Efficacy of Acupuncture in the Treatment of Residual Pain After Osteoporotic Vertebral Compression Fractures Percutaneous Vertebroplasty Among Older Adults: A Study Protocol for a Randomized Controlled Clinical Trial

BACKGROUND: Osteoporotic vertebral compression fractures (OVCF) are common fractures in the elderly and have reached epidemic proportions, not only affecting individual health, but also creating an economic burden worldwide. Percutaneous vertebroplasty has been widely used to treat OVCF and achieve analgesic effects, but the incidence of residual pain after percutaneous vertebroplasty is still high. There is evidence that electroacupuncture when combined with lifestyle interventions, can effectively reduce the effects of residual pain after percutaneous vertebroplasty. This clinical trial aims to evaluate and compare the safety and clinical efficacy of electroacupuncture and floating acupuncture for residual pain after percutaneous vertebroplasty. METHODS: This will be a blank-controlled, three-arm randomized clinical trial. A total of 111 participants who met the inclusion and exclusion criteria aged between 60 and 80 years will be recruited. The 111 participants meeting the inclusion and exclusion criteria will be randomly divided into three groups including a blank control group, an electroacupuncture treatment group, and a floating acupuncture treatment group. The total course of research in this study will be 3 weeks, including a 1-day interview valuation, a 3-day treatment period and a 2-week follow-up period. Participants will receive three treatments for the whole trial. The primary outcome will be the assessment of the Visual Analogue Scale score while the secondary outcome will be the measurement of traditional Chinese medicine syndrome diagnosis scale and Oswestry Disability Index. All patients will be assessed at baseline and the end points of day 1 of enrollment, day 1, day 2, day 3, day 7 and day 14 after surgery. CLINICAL TRIAL REGISTRATION: This trial has been registered at the International Traditional Medicine Clinical Trial Registry. Registration number:ITMCTR2024000853. Registration date: 22 December 2024.