| ObjectiveTo investigate the efficacy of Botulinum Toxin A(BTX)in the treatment of pain in Knee osteoarthritis(KOA)patients and the possible mechanism of BTX in relieving pain.MethodsThis study was a single-center,randomized,double-blind,placebo-controlled parallel study.Inclusion criteria were that the study met the criteria established by the American College of Rheumatology and the European Union against Rheumatology,had poor efficacy after conservative treatment,and had a strong desire for injection therapy.An investigator conducts a screening interview to introduce the patient to the overall protocol and rationale for the drug.If the patient refuses to participate in the trial,we proceed to the next patient.The screening interview involves a history,a review of case data,and a physical examination.Subjects in the study signed informed consent and completed a full baseline assessment.Subjects were randomly assigned to one of two treatment groups according to A simple randomization procedure(A computer-generated table of random numbers): BTX-A and placebo(this was done by A computer operated by A person who was not clinically involved in the trial).Both BTX-A and placebo were powdered in the same appearance,packaged in bottles and numbered consecutively.After each subject completed all baseline assessments,each subject was assigned A number according to A random assignment table,and A pre-filled powder bottle with the corresponding number was assigned to the subjects by the nurse.The distribution list is kept in the safe of the Second Department of Rehabilitation,Affiliated Hospital of Qingdao University.Finally,a doctor trained in intraarticular injection is given the injection in a standard posture.Neither the subjects nor the injector knew whether the injected drug was BTX-A or placebo,and the assignment was blinded to outcome evaluators and data analysts.VAS score,WOMAC Osteoarthritis Index,40 m walking time and peri-knee and tibial anterior muscle tenderness threshold were evaluated before and 2,4,8 and 4 weeks after injection,and the changes of values were observed,and adverse reactions were recorded.The results of1.A total of 79 patients were enrolled,including 35 in the experimental group and 35 in the placebo group after unblinding,and 9 patients were lost to follow-up.There was no statistical significance in gender,age,body weight,BMI and imaging classification between the two groups(P > 0.05).2.Compared with before treatment,VAS score,WOMAC index and 40 m walking time of the two groups were decreased at different time points after treatment(P <0.05);Compared with the placebo group at the same time point after treatment,the VAS score,WOMAC index and 40 m walking time were lower in the Botox group at 2,4 and 8weeks after injection(P < 0.05).3.Compared with before treatment,the tenderness threshold of 2,4 and 8 weeks after treatment in 2 groups was significantly improved(P < 0.05);Compared with placebo group at the same time point after treatment,the pain threshold of Botox group was significantly improved at 2,4 and 8 weeks after treatment(P < 0.05).4.No serious adverse reactions were observed in all patients during injection and follow-up.ConclusionBotulinum toxin type A can be used as A method for the treatment of pain in patients with knee osteoarthritis.It may improve nerve sensitization and tenderness threshold in patients with knee osteoarthritis,and further relieve pain and improve dysfunction. |
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