but the selection of acupoints is indeterminate and lacks biological basis. The skin temperature of acupoints can reflect the state of local tissue and may be a potential factor for guiding acupoint selection. This study aims to compare the skin temperature of acupoints between KOA patients and the healthy population. STUDY DESIGN AND METHODS: This is a protocol for a cross-sectional case-control study with 170 KOA patients and 170 age- and gender-matched healthy individuals. Diagnosed patients aged 45 to 70 will be recruited in the KOA group. Participants in the healthy group will be matched with the KOA group based on mean age and gender distribution. Skin temperature of 11 acupoints (ST35, EX-LE5, GB33, GB34, EX-LE2, ST34, ST36, GB39, BL40, SP9, SP10) will be extracted from infrared thermography (IRT) images of the lower limbs. Other measurements will include demographic data (gender, age, ethnicity, education, height, weight, BMI) and disease-related data (numerical rating scale, pain sites, duration of pain, pain descriptors, pain activities). DISCUSSION: The results of this study will provide biological evidence for acupoint selection. This study is a precondition for follow-up studies, in which the value of optimized acupoint selection will be verified. TRIAL REGISTRATION: ChiCTR2200058867.

Smart phone-based transcutaneous electrical acupoint stimulation as adjunctive therapy for hypertension (STAT-H trial): protocol for a cluster randomised controlled trial.

INTRODUCTION: Hypertension is a common risk factor for cardiovascular disease. Transcutaneous electrical acupoint stimulation (TEAS) may be effective for hypertension, but the evidence remains limited. The aim of this study is to evaluate the effectiveness and safety of the smart phone-based TEAS as adjunctive therapy for hypertension. METHODS AND ANALYSIS: This study is a 52-week cluster randomised controlled trial with 1600 hypertension patients in 32 community health service centres. Patients who meet the inclusion criteria will be randomised into usual care group or TEAS group in a 1:1 ratio. All patients will be provided with usual care as recommended by the guidelines. In addition to this, patients in the TEAS group will receive non-invasive acupoint electrical stimulation for 30 min at home, 4 times weekly for 12 weeks. The primary outcome will be the mean difference in the changes in office systolic blood pressure from baseline to 12 weeks between TEAS and usual care groups. Secondary outcomes will include the change of mean diastolic blood pressure, proportion of patients with controlled blood pressure (blood pressure <140/90 mm Hg), proportion of patients taking antihypertensive drugs, change in number of antihypertensive drugs and changes in 12-item Short-Form. Tertiary outcomes will include change in body mass index, change in waist circumference, physical activity and medication adherence. Safety outcomes will be any serious adverse events and clinical events. ETHICS AND DISSEMINATION: This study has been approved by ethics committee of Beijing University of Chinese Medicine (No. 2020BZHYLL0104). Written informed consent will be obtained from all patients before randomisation. Trial results will be disseminated in peer-reviewed publications. TRIAL REGISTRATION NUMBER: ChiCTR2000039400.

[Application of "patient and public involvement" in acupuncture clinical research].

In order to explore the application of "patient and public involvement" (PPI) in acupuncture clinical research, the connotation, reporting standards and research status of PPI at home and abroad are collated, and the key problems of PPI encountered in acupuncture clinical research are deeply considered and summarized. It is suggested that the short-form checklist of the Guidance for Reporting Involvement of Patients and the Public (GRIPP) of the 2nd edition should be applied to acupuncture clinical research. PPI provides a new perspective for acupuncture clinical research. It is beneficial for each stage of research, contributes to the improvement of acupuncture medical service mode and increases the success rate and cost-effectiveness of research so that the innovation and development of acupuncture science can be promoted.

Effectiveness and safety of acupotomy for knee osteoarthritis: study protocol for a randomized controlled trial.

BACKGROUND: Knee osteoarthritis (KOA) is one of the most common musculoskeletal disorders. Acupotomy may be effective for KOA, but the evidence is limited. This trial aims to determine the effectiveness and safety of acupotomy for KOA. METHODS/DESIGN: This is a parallel-group, assessor-blinded randomized controlled trial. Two hundred patients with KOA will be recruited and randomly assigned to two groups (group A or group D) in a 1:1 ratio. Patients in group A will receive acupotomy and topical diclofenac diethylamine for 4 weeks, while patients in group D will receive topical diclofenac diethylamine alone for 4 weeks. The primary outcome will be the response rate-the proportion of patients who achieve the minimal clinically important improvement in pain and function at week 4 compared with baseline. Secondary outcomes will include pain, function, quality of life, the use of rescue medicine (loxoprofen sodium), and adverse events at weeks 4, 8, and 24 after randomization. Besides, joint fluid and serum will be collected to assess the level of inflammatory cytokines, like TNF-α, IL-1ß, and MMP-3. DISCUSSION: This study will contribute to a better understanding of the effectiveness and safety of acupotomy in combination with topical nonsteroidal anti-inflammatory drugs. If the hypothesis is confirmed, acupotomy may be recommended as adjunctive therapy for patients with KOA. Results of the study will be of great importance for the guidelines of clinical therapy. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2100043005 Registered on 4 February 2021.

Home-based transcutaneous electrical acupoint stimulation for hypertension: a randomized controlled pilot trial.

The aim of this trial was to evaluate the feasibility and effect of home-based transcutaneous electrical acupoint stimulation (TEAS) in patients with hypertension. In this randomized pilot trial, patients with hypertension were randomly assigned to the TEAS group or the usual care group. Participants in the usual care group were instructed to continue taking their antihypertensive drugs and received education on lifestyle modifications. In addition, participants in the TEAS group received 4 weekly sessions of noninvasive acupoint stimulation for 12 weeks at home. The primary outcome was the change in office systolic blood pressure at week 12 from baseline. Withdrawal from the study and adverse events associated with TEAS were also recorded. Sixty patients were randomized, with 30 patients in the TEAS group, of whom 1 was lost at week 36, and 30 patients in the usual care group, of whom 3 were lost by week 12. The reduction in systolic blood pressure at week 12 was greater in the TEAS group (-8.53 mm Hg; 95% CI [-13.37, -3.70 mm Hg]) than in the usual care group (-1.70 mm Hg; 95% CI [-4.29, -0.89 mm Hg]), with a between-group difference of -6.83 mm Hg (95% CI, [-12.23, -1.43 mm Hg]; P = 0.014). No TEAS-related adverse events occurred. In conclusion, home-based TEAS added to usual care for patients with hypertension was acceptable and safe and may be a potential treatment option. A larger randomized controlled trial of this intervention is warranted.