The clinical effects and biomechanical mechanisms of Peony and licorice decoction fumigation in the treatment of poststroke cavovarus foot: study protocol for a randomized controlled pilot trial

2020 ◽  
Author(s):  
Chengyang Jing ◽  
Li Zhou ◽  
Juanjuan Ai ◽  
Zongheng Li ◽  
Jiabao Wu ◽  
...  

Abstract Background: As the most common functional disability in stroke patients with hemiplegia, poststroke cavovarus foot (PCF) seriously affects the life quality of patients and causes mental and emotional disorders. Some studies have suggested that the traditional Chinese medicine fumigation therapy could be an effective intervention method for PCF patients. This study aims to investigate the biomechanical effect of the classic prescription Peony and licorice decoction (PLD) fumigation in the treatment of PCF. Methods/Design: This study is a multi-center, randomized, placebo-controlled, double blind trial. A total of 190 patients with PCF according to the inclusion criteria will be recruited in three centers and randomized and distributed to either the intervention group or the control group at a 1:1 ratio. All patients will receive standardized modern rehabilitation treatment according to the “Chinese Guidelines for Stroke Rehabilitation” (2011 version). Patients will stick to the treatments they used to take, and will be given present general treatment when acute exacerbation of stroke occurs during the trial. The intervention group will receive PLD fumigation treatment, while the control group will receive placebo fumigation treatment. The primary outcome measure is medial plantar area (M1+M2+HM) generating from the RSSCAN gait system. The secondary outcome measures contain the scores of clinical scales including Berg Balance Scale, Fugl-Meyer Assessment, Modified Ashworth Scale, Barthel Index, and Stroke-Specific Quality of Life Scale. All assessments will be implemented at baseline, 4 weeks after intervention and at the end of 3 month’ follow-up. Intention-to-treat analysis and per-protocol analysis will be applied in this trial. Discussion: The results of this study are expected to provide detailed interpretations of clinical effects and biomechanical mechanisms of PLD fumigation in the treatment of PCF. If PLD fumigation treatment is confirmed as an effective option, this study may additionally set up the new treatment method for patients with PCF and provide foundations for further clinical studies on a larger scale. Trial registration: Chinese Clinical Trial Registry, ChiCTR2000032433. Registered on 28 April 2020.

2021 ◽  
Vol 2021 ◽  
pp. 1-9
Author(s):  
Zhancheng Gu ◽  
Guoli Wei ◽  
Liangjun Zhu ◽  
Lingjun Zhu ◽  
Jing Hu ◽  
...  

Background. Oxaliplatin-induced peripheral neuropathy (OIPN) is one of the most common side effects of oxaliplatin, which can cause reduction and cessation of oxaliplatin-based chemotherapy and significantly affect patients’ quality of life. However, no drug has got recognition to prevent or treat OIPN. Yiqi-Wenjing-Fang (YWF) is a joint name of Chinese medicine prescriptions with similar effects of tonifying qi and warming meridians, represented by Huangqi Guizhi Wuwu decoction (HGWD) and Danggui Sini decoction (DSD), both from “Treatise on Cold Pathogenic and Miscellaneous Diseases.” YWF granules, including HGWD granules and DSD granules, have been, respectively, demonstrated to be effective in preventing OIPN in previous small-sample observations. The purpose of this study is to enlarge the sample size for further evaluation of the preventive efficacy and safety of YWF granules on OIPN. Methods and Analysis. This study is a randomized, double-blind, placebo-controlled, and multicenter clinical trial. 360 postoperative patients with stage IIa-IIIc colorectal cancer will be randomly assigned into placebo-control group, intervention group I, and intervention group II, taking the mimetic granules of YWF as placebo, HGWD granules and DSD granules, respectively. All subjects will receive oxaliplatin-based chemotherapy regimen at the same time. EORTC QLQ-CIPN20 will be used to assess the degree of OIPN as the primary outcome measure. The grades of OIPN, quality of life, chemotherapeutic efficacy, and the number of completed chemotherapy cycles are selected as the secondary outcome measures. Discussion. Based on the condition of no recognized effective drugs in preventing OIPN, evidence-based medical study will be conducted for seeking a breakthrough in the field of Chinese herb medicine. This protocol could provide reliable and systemic research basis about the efficacy of YWF granules and the differentiation of two classical prescriptions of YWF on preventing OIPN objectively. Trial Registration. This study was registered at ClinicalTrials.gov on 26 December 2020 (ID: https://clinicaltrials.gov/ct2/show/NCT04690283).


2019 ◽  
Author(s):  
Emily Guhl ◽  
Andrew D Althouse ◽  
Alexandra M Pusateri ◽  
Everlyne Kimani ◽  
Michael K Paasche-Orlow ◽  
...  

BACKGROUND Atrial fibrillation (AF) is a common arrhythmia that adversely affects health-related quality of life (HRQoL). We conducted a pilot trial of individuals with AF using a smartphone to provide a relational agent as well as rhythm monitoring. We employed our pilot to measure acceptability and adherence and to assess its effectiveness in improving HRQoL and adherence. OBJECTIVE This study aims to measure acceptability and adherence and to assess its effectiveness to improve HRQoL and adherence. METHODS Participants were recruited from ambulatory clinics and randomized to a 30-day intervention or usual care. We collected baseline characteristics and conducted baseline and 30-day assessments of HRQoL using the Atrial Fibrillation Effect on Quality of Life (AFEQT) measure and self-reported adherence to anticoagulation. The intervention consisted of a smartphone-based relational agent, which simulates face-to-face counseling and delivered content on AF education, adherence, and symptom monitoring with prompted rhythm monitoring. We compared differences in AFEQT and adherence at 30 days, adjusted for baseline values. We quantified participants’ use and acceptability of the intervention. RESULTS A total of 120 participants were recruited and randomized (59 to control and 61 to intervention) to the pilot trial (mean age 72.1 years, SD 9.10; 62/120, 51.7% women). The control group had a 95% follow-up, and the intervention group had a 93% follow-up. The intervention group demonstrated significantly higher improvement in total AFEQT scores (adjusted mean difference 4.5; 95% CI 0.6-8.3; <i>P</i>=.03) and in daily activity (adjusted mean difference 7.1; 95% CI 1.8-12.4; <i>P</i>=.009) compared with the control between baseline and 30 days. The intervention group showed significantly improved self-reported adherence to anticoagulation therapy at 30 days (intervention 3.5%; control 23.2%; adjusted difference 16.6%; 95% CI 2.8%-30.4%; <i>P</i>&lt;.001). Qualitative assessments of acceptability identified that participants found the relational agent useful, informative, and trustworthy. CONCLUSIONS Individuals randomized to a 30-day smartphone intervention with a relational agent and rhythm monitoring showed significant improvement in HRQoL and adherence. Participants had favorable acceptability of the intervention with both objective use and qualitative assessments of acceptability.


Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Michael Wester ◽  
Franziska Koll ◽  
Florian Zeman ◽  
Astrid Dempfle ◽  
Michael Koller ◽  
...  

Abstract Background Stable coronary artery disease (CAD), recently termed chronic coronary syndrome (CCS), is a highly prevalent disease. Current treatment strategies often include a relevant placebo effect. The hypothesis is that visual angiographic demonstration of the coronary arteries before and after successful percutaneous coronary intervention (PCI) by itself reduces the symptom burden of stable CAD/CCS. Design and methods The PLA-pCi-EBO-pilot-trial is a prospective, multi-center, randomized, controlled investigator-initiated pilot trial to study the effect of visual demonstration of successful PCI on quality of life (QoL) and angina pectoris (AP) in patients with symptomatic stable CAD/CCS. All patients with stable CAD/CCS and successful PCI will be screened. One hundred forty four patients with a frequency of AP ≥ 2/week will be randomized 1:1 stratified for AP frequency > 1/day. The control group will receive the common written procedural report on the procedure. Patients in the intervention group will additionally be given a printout picture of their coronary angiogram both before and after PCI. Primary endpoints are change in the Seattle Angina Questionnaire (SAQ)-derived QoL score 1 and 6 months after PCI. Secondary endpoints are changes in other SAQ-derived scores and dyspnea (NYHA score) 1 and 6 months after PCI. Discussion The PLA-pCi-EBO-pilot-trial evaluates the effect of visual angiographic result demonstration on disease symptoms and QoL in patients with stable CAD/CCS on top of PCI. A positive outcome of our study would encourage the routine use of angiographic picture demonstration and has thus the potential to change daily routine in the catheterization laboratory. Trial registration German Clinical Trials Register DRKS00017524. Registered on 5 July 2019


2012 ◽  
Vol 40 (04) ◽  
pp. 685-693 ◽  
Author(s):  
Peng-Fei Shen ◽  
Li Kong ◽  
Li-Wei Ni ◽  
Hai-Long Guo ◽  
Sha Yang ◽  
...  

Stroke is one of the most common causes of death and few pharmacological therapies show benefits in ischemic stroke. In this study, 290 patients aged 40–75 years old with first onset of acute ischemic stroke (more than 24 hours but within 14 days) were treated with standard treatments, and then were randomly allocated into an intervention group (treated with resuscitating acupuncture) and a control group (treated using sham-acupoints). Primary outcome measures included Barthel Index (BI), relapse and death up to six months. For the 290 patients in both groups, one case in the intervention group died, and two cases in the control group died from the disease (p = 0.558). Six patients of the 144 cases in the intervention group had relapse, whereas 34 of 143 patients had relapse in the control group (p < 0.001). The mean values for BI at six months were 70.25 ± 20.37 and 57.43 ± 19.61 for the two groups, respectively (p < 0.01). Acupuncture resulted in a significant difference between the two groups for the National Institute of Health Stroke Scale (NIHSS), not at two weeks (7.03 ± 3.201 vs. 8.13 ± 3.634; p = 0.067), but at four weeks (4.15 ± 2.032 vs. 6.35 ± 3.131, p < 0.01). The Chinese Stroke Scale (CSS) at four weeks showed more improvement in the intervention group than that in the control group (9.40 ± 4.51 vs. 13.09 ± 5.80, p < 0.001). Stroke Specific Quality of Life Scale (SS-QOL) at six months was higher in the intervention group (166.63 ± 45.70) than the control group (143.60 ± 50.24; p < 0.01). The results of this clinical trial showed a clinically relevant decrease of relapse in patients treated with resuscitating acupuncture intervention by the end of six months, compared with needling at the sham-acupoints. The resuscitating acupuncture intervention could also improve self-care ability and quality of life, evaluated with BI, NIHSS, CSS, Oxford Handicap Scale (OHS), and SS-QOL.


Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Shanze Wang ◽  
Jiping Zhao ◽  
Weimei Zeng ◽  
Wanqing Du ◽  
Tenghui Zhong ◽  
...  

Abstract Background The incidence rate of Hashimoto thyroiditis (HT) has gradually increased in recent years. There has been no specific etiological treatment for HT. Even though with normal level of thyroid hormone, the patients may still suffer from various clinical symptoms, such as anterior neck discomfort, fatigue, and mood swings, which seriously impair their quality of life. Acupuncture has long been used in the treatment of thyroid diseases, but there has been no related standardized clinical study as of today. This study aims to assess the feasibility, efficacy, and safety of acupuncture for HT. Methods This is a randomized, black-controlled assessor-blinded pilot trial. A total of 60 patients will be recruited and divided into the experimental group (n = 30) or the control group (n = 30). The experimental group will undergo acupuncture therapy (penetration needling of Hand-Yangming meridian, PNHM) for 16 weeks, followed by a 16-week follow-up period, and the control group will first go through an observation period for 16 weeks, followed by a 16-week compensation PNHM therapy. The primary outcome will be the change of the concentrations of anti-thyroperoxidase antibodies (TPOAb), antithyroglobulin antibodies (TgAb), and thyroid hormone, including total thyroxine (FT4), free thyroxine (FT3), and thyroid-stimulating hormone (TSH). The secondary outcome measurements include the thyroid-related quality of life questionnaire short-form (ThyPRO-39), The Mos 36-item Short Form Health Survey (SF-36), and Hospital Anxiety and Depression Scale (HAD). Data collection will be performed before the start of the study (the baseline assessment) and at weeks 8, 16, 24, and 32. Discussion The study is designed to assess the feasibility and effectiveness of PNHM in reducing the thyroid antibody level and improving the quality of life of HT patients with hypothyroidism or subclinical hypothyroidism. Results of this trial will assist further analyses on whether the acupuncture treatment can alleviate symptoms for patients with HT. Trial registration Acupuncture-Moxibustion Clinical Trial Registry AMCTR-IOR-19000308 (ChiCTR1900026830). Registered on 23 October 2019.


2006 ◽  
Vol 189 (4) ◽  
pp. 330-336 ◽  
Author(s):  
Mike Slade ◽  
Paul McCrone ◽  
Elizabeth Kuipers ◽  
Morven Leese ◽  
Sharon Cahill ◽  
...  

BackgroundRoutine use of standardised outcome measures is not universal.AimsTo evaluate the effectiveness of standardised outcome assessment.MethodA randomised controlled trial, involving 160 representative adult mental health patients and paired staff (ISRCTN16971059). The intervention group (n=101) (a) completed monthly postal questionnaires assessing needs, quality of life, mental health problem severity and therapeutic alliance, and (b) received 3-monthly feedback. The control group (n=59) received treatment as usual.ResultsThe intervention did not improve primary outcomes of patient-rated unmet need and of quality of life. Other subjective secondary outcome measures were also not improved. The intervention reduced psychiatric inpatient days (3.5 v. 16.4 mean days, bootstrapped 95% CI 1.6-25.7), and hence service use costs were £2586 (95% CI 102-5391) less for intervention-group patients. Net benefit analysis indicated that the intervention was cost-effective.ConclusionsRoutine use of outcome measures as implemented in this study did not improve subjective outcomes, but was associated with reduced psychiatric inpatient admissions.


Author(s):  
Philipp Klemm ◽  
Gabriel Dischereit ◽  
Uwe Lange ◽  
Shaban Fetaj ◽  
Markus Ehnert

Abstract Background Mud bath and pack have been used to treat musculoskeletal disorders since ancient times. However, the actual mechanisms of action of mud therapy on the inflammatory processes are complex and still not clarified. Methods Therefore, the clinical effects of serial mud packs in patients with knee osteoarthritis were investigated on the molecular level. A total of 52 patients were recruited from an in-patient rheumatology clinic. The participants were randomized in 2 groups: the intervention group (IG, n=26) underwent 9 mud packs in 21 days and a standardized multimodal physical therapy in an in-patient setting, whereas the control group (CG, n=26) only received the multimodal physical therapy. Primary outcome parameters were changes in the serum levels of interleukin(IL)-1ß and IL-10. Secondary outcome parameters were changes of the C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), Western Ontario and Mc Master Universities Arthritis (WOMAC) index and pain (visual analog scale - VAS). Results The IG presented after the serial mud packs significantly decreased pro-inflammatory IL-1ß levels and significantly increased anti-inflammatory IL-10 levels, whereas the CG showed no changes of the 2 cytokines. CRP and ESR remained within in the normal range in both groups without significant changes. Furthermore, the IG presented a significant decrease of the WOMAC index and pain (VAS). Conclusions The results suggest an additive anti-inflammatory effect of serial mud packs within a multimodal physical therapy concept in patients with knee osteoarthritis and could explain the beneficial clinical effects.


2018 ◽  
Author(s):  
Renee Chan ◽  
Matthew Nguyen ◽  
Rachel Smith ◽  
Sarah Spencer ◽  
Sabrina Winona Pit

BACKGROUND Obesity is an endemic problem with significant health and financial consequences. Text messaging has been shown to be a simple and effective method of facilitating weight reduction. In addition, waist-to-hip ratio (WHR) has emerged as a significant anthropometric measure. However, few studies have examined the effect of serial anthropometric self-measurement combined with text messaging. OBJECTIVE The primary aim of this study was to assess whether an 8-week program, consisting of weekly serial self-measurements of waist and hip circumference, combined with motivational text messages, could reduce WHR among Australian workers. METHODS This was a community-based, participant-blinded, staggered-entry, parallel group study. Adult workers with access to mobile phones were eligible and recruited through an open access Web-based survey. Participants were randomly allocated to receive intervention or control messages for 8 weeks. Outcome data were self-assessed through a Web-based survey. RESULTS A total of 60 participants were randomized with 30 participants each allocated to a control and an intervention group. There was no significant change in WHR (P=.43), and all secondary outcome measures did not differ between the intervention group and the control group at the end of the 8-week intervention. Both groups, however, showed a significant decrease in burnout over time (mean [SE]: pre 4.80 [0.39] vs post 3.36 [0.46]; P=.004). The intervention uptake followed a downward trend. Peak participant replies to weekly self-measurements were received in week 3 (14/23, 61%) and the least in week 8 (8/23, 35%). No harm was found to result from this study. CONCLUSIONS This study is an innovative pilot trial using text messaging and serial anthropometric measurements in weight management. No change was detected in WHRs in Australian workers over 8 weeks; therefore, it could not be concluded whether the intervention affected the primary outcome. However, these results should be interpreted in the context of limited sample size and decreasing intervention uptake over the course of the study. This pilot trial is useful for informing and contributing to the design of future studies and the growing body of literature on serial self-measurements combined with text messaging. CLINICALTRIAL Australian New Zealand Clinical Trials Registry ACTRN12616001496404; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371696&isReview=true (Archived by WebCite at http://www.webcitation.org/73UkKFjSw)


JMIR Cardio ◽  
10.2196/17162 ◽  
2020 ◽  
Vol 4 (1) ◽  
pp. e17162
Author(s):  
Emily Guhl ◽  
Andrew D Althouse ◽  
Alexandra M Pusateri ◽  
Everlyne Kimani ◽  
Michael K Paasche-Orlow ◽  
...  

Background Atrial fibrillation (AF) is a common arrhythmia that adversely affects health-related quality of life (HRQoL). We conducted a pilot trial of individuals with AF using a smartphone to provide a relational agent as well as rhythm monitoring. We employed our pilot to measure acceptability and adherence and to assess its effectiveness in improving HRQoL and adherence. Objective This study aims to measure acceptability and adherence and to assess its effectiveness to improve HRQoL and adherence. Methods Participants were recruited from ambulatory clinics and randomized to a 30-day intervention or usual care. We collected baseline characteristics and conducted baseline and 30-day assessments of HRQoL using the Atrial Fibrillation Effect on Quality of Life (AFEQT) measure and self-reported adherence to anticoagulation. The intervention consisted of a smartphone-based relational agent, which simulates face-to-face counseling and delivered content on AF education, adherence, and symptom monitoring with prompted rhythm monitoring. We compared differences in AFEQT and adherence at 30 days, adjusted for baseline values. We quantified participants’ use and acceptability of the intervention. Results A total of 120 participants were recruited and randomized (59 to control and 61 to intervention) to the pilot trial (mean age 72.1 years, SD 9.10; 62/120, 51.7% women). The control group had a 95% follow-up, and the intervention group had a 93% follow-up. The intervention group demonstrated significantly higher improvement in total AFEQT scores (adjusted mean difference 4.5; 95% CI 0.6-8.3; P=.03) and in daily activity (adjusted mean difference 7.1; 95% CI 1.8-12.4; P=.009) compared with the control between baseline and 30 days. The intervention group showed significantly improved self-reported adherence to anticoagulation therapy at 30 days (intervention 3.5%; control 23.2%; adjusted difference 16.6%; 95% CI 2.8%-30.4%; P<.001). Qualitative assessments of acceptability identified that participants found the relational agent useful, informative, and trustworthy. Conclusions Individuals randomized to a 30-day smartphone intervention with a relational agent and rhythm monitoring showed significant improvement in HRQoL and adherence. Participants had favorable acceptability of the intervention with both objective use and qualitative assessments of acceptability.


Author(s):  
Havva Bozdemir ◽  
Dilek Aygin

Abstract Objective: The aim of this study the effect of the education given according to daily living activities (DLA) model on arm dysfunction, lymphedema and quality of life in patients undergoing breast cancer surgery. Interventions/Methods: In the design of the research, a randomized controlled experimental model with recurrent measurement was used. The data were collected from 60 patients (control group: 30, Intervention Group: 30) at a teriary hospital. In Research ,Patient Information Form, SPOFIA, KATZ-DLA indeks, arm, shoulder and hand injuries scale (DASH) and quality of life scale short form (SF-36) were used. Three interviews (1st week, 1st and 3rd month) were performed after surgery with patients. Analysis of data; independent T-Test, Chi-squared and Repeated Measures ANOVA were utilized. Results: SPOFIA, DASH and KATZ, GYA scale averages decreased by the time, SF-36 were found to increase the average score. In the intervention group, the measurements of the upper arm circumference are significantly better than the control group and In terms of SPOFIA3, DASH2 and DASH3 scale averages, there is a statistically significant difference between the groups (P < 0.05). Conclusions: KATZ, SPOFIA, SF-36, DASH scale score averages were recovered as the time elapsed after the operation increased. Intervention group was found to recover more early. Implications for Practice: The education programme is effective in the prevention of arm dysfunction and lymphedema and in improving quality of life. Keywords: Breast cancer, lymphedema, daily life activity model, quality of life, Continuous...


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