• Korean Journal of Oriental Medicine
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• v.13 no.1 s.19
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• pp.93-100
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• 2007

TObjectives: Develop a sham moxibustion and determine whether subjects can distinguish a sham moxibustion from a real moxibustion. Design: Single-blinded, randomized, placebo-controlled clinical trial Methods: Sham and real moxibustion resemble each other in appearance, burning procedure, but the base of the sham moxibustion isolates the moxa-producing heat and smoke. This device was tested in a clinical trial in which subjects received moxibustion at Zhongwan(CV12), Mingmen(GV4), Quchi(LI11), Zusanli(ST36), Taichong(LR3)), Hegu(LI4). Volunteers(n=32) were given pre-treatment questionnaire to assess their experience in getting moxibustion therapy and performing it. They randomized into treatment(n=16) or sham controlled group(n=16), received moxibustion according their groups. After treatments, the effectiveness of blinding was assessed. Results: There were no significant differences between two groups in sex, age, moxibustion experience. In the treatment group and the sham group, the number of subjects who believed they received real moxibustion or sham is not different significantly.(P=.668) The consistency of a moxibustion type which subjects received actually and the their guess about that, isn't different significantly in two groups.(P=.465) Conclusion: The sham moxibustion was successfully validated in this study, The results demonstrate that this sham moxibustion blinds subjects and can be used as effective placebo-control in moxibustion clinical trials.

• Journal of Acupuncture Research
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• v.27 no.1
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• pp.117-127
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• 2010

Background : To demonstrate the efficacy of moxibustion therapy, randomized controled trials are required. But, clinical trials of moxibustion had limitations due to the absence of a sham moxibustion model for an appropriate placebo. Objectives : To develop a new sham moxibustion model based on the thermal characteristics of commercial indirect moxibustion, especially temperature, and to evaluate whether it could be applied in clinical trials. Methods : By applying heat insulation, we created a sham moxibustion device that was indistinguishable from a real one with the naked eye. It also stimulated heat but had inert remedial value. A clinical trial was performed on subjects to test double blinding. The subjects were randomly assigned into two groups, a treatment group and a sham group. Acupoint Zusanli($ST_{36}$) was used in each group for 3 times. A sham acupuncture credibility questionnaire was modified into a moxibustion credibility questionnaire and was filled out after treatment. Results : No major difference was detected in the subjects' baseline data. Most subjects and practitioners could not distinguish the sham moxibustion device from the real one. But, subjects who had experience of moxibustion therapy more likely to distinguish the sham moxibustion device from the real one than subjects who didn't have experience of moxibustion therapy. The treatment group showed a significant difference in the VAS(Visual Analog Scale) for intensity of sensation during treatment than that of the sham group. Conclusions : The sham moxibustion device in this study is proved sufficient and credible to be applied in investigations of the effect of moxibustion. But it is more appropriate for the people who don't have experience of moxibustion therapy.

• Medical Lasers
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• v.9 no.2
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• pp.150-158
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• 2020

Background and Objectives Low-level laser therapy (LLLT) is used widely to promote hair growth in androgenetic alopecia (AGA). This study examined the clinical efficacy and safety of a home-use LLLT device with a newly designed array of light sources and software optimized for individual types of AGA. Materials and Methods The study was a randomized, double-blind, sham device-controlled trial. Forty-eight subjects (39 men and nine women) were assigned randomly in a 2:1 ratio to use either the test device (LG Pra'L HGN1, LG electronics, Korea) or sham device. The subjects used the LLLT device three times a week for 16 weeks. Phototrichogram was used to measure the hair density and hair thickness at 0, 8, and 16-weeks. Adverse events were closely monitored. Results After 16 weeks of using the device, the test group showed a significant increase in hair density and hair thickness compared to the control. In the test group, the hair density increased 6.96 counts/cm² at eight weeks and 13.67 counts/cm² at 16 weeks from the baseline. The hair thickness increased 7.21 ㎛ at eight weeks and 11.80 ㎛ at 16 weeks compared to the baseline. Conclusion The home-use LLLT device with a novel array of light sources and an individualized program according to the types of hair loss appears to be an effective and safe treatment modality for both male and female AGA patients.

• Journal of Magnetics
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• v.19 no.2
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• pp.161-169
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• 2014

The aim of this study is to investigate the efficacy of pulsed electromagnetic field (PEMF) on the alleviation of lumbar myalgia. This is a randomized, real-sham, double blind pilot study. 38 patients were divided into the PEMF group and the Sham group, each of which was composed of 19 patients (1 patient dropped out in the Sham group) of randomized allocation. The PEMF group was treated by using the PEMF device and the Sham group by using a sham device on the lumbar muscle and acupuncture points, three times a week for a total of two weeks. Evaluations of Visual Analogue Scale for bothersomeness (VASB), Visual Analogue Scale for pain intensity (VASP), Oswestry Disability Index (ODI), 36-Item Short Form Health Survey Instrument (SF-36), EuroQol-5Dimension (EQ-5D), Beck's Depression Inventory (BDI) and Roland-Morris Disability Questionnaire (RMDQ), etc. before and 1 week after treatment were carried out. The primary outcome measure was the VASB, measured 1 week after the end of the pulsed electromagnetic therapy. VASB scores for the PEMF group changed by $-2.06{\pm}2.12$ from the baseline, and that for the Sham group changed by $-0.52{\pm}0.82$ (p < 0.05). VASP scores for the PEMF group were reduced by $-2.10{\pm}2.12$ from the base line, and that for the Sham group was reduced by $-0.53{\pm}1.50$ (p < 0.05). PEMF group showed significant improvements in all VASB, VASP, ODI, SF-36, EQ-5D, BDI and RMDQ scores, while the Sham group showed significant improvements in all scores, except the VASP score. However, the VASB, VASP and RMDQ scores of the PEMF group were much lower than those of the Sham group. The two groups showed no significant difference in ODI, SF-36, EQ-5D and BDI. This study demonstrates the effectiveness of PEMF treatment for alleviating lumbar myalgia.

• Journal of Acupuncture Research
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• v.28 no.6
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• pp.1-17
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• 2011

Objectives : This study aimed to review randomized controlled trials of acupuncture performed in South Korea that used sham acupuncture as a control group. Methods : The following databases were searched through the end of September 2011: Koreanstudies information service system (KISS), Korean medical database (KMbase), national discovery OR science leaders (NDSL), oriental medicine advance searching integrated system (OASIS), and research information service system (RISS). The following search terms were used: acupuncture AND (sham or placebo). The reference lists of searched articles and Korea institute of oriental medicine (KIOM) reports(2005~2009) were identified. The following data were extracted: year/first author, disease, number of participants, blinding, intervention, outcome, and result. Where appropriate, we performed meta-analysis. The methodological quality was assessed according to the Jadad scale and 'risk of bias' by Cochrane Handbook procedure. Results : Twenty-nine studies were included in this review. In eighteen studies, penetrating sham controls were used as the control intervention, whereas the remaining eleven studies adopted non-penetrating sham controls such as the Park Sham Device or blunt auricular acupuncture. Nine studies showed statistically significant difference in outcomes. Twelve studies concerning insomnia after stroke, chronic tension-type headache, idiopathic Parkinson's disease, Hwa-Byung, and smoking cessation were included in meta-analysis. A meta-analysis of insomnia after stroke only found significant difference(MD -4.31, 95% Cl -6.19 to -2.42, $p$<0.00001). In general, all of the studies showed low methodological quality(Jadad score: mean 2.1). Risk of bias by Cochrane Handbook procedure varied. Conclusions : The results of this study could not suggest conclusive evidence that acupuncture is more effective than sham acupuncture in several diseases. In the future, more studies with rigorous acupuncture trials using sham controls should be conducted.

• Journal of Biomedical Engineering Research
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• v.38 no.1
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• pp.49-55
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• 2017

The prevalence of obesity has noticeably increased worldwide over several decades with various complication. Even though anti-obesity drug treatments have been spotlighted by resulting in effective mean weight losses, its adverse effects cannot be overlooked. Thus, this study aimed to evaluate the effects of multi-frequency whole body vibration, one of the mechanical stimulus, as a countermeasure against obesity. Thirty-two-6-week-old C57BL/6J male mice were equally assigned to four groups: the Control group (CON, n = 8), the Sham group (Sham, n = 8), the sham with single frequency whole body vibration (S+V, n = 8), and the sham with multi frequency whole body vibration (S+MV, n = 8). After 4 weeks, morphologic changes in the adipose tissue were evaluated from three-dimensional images using in vivo micro-computed tomography. At 4 weeks, the volume of the abdominal adipose tissue, which had the highest value in Sham group, noticeably reduced in S+MV group compared to it in S+V group. These results implied that the accumulation of abdominal adipose tissue can be effectively reduced through applying multi-frequency whole body vibration.

• Journal of The Korean Society of Integrative Medicine
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• v.4 no.4
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• pp.41-51
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• 2016

PURPOSE : The purpose of this study was to identify whether 3D motion input device based mirror therapy could improve on upper extremity function, quality of life and depression in chronic stroke patients METHOD : Thirty six patients with chronic stroke were enrolled and randomly divided into three groups: 3D leapmotion mirror therapy group, mirror therapy group, and sham therapy group. 3D leapmotion mirror therapy group performed 3D motion input device based mirror therapy, mirror therapy group performed general mirror therapy, control group performed sham therapy. All patients received a total of 15 exercise session over a 5 week period (three times per week). Fugl-Meyer Assessment-upper extremity(FMA-UE), Stroke Specific-Quality of Life(SS-QOL), Beck Depression Inventory(BDI) were performed prior to and five weeks after the treatment RESULT : Subjects in the 3D leapmotion mirror therapy group showed significant improvements in upper extremity function, quality of life and depression following training. The changes of upper extremity function, quality of life and depression in the 3D leapmotion mirror therapy group were significantly more than them of the control group. CONCLUSION : The result of this study suggest that 3D motion input device based mirror therapy is an intervention to improve on upper extremity function, quality of life and depression in chronic stroke patients.

• The Journal of Korean Physical Therapy
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• v.32 no.4
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• pp.193-197
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• 2020

Purpose: The purpose of this study was to investigate the immediate effects of calf muscle Kinesio taping on ankle joint reposition sense (JRS) and force sense (FS) in healthy elderly. Methods: Thirteen healthy elderly subjects were participated in this study. The error of ankle JRS and FS was evaluated by 3D motion capture device and digital dynamometer depending on three different taping conditions (Kinesio taping, sham taping, and no taping) respectively. All of subjects were asked to perform a proprioceptive task of ankle JRS and FS. One-way repeated ANOVA test was used to compare the error of JRS and FS depending on three different taping conditions. Results: With Kinesio taping over calf muscle, ankle joint reposition sense error and force sense error significantly decreased, if compared with a sham taping or no taping condition. Conclusion: To apply Kinesio taping over calf muscle could enhance ankle proprioceptive sense in the elderly people.

• Journal of Acupuncture Research
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• v.27 no.6
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• pp.43-57
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• 2010

Objectives : To investigate the effects of electroacupuncture on parameters related to obesity in adults with abdominal obesity. Methods : A three arm randomized single blind pilot study was conducted from Jan 4 to March 25, 2010 in Kyung Hee Oriental Medical Hospital. The subjects were 39 adults with abdominal obesity and were randomly divided by computer generated random table into 3 groups; EA(electroacupuncture), sham EA(sham electroacupuncture) and waitlist groups. Acupuncture points located at abdomen($CV_{12}$, $CV_6$, $ST_{25}$, $SP_{15}$, $SP_{14}$) and extremities($LI_4$, $LI_{11}$, $ST_{36}$, $ST_{44}$) were inserted by disposable stainless steel needles and were stimulated 30 minutes with 24Hz, 0.27~1.3mA(tolerable strength), asymmetric biphasic continuous pulse wave form by STN-111 Stratek device in EA group. Two treatment sessions per week for 5 weeks(10 sessions in total) were done in EA and sham EA groups. The primary outcome measurement was WC(waist circumference), and the secondary outcome measurements included WHR(waist hip ratio), ASF(thickness of abdominal subcutaneous fat), and inbody measurements of BW(body weight), BMI(body mass index), BFR(body fat ratio) and VFA(visceral fat area), and also scores of BULIT-R(bulimia test revised), KoQoL(Korean obesity of QoL) and BSQ(body shape questionnaire). Results : All of 39 subjects were included in ITT(intention-to-treat) analysis. There were significant reductions in WC, WHR and ASF after 5-week electroacupuncture treatments and the percentage reductions were significantly greater than sham EA or waitlist group. There were no significant differences between groups in percentage reductions of other parameters(BW, BMI, BFR, VFA, BULIT-R, KoQoL and BSQ). But, there were continuous reductions in BW, BMI, BFR and VFA at 3 weeks after the end of treatment and there was significant reduction in BW compared with the baseline value in EA group. No seriously adverse effects were reported during the period. Conclusions : Electroacupuncture was more effective than sham electroacupuncture or no intervention on the reduction of WC, WHR and ASF in adults with abdominal obesity.

• Journal of Acupuncture Research
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• v.33 no.2
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• pp.77-87
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• 2016

Objectives : This is a pilot study for a large randomized controlled trial to investigate the efficacy and safety of a newly developed contrast therapy device-- alternating topical heat and cold -- for patients with chronic low back pain. The main objective of this study is to confirm the feasibility of the study design. Methods : The design was a randomized, 2-arm, parallel-group, single-blind, placebo controlled trial. Patients in each group received real or sham contrast therapy in an acupuncture point 10 times over four weeks. The primary outcome measure was pain intensity on a 100-mm visual analogue scale (VAS). The secondary outcomes were back-related dysfunction based on the Oswestry Disability Index (ODI), the Roland-Morris disability questionnaire (RMDQ), and range of motion of lumbar spine based on the modified Schober test (mSchober test), Finger-to-Floor distance (FTF distance), and Finger-to-Thigh distraction (FTT distraction). Results : A total of 30 subjects with chronic low back pain were randomly assigned to a contrast therapy group (n＝15) or a sham group (n＝15). A repeated-measures analysis of variance showed statistically significant group time interaction for VAS, RMDQ, mSchober test and FTF distance (p<0.05). The treatment group showed significant improvement in pain intensity and functional disability as compared to the sham group. Conclusion : Contrast therapy may be an effective and safe treatment for chronic low back pain.