| PurposeTo evaluate the clinical effects and the advantages of the trinity of Traditional Chinese Medicine (TCM) synthetic rehabilitation therapy (integration of Chinese medicine and western medicine, integration of doctor-patient cooperation and the integration of evaluation and exercise) by means of randomized controlled trial (RCT); To explore factors affecting the TCM synthesis rehabilitation curative effect of distal radius fractures through multi-factor logistic regression analysis; To probe into integrated treatment of the TCM synthesis rehabilitation therapy(evaluation-choose rehabilitation methods-cooperation of doctors and patients for functional recovery-reevaluation) applying to the recovery of wrist function after distal radius fractures. Finally, Basic study was made on the application of the equal emphasis on bones and tendons (unification of the structure and function of the muscle and bones), dynamic-static integration (unification of active activities and passive activities), internal and external treatment (unification of partial and whole functional recovery) and doctor-patient cooperation (doctor-patient cooperation must run through the whole rehabilitation therapeutic process) to the rehabilitation of distal radius fractures. Method Using central randomization system for clinical research provided by China Academy of Chinese Medical Sciences Clinical Research Center,72 cases with functional disability of wrist joints after distal radius fractures meeting standards were divided into experimental group and control group,36 patients for the experimental group and 36 patients for the control group. The experimental group was given TCM synthetic rehabilitation (manipulative therapy, joint mobilization, soaking-washing with Chinese medicinal herbs, functional exercise), and the control group was given functional exercise as well as soaking-washing with Chinese medicinal herbs,3 weeks for both. Eight evaluation standards were used in this research,which were Visual analogue scale/score (VAS), grip strength, imaging examination outcomes(the height of radical styloid, angle of ulnar drift, and palmaris inclination), range of wrist motion, patient-rated wrist evaluation (PRWE), Gartland and Werley wrist score, self-rating anxiety scale (SAS) and the overall curative effect evaluation. Before treatment (baseline), after 3 weeks of treatment and 3 months after fracture were the three points in time when collected the data. Case report form (CRP) was used to collect, conserve and manage the relevant original data. Original database was set up by ClinResearch Electronic Data Capture developed and led by China Academy of Chinese Medical Sciences Clinical Research Center. To guarantee the accuracy of original database,this research adopted two-people double data input. All statistical tests were two-sided and conducted at statistical significance level of P equals 0.05. The collected data were given statistical analysis by SPSS 20.0 software. Result72 cases who come from Wangjing hospital outpatient department were divided into the experimental group and the control group. Each group had 36 cases.69 cases were finished treatment and followed up in the end,35 patients for the experimental group and 34 patients for the control group. The treatment group fall off 1 case, and the control group fall off 4 cases. General medical information and baseline data were comparable between the experimental group and the control group (P> 0.05).With regard to the overall curative effect evaluation, when compared to the data after 3 weeks of treatment, which was 20.59% and 35.29% respectively,the percentage of patients who were evaluated "cure" was significantly higher both in the experimental group and the control group at 3 months after fracture, which was 71.4% and 64.7% respectively. In addition, the intergroup difference between the experimental group and the control group were statistically significant regarding the overall curative effect evaluation of patients by chi-square test compared with after 3 weeks of treatment and at 3 months after fracture(P< 0.05). In terms of pains and grip strength recovery, after 3 weeks of treatment, the intergroup difference between the experimental group and the control group were statistically significant relative to the baseline regarding the pain and grip strength of ipsilateral wrist by group t-test (P < 0.05). However, the experimental group and the control group had no statistically significant relative to the baseline at 3 months after fracture in pain and grip strength (P< 0.05). Furthermore, after 3 weeks of treatment and at 3 months after fracture, except ipsilateral forearm pronation and supination activity, the intergroup difference between the experimental group and the control group were statistically significant relative to the baseline regarding the palmar flexion, dorsiflexion, ulnar deviation and radial deviation of ipsilateral wrist motion, PRWE and G-W wrist score by group t-test(P<0.05).Following consideration of the imaging examination outcomes, the results of variance analysis showed that the difference regarding the height of radical styloid, angle of ulnar drift, and palmaris inclination was not statistically significant within the experimental group and the control group at before treatment (baseline), after 3 weeks of treatment and 3 months after fracture (T>0.05).With regard to the anxiety state of patients, when compared to the data before treatment, which was 42.9% and 35.3% respectively,the percentage of patients with anxiety was significantly higher both in the experimental group and the control group after treatment, which was 71.4% and 64.7%respectively. In addition.,the difference within groups before and after treatment of the anxiety state of patients had statistical significance with chi-square test both in the experimental group and the control group(P< 0.05). After 3 weeks of treatment, the intergroup difference between the experimental group and the control group were statistically significant relative to the baseline regarding SAS score by group t-test (P< 0.05).Univariate statistical analysis showed that the following four factors, including the time of rehabilitation intervention within 6 weeks or 6 weeks after fractures, excellent or inferior quality of fracture reduction, TCM synthetic rehabilitation therapy or traditional rehabilitation method, and whether the fracture patients had ever experienced symptoms of anxiety or not, all indicated correlations with wrist rehabilitation effect of patients (P< 0.05). Furthermore, through binary logistic regression analysis, the selection of rehabilitation methods and the anxiety level in fractures patients were independent factors influencing the rehabilitation effect of wrist joint function (P<0.05). In addition, TCM synthetic rehabilitation therapy was a strong protective factor in influencing the rehabilitation effect of wrist joint function, and the anxiety of patients served as an independent high risk factor.Conclusion1 TCM synthetic rehabilitation therapy has better curative effects on the treatment of functional disability of wrist joints after distal radius fractures than the general therapy of soaking-washing with Chinese medicinal herbs and functional exercise. In the process of three weeks treatment, manipulative therapy and joint mobilization have significant effects and advantages on the recovery of pains and grip. However, there is no difference on the recovery of pains and grip between the experimental group and control group at the third month of fracture.. After 3 weeks of treatment and 3 months after fracture, except ipsilateral forearm pronation and supination activity, the recovery of the palmar flexion, dorsiflexion, ulnar deviation and radial deviation of ipsilateral wrist motion,PRWE, G-W wrist score and the overall curative effect evaluation of the experimental group show better curative effects than the control group.2 In terms of In terms of imageology, the TCM synthetic rehabilitation therapy has no effects on the changes of the height of radical styloid, angle of ulnar drift, and palmaris inclination after four weeks of distal radius factures.3 For the anxiety of patients, Compared with the experimental group and control group at before and after rehabilitation treatment, the anxiety of both experimental group and control group is eased. However, The degree of anxiety relief in experimental group and control group cases has no difference.4 In the process of distal radius facture rehabilitation, systematical and complete TCM synthetic rehabilitation guidelines and treatment is vital for the effects of rehabilitation. while anxiety is the independent and dangerous factor for the TCM synthetic rehabilitation therapy of functional disability of wrist joints after distal radius fractures, clinicians must give adequate attentions in the process of clinical rehabilitation. In addition, The excellent or inferior quality of distal radius fractures reduction is not the independent factor influencing the wrist joint function, it usually forms confounding factors with the rehabilitation intervention time, types of fracture, ages, and the fixation time of fractures to affect the rehabilitation effects.5 With the integration of Chinese medicine and western medicine, integration of doctor-patient cooperation and the integration of evaluation and exercise as the guideline direction of fracture rehabilitation, as well as with equal emphasis on bones and tendons (unification of the structure and function of the muscle and bones), dynamic-static integration (unification of active activities and passive activities), internal and external treatment (unification of partial and whole functional recovery) and doctor-patient cooperation (doctor-patient cooperation must run through the whole rehabilitation therapeutic processes the principle of fracture rehabilitation treatment, forming the integrated operation procedures and processes of TCM synthetic rehabilitation(evaluation-choose rehabilitation methods-cooperation of doctors and patients for functional recovery-reevaluation), it has achieved significant curative effects, which is worthy of promotion and application on clinic. |
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