• Title/Summary/Keyword: Pilot trial

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Comparison of Sensorimotor Training using Chin-Tuck Exercise with Therapeutic Stretching Training on Neck Pain and Mobility in Individuals with Chronic Non-Specific Neck Pain: A pilot randomized controlled trial

  • Kim, Chang-Yong;Kim, Hyeong-Dong
    • Journal of the Korean Society of Physical Medicine
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    • v.14 no.2
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    • pp.29-40
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    • 2019
  • PURPOSE: Despite the widespread occurrence in the general population, few studies have directly evaluated the effects of shingles on non-specific neck pain (NSNP). This study investigated whether sensory training or therapeutic stretching exercises are more effective in increasing neck mobility and reducing neck pain in chronic NSNP patients. METHODS: Eighty-one subjects aged between 20 and 32 years with chronic neck pain (> six months), were allocated randomly to three groups: sensorimotor training group (STG), therapeutic stretching group (TSG), and home exercise group (HEG). All participants received a half-hour training session, three times weekly for six weeks. The outcomes were evaluated using the neck disability index for measuring neck pain, and a universal goniometer to measure the cervical passive range of motion before and after the six-week intervention. RESULTS: The post-test neck disability index scores in the STG (t = 4.86) and TSG (t = 3.24) were decreased significantly (p < .05). The passive range of motion changes in all cervical movements in the STG was increased significantly (p < .05) after intervention compared to those in the other two groups. CONCLUSION: Sensorimotor training using chin tuck exercises may improve neck pain and mobility in subjects with chronic NSNP.

Effectiveness of graded motor imagery in subjects with frozen shoulder: a pilot randomized controlled trial

  • Gurudut, Peeyoosha;Godse, Apurva Nitin
    • The Korean Journal of Pain
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    • v.35 no.2
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    • pp.152-159
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    • 2022
  • Background: Subjects with frozen shoulder (FS) might not be comfortable with vigorous physical therapy. Clinical trials assessing the effect of graded motor imagery (GMI) in FS are lacking. The aim of this study was to determine the effect of GMI as an adjunct to conventional physiotherapy in individuals with painful FS. Methods: Twenty subjects aged 40-65 years having stage I and II of FS were randomly divided into two study groups. The conventional physiotherapy group (n = 10) received electrotherapy and exercises while the GMI group (n = 10) received GMI along with the conventional physiotherapy thrice a week for 3 weeks. Pre- (Session 1) and post- (Session 9) intervention analysis for flexion, abduction, and external rotation range of motion (ROM) using a universal goniometer, fear of movement using the fear avoidance belief questionnaire (FABQ), pain with the visual analogue scale, and functional disability using the shoulder pain and disability index (SPADI) was done by a blinded assessor. Results: Statistically significant difference was seen within both the groups for all the outcomes. In terms of increasing abduction ROM as well as reducing fear of movement, pain, and functional disability, the GMI group was significantly better than control group. However, both groups were equally effective for improving flexion and external rotation ROM. Conclusions: Addition of GMI to the conventional physiotherapy proved to be superior to conventional physiotherapy alone in terms of reducing pain, kinesiophobia, and improving shoulder function for stage I and II of FS.

Comparison of Effects of Static Core Training and Additional Dynamic Core Training in Young Adults: An Experimental Study

  • Namjeong Cho;Hyunjoong Kim
    • Physical Therapy Rehabilitation Science
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    • v.12 no.1
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    • pp.56-61
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    • 2023
  • Objective: Core training is a key exercise for conditioning and fitness programs, injury prevention, and more. This study aimed to find out the effect of adding dynamic core training, which is frequently prescribed in clinical practice, on dynamic balance and muscle activity compared to conventional static core training. Design: An experimental study Methods: This study is an experimental pilot study of prospective parallel design. Six healthy young adults were allocated to static core training group (SCG; crunch and plank) and blended group (BG; crunch, plank, and dead bug exercise) for two weeks to perform core training. Dynamic balance and muscle activity (erector spinae, rectus abdominis) were measured for all participants before and after core training. Results: All six healthy young adults enrolled completed the study. No significant difference was found before and after 6 sessions of core training in each group (P>0.05). Likewise, no significant difference was found in the results of the difference comparison between groups (P>0.05). Conclusions: In conclusion, in this experimental study, no difference was found when dynamic core training was added. Although the results before and after core training did not show improvement in dynamic balance and muscle activity, a randomized controlled trial is needed considering the results of previous studies and the limitations of this experimental study.

The Effect of Sweet Bee Venom Pharmacopuncture(SBVP) on Cancer-Related Pain : A Randomized Controlled Trial and Double Blinded - Pilot study (암성통증에 대한 SBVP 효과 - 무작위대조시험, 이중맹검)

  • Yoo, Hwa-Seung;Kim, Jung-Sun
    • Journal of Pharmacopuncture
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    • v.11 no.1
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    • pp.21-29
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    • 2008
  • Objectives : To investigate the therapeutic effects of SBVP in the treatment of patients with cancer-related pain. Design : A prospective randomized, double-blind, placebo-controlled study of SBVP. Setting : The study was conducted at the East West Cancer Center of Daejeon University Dunsan Oriental Hospital from March 1, 2007 to June 20, 2007. Patients : 11 patients diagnosed with cancer-related pain of over 3rd degree on the Numeric Rating Scale(NRS)(0, no pain at all, 10, worst pain imaginable) were entered into a double-blind, placebo-controlled trial of SBVP. They were randomized into Groups A and B(SBVP and control group, respectively) using the table of random sampling numbers and never informed of their affiliation by the coordinator. 5 of 6 patients in Group A and 4 of 5 patients in Group B completed the clinical trial. Intervention : SBVP(1ml/day) for group A and Normal Saline Placebo(1ml/day) for group B was injected into the abdomen acupoint, Zhong Wan(CV 12). The treatment was administered daily for five days. Outcome Measures : Degree of cancer-related pain was measured using the Numeric Rating Scale(NRS) before and after each treatment for "Pain right now" and "Average pain in last 24 hours". Statistical Analysis : Analysis regarding variations in NRS was carried out by applying t-tests(independent sample t-test and paired sample t-test) and Wilcoxon signed rank test with level of significance at 5%. Results : Differences in NRS of "Pain right now" for the two groups were statistically significant. The mean improvement point of SBVP was significantly higher than the control group($2.48^{\circ}{\pm}1.52$ vs $0.97^{\circ}{\pm}1.88$, p<0.05). Differences in average pain score before and after treatment in SBVP group were also significant($5.13^{\circ}{\pm}1.77$ vs $2.65^{\circ}{\pm}0.67$, p<0.05) compared with control group. The two groups showed no significant differences for long term effects in "Average pain in last 24 hours." Conclusion : Although further study will be needed on the large scale, SBVP shows potential as an effective treatment for immediate relief of cancer-related pain.

Acupuncture for Prehypertension and Stage 1 Hypertension in Postmenopausal Women: Protocol for a Randomized Controlled Pilot Trial (폐경 후 여성의 전단계 및 1기 고혈압에 대한 침 치료: 다기관 무작위 대조 예비연구)

  • Kim, Jung-Eun;Choi, Jin-Bong;Kim, Hyeong-Jun;Kang, Kyung-Won;Liu, Yan;Jung, Hee-Jung;Lee, Min-Hee;Shin, Mi-Suk;Kim, Jae-Hong;Choi, Sun-Mi
    • Korean Journal of Acupuncture
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    • v.31 no.1
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    • pp.5-13
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    • 2014
  • Objectives : This study aims to evaluate the effectiveness and safety of acupuncture and explore the appropriate number of treatment for postmenopausal women diagnosed with prehypertension and stage 1 hypertension. Methods : A 4-arm randomized open label pilot trial will be performed at 2 centers. Sixty participants will be divided into 2 treatment groups and 2 control groups. Treatment groups will receive acupuncture at 8 points(bilateral GB20, LI11, ST36, SP6) for 4 weeks(treatment group A, 10 total sessions) or 8 weeks(treatment group B, 20 total sessions), while maintaining usual care. Control groups will not receive acupuncture but will be under usual care for 16 weeks(control group C) or 20 weeks(control group D). Each patient's living habits will be corrected and drugs that may affect blood pressure(BP) will be prohibited. Treatment group A and control group C will be evaluated at 4, 8, 12, and 16 weeks after randomization, while treatment group B and control group D will be evaluated at 4, 8, 12, 16, and 20 weeks after randomization. The major outcome variable is the magnitude of change in diastolic BP levels at 4 weeks after randomization; auxiliary outcome variables are (1) diastolic BP change at 8, 16, and 20 weeks, (2) systolic BP change, (3) BP control rate, (4) lipid profiles, and (5) high-sensitivity C-reactive protein. Patient safety will be assessed at every visit. Results and Conclusions : The study findings may help develop evidence for the effectiveness and safety of acupuncture for BP control.

Effects of Electroacupuncture on Parameters Related to Obesity in Adults with Abdominal Obesity:Three arm Randomized Single Blind Pilot Study (전침이 복부비만 성인의 비만관련 지표에 미치는 영향-무작위배정 단일 맹검 예비연구-)

  • Chung, Jie-Youn;Kim, Jong-In;Lee, Sang-Hoon;Kang, Sung-Keel
    • 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.

Korea Academy of Prosthodontics criteria for longevity studies of dental prostheses (보철물 수명 연구를 위한 대한치과보철학회 표준 방안: KAP Criteria)

  • Yoon, Joon-Ho;Park, Young-Bum;Youn, Seung-Hwan;Oh, Nam-Sik
    • The Journal of Korean Academy of Prosthodontics
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    • v.54 no.4
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    • pp.341-353
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    • 2016
  • Purpose: The most important factor in longevity studies of dental prostheses is objective and consistent evaluation of the prosthesis. The Korean Academy of Prosthodontics suggested developing a standardized method for longevity studies of dental prostheses. The purpose of this study is to evaluate previously-used criteria and to develop new criteria, in the form of a procedure flowchart and an evaluation sheet. These new criteria may be able to provide a unified standard for future longevity studies of dental prostheses. Materials and methods: A literature review was performed about the evaluation of dental prostheses. Taking into account the strengths and weaknesses of previously used criteria, a novel, intuitive and objective method was developed for assessment of dental prostheses. Then, a pilot survey was performed with the newly developed flowchart and evaluation sheet to determine problems and implement possible improvements. Results: Thirty cases of fixed dental prosthesis (FDP), 25 cases of removable dental prosthesis (RDP), and 13 cases of implant supported prosthesis (ISP) were evaluated. The average life expectancy estimate was 12.82 years for FDP, 5.96 years for RDP, and 4.82 years for ISP with Kaplan-Meier survival analysis. Additionally, possible improvements discovered by the pilot survey were reflected in the flowchart and evaluation sheet. Conclusion: The newly developed KAP criteria, flowchart and evaluation sheet enabled objective and consistent results in trial longevity studies of dental prostheses. It is expected that future studies will not only use the KAP criteria but also further improvement will be made on them.

Effect of Auricular Acupress Therapy on Insomnia of Cancer Patients : Randomized, Single Blinded, Placebo Controlled Trial (이압요법이 암환자의 불면증에 미치는 효능 : 무작위배정, 단일맹검, 위약대조군 연구)

  • Jung, In-Sook;Kim, Jung-Sun;Yoo, Hwa-Seung
    • Journal of Pharmacopuncture
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    • v.13 no.2
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    • pp.93-100
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    • 2010
  • Background: Auricular acupressure is one of the traditional health care treatments in oriental medicine. Approximately, 30~40% of the cancer patients have said to be suffering from insomnia and half of them having chronic and severe insomnia at the same time. Insomnia caused cancer patients feel more pain, fatigue, depression and anxiety and it sometimes let the power to have the best of cancer pull down. Objective: To investigate how effective the auricular acupressure treatment to cancer patients suffering from insomnia. Methods: We recruited participants from East-West Cancer Center of Daejeon University. Finally, of the people whose age range from 20 to 75, 12 patients who got less than 40 points from the score of Oh's sleeping score (OSS) were recruited. Single-blind, randomized pilot study was performed. The treatment group received auricular acupressure treatment (AAT) on active points and the control group had received sham acupressure treatment (SAT) for five times. Sleep parameters were checked by using OSS and numeric rating scale (NRS). We checked the scale everytime, both before and after treatment. We analyzed the data statistically by using independent T-test, paired T-test and analysis of variance (ANOVA) test. (p<0.05) Results: Twelve cancer patients participated in this pilot study and there was no significant difference between control and treatment group. Only 7 of them had completed the whole treatment process, 4 patients of AAT group and 3 participants of SAT. The OSS of AAT group had increased from $34.0{\pm}4.3$ to $39.5{\pm}3.1$ and that of SAT group had increased from $38.3{\pm}3.5$ to $40.0{\pm}0.0$. There was no significant difference between them. The NRS of AAT group had increased from $6.3{\pm}2.9$, $04.8{\pm}2.1$ and that of SAT group had increased from $7.0{\pm}1.0$ to $5.0{\pm}2.6$. No significant difference was observed between them. Conclusion: Although both groups did not show significant differences, most of the experimental participants showed increasing OSS and NRS after treatments. Significant participants' number will be needed in the next study.

Effect of Pulsed Electromagnetic Field Treatment on Alleviation of Lumbar Myalgia; A Single Center, Randomized, Double-blind, Sham-controlled Pilot Trial Study

  • Park, Won-Hyung;Sun, Seung-Ho;Lee, Sun-Gu;Kang, Byoung-Kab;Lee, Jong-Soo;Hwang, Do-Guwn;Cha, Yun-Yeop
    • 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.

A Pilot Study of Brief Eye Movement Desensitization and Reprocessing(EMDR) for Treatment of Acute Phase Schizophrenia (급성기 정신분열병의 치료로서 단기적인 안구운동 민감소실 및 재처리요법에 대한 예비연구)

  • Kim, Daeho;Choi, Joonho;Kim, Seok Hyeon;Oh, Dong Hoon;Park, Seon-Cheol;Lee, Sun Hye
    • Korean Journal of Biological Psychiatry
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    • v.17 no.2
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    • pp.94-102
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    • 2010
  • Objectives : Eye movement desensitization and reprocessing(EMDR) is a novel, time-limited psychotherapy originally developed for treatment of psychological trauma. The effectiveness of this therapy has been validated only for posttraumatic stress disorder ; however, EMDR is often applied to other psychiatric illnesses, including other anxiety disorders and depression. This pilot study tested the efficacy of EMDR added to the routine treatment for individuals with acute stage schizophrenia. Methods : This study was conducted in the acute psychiatric care unit of a university-affiliated training hospital. Inpatients diagnosed with schizophrenia were randomly assigned to either three sessions of EMDR, three sessions of progressive muscle relaxation(PMR) therapy, or only treatment as usual(TAU). All the participants received concurrent typical treatments(TAU), including psychotropic medication, individual supportive psychotherapy and group activities in the psychiatric ward. The Positive and Negative Syndrome Scale(PANSS), the Hamilton Depression Rating Scale and the Hamilton Anxiety Rating Scale were administered by a clinical psychologist who was blinded to the patients' group assignment. Results : Forty-five patients enrolled and forty patients(89%) completed the post-treatment evaluation. There were no between-group differences in the withdrawal rates of patients during the treatment or at the three-month follow-up session. All three groups improved significantly across each of the symptomatic domains including schizophrenia, anxiety, and depressive symptoms. However, a repeated measures ANOVA revealed no significant differences among the groups over time. Effect size for change in total PANSS scores was also similar across treatment conditions, but effect size for negative symptoms was large for EMDR(0.60 for EMDR, 0.39 for PMR and 0.21 for TAU only). Conclusion : These findings supported the use of EMDR in treating the acute stage of schizophrenia but the results failed to confirm the effectiveness of the treatment over the two control conditions in three sessions. Further studies with longer courses of treatment, more focused target dimensions of treatment, and a sample of outpatients are necessary.