| Purpose1.To observe the clinical effect of exercise therapy on pain and lumbar spine function in patients with chronic non-specific low back pain and osteopenia,and to compare the clinical effects of different exercise methods in the treatment of chronic non-specific low back pain with bone mass reduction;2.Changes in bone mineral density,bone metabolic markers,risk of falling,and fracture risk after oral administration of Mi Gu capsule in patients with chronic non-specific low back pain and osteopenia.Method Randomized controlled trials were performed: 90 patients who met the inclusion criteria were randomized into group A(Migu capsule group),group B(Shishi strong tendon group),and group C(core stable training group).Group A does not exercise,group B uses Shi's injury department to strengthen the muscles and exercises,one time each morning and evening,each time to do 10 sets,group C uses core stability training,one time each morning and evening,each time 10 sets,the course of treatment is 12 weeks,and Mi Gu capsules as a basic treatment,3 times a day,three times a day orally,the course of treatment is 26 weeks.In this trial,visit 1(inset 0 days)indicators were used as baseline,visit 2(1 weeką2days),visit 3(4 weeksą5 days),visit 4(8 weeksą5 days),interview Visual5(12 weeksą5 days)was the evaluation point of efficacy,and visit 6(26 weeksą5 days)was the last follow-up time point.Result1.A total of 90 subjects were included in the study.One of the three groups fell off,and the rate of shedding was 3.33%.After Fisher's exact probability method,P=1.00 was obtained,and the difference was not statistically significant.Thirty subjects were completed in the last three groups.There was no significant difference in the baseline of different group age,gender,BMI,duration of disease,and menopausal age distribution(P>0.05).The baselines of the three groups were consistent and comparable.2.Comparison within the three groups(comparison of data at different time points):Mauchly's W spherical test results P ? 0.05,so the repeated measures variance analysis of Greenhouse-Geisser correction degrees of freedom was used,and the results were compared at each time point F = 658.679,P < 0.001,indicating that the NRS scores of the patients at 6 time points were not all the same(P < 0.001),the three groups of pain relief values(NRS scores)decreased after treatment,and the difference was statistically significant(P < 0.05);In comparison,the NRS scores were not statistically different before treatment and were comparable.There were significant differences between the three groups at the 8th,12 th,and 26 th week of treatment(P<0.05),1st week,4th.There was no statistical difference in weeks(P>0.05).3.Evaluate the efficacy and total effective rate of pain relief(NRS score)at week 26 of the three groups.Among the 30 subjects in group A,0(0%)and 7 effective cases were achieved.(23.33%),effective in 18 cases(60%),ineffective in 5 cases(16.67%),the total effective rate was 83.33%;among the 30 subjects in group B,4 cases(13.33%)achieved clinical cure criteria,markedly effective 11(36.67%),effective in 13 cases(43.33%),ineffective in 2 cases(6.67%),the total effective rate was 93.33%;among the 30 subjects in group C,1 case(3.33%)was achieved in clinical cure criteria.14 cases(46.67%),13 cases(43.33%),and 2 cases(6.67%)were ineffective,and the total effective rate was 93.33%.Group A and group B were analyzed by group rank sum test to analyze the efficacy distribution of the two groups z=-2.012,P=0.044.There was a significant difference in the efficacy distribution between the two groups,and it was suggested that group B had better pain relief than group A;group A and group C The grouped rank sum test was used to analyze the curative effect distribution of the two groups,z=-2.256,P=0.024.There was a significant difference in the efficacy distribution between the two groups,and it was suggested that the curative effect of group C was better than that of group A.Group B and group C were tested by group rank sum test.The distribution of curative effect was analyzed by z=-0.810,P=0.418.There was no significant difference in the distribution of curative effect between the two groups.4.Comparison of three groups of patients(comparison of data at different time points):Mauchly's W spherical test results P ? 0.05,so the repeated measures variance analysis of Greenhouse-Geisser corrected degrees of freedom was used,and the results were compared at each time point F = 253.287 P < 0.001,indicating that the ODI scores of patients at each time point were not all the same(P < 0.001).Within the group,the three groups of dysfunction values(ODI score)decreased after treatment,and the difference was statistically significant(P<0.05).There was no statistical difference between the groups before the treatment,and the three groups were comparable.The ODI scores were significantly different between the three groups at the 8th week,the 12 th week,and the 26 th week(P<0.05).There was no significant difference between the first week and the fourth week(P>0.05).5.Efficacy evaluation and total effective rate of dysfunction(ODI value)at the 26 th week of the three groups of subjects,among the 30 subjects in group A,4 cases(13.33%)and 14 cases(46.67)were achieved.%),effective in 8 cases(26.67%),ineffective in 4cases(13.33%),the total effective rate was 86.67%;among the 30 subjects in group B,14cases(46.67%)achieved clinical cure criteria and 13 cases markedly effective(43.33%),effective in 3 cases(10%),ineffective in 0 cases(0%),the total effective rate was 100%.Among the 30 subjects in group C,10(33.33%),16(53.33%),3(10%),and 1(3.33%)were cured,and the total effective rate was 96.67%..Group A and group B were analyzed by group rank sum test to analyze the efficacy distribution of the two groups z=-3.080,P=0.002.There was a significant difference in the efficacy distribution between the two groups,and it was suggested that the improvement of dysfunction in group B was better than that in group A.Group A and group C were analyzed by group-ranking test to analyze the efficacy distribution of the two groups,z=-2.655,P=0.008.There was a significant difference in the efficacy distribution between the two groups,and it was suggested that the improvement of dysfunction in group C was better than that in group A,group B and C.The group was analyzed by group rank sum test to analyze the efficacy distribution of the two groups z=-0.024,P=0.981.There was no significant difference in the efficacy distribution between the two groups.6.Compare the changes of bone mineral density before and after treatment in 90 subjects.After 12 weeks of treatment,the femoral neck and total hip bone density increased by 0.5% and 0.1%,respectively.After 26 weeks,the femoral neck,total hip and L1-L4 bone mineral density were respectively.It increased by 2.5%,1.0%,and 0.1%.In addition to the decrease in bone density of L1-L4 after 12 weeks of treatment,bone mineral density increased at different sites in different periods.There were no significant differences in the changes of bone mineral density(P>0.05)between the A,B and C groups before treatment,12 weeks of treatment,26 weeks of treatment,L1-L4,femoral neck and total hip.7.The variance biochemical parameters of bone metabolism before and after treatment were compared by analysis of variance.The results showed that the levels of osteocalcin and ?-CTX decreased at 12 weeks and 26 weeks,and the difference was statistically significant(P<0.05).The remaining biochemical indicators of bone metabolism in the three groups were not statistically different at different time periods.8.The non-parametric test was used to compare the risk of fall in 90 subjects before and after treatment.The risk of fall decreased at 12 weeks and 26 weeks,and the difference was statistically significant(P<0.05).9.Non-parametric test was used to analyze the risk of hip fracture in 90 subjects.The risk of hip fracture decreased at the 12 th and 26 th week after treatment,and the difference was statistically significant(P<0.05).The main fracture risk was There was no significant difference before and after treatment.10.The safety index(total bilirubin,alanine aminotransferase,aspartate aminotransferase,?-glutamine transferase,serum creatinine,urea nitrogen)was not statistically different(P>0.05).After 26 weeks of taking the drug,the above six indicators did not change.The drug had no effect on these indicators.In the course of this test,the use of Migu capsule was safe and had no damage to liver and kidney function.11.Comparison of clinical satisfaction between the three groups of treatments: The three groups of subjects completed the satisfaction questionnaire at the 26 th week of treatment.Group A was very satisfied with 2 people(6.7%),satisfied with 10 people(33.3%),and generally 8 people.(26.7%),5 people were dissatisfied(16.7%),5 people were very dissatisfied(16.7%);Group B was very satisfied with 9 people(30%),13 people were satisfied(43.3%),and 5 people were generally(16.7%)2 people were dissatisfied(6.7%),very dissatisfied with 1 person(3.3%);Group C was very satisfied with 7 people(23.3%),satisfied with 11 people(36.7%),generally 7 people(23.3%),not satisfied 2People(6.7%),very dissatisfied with 3 people(10%).Comparison of multiple independent sample rates,P=0.002,the difference between the three groups of satisfaction scores was statistically significant(P<0.05).12.Comparison of the scores of exercise therapy difficulty between the two groups:Group B is very simple 2(16.7%),simple 10(33.3%),generally 5(26.7%),difficult 3(10%),Very difficult for 3 people(10%);three groups of subjects filled out the satisfaction questionnaire at the 12 th week of treatment,group B is very simple 2(16.7%),simple 9(33.3%),generally 5(26.7 %),difficult for 8 people(10%),very difficult for 6 people(10%).Using a comparison of two independent sample rates,P=0.021,the difference in the scores of exercise therapy difficulty between the two groups was statistically significant(P<0.05).13.Adverse events: During the observation of this subject,1 patient in group A developed nausea and bloating,and the symptoms were improved after the corresponding treatment.The other patients did not have other adverse reactions.After 4 weeks of strong gluten exercises,the patient developed low back pain.The right lower extremity was numb.After the treatment,the symptoms improved,and the prognosis was good.In the core stable exercise group,1 case had increased lumbar pain,and the bed rested.The pain was improved after oral painkilling.Conclusion:1.Shishi injury department strong muscle work and core stable exercise can improve the degree of pain and lumbar dysfunction in chronic non-specific low back pain and bone loss,and enhance waist stability.2.Migu capsule can inhibit the activity of osteoclasts,maintain bone mineral density,reduce the risk of falling to the risk of hip fracture.3.Shishi injury department strong gluten work combined with Migu capsule can effectively improve the pain and functional activities of chronic non-specific low back pain with bone loss,maintain bone mass,better curative effect,and Shi's strong tendon method It is simple,easy and inexpensive,and is suitable for clinical application. |
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