Efficacy of electroacupuncture in patients with failed back surgery syndrome: study protocol for a randomized controlled trial.

BACKGROUND: Persistent pain following back surgery called failed back surgery syndrome remains a major treatment challenge. The aim of this study is to evaluate the efficacy and safety of electroacupuncture on relieving back pain in FBSS patients. METHODS/DESIGN: This is a randomized, single-blind, single-site, placebo-controlled trial. A total of 144 eligible FBSS patients will be randomly assigned to the electroacupuncture, manual acupuncture, or sham acupuncture group in a 1:1:1 ratio. Each group will receive 2 treatment sessions per week for 12 weeks. The primary outcome will be low back pain intensity based on the 11-point numerical rating scale (NRS). The secondary outcomes include Oswestry Disability Index (ODI) questionnaire, Beck Depression Inventory-II (BDI-II), Pittsburgh Sleep Quality Index (PSQI), and analgesic consumption. All clinical outcomes will be collected at baseline, during the treatment phase (at 8 and 12 weeks), and at the 16-, 24- and 36-week follow-ups. All data will be analyzed based on the intention-to-treat principle and adverse events will be assessed during the trial. DISCUSSION: This pilot randomized controlled trial will evaluate the efficacy of electroacupuncture for treating failed back surgery syndrome. The outcomes will determine whether electroacupuncture is efficacious in relieving low back pain as well as improving the quality of life in failed back surgery syndrome patients. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2000040144 . Registered on 22 November 2020.

[A method to create a new rat model of combination of disease and syndrome with cervical vertigo hyperactivity of liver yang syndrome].

OBJECTIVE: To establish a simple and reliable model of cervical vertigo in rats with hyperactivity of liver-yang syndrome, and to establish a simple and feasible method for evaluating the degree of vertigo in animals. METHODS: SPF male SD rats (aged 8 weeks, weighing 280 to 320 g) were randomly divided into 4 groups (6 rats in each group). The model of cervical vertigo of hyperactivity of liver yang syndrome (joint modeling group) was established by combining local injection of lauromacrogol (hardener) and receiving fuzi decoction by gavage. The joint modeling group was compared with the hardener group, the fuzi decoction group and the blank control group. The vertigo degree of rats was measured by the time of passing through a glass tube (running time) before modeling, 2 weeks and 3 weeks after the established model. RESULTS: There was no statistical difference in the running time between control group and fuzi decoction group, between joint modeling group and hardener group. The running time in the hardener group and the joint modeling group was longer than that in the control group (P< 0.05), and was even longer than that in the fuzi decoction group (P<0.01). There was significant difference in running time after modeling compared with that before modeling (P<0.05); there was no significant difference in running time between 2 and 3 weeks after modeling (P>0.05). CONCLUSION: This method can effectively establish a rat model of cervical vertigo with hyperactivity of liver-yang syndrome, and the running time can reflect the degree of vertigo in rats to a certain extent. This experiment provides a simple and feasible animal model and detection method for research of cervical vertigo in the future.