Objective : Acupuncture has been widely used throughout the world for the treatment of knee osteoarthritis (knee OA). This study investigated whether acupuncture, particularly Sa-am acupuncture, could be effective in relieving pain and improving the symptoms of knee OA. Method : This study was condu...
Objective : Acupuncture has been widely used throughout the world for the treatment of knee osteoarthritis (knee OA). This study investigated whether acupuncture, particularly Sa-am acupuncture, could be effective in relieving pain and improving the symptoms of knee OA. Method : This study was conducted as a prospective, randomized, controlled, and patient- and investigator-blinded clinical trial. Forty volunteers with knee OA participated in the study. All participants were screened through an inclusion and exclusion criteria. Thirty four participants completed the clinical trial. In total, forty subjects were randomly selected to receive Sa-am acupuncture. Eight sessions of acupuncture were given at the contralateral side of the problematic knee for 4 weeks. Korean translation of Western Ontario and McMaster Universities Osteoarthritis Index (KWOMAC) scores were measured twice: at the beginning and end of the clinical trial period. Both the Patient Global Assessment and physical health scores based on the 36-Item Short-Form Health Survey were also used to measure the results. Results : Compared to the pre-trial scores, the Sa-am acupuncture group (n=34) showed a significant decrease in KWOMAC total scores according to a paired t-test. The Sa-am acupuncture group also showed significant improvement in the Patient Global Assessment when compared to the pre-trial. Conclusions : Sa-am acupuncture for knee OA resulted in an improved KWOMAC total score. This was mostly driven by the function component score that was greatly affected by acupuncture. However, further studies with expanded designs are needed to solidify this finding with scientific rigor.
Objective : Acupuncture has been widely used throughout the world for the treatment of knee osteoarthritis (knee OA). This study investigated whether acupuncture, particularly Sa-am acupuncture, could be effective in relieving pain and improving the symptoms of knee OA. Method : This study was conducted as a prospective, randomized, controlled, and patient- and investigator-blinded clinical trial. Forty volunteers with knee OA participated in the study. All participants were screened through an inclusion and exclusion criteria. Thirty four participants completed the clinical trial. In total, forty subjects were randomly selected to receive Sa-am acupuncture. Eight sessions of acupuncture were given at the contralateral side of the problematic knee for 4 weeks. Korean translation of Western Ontario and McMaster Universities Osteoarthritis Index (KWOMAC) scores were measured twice: at the beginning and end of the clinical trial period. Both the Patient Global Assessment and physical health scores based on the 36-Item Short-Form Health Survey were also used to measure the results. Results : Compared to the pre-trial scores, the Sa-am acupuncture group (n=34) showed a significant decrease in KWOMAC total scores according to a paired t-test. The Sa-am acupuncture group also showed significant improvement in the Patient Global Assessment when compared to the pre-trial. Conclusions : Sa-am acupuncture for knee OA resulted in an improved KWOMAC total score. This was mostly driven by the function component score that was greatly affected by acupuncture. However, further studies with expanded designs are needed to solidify this finding with scientific rigor.
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문제 정의
It is important to note how the sham control group was treated to evaluate the effect of clinical acupuncture in this study. The control group of OA subjects received either sham acupuncture or minimal acupuncture or physical therapy or waiting list or education in the previous studies12,17,20,21,24,25), and Park sham acupuncture was used for the sham control group in this study15).
제안 방법
A Patient Global Assessment was made out by the subjects themselves at the end of the four weeks’trial in order to evaluate the condition of OA in their knee.
This statistical value was calculated by applying an intention‐totreat analysis. An independent t-test and a Mann‐Whiney U-test were performed for both groups to confirm the possibility of success of randomized allocation and to compare the characteristics of the participants. Both an independent t-test and ANCOVA analysis were applied for the KWOMAC score, whereas only independent t-test for the SF-36 score.
For each treatment, Sa-am acupuncture uses a set of four acupoints (two acupoints for tonifying and two acupoints for purging) selected from “Five Phases” (Table 3).
In the Sa-am acupuncture group, Sa-am acupuncture was performed at the selected acupoints as shown in Table 1. Patients were acupunctured two times per week over a four-week period. The depth of Sa-am acupuncture was about 1 mm - 5 mm, and the duration of the acupuncture was about 20 minutes.
Two operators licensed in oriental medicine, having over seven years’ experience in clinical treatment, performed the acupuncture. The subjects of both groups were assigned to two operators, and each established operator throughout the trial administered both Sa am and sham acupunctures.
The subjects were divided into Sa-am acupuncture and sham acupuncture groups using a random table generated by SPSS 12.0. Two operators licensed in oriental medicine, having over seven years’ experience in clinical treatment, performed the acupuncture.
Sa-am acupuncture, which is needled at acupoints remote from sick regions following the meridian theory, has been widely adopted in Korean traditional clinical medicine. This study was designed to assess the pain relief effect of Sa-am acupuncture on OA of the knee on the basis of the KWOMAC score, SF 36, and Patient Global Assessment. The Sa-am acupuncture group showed more significant pain relief effect on OA than the sham group through the KWOMAC total score in independent t‐test, but not in ANCOVA analysis.
(The participant flowchart is shown in Figure 1.) With their consent, this study was initiated as double blinding for both all subjects and analyzer as a randomized controlled trial. Seventy‐eight subjects were divided into each group using a random table, the Sa-am acupuncture group with 40 participants and the sham group with 38.
대상 데이터
Disposable stainless steel needles were used for the Sa-am acupuncture group (DongBang Acupuncture, Korea, 0.25 × 40 mm).
Seventy-eight subjects were divided into each group using a random table, the Sa-am acupuncture group with 40 participants and the sham group with 38. During the trial, the number of dropouts was 6 in the Sa-am group and 7 in the sham group.
Seventy-eight subjects were divided into each group using a random table, the Sa-am acupuncture group with 40 participants and the sham group with 38. During the trial, the number of dropouts was 6 in the Sa-am group and 7 in the sham group.
데이터처리
1. 4‐weeks’ Sa-am acupuncture has no effect on OA through KWOMAC index scores by ANCOVA analysis.
In addition, there was no interaction among the variables, which included time, age, and the oriental medical doctor (Table 7). This result shows that Sa-am acupuncture can have a significant effect on OA of the knee in spite of the change of variables just as estimated in independent t-test. However, as these results are based on KWOMAC scores, no significance of KWOMAC scores by ANCOVA analysis may have an influence on these results.
We analyzed repeatedly measured KWOMAC total scores using a mixed-model procedure of SAS. Although pre-trial measurements of the KWOMAC total scores were changed, we analyzed whether Sa-am acupuncture on OA of the knee was effective by using them as a variable.
이론/모형
. As a measurement of secondary outcomes, the 36-Items Short‐Form Health Survey (SF-36) was used, estimating the quality of life at pre‐trial and post‐trial. In addition, the Patient Global Assessment was used to assess the improvement of the symptoms after four weeks of treatment.
To estimate the pain relief effects of Sa-am acupuncture on OA of the knee, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) translated into Korean (Korean WOMAC, KWOMAC) was used as a measurement of primary outcomes following four weeks of treatment16). As a measurement of secondary outcomes, the 36-Items Short‐Form Health Survey (SF-36) was used, estimating the quality of life at pre‐trial and post‐trial.
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