Feasibility and preliminary efficacy of acupuncture for angina in an underserved diverse population

2021 ◽  
pp. 096452842110557
Author(s):  
Holli A DeVon ◽  
Glorieuse Uwizeye ◽  
Hui Yan Cai ◽  
Adhir R Shroff ◽  
Joan E Briller ◽  
...  

Purpose: Stable angina is ischemic chest pain on exertion or with emotional stress. Despite guideline-directed therapy, up to 30% of patients have suboptimal pain relief. The aims of this study were to: (1) determine the feasibility and acceptability of a randomized controlled trial (RCT) of acupuncture; and (2) evaluate preliminary efficacy of acupuncture with respect to reduction of pain and increased functional status and health-related quality of life (HRQoL). Methods: Participants with stable angina for ⩾1 month received either a standardized acupuncture protocol, twice per week for 5 weeks, or an attention control protocol. Measures included the McGill Pain Questionnaire (average pain intensity (API), pain now) and the Seattle Angina Questionnaire–7 (functional status, symptoms, and HRQoL). Feasibility was defined as ⩾80% recruitment, ⩾75% retention following enrollment, and ⩾80% completion. Descriptive statistics and mixed-effects linear regression were used for analysis. Results: The sample (n = 24) had a mean age of 59 ± 12 years, was predominantly female (63%), and represented minority groups (8% White, 52% Black, 33% Hispanic, and 8% Other). Feasibility was supported by 79% retention and 89% completion rates. The recruitment rate (68%) was slightly lower than expected. Acceptability scores were 87.9% for the acupuncture group and 51.7% for the control group. Outcomes were significantly better for the acupuncture versus control groups (API, b = −2.1 (1.1), p = 0.047; functional status, b = 27.6 (7.2), p < 0.001; and HRQoL, b = 38.8 (11.9), p = 0.001). Conclusions and implications: Acupuncture was feasible and acceptable in our diverse sample. We were slightly under the recruitment target of 80%, but participants who started the study had a high likelihood of completing it. Acupuncture shows promise for stable angina, but its effectiveness needs to be confirmed by a larger, adequately powered RCT. Trial registration number: NCT02914834 (ClinicalTrials.gov).

2019 ◽  
Author(s):  
Judith Schlaeger ◽  
Hui Yan Cai ◽  
Alana D. Steffen ◽  
Veronica Angulo ◽  
Adhir R. Shroff ◽  
...  

BACKGROUND Acupuncture has demonstrated physiologic analgesic effects in Chinese patients with stable angina. One proposed mechanism of action for analgesic effects is the downregulation of M1 macrophages, Interleukin-1β, Interleukin-6, Interleukin-18, and tumor necrosis factor alpha (TNF-α). OBJECTIVE The purpose of this study is to test a 10-session, 5-week acupuncture treatment protocol as a complementary therapy for symptoms of stable angina for American patients, who vary from Chinese patients in healthcare systems and other salient variables. METHODS We are conducting a randomized controlled trial (RCT) of 69 adults (35 assigned to initial acupuncture and 34 to an attention control condition) with a medically confirmed diagnosis of stable angina, whose pain and associated symptoms have not been controlled to their satisfaction with guideline-directed medical management. Participants in the experimental group will receive a standardized Traditional Chinese Medicine (TCM) point prescription. The attention control group will view non-pain-related health education videos over 5 weeks equal to the 10 hours of treatment for the acupuncture group. Participants will complete the McGill Pain Questionnaire and the Seattle Angina Questionnaire-7, as well as have inflammatory cytokines measured at baseline and study completion. Primary outcomes are anginal pain and quality of life. RESULTS Results will be available upon completion of the randomized controlled trial and the analysis of the data. CONCLUSIONS We will generate data on feasibility, acceptability, effect sizes, and protocol revisions for a future fully powered RCT of the protocol. Findings will help determine if patients with persistent ischemic symptoms experience a pro-inflammatory state and/or hyperalgesia caused by multiple neural and immune processes not always relieved with medication. CLINICALTRIAL ClinicalTrials.gov Identifier: NCT02914834


10.2196/14705 ◽  
2019 ◽  
Vol 8 (7) ◽  
pp. e14705 ◽  
Author(s):  
Judith Schlaeger ◽  
Hui Yan Cai ◽  
Alana D Steffen ◽  
Veronica Angulo ◽  
Adhir R Shroff ◽  
...  

BackgroundAcupuncture has demonstrated physiologic analgesic effects in Chinese patients with stable angina. One proposed mechanism of action for these analgesic effects is the downregulation of M1 macrophages, interleukin 1 beta, interleukin-6, interleukin-18, and tumor necrosis factor alpha.ObjectiveThis study aims to test a 10-session, 5-week acupuncture treatment protocol as a complementary therapy for symptoms of stable angina for American patients, who vary from Chinese patients in health care systems and other salient variables.MethodsWe are conducting a randomized controlled trial (RCT) of 69 adults (35 assigned to initial acupuncture and 34 to an attention control condition) with a medically confirmed diagnosis of stable angina, whose pain and associated symptoms have not been controlled to their satisfaction with guideline-directed medical management. Participants in the experimental group will receive a standardized traditional Chinese medicine point prescription. The attention control group will view non–pain-related health education videos over 5 weeks equal to the 10 hours of treatment for the acupuncture group. Participants will complete the McGill Pain Questionnaire and the Seattle Angina Questionnaire-7, as well as have inflammatory cytokines measured at baseline and study completion. The primary outcomes are anginal pain and quality of life.ResultsThis study has been funded over 2 years by the National Institutes of Health, National Institute for Nursing Research. We are currently recruiting and expect to have initial results by December 2020.ConclusionsWe will generate data on feasibility, acceptability, effect sizes, and protocol revisions for a future fully powered RCT of the protocol. Findings will help determine if patients with persistent ischemic symptoms experience a proinflammatory state and hyperalgesia caused by multiple neural and immune processes not always relieved with medication.International Registered Report Identifier (IRRID)DERR1-10.2196/14705


2020 ◽  
Vol 2020 ◽  
pp. 1-12 ◽  
Author(s):  
Hanna Johansson ◽  
Malin Freidle ◽  
Urban Ekman ◽  
Ellika Schalling ◽  
Breiffni Leavy ◽  
...  

Background. Recent studies indicate that exercise can induce neuroplastic changes in people with Parkinson’s disease (PwPD). Reports of feasibility outcomes from existing pilot trials however are, of date, insufficient to enable replication by others in larger definitive trials. Objective. To evaluate trial design for a definitive trial by exploring process and scientific feasibility. Methods. The trial design was a parallel-group RCT pilot with a 1 : 1 allocation ratio to either HiBalance or an active control group (HiCommunication). Both groups received one-hour sessions twice weekly, plus home exercises weekly, for 10 weeks. Participants with mild-to-moderate Parkinson’s disease (PD) were recruited via advertisement. Assessment included physical performance, structural and functional MRI, blood sampling, neuropsychological assessment, and speech/voice assessment. Process and scientific feasibility were monitored throughout the study. Process feasibility involved recruitment, participant acceptability of assessments and interventions, assessment procedures (focus on imaging, blood sampling, and dual-task gait analysis), and blinding procedures. Scientific feasibility involved trends in outcome response and safety during group training and home exercises. Data are presented in median, minimum, and maximum values. Changes from pre- to postintervention are reported descriptively. Results. Thirteen participants were included (4 women, mean age 69.7 years), with a recruitment rate of 31%. Attendance rates and follow-up questionnaires indicated that both groups were acceptable to participate. Image quality was acceptable; however, diplopia and/or sleepiness were observed in several participants during MRI. With regard to dual-task gait performance, there appeared to be a ceiling effect of the cognitive tasks with seven participants scoring all correct answers at pretest. Blinding of group allocation was successful for one assessor but was broken for half of participants for the other. Conclusions. The overall trial design proved feasible to perform, but further strengthening ahead of the definitive RCT is recommended, specifically with respect to MRI setup, cognitive dual-tasks during gait, and blinding procedures. This trial is registered with NCT03213873.


Author(s):  
Yong-Soon Yoon ◽  
Myoung-Hwan Ko ◽  
Il-Young Cho ◽  
Cheol-Su Kim ◽  
Johny Bajgai ◽  
...  

Electrotherapy is commonly used for myalgia alleviation. Low-frequency stimulation (LFS) is primarily used for controlling acute and chronic pain and is a non-invasive therapy that can be easily performed with electric stimulation applied on the skin. However, little evidence exists regarding the pain alleviation effects of personal low-frequency stimulation device for home use. Moreover, no studies have compared myalgia alleviation effects between personal low-frequency stimulation (PLS) and physical therapy (PT), which are most commonly used for patients with myalgia in hospitals and clinics. Therefore, we aimed to investigate the pain alleviation effects of PLS in patients with myalgia and compare these effects with those of conventional PT (transcutaneous electrical nerve stimulation + ultrasound). In total, 39 patients with myalgia in the neck, shoulder, back, and waist areas were randomly assigned to the personal low-frequency stimulation group (PLSG: n = 20) and physical therapy group (PTG: n = 19). Both groups were treated for 3 weeks (20 min per session and 5 sessions per week). Patients were assessed for pain intensity by surface electromyography (sEMG), visual analogue scale (VAS) and a short-form McGill pain questionnaire (SF-MPQ) before and after the intervention period. Our results showed that PLSG showed a tendency of muscle relaxation with a significant decrease in sEMG in the neck (p = 0.0425), shoulder (p = 0.0425), and back (p = 0.0046) areas compared to the control group. However, there was no significant difference in waist area. Additionally, VAS scores significantly decreased between pre- and post-treatment in both PTG (p = 0.0098), and PLSG (p = 0.0304) groups, but there was no significance difference between the groups. With respect to SF-MPQ, the PLSG showed greater pain alleviation (5.23 ± 0.25) effects than the PTG (6.23 ± 0.25). Accordingly, our results suggest that PLS treatment using a home device might offer positive assistance in pain alleviation for patients with myalgia that is as equally effective as conventional PT treatment. However, further detailed studies are required considering larger samples to fully claim the effectiveness of this device.


2020 ◽  
Vol 2020 ◽  
pp. 1-10
Author(s):  
Shaojun Liao ◽  
Zhe Zhang ◽  
Geng Li ◽  
Li Zhou ◽  
Junwen Jiang ◽  
...  

Introduction. Stable angina (SA) in coronary heart disease is a common ischemic heart disease endangering the patient’s quality of life and longevity. Clinical trials have demonstrated that the Chinese herbal formula Xuefu Zhuyu (XFZY) has benefits for SA patients. However, there remains a lack of high-quality evidence to support clinical decision-making. Therefore, we designed a randomized controlled trial (RCT) to evaluate the efficacy and safety of XFZY for SA. Methods and Analysis. This multicenter, double-blinded RCT will be conducted in China. 152 eligible participants will be randomly assigned to either an XFZY group or a control group at a 1 : 1 ratio. Participants in the XFZY group will receive XFZY plus routine care, while those in the control group will receive placebo plus routine care. The study period is 26 weeks, including a 2-week run-in period, a 12-week treatment period, and a 12-week follow-up. The primary outcome is the change in visual analogue scale score for angina pain intensity from baseline to 12 weeks. The secondary outcomes are the angina attack frequency and duration, the nitroglycerin dosage consumed, the Canadian Cardiovascular Society grading of effort angina, the Seattle Angina Questionnaire, the EuroQol-5-Dimensions-5-Level, the incidence of major adverse cardiac events, health cost evaluation, and overall assessment for study drugs. Ethics and Dissemination. The study has been approved by the ethics committee of Guangdong Provincial Hospital of Chinese Medicine (approval no. BF2019-175-01). Results will be submitted for publication in peer-reviewed journals and disseminated at scientific conferences. This trial is registered with ChiCTR1900026899, registered on 26 October 2019.


2020 ◽  
Vol 41 (Supplement_1) ◽  
pp. S267-S268
Author(s):  
Xiu-Hang Zhang ◽  
Jia-Ao Yu ◽  
Xin-Xin Chen

Abstract Introduction Burn injuries have significant physiological and psychological consequences. Dressing changes have been considered the most painful among all non-surgical procedures. Anxiety, which is closely associated with pain, is a part of the burn and wound-healing process and can cause delays in wound healing and recovery procedures. In addition, anxiety may have a devastating mental and physical influence on patients.What’s more,patients whose symptoms were not adequately alleviated are likely to suffer more in their subsequent dressing changes. Pharmacological treatment is the primary approach for relieving pain and anxiety related to burns. In comparison with traditional analgesics, tramadol is a more manageable drug under clinical conditions. However, due to the variability of the intensity of pain and anxiety in patients, the two symptoms remain under-treated. Recently, much attention has been paid to pain management approaches that combine pharmacological treatments with non-pharmacological therapies. In this regard, this study was designed to analyze the effect of tramadol and its combination with self-selected music on burn patient. Methods To investigate the effects of music and/or tramadol on pain and anxiety in burn outpatients undergoing dressing changes. Patients (N = 180) with burns on up to 10%-30% of the total body surface area (TBSA). The patients were selected using a convenience sampling method and randomly allocated to 4 equal-sized groups as follows: 1) tramadol group (TG), patients received 100 mg of tramadol orally 20 min before the dressing change; 2) music group (MG), patients listened to self-selected music during the dressing change; 3) music-plus-tramadol group (MTG), patients received tramadol and listened to self-selected music; and 4) control group (CG), patients received a routine dressing change only. All patients underwent the interventions once per day for 2 days. McGill Pain Questionnaire Short Form (MPQ-SF) (primary outcome), McGill Pain Persian version of Burn Specific Pain Anxiety Scale (BSPAS) (primary outcome), and heart rate (HR) and overall patient satisfaction (secondary outcomes). Results The results showed that MTG had better outcomes with respect to pain and anxiety management during dressing changes. Conclusions In comparison with music or tramadol alone, the integration of music and tramadol offers a secure and favorable treatment choice to relieve pain and anxiety, ultimately improving the satisfaction levels of burn outpatients during dressing changes. Applicability of Research to Practice The findings showed that the combined approach was more effective in reducing pain and anxiety among the outpatients, as the findings outline the potential use of this technique in the management of dressing changes in burn outpatients.


Gut ◽  
2021 ◽  
pp. gutjnl-2020-321811
Author(s):  
Rakesh Kalapala ◽  
Arun Karyampudi ◽  
Zaheer Nabi ◽  
Santosh Darisetty ◽  
Nitin Jagtap ◽  
...  

BackgroundThe majority of endoscopic antireflux procedures for GERD are cumbersome to use and randomised long-term data are sparse. We conducted such a trial to determine the efficacy and safety of a novel, easy to use endoscopic full-thickness fundoplication (EFTP) device in patients with GERD.DesignPatients with proton pump inhibitor (PPI)-dependent GERD were randomised to either EFTP or a sham procedure in 1:1 ratio. The primary endpoint was ≥50% improvement in the health-related quality of life (GERD-HRQL) score at 3 months. Secondary end points included improvement in GERD-HRQL, reflux symptom scores, PPI usage, oesophageal acid exposure and reflux episodes and endoscopic findings at 3, 6 and 12 months.ResultsSeventy patients were randomised; 35 in each group with a median (IQR) age of 36 (29–42) years, 71.4% males. 70% had non-erosive reflux disease on endoscopy with a mean DeMeester score of 18.9 (±19.93). The mean (±SD) duration of EFTP procedure was 17.4 (±4) min. The primary end point was more frequently achieved in the EFTP group (65.7% vs 2.9%; p<0.001). Median (IQR) % improvement in GERD-HRQL was significantly higher in the EFTP group at 6 (81.4 (60.9–100.0) versus 8.0 (2.2–21.6); p<0.001) and 12 (92.3 (84.4–100.0) versus 9.1 (4.8–36.0); p<0.001) months. In the EFTP group, 62.8% patients were off-PPI at 12 months compared with 11.4% in the sham group (p<0.001). pH-metry parameters partially improved at 3 months, (n=70; total reflux episodes in EFTP arm and non-acid reflux episodes for EFTP vs sham) but not at 12 months (n=27); endoscopic oesophagitis was seen in 0% in the treatment (n=18) and 5 (29.4%) in the control group (n=17) at 12 months. No major procedure-related adverse events were encountered in either group.ConclusionEFTP using a novel device is safe and effective in improving quality of life in patients with PPI dependent mostly non-erosive reflux disease at short and long terms; objective parameters showed a limited response rate.Trial registration numberNCT03322553.


2019 ◽  
Author(s):  
Marius Butz ◽  
Jasmin El-Shazly ◽  
Gebhard Sammer ◽  
Marlene Tschernatsch ◽  
Sabrina Kastaun ◽  
...  

Abstract Background The occurrence of postoperative cognitive deficits, especially after heart surgery, has been demonstrated in several studies. These deficits can clearly be noticed by the patients as well as by their close relatives in daily life. Furthermore, postoperative cognitive deficits can decrease quality of life in social functioning and earning capacity. The aim of this study is to investigate whether early postoperative cognitive training can reduce subjective and objective postoperative cognitive deficits Methods The proposed study is a multicenter, 2-arm randomized controlled trial involving 144 elderly patients undergoing elective heart valve surgery with extracorporeal circulation. Patients will be assigned to either a training group or a control group. The intervention involves a paper-and-pencil-based cognitive training, which is conducted for 36 minutes over a period of 18 days. The training starts about 1 week after surgery and is carried out during the hospitalized rehabilitation phase. The control group will not receive a cognitive training or a placebo intervention. A detailed assessment of psychological functions and health-related quality of life prior to surgery at discharge from rehabilitation and 3 and 12 months after discharge will be performed. The Primary outcome of this trial is the training effect on objective cognitive functions at discharge from rehabilitation. Secondary outcomes are the training effect on objective and subjective cognitive functions (3 and 12 months after discharge), depression, health-related quality of life, and the impact of perioperative cerebral ischemia on the training effect. Perioperative cerebral ischemia will be measured with postoperative magnetic resonance imaging including diffusion-weighted sequences. Discussion Should it be shown that our cognitive training can improve postoperative cognitive deficits as well as quality of life, one possibility could be to integrate this intervention into early rehabilitation. Furthermore, we hope that the investigation of perioperative ischemia by diffusion-weighted magnetic resonance imaging will improve our understanding of neurobiological factors influencing the course of postoperative cognitive plasticity.


Author(s):  
Kuan-Yin Lin ◽  
Hui-Ching Cheng ◽  
Chia-Jui Yen ◽  
Ching-Hsia Hung ◽  
Yu-Ting Huang ◽  
...  

Background: Cisplatin administration may induce muscle atrophy, thereby reducing the fitness level of patients with head and neck cancer (HNC). To date, only animal studies have been conducted to test the effectiveness of exercise interventions in diminishing side effects of cisplatin. Aim: To determine whether exercise training improves physical fitness and health-related quality of life (HRQoL) in patients receiving chemotherapy for Head & Neck (H&N). Material and methods: This pilot-randomized controlled trial was conducted on 57 participants receiving chemotherapy for HNC. The participants were randomized into an exercise group and a control group. The exercise group received moderate-intensity combined aerobic, resistance and flexibility exercises three times a week for eight weeks during chemotherapy. The control group received no specific information regarding exercise. The outcome measures including body composition, muscle strength, balance, flexibility, cardiovascular fitness and health-related quality of life (HRQoL) were assessed at baseline and eight weeks following baseline. Results: The body composition (body fat percentage, p = 0.002; skeletal muscle percentage, p = 0.008), dynamic balance (p = 0.01), muscle strength (upper extremity, p = 0.037; lower extremity, p = 0.025) and HRQoL (p = 0.001) showed a significant difference between the exercise group and the control group eight weeks following baseline. Significant deteriorations were noted in flexibility, muscle strength, cardiovascular fitness and several domains of HRQoL scale in the control group at eight weeks following baseline. Conclusions: This study found that a combined aerobic, resistance and flexibility exercise program during chemotherapy may improve physical fitness (i.e., muscle strength, balance, flexibility and body composition) and HRQoL and alleviate the deterioration of cardiovascular fitness in patients with HNC. Further research studies with large sample sizes are warranted to investigate the long-term effects of exercise in this population.


Hand ◽  
2021 ◽  
pp. 155894472110068
Author(s):  
Hossein Ali Abdolrazaghi ◽  
Mahmoud Khansari ◽  
Maryam Mirshahi ◽  
Mahin Ahmadi Pishkuhi

Background There is limited evidence regarding the efficacy of different treatment options in patients with carpal tunnel syndrome (CTS). This study aimed at assessing the effectiveness of nerve and tendon gliding exercises in the treatment of patients with mild CTS. Methods The current prospective, randomized trial with pretest-posttest design was conducted on 80 patients with mild CTS randomly assigned to 2 groups. The treatment group was instructed to perform gliding exercises in addition to the wrist splint use. The control group only used the wrist splint. All the patients were instructed to use the splint at night and during the day if required. Patients were evaluated in terms of clinical parameters (ie, grip and pinch strength). The severity of symptoms and functional status was also determined using the Boston Carpal Tunnel Syndrome Questionnaire. The subjects were followed up for 6 weeks. Results There were no significant differences in all parameters between groups. The pretest-posttest analysis showed a statistically significant improvement in subjective and objective parameters in the treatment group. However, in the control group, only a significant improvement was observed in grip strength. Wrist splint use led to a significant change in the severity of symptoms only over the second week. Conclusions Both gliding exercise and wrist splint groups showed some improvement in the severity of symptoms and functional status scores. However, the gliding exercises did not offer additional benefit compared with wrist splint alone.


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