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(Efficacy of Hehe instrument on the pain and swelling of goneitis: a multi-center, randomized, double-blind and controlled trial) [Chinese - simplified characters]
Tong C, Geng Y, Huo G, Wang X
Zhongguo Zuzhi Gongcheng yu Linchuang Kangfu [Journal of Clinical Rehabilitative Tissue Engineering Research] 2007 Apr 1;11(13):2528-2530
clinical trial
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: Yes; Blind therapists: Yes; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

AIM: To evaluate the efficacy and safety of Hehe instrument in the treatment of goneitis through a multi-center, randomized, double-blind and controlled clinical trial. METHODS: A total of 240 goneitis patients were enrolled from Department of Physiotherapy in Xiyuan Hospital, Beijing Municipal Corps Hospital, Chinese Peoples Armed Police Forces and Naval General Hospital of Chinese PLA between 2005 and 2006, and were randomized into 2 groups by SAS program. (1) Hehe instrument group: the type of products was HH-1 produced by Beijing Taiji Hehe Scientific Development Co Ltd. Cases were treated for 40 minutes one time daily. The period of treatment was 20 days. (2) Control group: the instrument had the same appearance as Hehe instrument. But the inner construction was different. The treatment method and time were same as experimental group. The patients were scored for knee joint function before and after treatment (totally 100 scores included 30 for walking ability, 25 for pain, upstairs and downstairs ability, 10 for swelling degree, 35 for flexibility degree). The lower scores indicated more serious symptom. RESULTS: There were 238 patients involved in the result analysis. (1) Scores of knee joint function were higher in experimental group post-treatment than experimental group before treatment (79.49 +/- 12.76, 50.94 +/- 15.95, t = 21.33, p < 0.0001) and control group post-treatment (67.34 +/- 15.61, t = 10.32, p < 0.0001). (2) Scores of symptoms including walking ability, upstairs and downstairs ability, swelling degree and flexibility degree were higher in experimental group post-treatment than experimental group before treatment and control group post-treatment (p < 0.05, 0.01). (3) No adverse effect or side effect occurred. CONCLUSION: Hehe instrument had good curative effect on goneitis by improving walking ability, upstairs and downstairs ability, swelling, flexibility and tetanization. Due to the non-therapy, non-trauma and non-pain, it presents safety and stablity.

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