• 제목/요약/키워드: Pilot clinical trial

검색결과 73건 처리시간 0.028초

만성 경항통(목부위 통증)의 도침요법, 진통제, 복합치료의 효능 및 안전성 연구 (Efficacy and Safety of Miniscalpel Acupuncture, Non-Steroidal Anti-Inflammatory Drugs or Combined Treatment for Chronic Neck Pain: An Assessor-Blinded Randomized Controlled Pilot Study)

  • 공한미;전승아;정연중;김주란;이정희;이현종;박정아;김재수
    • Korean Journal of Acupuncture
    • /
    • 제37권1호
    • /
    • pp.14-23
    • /
    • 2020
  • Objectives : We investigated the efficacy and safety of miniscalpel acupuncture (MA) treatment combined with non-steroidal anti-inflammatory drugs (NSAIDs) for chronic neck pain (CNP) in an assessor-blinded randomized controlled pilot trial to establish a basis for larger-scale randomized controlled studies on this subject. Methods : Participants (n=36) were recruited and randomly allocated to the MA group, NSAIDs and combined treatment group. The MA group received MA three times over three weeks. The NSAIDs group was administered orally with zaltoprofen 80mg t.i.d. over three weeks. The combined treatment group received MA and zaltoprofen in the same manner as MA and NSAIDs groups. The primary outcome was pain as assessed by a visual analogue scale (VAS) and the secondary outcomes were assessed using the Neck Disability index (NDI), EuroQol 5-dimension questionnaire (EQ-5D), and Patients' Global Impression of Change scale (PGIC). Assessments were made at week 0 (baseline), 1, 2, 3 (primary end point) during treatment and at week 7 (4 weeks after the end of treatment). Results : 35 participants completed the study. No serious adverse event occurred and blood test results were within normal limits. The improvement of VAS and NDI was significantly greater in combined and MA group than that in NSAIDs group (p<0.017). The combined group showed better outcomes in EQ-5D at visit 2 and 5, in PGIC at visit 4 than the NSAIDs group (p<0.017). No significant differences were found between combined and MA group. Conclusions : Our results suggest that both combined and MA group can be more effective in improving pain control than NSAIDs group. A large-scale clinical study is warranted to further clarify these findings.

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

  • 김대호;최준호;김석현;오동훈;박선철;이선혜
    • 생물정신의학
    • /
    • 제17권2호
    • /
    • pp.94-102
    • /
    • 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.

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

  • 유화승;김정선
    • 대한약침학회지
    • /
    • 제11권1호
    • /
    • pp.21-29
    • /
    • 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.

월경곤란증의 자하거 약침효과에 관한 연구 (Effect of Hominis placenta Pharmacopuncture on the Dysmenorrhea (A Pilot study, Single blind, Randomized, Controlled Clinical Trial))

  • 김수민;장선희;김철홍;윤현민;송춘호;안창범;장경전
    • 대한약침학회지
    • /
    • 제11권3호
    • /
    • pp.123-131
    • /
    • 2008
  • Objective: This study was designed to evaluate the effect of Hominis placenta Pharmacopuncture treatment on Dysmenorrhea of Women. Methods: 49 subjects who were suffering from dysmenorrhea volunteered to answer the MMP(Measure of Menstrual Pain) and MSSL(Menstrual Symptom Severity List) questionnaire. They were divided into two groups, a Hominis placenta Pharmacopuncture treatment group(Experiment al group, n=25) and a Normal Saline(N/S) treatment group(Control group, n=24). The two groups were injected on the $CV_4,\;S_{36},\;Sp_9$ and $Sp_6$ acupuncture point. They were treated totally five times depending on the individual menstruation cycles. The scores of MMP and MSSL were measured overall three times before and after the menstruation cycle. The collected data were analyzed as paired t-test, independent t-test using SPSS 12.0 WIN Program. Results: As a result of the evaluation by MMP and MSSL, a significant improvement on dysmenorrhea was made in the two groups(p<0.05), and both scores of Experiment group were decreased more than Control group. But there was no significant difference between the two groups. Conclusions: The Hominis placenta Pharmacopuncture treatment and the Normal Saline treatment were effective in decreasing the symptom of Dysmenorrhea.

Therapeutic Potential of Atopy-camp: A pilot study

  • Lee, Nam-Ryul;Kim, Hyung-Geug;Seo, Kyoung-Suk;Son, Chang-Gue
    • 대한한의학회지
    • /
    • 제31권6호
    • /
    • pp.40-46
    • /
    • 2010
  • Objective: This study investigated the therapeutic possibility of natural therapy in atopy-camp for children with atopic dermatitis. Methods: 30 children (19 boys and 11 girls, median age 11.5 years, ranging from 9 to 15) participated in natural environment-based activities in a camp-village located in Geumsan-gun for five days. Assessment of symptom change was conducted by self-reporting numeric scale (NRS) for pruritus and sleeping difficulty, investigator global assessment (IGA), eczema area and severity index (EASI score), serum histamine and IgE concentration before and after the camp period. Statistical significance was analyzed by paired t-test. Results: NRS for pruritus ($4.7{\pm}2.0$ into $4.3{\pm}2.1$), sleeping difficulty ($3.1{\pm}2.1$ into $2.9{\pm}2.0$), and serum histamine concentration ($4.27{\pm}7.39$ mol / L into $3.21{\pm}6.08$ mol / L) showed positive changes but didn't reach statistical significance (p > 0.05). IGA ($3.8{\pm}0.9$ into $4.13{\pm}1.0$), while EASI score ($10.8{\pm}9.7$ into $9.1{\pm}9.2$) and IgE ($408{\pm}320$ IU / mL into $385{\pm}3.8$ IU / mL) were significantly improved (p < 0.01). Conclusions: In spite of the limitation of the clinical trial protocol, this study may provide the possibility of natural environment-based therapy for children with atopic dermatitis.

Pilot Study: Effects of Acupuncture on the Muscle Cramps of Liver Cirrhosis Patients

  • Kim, Seung-mo;Kwak, Min-ah;Joo, Jeong-hyun;Kim, Kyung-soon;Shin, Im-hee;Lee, Chang-hyeong
    • 대한한방내과학회지
    • /
    • 제39권3호
    • /
    • pp.293-301
    • /
    • 2018
  • Objective: The purpose of this clinical trial is to examine the efficacy and safety of electroacupuncture on liver cirrhosis patients suffering from muscle cramps. Methods: A total of 14 liver cirrhosis patients with muscle cramps were treated by electroacupuncture three times a week for four weeks (12 times total). The electrical stimulation was a frequency of 100 Hz. Evaluation of the muscle cramps was measured by a questionnaire of subjective symptoms. The patients' condition was evaluated four times over a period of eight weeks. We also assessed the deterioration of liver disease using the Child-Pugh score and blood tests. Results: This study proves that four weeks of electroacupuncture treatment is effective in reducing the frequency of muscle cramps and that the effects of electroacupuncture treatment lasted during another four-week follow-up period after treatment. Conclusions: This study suggests that electroacupuncture treatment is beneficial for improving muscle cramps in liver cirrhosis patients (p=0.000). Electroacupuncture is thought to be a safe treatment for liver cirrhosis patients with muscle cramps without contributing to the worsening of liver function. Further study with a larger sample size is needed to confirm our findings.

중풍 환자의 하지 경직에 대한 자하거 약침의 효과 연구 (The effect of Hominis Placenta Pharmacopuncture on Leg spasticity of stroke patients (A Pilot study, Double blind, Randomized, Controlled Clinical Trial))

  • 노주환;박정아;윤현민;장경전;송춘호;안창범;김철홍
    • 대한약침학회지
    • /
    • 제12권4호
    • /
    • pp.97-110
    • /
    • 2009
  • Objective : The purpose of this study is to determine the effect of Hominis Placenta Pharmacopuncture(HPP) on lower limb spasticity control in stroke patients. Methods : Twenty stroke patients with Leg spasticity were randomly divided into two groups, a Distilled water Pharmacopuncture(group I) and a HPP(group II). The number of Pharmacopuncture was 5 times a week and acupuncture treatment was 3 times a week for 3 weeks. Modified Ashworth Scale(MAS), H-reflex/M-response ratio(H/M ratio), Berg Balance Scale(BBS) and Time Up & Go(TUG) were used for evaluation of spasticity control before experiment, after 1 week, 2 weeks, 3 weeks. Results : Group I showed significant improvement(p$<$.05) in BBS but no significant improvement in MAS, H/M ratio, and TUG. Group II showed significant improvement(p$<$.05) in MAS, BBS, and TUG, but no significant improvement in H/M ratio. The results showed significant difference in TUG, but no significant difference in MAS, H/M ratio and BBS between 2 groups. Conclusion : These results showed that HPP might decrease lower limb spasticity and increase leg motor function in stroke patients. Further studies will be required to examine more cases in the long period for the effect on lower limb in spasticity by HPP.

무작위 대조 시험을 통한 족관절 염좌의 자침 중 심자와 천자의 비교 연구-준비 조사 (Comparison of Superficial and Deep Acupuncture in the Treatment of Ankle sprain : A Randomized Controlled Trial-Pilot study)

  • 박준성;김우영;백승태;이승덕;김갑성
    • Journal of Acupuncture Research
    • /
    • 제21권5호
    • /
    • pp.137-147
    • /
    • 2004
  • Objective : The aim of the study was to compare the therapeutic effect of the superficial and in-depth insertion of acupuncture needles in the treatment of patients with ankle sprain. Design : A prospective randomized single-blind study of superficial and deep acupuncture was conducted. Setting : The study was conducted in the Kang-nam Oriental Hosp. of Dong-Guk University. Patients: The study comprised 14 patients with ankle sprain who were divided into two groups (A and B). Intervention : In group A, the needle was introduced in the skin at a depth of 2 mm, whereas in group B the needle was placed deeply into muscular tissue or the articular capsule at a depth more than 1.5 Cm The treatment was planned for a duration of 1 week, 3 times. Outcome Measures : The intensity of pain was evaluated with the Ankle grade pain chart(AGPC) before and after treatment and at the 1-week follow-up examination. The AGPC includes Swelling, Tenderness, Exudation, Bruise, Medial/Lateral. stability test, Anterior drawer test, Squeeze test, Bearing weight, Pressure Algometer, Walking state and VAS. Results : Although at the end of the treatment there was no evidence of significant statistical differences between the two different groups, Pain reduction(VAS) was greater in the group treated with deep acupuncture. A statistical difference existed between the two groups at the 1 week follow up, with a better result in the deeply stimulated group in VAS. Conclusion : Clinical results show that deep stimulation has a better analgesic effect when compared with superficial stimulation in pain reduction(VAS, Visual analogic scale).

  • PDF

마황복용이 정상성인의 체중 감소와 심박변이도에 미치는 영향에 관한 예비 연구: 무작위배정 이중맹검시험 (Effects of Ephedra on Weight Loss and Heart Rate Variability: A Double-Blind Randomized Controlled Pilot Study)

  • 양창섭;형례창;여진주;서의석;장인수
    • 대한한방내과학회지
    • /
    • 제27권4호
    • /
    • pp.836-844
    • /
    • 2006
  • Background: Mahuang (Ephedra sinica STAPF) is well known as an herbal medicine and has been widely used to reduce body weight and increase athletic ability. However, as a result of reporting many cases of adverse effects on the cardiovascular system, use of dietary supplements containing ephedra was prohibited by the FDA. Objectives : The object of this study was to find the effectiveness of ephedra on weight loss without severe adverse effect. Methods : 16 healthy volunteers consisting of an ephedra group (N=8) and a placebo group (N=8) were investigated. Study form was a randomized, controlled, double-blind clinical trial. The ephedra group took 12g of ephedra while the placebo group took 12g of glutinous rice powder. Both groups were measured with BCA (body composition analysis) on weight loss and with HRV (heart rate variability) on its adverse effect before and after medication. Results : The following results were obtained after taking 12g of ephedra for 14 days. In the ephedra group, body weight reduced significantly. In the placebo group, there were no significant differences of body weight between before and after placebo treatment. There was a slight increase of heart beat rate and deactivation of cardiac activity. Parasympathetic nerves were deactivated, but balances of autonomic nervous system were well maintained. Conclusions : The results suggest that ephedra in healthy adults tends to reduce body weight and deactivation of autonomic nervous system and cardiac activity.

  • PDF

Effects of Catgut -Embedding Therapy in Patients with Carpal Tunnel Syndrome: a Retrospective Pilot Study

  • You, Kyung-Gon;Kwon, Young-Dal
    • 대한한의학회지
    • /
    • 제36권2호
    • /
    • pp.43-49
    • /
    • 2015
  • Objectives: We evaluated the effect of the traditional Korean medical therapy of catgut-embedding therapy in patients with carpal tunnel syndrome (CTS). Methods: Thirteen patients(20 hands) with CTS underwent catgut-embedding therapy once per week for a total of 1-4 sessions. We measured the time to tingling in the fingers on performing Phalen's test. We also had patients use a visual analog scale (VAS) to indicate the severity of tingling. We also asked about the awakening time at night due to pain and tingling. We controlled the treatment as being limited to four sessions. Even if a patient had not been treated for four sessions, we ended the patient's treatment if symptoms resolved. Results: Patients who received catgut-embedding therapy showed significant improvements in the clinical symptoms of CTS. After treatment, in a total of 19 hands, the status of fourteen was changed from positive to negative in Phalen's test and the average of tingling occurrence time in that test was delayed. Among the 20 hands, the VAS in eight hands changed to zero and the average of VAS score decreased. Furthermore, in nine patients, four could sleep well without the use of a splint. Conclusions: Patients undergoing this traditional Korean medical therapy showed alleviation of finger tingling after even a single treatment. We thus concluded that this traditional Korean catgut-embedding therapy, may be effective for treating CTS. However, to confirm the effects of catgut-embedding therapy on CTS, further tests are required, including under the defined, strict conditions of a randomized controlled trial.