scholarly journals Electroacupuncture for postoperative pain after nasal endoscopic surgery: Study protocol for a Randomized Controlled Trial

2019 ◽  
Author(s):  
Shanshan Li ◽  
Qing Zhang ◽  
Xuan Yin ◽  
Hongyu Yue ◽  
Wei Zhang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Postoperative Pain ◽  
Endoscopic Surgery ◽  
Rating Scale ◽  
Short Form ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Randomized Controlled ◽  
Electroacupuncture Treatment

Abstract Background: Postoperative pain is a common disorder that interferes with the quality of sleep after nasal endoscopic surgery and delays postoperative recovery. Acupuncture is an effective tool for pain management. However, electroacupuncture specifically for the relief of postoperative pain after nasal endoscopic surgery has not yet been studied through a randomized controlled trial. Method/Design: A randomized, sham-controlled, patient- and- assessor-blind trial is designed to evaluate the efficacy and safety of acupuncture in managing postoperative pain following nasal endoscopic surgery of sinusitis with nasal polyps. There will be 30participants randomly allocated to an electroacupuncture or non-invasive sham control in a 1:1 ratio. Treatment will be done within 2 hours before operation, immediately after the operation upon arrival to the recovery ward, and once daily for 3 days. The primary outcome of the Pain Numerical Rating Scale (NRS) will be analyzed using the area-under-the-curve (AUC) method. The secondary outcome measures include Heart Rate (HR) and Blood Pressure (BP) after operation, the sleep quality during the hospital stay (Actigragh),Quality of Recovery-15 (QoR-15), and the MOS item short form health survey (SF-36). ITT analysis will be used in this RCT. Discussion: This trial protocol provides an example of clinical application for the management of postoperative pain using electroacupuncture treatment. If the electroacupuncture treatment protocol confirms that this treatment method is effective and safe, it can be implemented as a standard of care for relieving postoperative pain in Chinese and Western medicine.

scholarly journals Electroacupuncture for postoperative pain after nasal endoscopic surgery: study protocol for a pilot randomized controlled trial

2020 ◽  
Author(s):  
Shanshan Li ◽  
Qing Zhang ◽  
Xuan Yin ◽  
Hongyu Yue ◽  
Wei Zhang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Controlled Trial ◽  
Postoperative Pain ◽  
Endoscopic Surgery ◽  
Short Form ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

Abstract Background: Postoperative pain is a common disorder that interferes with the quality of sleep after nasal endoscopic surgery and delays postoperative recovery. Acupuncture is an effective tool for pain management. However, electroacupuncture specifically for the relief of postoperative pain after nasal endoscopic surgery has not yet been studied through a randomized controlled trial. Method/Design: A pilotrandomized, sham-controlled, patient- and- assessor-blind trial is designed to evaluate the efficacy and safety of electroacupuncturein managing postoperative pain following nasal endoscopic surgery of sinusitis with nasal polyps. There will be 30participants randomly allocated to an electroacupuncture or non-invasive sham control in a 1:1 ratio. Treatment will be done within 2 hours before operation, immediately after the operation upon arrival to the recovery ward, and once daily for 3 days. The primary outcome of the Pain Numerical Rating Scale (NRS) will be analyzed using the area-under-the-curve (AUC) method. The secondary outcome measures include Heart Rate (HR) and Blood Pressure (BP) after operation, the sleep quality during the hospital stay (Actigragh),Quality of Recovery-15 (QoR-15), and the MOS item short form health survey (SF-36). ITT analysis will be used in this RCT. Discussion: This pilot randomized controlled trial will explore the feasibility of further clinical application for the management of postoperative pain using electroacupuncture treatment, and it will inform the design of a further full-scale trial. Trial Registration: Chinese Clinical Trial Registry, ChiCTR1900024183, Date: 2019-06-29. URL: http://www.chictr.org.cn/showproj.aspx?proj=40573 Keywords: Electroacupuncture; postoperative pain;nasal endoscopic surgery; RCT; randomized controlled trial; clinical trial

scholarly journals Effect of posterior quadratus lumborum blockade on the quality of recovery after major gynaecological laparoscopic surgery: A randomized controlled trial

2019 ◽  
Vol 47 (2) ◽  
pp. 146-151 ◽  
Author(s):  
Hiroko Fujimoto ◽  
Tomoya Irie ◽  
Takahiro Mihara ◽  
Yusuke Mizuno ◽  
Takeshi Nomura ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Laparoscopic Surgery ◽  
Postoperative Pain ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Control Group ◽  
Quality Of Recovery ◽  
Randomized Controlled ◽  
Quadratus Lumborum

Bilateral quadratus lumborum blockade (QLB) using ultrasound guidance has been introduced as an abdominal truncal block to improve postoperative analgesia and quality of recovery (QoR) after abdominal surgery, but efficacy remains controversial. The primary aim of this study was to evaluate the efficacy of posterior QLB on the postoperative QoR, and secondarily to evaluate postoperative pain after gynaecological laparoscopic surgery (LS). This study was a single-centre randomized controlled trial. QLB group patients underwent bilateral posterior quadratus lumborum injections with 25–30 mL of 0.25% levobupivacaine after induction of general anaesthesia; the control group underwent no block. Both groups were administered fentanyl-based intravenous patient-controlled analgesia postoperatively. The postoperative QoR was measured using the Quality of Recovery 40 (QoR-40) questionnaire score; postoperative pain was evaluated using the visual analogue scale (VAS) and the cumulative postoperative fentanyl dose. Thirty-one and 29 patients were randomised to the QLB and control groups, respectively. The intraoperative remifentanil dosage was significantly less in the QLB group. The median (interquartile range) for the QoR-40 score was not different between the groups: 154 (133–168) in the QLB group and 158 (144–172) in the control group. There were no statistically significant differences in secondary outcome variables. Single-shot QLB did not improve the QoR or postoperative pain in patients managed by multimodal analgesia after gynaecological LS.

scholarly journals Does regular strength training cause urinary incontinence in overweight inactive women? A randomized controlled trial

2021 ◽  
Author(s):  
Kari Bø ◽  
Lene Anette H. Haakstad ◽  
Gøran Paulsen ◽  
Anne Mette Rustaden
Keyword(s):  
Randomized Controlled Trial ◽  
Urinary Incontinence ◽  
Strength Training ◽  
Short Form ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Control Group ◽  
Randomized Controlled ◽  
Sum Score ◽  
New Onset

Abstract Introduction and hypothesis Urinary incontinence (UI) is common in women who exercise. We aimed to investigate new onset UI in formerly inactive, overweight or obese women (BMI > 25) participating in three different strength training modalities compared with a non-exercising control group. Methods This was a secondary analysis of an assessor blinded randomized controlled trial investigating the effect of 12 weeks of three strength training concepts for women on muscle strength and body composition. None of the programs included pelvic floor muscle training. International Consensus on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI-SF) was used to investigate primary outcome; new onset UI, and secondary outcome; ICIQ-UI-SF sum score. Suissa and Shuster’s exact unconditional test was used to analyze difference in new onset UI. Difference in ICIQ-UI-SF sum score is presented as mean with 95% CI. Results At baseline 40 out of 128 (31.2%) participants reported UI. Three out of 27, 2 out of 17, 2 out of 23, and 0 out of 21 women in the three training and control groups respectively had new onset UI. There were no statistically significant differences in new onset UI across the groups or when collapsing new onset UI in the intervention groups compared with the controls (7 out of 67 vs 0 out of 21), p = 0.124. After the intervention the control group reported worse ICIQ-UI-SF sum score than any of the training groups; mean difference − 6.6 (95% CI: −11.9, −1.27), p = 0.012, but there was no difference in change from baseline to 12 weeks between the groups p = 0.145). Conclusions There was no statistically significant change in UI after strength training.

The Therapeutic Effects of Acupuncture on Patients with Chronic Neck Myofascial Pain Syndrome: A Single-Blind Randomized Controlled Trial

2010 ◽  
Vol 38 (05) ◽  
pp. 849-859 ◽  
Author(s):  
Mei-Yuan Sun ◽  
Ching-Liang Hsieh ◽  
Yung-Yen Cheng ◽  
Hung-Chang Hung ◽  
Tsai-Chung Li ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Myofascial Pain ◽  
Short Form ◽  
Controlled Trial ◽  
Pain Syndrome ◽  
Myofascial Pain Syndrome ◽  
Randomized Controlled ◽  
Single Blind

Chronic neck myofascial pain syndrome (MPS) is a common disorder seen in clinics. There is no gold standard method to treat myofascial pain. We investigated the effects of acupuncture on patients with chronic neck MPS by a single-blind randomized controlled trial. A total of 35 patients were randomly allocated to an acupuncture group (AG) or a sham acupuncture group (SG). Each subject received acupuncture treatment twice per week for three consecutive weeks. The primary outcome measure was quality of life as assessed with Short Form-36, and secondary outcome measures were neck range of motion (ROM), motion-related pain, and Short-Form McGill Pain Questionnaire (SF-MPQ), as determined by a blinded investigator. The clinical assessments were made before treatment (BT) and after six acupuncture treatments (AT), as well as four weeks (F1) and 12 weeks (F2) after the end of the treatment. A total of 34 patients completed the trial. The results indicated that there is no significant difference in the ROM, motion-related pain, and SF-MPQ scores between AG and SG at AT, F1 and F2 (all p > 0.05). However, AG has greater improvement in physical functioning and role emotional of Short Form-36 quality of life at F2. The results indicate that acupuncture may be used to improve the quality of life in patients with chronic neck MPS.

scholarly journals Taking Charge after Stroke: A randomized controlled trial of a person-centered, self-directed rehabilitation intervention

2020 ◽  
Vol 15 (9) ◽  
pp. 954-964 ◽  
Author(s):  
Vivian Fu ◽  
Mark Weatherall ◽  
Kathryn McPherson ◽  
William Taylor ◽  
Anna McRae ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Physical Component Summary ◽  
Short Form ◽  
Controlled Trial ◽  
Short Form 36 ◽  
Randomized Controlled ◽  
Rehabilitation Intervention ◽  
Related Quality

Background and purpose “Take Charge” is a novel, community-based self-directed rehabilitation intervention which helps a person with stroke take charge of their own recovery. In a previous randomized controlled trial, a single Take Charge session improved independence and health-related quality of life 12 months following stroke in Māori and Pacific New Zealanders. We tested the same intervention in three doses (zero, one, or two sessions) in a larger study and in a broader non-Māori and non-Pacific population with stroke. We aimed to confirm whether the Take Charge intervention improved quality of life at 12 months after stroke in a different population and whether two sessions were more effective than one. Methods We randomized 400 people within 16 weeks of acute stroke who had been discharged to institution-free community living at seven centers in New Zealand to a single Take Charge session (TC1, n = 132), two Take Charge sessions six weeks apart (TC2, n = 138), or a control intervention (n = 130). Take Charge is a “talking therapy” that encourages a sense of purpose, autonomy, mastery, and connectedness with others. The primary outcome was the Physical Component Summary score of the Short Form 36 at 12 months following stroke comparing any Take Charge intervention to control. Results Of the 400 people randomized (mean age 72.2 years, 58.5% male), 10 died and two withdrew from the study. The remaining 388 (97%) people were followed up at 12 months after stroke. Twelve months following stroke, participants in either of the TC groups (i.e. TC1 + TC2) scored 2.9 (95% confidence intervals (CI) 0.95 to 4.9, p = 0.004) points higher (better) than control on the Short Form 36 Physical Component Summary. This difference remained significant when adjusted for pre-specified baseline variables. There was a dose effect with Short Form 36 Physical Component Summary scores increasing by 1.9 points (95% CI 0.8 to 3.1, p < 0.001) for each extra Take Charge session received. Exposure to the Take Charge intervention was associated with reduced odds of being dependent (modified Rankin Scale 3 to 5) at 12 months (TC1 + TC2 12% versus control 19.5%, odds ratio 0.55, 95% CI 0.31 to 0.99, p = 0.045). Conclusions Confirming the previous randomized controlled trial outcome, Take Charge—a low-cost, person-centered, self-directed rehabilitation intervention after stroke—improved health-related quality of life and independence. Clinical trial registration-URL http://www.anzctr.org.au . Unique identifier: ACTRN12615001163594

scholarly journals Relapse after conservative surgery combined with Triptorelin Acetate versus conservative surgery only in women with focal adenomyosis: study protocol for a multicenter, prospective, randomized controlled trial

2019 ◽  
Author(s):  
Wenwen Wang ◽  
Xiangyi Ma ◽  
Wei Zhang ◽  
Zhiying Li ◽  
Yan Wang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Recurrence Rate ◽  
Rating Scale ◽  
Short Form ◽  
Controlled Trial ◽  
Conservative Surgery ◽  
Postoperative Treatment ◽  
Randomized Controlled ◽  
Prospective Randomized Controlled Trial ◽  
Triptorelin Acetate

Abstract Background: To preserve fertility or integrity of organs was on the rise for the most women with adenomyosis. Adenomyomectomy is now a widely applied conservative surgery, however relapse is a serious problem after operation. Postoperative treatment, such as gonadotropin-releasing hormone agonist (GnRHa) has been suggested to result in reducing the recurrence rate in patients. However, there is still a lack of evidence from randomized clinical trials comparing the efficacy of GnRHa for decreasing the postoperative recurrence rate. Method/Design：Relapse after conservative surgery combined with Triptorelin Acetate versus conservative surgery only in women with focal adenomyosis is a multicenter, prospective, randomized controlled trial. The primary outcome is relapse accessed with Visual Analogue Scale (VRS) and Numeric Rating Scale (NRS), Pictorial blood loss assessment chart (PBAC) score and the size of uterus and lesion are measured by two/three-dimensional color doppler ultrasonography (2D/3D-CDUS) or magnetic resonance imaging (MRI). The secondary outcomes include quality of life, clinical pregnancy, ovarian reserve, and adverse events, assessing by Short Form (36) Health Survey and Female Sexual Function index, serum follicle-stimulating hormone, estradiol levels and anti-muellerian hormone and so on. All these indexes are measured at 3, 6, 12, 18, 24, 30, 36 months after conservative surgery. Discussion：The result of this large multicenter randomized trial will provide evidence for one of the strategies of long-term management in focal adenomyosis after conservative operation.

scholarly journals Consumption of OLL1073R-1 yogurt improves psychological quality of life in women healthcare workers: secondary analysis of a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Tetsu Kinoshita ◽  
Koutatsu Maruyama ◽  
Keiko Suyama ◽  
Mariko Nishijima ◽  
Kimiko Akamatsu ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Healthcare Workers ◽  
Short Form ◽  
Controlled Trial ◽  
Lactobacillus Delbrueckii ◽  
Control Group ◽  
Randomized Controlled ◽  
Psychological Quality Of Life

Abstract Background We conducted a randomized controlled trial to investigate the effects of consumption of yogurt fermented with Lactobacillus delbrueckii ssp. bulgaricus OLL1073R-1 in women healthcare workers. In a previous study we used these data to investigate hypothesized preventive effects against flu, however any effects on improving mental quality of life were not analyzed at that time. In the present study, we focus on that aspect. Methods The participants (961 women; mainly nurses, aged 20–71 years) were randomly allocated to either the yogurt group (n = 479) or the control group (n = 482). Participants in the yogurt group drank 112 mL of OLL1073R-1 yogurt for 16 weeks, while those in the control group did not consume any yogurt. All participants were prohibited from consuming other yogurt or fermented dairy products during the study period. The participants answered the Pittsburgh Sleep Quality Index (PSQI), Short Form-8 Health Survey (SF-8), and Gastrointestinal Symptom Rating Scale (GSRS) questionnaires at baseline and after 16 weeks. Results The PSQI score showed significant improvement after the intake of yogurt (p < 0.01). SF-8 results showed significant intervention effects in the General Health and Vitality scores (p = 0.02 and p = 0.01, respectively). In other subscales of SF-8, we did not observe significant effects of the yogurt. In the GSRS, daily intake of yogurt exerted a preventive effect on constipation (p = 0.03). Conclusions Consumption of yogurt fermented with Lactobacillus delbrueckii ssp. bulgaricus OLL1073R-1 enhances subjective psychological quality of life by improving quality of sleep and gastrointestinal condition among women healthcare workers.

scholarly journals Immediate effect of an acupressure strap simulating wrist-ankle acupuncture on menstrual pain in young women: study protocol for a randomized controlled trial

2019 ◽  
Author(s):  
Shu-jie Zhai ◽  
Yi Ruan ◽  
Yue Liu ◽  
Zhen Lin ◽  
Chen Xia ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Outcome Measures ◽  
Analgesic Effect ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Control Group ◽  
Pain Intensity Score ◽  
Primary Dysmenorrhea ◽  
Randomized Controlled

Abstract Background: Dysmenorrhea seriously affects the ability to perform normal social activities and decreases quality of life. Primary dysmenorrhea can be effectively treated with acupuncture. Based on the wrist-ankle acupuncture (WAA) theory, we designed a portable WAA point compression treatment strap that treats diseases by automatically applying pressure to acupuncture points. The proposed study aims to evaluate the analgesic effect of the acupressure wrist-ankle strap in patients with primary dysmenorrhea. Methods: The study will be a randomized controlled trial conducted from 1 May 2019 30 May 2020 that includes 78 students from Shanghai University of Traditional Chinese Medicine who have primary dysmenorrhea and meet the eligibility criteria. Participants will be randomly divided into two groups in a 1:1 allocation ratio. The intervention group will use the acupressure wrist-ankle strap equipped with tip compression component parts on the internal side; the control group will use the non-acupressure wrist-ankle strap with the tip compression parts removed. All participants will be treated for 30 min on the first day of menstruation. The main outcome measures are the pain intensity score measured by the visual analogue scale, and the onset time of analgesia. The secondary outcome measures are the pain threshold at Yinlingquan (SP 9) , skin temperature at Guanyuan (CV 4) , and expectations and satisfaction of patients as investigated via the Expectation and Treatment Credibility Scale. Discussion: This trial will be the first study to evaluate the analgesic effect of the acupressure wrist-ankle strap in patients with primary dysmenorrhea. The quality of this study is ensured by the strict randomization, non-acupressure control, and blinded design. The results may provide a potential alternative treatment for primary dysmenorrhea and evidence-based proof of the analgesic effect of WAA. Trial registration: Chinese Clinical Trial Registry, ID: ChiCTR1900021727. Registered on 7 March 2019. http://www.chictr.org.cn/listbycreater.aspx

scholarly journals Cerebral Mechanism of Tuina Analgesia in Management of Knee Osteoarthritis using multimodal MRI: Study Protocol for a Randomized Controlled Trial

2021 ◽  
Author(s):  
Guangxin Guo ◽  
Yazhuo Kong ◽  
Qingguang Zhu ◽  
Zhiwei Wu ◽  
Shuaipan Zhang ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Chronic Pain ◽  
Randomized Controlled Trial ◽  
Short Form ◽  
Controlled Trial ◽  
Clinical Assessments ◽  
Randomized Controlled ◽  
Education Group ◽  
Multimodal Mri

Abstract Background: Chronic pain of patients with knee osteoarthritis (KOA) seriously affects the quality of life and leads to the heavy social and economic burden. As one of the representative non-drug therapies in Traditional Chinese Medicine (TCM), Tuina has been generally recognized as safe and effective for reducing the chronic pain of KOA, however the underlying central mechanisms of Tuina for improving the pain of KOA are not fully understood.Methods/design: This study is a randomized controlled trial with parallel-group design. In total, 60 eligible participants will be randomly assigned to a Tuina group and a health care education group (Education group) in a 1:1 ratio with gender and age matched. The interventions of both groups will last for 30 min per session and be conducted twice each week for 12 weeks. This study will focus on detecting the changes of brain gray matter structure (GM), white matter structure (WM), the cerebral functional connectivity (FC) elicited by Tuina treatment, e.g thalamus, hippocampus, anterior cingulate gyrus, S1, insula, the periaqueductal gray subregions (PAG) etc. The two groups of patients will be evaluated by clinical assessments and multimodal magnetic resonance imaging (MRI) at the baseline and the end of 6 and 12 weeks’ treatment, and still be evaluated by clinical assessments for 48 weeks of follow-up. The Visual Analog Scale (VAS) of current pain, Short-form McGill Pain Questionnaire (SF-MPQ), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), the 36-Item Short Form Health Survey (SF-36), Hamilton Depression Scale (HAMD) and the Hamilton Anxiety Scale (HAMA) will be used to evaluate the pain intensity, pain feeling, pain emotion, clinical symptoms and quality of life respectively. The evaluators and statisticians will be blinded to the group allocation. The repeated measures analysis of variance (2 groups × 6 time points ANOVA) will be employed to analyze numerical variables of the clinical and neuroimaging data obtained in the study. P<0.05 will be the statistical significance level. Discussion: The results of this randomized controlled trial with clinical assessments and multimodal MRI will help to reveal the influence of Tuina treatment on the potential morphological changes of cortical and subcortical brain structures, the white matter integrity and the functional activities and connectivity of brain regions of patients with KOA, which might provide scientific evidence for the clinical application of Tuina in management of KOA.Trial registration: Chinese Clinical Trial Registry: ChiCTR2000037966. Date of Registration: 8, Sep. 2020. http://www.chictr.org.cn/edit.aspx?pid=61083&htm=4

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