| ObjectiveTo evaluate effectiveness and safety of balancing acupuncture for treatment of shoulder periarthritis, and to look for new thought and scientific effective proposal for treating shoulder periarthritis, the randomized-controlled trial was undertaken.MethodsThe objects were patients with periarthritis of shoulder. Qualified trial objects:80 patients from Hui An traditional Chinese medicine clinic during 2007 to 2008 were selected. Chinese diagnosis standard referred to Diagnosis and Treatment Routine of Traditional Chinese Internal Medicine; western medicine diagnosis standard, met the diagnosis standard of shoulder periarthritis instituted by the second nationwide academic symposium of shoulder periarthritis,1991. adapted the methods of randomized-controlled trial, randomize by 1:1 qualified cases into balancing acupuncture group and ordinary acupuncture group,40 cases in each group. All patients came from outpatient department.Cases grouping used simple random method. Allocation of specific random was designated to the researchers, by operating SAS (Statistical Analysis System) software to get the random number, and making random distribution cards, then adding sealed envelopes, whose serial number were the same with cards serial number. When qualified cases entered in the trial, according to their entry order, researcher opened the same number of envelopes to give patients treatment stated grouping by cards in envelopes. Random number tables were preserved according to requirements.Therapeutic methods:(1) balancing acupuncture group:point selection: jiantong point(BP-LB6):located between shin bone and fibular bone, at the upper 1/3 of the on-line between interior capitulum fibulae and high spot of lateral malleoulus, to be equivalent to the spot under 2 cun from zusanli point, and at the fibulae side.Operation methods:(reference:Wang Wenyuan. state administration of traditional Chinese medicine special column for popularizing suitable technique of Chinese medicine countryside:technique of "balancing acupuncture and moxibustion" needling jiantong point for treating shoulder periarthritis,2007,14 (1) 36.) crossover select points, select the points at the left side when pathological changes at the right, and select the points at the right side when pathological changes at the left. Use NO.28 number filiform needle of 3 cun, insert directly into the point about 1.5 cun, and apply reduction technique. Needling sensation induced feel mainly as local sour, numb, swell up, accompanying by lightning-like numb radiating to ankle, foot instep, toes. Withdraw needle instead of remaining needle when needling sensation above appear. The whole course is controlled within 3 seconds. The operation is conducted 3 times every week, and 10 times make a course. (2) ordinary acupuncture group:referred to Science of Acupuncture and Moxibustion (the Fifth Edition Textbook for Higher Medical and Pharmaceutical Colleges and Universities, Qiu Maoliang chiefly edit, pubulished by Shanghai Scientific and Technical Publishers). Point selection:jiangyu, jiangliao, jianqian, a shi, tiaokou, yanglingquan. Subsidiary points:pain of upper arm:jian zhuan, quchi; pain of scapular:quhuan, tianzong. Operation: place patient in sitting position, use the filiform needle of the same diameter as that used in trial goup, insert the needle into point mentioned above for appropriately 1-1.5 cun, after arrival of qi, remain needle about 30 minutes, manipulate needle at the interval of 10 minutes, withdraw needle 30 minutes later. The therapeutic course was the same as the trial group. Any other drugs that have clinical effect should not be used. Operation is conducted 3 times every week,10 times make a course and two courses are made.Observation indices:evaluation of shoulder pain and shoulder joint activity function:refer to score standard of American Michael Reese medical treatment (Dai Kerong, shoulder surgery, Beijing:People's Medical Publishing House,1992:401-402). Total score of shoulder pain is 75 points, and total score of shoulder joint activity function is 25 points (record function and activity both by 50%), to see the evaluation table of shoulder joint function. Pain evaluation use Mcgill observation scale and self-made observation scale. Record information once patient is on admission and record again when the treatment course is over. Observation methods:clinical symptoms and signs should be recorded before treatment, and observed and recorded one time every week after treatment. Urine routine, blood routine, stool routine, electrocardiogram, liver function(ALT),kidney function(BUN) are tested one time before treatment and another time after treatment.Global efficacy evaluation is according to effectiveness criteria of shoulder periarthritis from "guiding principles of new drugs in Chinese medicine clinical research" (established and published by Department of Health, 1997 the third edition):recovery:(clinical cure):disappearance of shoulder pain disappear, scope of shoulder joint activities recovery to normal. Excellence:shoulder pain release obviously, scope of shoulder joint activities improve obviously. Efficiency:shoulder pain release generally, scope of shoulder joint activities improve partially. Inefficacy:clinical symptom change less.When the trial was over, clinical information was gather in time, input into computer, set up database and carried out data management, and then used Epi Data software to make statistic analysis. Compared with the total clinical efficacy, efficacy of clinical symptoms and signs between three groups, by statistic analysis, and at last evaluated objectively their clinical effects and safety.Statistic methods:classification data usedχ2 test, rank data used two-samples comparison Wilcoxon rank sum test (corrected), two samples mean comparisons used t test or Wilcoxon rank sum test, before and after self-comparison matching t test or Wilcoxon matching rank sum test. Statistic analysis used SPSS17.0 software to finish.ResultsClinical research design use randomized-controlled trial methods. Randomized total 80 qualified cases by 1:1 into 2 groups:balancing acupuncture group and ordinary acupuncture group. Objects all came from outpatient department.Comparability test of baseline characteristic in two groups:there were no statistical significant difference of age, gender, disease course, pre-treatment pathogenetic condition degree, shoulder joint pain degree, shoulder joint inward turning degree, shoulder joint outward turning degree, backhand touching back degree, sick hand touching ear degree, tongue texture, coated tongue, pulse manifestation between two groups (P>0.05), indicating that the baseline information between two groups is comparable.Efficacy comparison:the efficacy of TCM syndrome comparison showed significant difference (z=2.10, P=0.03), and the trial group is better than the control group. Clinical curative rate was 62.5%, excellent rate was 15.0%, effective rate was 30.0%, and total effective rate was 95.0% in the trial group; Clinical curative rate was 45%, excellent rate was 25%, effective rate was 37.5%, and total effective rate was 90.0% in the control group.Compared with change of shoulder joint inward turning, change of shoulder joint outward turning, change of sick hand touching ear, there was no significance of difference (P>0.05). Compared with improvement of shoulder pain, change of backhand touching back, there was significance of difference (P<0.05)After treatment, comparison of disappearance rate of main clinical symptoms and signs, difference of pain, backhand touching back difficulty, sick hand touching ear difficulty was significant (P<0.05), while difference of inward turning and outward turning was not significant (P>0.05)Before treatment, comparison of TCM symptoms accumulated points showed no statistical significant difference (P>0.05),indicating two groups were comparable, intra-group comparison of improvement of TCM symptoms accumulated points of pre-treatment and post-treatment, showed statistical significant difference (P<0.05). after treatment, comparison of TCM symptoms accumulated points between two groups, had no statistical significant difference (P> 0.05). Comparison of improvement of TCM symptoms accumulated points of pre-treatment and post-treatment, between two groups, showed statistical significant difference (P<0.05)Before treatment, comparison of pain index score, showed no statistical significant difference (P>0.05), indicating two groups were comparable, intra-group comparison of improvement of pain index score of pre-treatment and post-treatment, showed statistical significant difference (P<0.05) after treatment, comparison of pain index score between two groups, had no statistical significant difference (P>0.05). Comparison of improvement of pain index score of pre-treatment and post-treatment, between two groups, showed statistical significant difference (P<0.05)Before treatment, comparison of joint activity function score, showed no statistical significant difference (P>0.05).indicating two groups were comparable, intra-group comparison of improvement of joint activity function score of pre-treatment and post-treatment, showed statistical significant difference (P<0.05). after treatment, comparison of joint activity function score between two groups, had no statistical significant difference (P>0.05). Comparison of improvement of joint activity function score of pre-treatment and post-treatment, between two groups, showed statistical significant difference (P<0.05)Safety test results showed, patients with normal result of blood routine, urine routine, stool routine, liver function, kidney function and electrocardiogram before treatment, were safe as their indices mentioned above were rechecked and showed no abnormality again.Adverse evens observation:during treatment, there was no any adverse reaction in both groups.ConclusionsBalancing acupuncture therapy for shoulder periarthritis have obvious therapeutic effect, could effectively improve patients'pain of shoulder joint, activity function of shoulder joint, improve patients'quality of life, and moreover the method is safe and reliable.
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