| Objective: 1.Verify the therapeutic effect of low-frequency electroacupuncture on promoting the postoperative healing of distal radius fractures in patients with postmenopausal osteoporosis.2.To preliminarily explore the relevant mechanism of low-frequency electroacupuncture in promoting the postoperative healing of distal radius fractures in patients with postmenopausal osteoporosis.Methods: A randomized,single blind(non blind subjects and treatment groups,and blind evaluators),controlled clinical trial was designed in this study.According to the sample estimation,50 patients with postmenopausal osteoporosis suffered from distal radius fracture who were treated in the Department of Orthopedics and Trauma,Yuxi Traditional Chinese Medicine Hospital from October 2021 to May 2022 were collected,and then were randomly divided into the test group(receiving low-frequency electroacupuncture + conventional postoperative rehabilitation treatment of the wrist joint,,N=25)and the control group(receiving only conventional postoperative rehabilitation treatment of the wrist joint,N=25)using the random sequence table.Fifty patients received treatment 3 times/week for 6 weeks,a total of 18 times.The evaluation was conducted at three time points before treatment,the 6th week of treatment,and the 6th week after treatment(follow-up).The primary outcome indicators such as X-ray evaluation of clinical fracture healing,Sarmiento Colles fracture efficacy scoring system evaluation,and the secondary outcome indicators such as visual analog scale(VAS)of pain,swelling degree,range of motion(ROM),bone metabolism index,bone mineral density(BMD),modified Barthel Index(MBI)were adopted in this study.The SPSS 20.0 software was used in the statistics analysis by the principle of intention to treat(ITT).Results: A total of 7 patients fell out,and ultimately 43 patients completed the trial(test group,N=21;control group,N=22).There was no statistically significant difference in general information,VAS score,swelling degree,joint activity,bone mineral density,and bone metabolism indicators between the two groups before intervention(P>0.05),which was comparable.All subjects showed good tolerance to electroacupuncture,and there were no serious adverse events or side effects reported during the entire trial process.1.Main outcome measures:(1)X-ray evaluation of clinical fracture healing:At follow-up(the 6th week after the end of treatment),no cases of nonunion were found in both groups,but during the 6th and 10 th weeks of treatment(Note: In the 6th week evaluation,if the X-ray results report that the fracture line is blurred.In order to compare the speed of fracture healing,we will ask the patient to review an X-ray one month later(i.e.,the 10 th week),In return for the results: the fracture line disappears and the fracture heals.It is only calculated that the fracture has reached healing,so there is an additional evaluation time for the 10 th week,and patients who have already healed will no longer undergo the next X-ray examination.The difference between the total number of cases of fracture healing during these two periods is statistically significant(P<0.05).(2)Sarmiento Colles Fracture Efficacy Scoring System Evaluation: At the follow-up((the 6th week after the end of treatment),in the comparison of the four grades of excellent,good,acceptable,and poor,the experimental group had an excellent and good rate of 95%,and acceptable and poor rate of 5%,while the control group had an excellent and good rate of 68%,and acceptable and poor rate of 32%.The difference between the two groups was statistically significant(P<0.05).2.Secondary outcome indicators:(1)Pain VAS score,wrist joint swelling,and wrist joint activity: At the 6th week of treatment and follow-up,the three indicators in the test group and the control group were significantly improved compared with those before treatment,with a statistically significant intragroup comparison(P<0.05).Although the improvement of the three indicators in the test group before and after treatment,during follow-up,and after treatment had a trend that was superior to the control group,this trend did not reach a statistically significant level,Namely,there was no significant difference between the groups(P>0.05).(2)Modified Barthel Index Score: The scores of the modified Barthel Index in the experimental group and the control group at the 6th week of treatment and at the follow-up were significantly higher than before(P<0.05);At the 6th week of treatment,there was a significant difference between the two groups(P<0.05),but at follow-up,there was no significant difference between the two groups(P>0.05).(3)Bone mineral density value: At the 6th week of treatment,the bone mineral density value in the test group significantly increased compared to that before treatment,with a significant difference within the group(P<0.05).At the follow-up,the bone mineral density value significantly decreased compared to that at the 6th week of treatment,with a statistically significant difference within the group(P<0.05);The bone mineral density of the control group showed a downward trend both at the 6th week of treatment and at follow-up,and there was statistically significant difference between the two groups(P<0.05);At the 6th week of treatment,there was a significant difference between the two groups(P<0.05),but there was no significant difference between the two groups during follow-up(P>0.05).(4)Bone metabolism indicators:(1)The values of parathyroid hormone(PTH)and calcitonin(CT)in the two groups of patients did not change significantly at the 6th week of treatment and at follow-up,and there was no statistically significant difference between intragroup and inter group comparisons(P>0.05).(2)The values of BGP and 25-hydroxyvitamin D(25-OH Vit D)in the experimental group at the 6th week of treatment increased significantly compared to those before treatment,with a significant difference between the two groups(P<0.05).At the follow-up,the BGP and 25-OH Vit D values significantly decreased compared to those at the 6th week of treatment,with a statistically significant difference between the two groups(P<0.05);The BGP and 25-OHVit D values in the control group did not significantly change at the 6th week of treatment and at follow-up,and there was no statistically significant difference between the two groups(P>0.05);At the 6th week of treatment,there was a significant difference between the two groups(P<0.05),and there was also a significant difference between the two groups during follow-up(P<0.05).Conclusion(s): The treatment method of electroacupuncture combined with routine rehabilitation training after wrist joint surgery can accelerate the fracture healing time of postmenopausal patients with osteoporotic distal radius fractures after surgery;In the evaluation of Sarmiento Colles fracture efficacy scoring system,among the four grades of excellent,good,fair,and poor,the efficacy was excellent and positive;At the 6th week of electroacupuncture treatment,BGP,25-OHVit D,and bone mineral density significantly increased compared to the control group,suggesting that electroacupuncture may promote fracture healing and improve treatment effectiveness by improving bone metabolism and bone mineral density.(This trial has been approved by the Ethics Committee of Yuxi Traditional Chinese Medicine Hospital(approval number: 2021kysc021)and registered with the China Clinical Trial Registration Center(registration number: Chi CTR 2200061528)). |
PDF Full Text Request