Background A sham control group enhances the quality of clinical trials by controlling for the placebo effect. To ensure rigorous blinding to enhance the quality of clinical trials on acupuncture treatment it is important to develop a more sophisticated sham needle. Discrepancies in perceived needling sensation and treatment expectations between patients and healthy volunteers may affect study outcomes. Thus, it may be inappropriate to generalize the findings of a sham needle validation study in healthy adults to patients who have had a stroke. Therefore, this is a protocol for a clinical trial in patients who have had a stroke to validate a newly developed sham needle to be used in double-blind trials.
Methods Sixty-six patients who have had a stroke will be randomly assigned to the verum or sham needle group using a 1:1 ratio. As the verum and sham needles are identical in appearance, both participants and practitioners will be unaware of the needle type used for acupuncture treatment. After the acupuncture procedure, the participants will be asked whether they believe they received the verum or sham acupuncture treatment and indicate penetration, pain, and de qi sensation for each acupuncture point. A between-group comparison of needle-related adverse events will be performed.
Discussion This double-blind randomized controlled trial will be the first study to validate a newly developed sham acupuncture needle for patients who have had a stroke. The results of this study may inform clinical trial study design for acupuncture treatment of patients who have had a stroke.
Background Strategies towards development and sustainability of integrative treatment in stroke rehabilitation medicine are needed. National expert recommendations based on the implementation of Integrative Medicine (IM) in stroke rehabilitation and IM outcomes would be invaluable.
Methods A pilot study was performed and the effectiveness of combining Korean traditional medicine and Western conventional medicine in post-stroke patients (ischemic stroke n = 15 and hemorrhagic stroke n = 4) was evaluated, and recommendations were developed through consensus with physicians in national centers of rehabilitative medicine. Outcome measures [Korean Modified Barthel Index (K-MBI), Korean Mini Mental State Examination (K-MMSE), Modified Rankin Scale (mRS), and EuroQol 5-dimension 5-level (EQ-5D-5L) assessment were used at baseline, 4, 8 (K-MBI, K-MMSE, mRS, and EQ-5D-5L) and 12 weeks post treatment (EQ-5D-5L and mRS).
Results Improvements were observed in functional and cognitive abilities at 8 weeks (K-MBI score p = 0.0062; K-MMSE score p = 0.046). Quality of life improvements (EQ-5D-5L) were observed but were not statistically significant. The disability assessment (mRS) indicated a gradual improvement from baseline to 12 weeks. No adverse events were reported. For effective, patient-centered IM treatment: (1) build a strong evidence base for IM as compared with Western medicine alone or traditional medicine alone; (2) active expert collaboration; (3) IM promotion in public medical institutions; and (4) continued government support.
Conclusion Functional and cognitive abilities of stroke patients statistically significantly improved following 8 weeks of IM treatment. Strategies have been suggested towards the development and sustainability of IM treatment in stroke rehabilitation medicine.
Background Acupoint CV23 is one of the most commonly used acupoints for the treatment of post-stroke dysphagia and tongue pain. However, care must be taken during the procedure to consider the position of glands and blood vessels in the subcutaneous space of the acupoint. Needling depths to the geniohyoid muscle reportedly range from 0.4 to 3.3 cm. Using ultrasound imaging, we aimed to observe the anatomical characteristics around acupoint CV23 to derive a safe needling depth.
Methods Ultrasound images of acupoint CV23 accessed from the Standard Ultrasound Image of Acupoint database were retrospectively analyzed for 30 participants aged in their 20s and 30s (15 male, 15 female), and the depth from the skin to the geniohyoid muscle was measured. Correlations between the needling depth and anthropometric factors (such as neck circumference) were analyzed.
Results The average needling depth to the geniohyoid muscle was 1.59 ± 0.49 cm (male; 1.43 ± 0.52 cm, female, 1.75 ± 0.42 cm, p = 0.03). The geniohyoid muscle, anterior digastric muscles, and genioglossus muscle were observed in the subcutaneous area of acupoint CV23, and a risk of sublingual gland damage needs to be considered for oblique insertion of the acupuncture needle. No statistically significant correlations between the needling depth and anthropometric factors were observed.
Conclusion Acupoint CV23 has a relatively shallow needling depth, and considering the presence of blood vessels and glands in the sublingual space, visualizing the surrounding anatomical structures using ultrasound was helpful to ensure safe needling practice.
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Survey on the current usage of ultrasound-guided procedures in Korean Medicine Clinics and Hospitals Ju Yeon Kim, Jung Min Yun, Sook-Hyun Lee, Yoon Jae Lee, Dong Kun Ko, In Heo, Woo-Chul Shin, Jae-Heung Cho, Byung-Kwan Seo, In-Hyuk Ha Medicine.2024; 103(14): e37659. CrossRef