This is the first clinical study on electroacupuncture intervention on the use of analgesics for low back pain in patients with POP.
Acupuncture has a history of thousands of years. Because of its wide application, quick effect and few adverse reactions, acupuncture has become a recognized green analgesia method at home and abroad [10]. Acupuncture not only relieves pain, but also improves the quality of life of patients with pain, and can avoid addiction, immunosuppression, gastrointestinal injury and other adverse reactions caused by analgesics to a certain extent[11]. Acupuncture has been a means of relieving opioid withdrawal symptoms for more than 50 years. More and more clinical studies have shown that acupuncture is effective to treat musculoskeletal pain and even cancer pain[12–14]. LiuCT et al.[15] pointed out that acupuncture can reduce the use of analgesics after rib fracture. A systematic review shows that acupuncture can reduce postoperative pain and opioid consumption and reduce adverse reactions such as nausea, vomiting and itching [16].The American Association of Physicians Clinical practice Guide [17] recommends acupuncture as an initial non-drug therapy for acute or chronic low back pain. Acupuncture has become widely accepted as a supplementary treatment for pain relief. In recent years, acupuncture has attracted more and more attention in the treatment of osteoporosis. A systematic review points out that the potential benefits of acupuncture in the treatment of osteoporosis mainly include pain relief and improved bone mineral density[18]. Schiller J et al. [19] through randomized controlled studies have shown that acupuncture can relieve the pain of osteoporosis and improve their quality of life. Through the current research situation at home and abroad, it is found that only a few RCT have investigated acupuncture treatment to reduce the use of analgesics addiction. Therefore, more randomized controlled trials are needed to support the evidence that acupuncture relieves pain symptoms and reduces the use of analgesics.
In our previous study [20], we emphasized the importance of muscles and bones and demonstrated that electroacupuncture, based on calcium, can improve pain symptoms and motor function in patients with POP. However, the effects of analgesics after electroacupuncture treatment have not yet been investigated. Therefore, in this study, we observed the clinical effect of electroacupuncture on pain relief in POP, recorded the use of analgesics, and explored its potential central analgesic mechanism through rs-fMRI.
Pain is a complex physical and mental activity, which is one of the most common clinical symptoms. The International Association for Pain Research revised the definition of pain in 2020, emphasizing that in addition to the perception of pain, pain emotion, cognitive and social skills are important dimensions for the assessment of pain [21]. Therefore, in this study, McGill pain scale was used to evaluate patients' pain from many aspects, such as pain sensation, intensity, emotion and so on. McGill pain scale was taken as the main outcome index. ODI is used to evaluate lumbar dysfunction in patients with low back pain. In this study, it is used as a secondary observation index to reflect the situation of low back pain and the severity of pain affecting their life in patients with primary osteoporosis. This study also takes the use of analgesics as its therapeutic index to observe whether electroacupuncture in the treatment of POP pain can reduce the use of analgesics from two aspects of its utilization rate and intensity (total oral dose). DeZordo et al. [22] applied real-time shear wave ultrasonic elastography (SWE) to the field of muscle and bone for the first time, described the elasticity of Achilles tendon in healthy adults, and confirmed its application value. In recent years, in the field of acupuncture research, SWE technology has made progress in acupoint determination, acupuncture qi extraction, manipulation research and curative effect evaluation[23]. Our group's previous study [24] found that the value of Young's modulus measured by SWE has the same trend as the improvement of pain symptoms, so we use Young's modulus as a secondary index in this study to explore the application value of its technique in the evaluation of patients with low back pain in POP.
With the widespread recognition of acupuncture analgesia, exploring the central mechanism of acupuncture analgesia has attracted more and more attention [25]. Functional magnetic resonance imaging (fMRI), as a non-invasive visualization technology, can directly reflect the external stimuli received by the brain, and has been widely used in the study of the mechanism of acupuncture in the treatment of chronic pain [26]. A neuroimaging systematic review showed that acupuncture improved abnormal brain structure and functional activity in patients with low back pain mainly through pain matrix, default pattern network (DMN), saliency network (SN) and descending pain regulation system (DPMS) [27]. Kong J et al. [28] have shown that the efficacy of acupuncture in the treatment of knee osteoarthritis pain is positively correlated with the activation of brain regions related to the marginal reward system (NAc, PFC and ACC). HaG et al. [29] have shown that acupuncture can regulate different brain regions, including thalamus, insular lobe, caudate body, claustrophobia and lenticular nucleus. The above studies provide an idea for exploring the central analgesic mechanism of acupuncture in relieving POP pain.
To the best of our knowledge, this study is also the first to explore the central mechanism of electroacupuncture in the treatment of POP low back pain. The results of this experiment will be helpful to provide visual evidence for the clinical application of electroacupuncture in the treatment of POP low back pain.
Trial status
The trial is currently in the recruitment stage and the study is expected to end in August 2024.