This study is a randomized, single-blind, parallel controlled clinical trial, aiming to observe the immediate effect of acupuncture on lower limb arterial vessels in healthy subjects and to provide evidence for acupuncture treatment of vascular lesions in lower limb arteries. Therefore, this study established an interventional group and a control group to observe whether acupuncture at ST36 can cause changes in the hemodynamics of lower limb arterial blood vessels.
According to the theory of acupuncture and moxibustion in traditional Chinese medicine, ST36, as the junction point of the Stomach Meridian of Foot Yangming. ST36 can promote the operation of blood, and thus nourish the lower limb blood vessels, and its effect is remarkable and extensive[14, 15]. Therefore, acupuncture at ST36 can promote local blood circulation, and is expected to produce the effect of improving blood circulation. According to modern anatomy [16, 17], the anterior tibial artery runs between the tibialis anterior and the extensor digitorum longus, while the dorsalis pedis artery separates from the anterior tibial artery, and the squeezing of the two muscles will cause"arterial stop"caused by spasm of the tow muscles and patients with coldness on back of the foot, acupuncture the gap between the tibialis anterior and the extensor digitorum longus to stimulate myofacia, thus reduce muscle tension, reduce the extrusion of blood vessels, improve blood circulation. Earlier research[18] indicates that acupuncture enhances blood circulation in the anterior tibial artery and markedly boosts blood supply. This discovery reinforces the regulatory role of ST36 in blood flow. Additionally, decreased blood circulation in the lower extremities impacts the occurrence of arterial vascular disease in these limbs[19].
LEAD (Lower extremity arterial disease, LEAD), also known as lower extremity peripheral artery disease (lower limb peripheral artery disease, PAD), or lower extremity PAD, belongs to a large PAD family. This disease is a chronic obstruction characterized by reduced blood flow to the downward limb artery, leading to ischemia, which may accompany with thromboembolism[20]. The survey indicates that approximately 200 million individuals globally suffer from lower limb arterial vascular lesions (LEAD)[21]. This condition represents not just a localized form of systemic arterial lesions, but also forms part of peripheral arterial lesions. In clinical terms, the initial phases of LEAD typically exhibit no clear symptoms. Nonetheless, with the advancement of the illness, the patient might experience sporadic symptoms in the lower extremities and progressively suffer from pain at rest, culminating in gangrene at the extremity. Additional symptoms encompass undernourishment in the skin of the lower extremities, muscle wasting, dry skin, and reduced elasticity. From a clinical perspective, one can notice a reduction in skin temperature, pigmentation, and a diminished or non-existent acroartery pulse[22]. LEAD ranks as a frequent long-term complication associated with diabetes mellitus. Among LEAD patients, approximately 20–30% had diabetes in the study population, 25–90% of amputations were diabetes-related[23]. Findings from Professor Ji Linong's survey at Peking University People's Hospital revealed that 21.2% of diabetic patients in China suffer from LEAD[24]. Research conducted across multiple centers in China revealed a 19.5% occurrence of LEAD in diabetic patients aged over 50 [25], in contrast to a single-center study which indicated a higher rate of 35.4% in diabetic patients over 60 years with LEAD[26]. Presently, LEAD's clinical treatments encompass endovascular therapy, pharmacotherapy, rehabilitation, surgical procedures, and cellular therapy[27]. While these therapies have demonstrated efficacy in enhancing LEAD patients' symptoms and outlook, the expense of their treatment remains irrefutable. Consequently, the use of acupuncture as a cost-effective and efficient substitute therapy offers us fresh alternatives. Acupuncture, now a favored substitute treatment in healthcare, offers not just reduced costs but also demonstrates promise in reducing LEAD symptoms and enhancing patient life quality. As a conventional Traditional Chinese Medicine treatment, acupuncture modifies qi and blood circulation in the body, aids in tissue repairment and recovery[28], helps to relieve LEAD pain and muscle weakness[29], and improves the blood circulation of patients, helps reduce the condition and improves the quality of life.
It's important to recognize that acupuncture, although beneficial for certain LEAD patients, does not suit everyone, with its effectiveness differing based on personal variations. Consequently, in evaluating acupuncture as a potential treatment for LEAD, it's crucial for patients to thoroughly discuss and assess with doctors to confirm the suitability of the treatment for each specific case. Therefore, a more thorough investigation into Zusanli point's impact on the vascular dynamics of lower limb arteries will aid in uncovering acupuncture's role in enhancing blood flow. This study protocol thereby offers a more efficient acupuncture regimen and a scientific foundation for treating lower limb vascular disorders.
Trial status
Participants are currently being recruited for this study.