scholarly journals Acupuncture for osteoporosis: study protocol for a randomized controlled trial

2020 ◽  
Author(s):  
M Huang ◽  
MX Lai ◽  
XY Wang ◽  
YF Wang ◽  
J Yang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Control Group ◽  
Primary Osteoporosis ◽  
Randomized Controlled ◽  
Acupuncture And Moxibustion ◽  
One Year ◽  
Experimental Group

Abstract Background: The rapid increase in the prevalence of osteoporosis and the rate of fractures after osteoporosis indicates that osteoporosis has become a serious global public health problem. A recent meta-analysis showed that oral alendronate and parenteral injection of zoledronate had no statistical significance in preventing postmenopausal hip fractures. Acupuncture and moxibustion are widely used in the treatment of osteoporosis due to their good analgesic effects. Early observation showed that integral adjustment of acupuncture and moxibustion therapy could improve the quality of life of patients with osteoporosis and prevent the occurrence of osteoporosis fractures. As the observation period of fracture is too long, it is necessary to carry out a large and strictly designed multi-center randomized trial covering the risk factors of fracture and fracture induction, so as to evaluate the effectiveness of acupuncture and moxibustion in the treatment of primary osteoporosis.Methods/Design: A multicenter randomized controlled trial will be performed in three hospitals. 312 participants patients within primary osteoporosis will be divided into an experimental group and a control group randomly. The experimental group is treated with acupuncture and western medicine while the control group is treated with Western medicine. All the patients will receive a 3-month treatment and 6-month,and one year follow-ups. The primary outcome is the bone mineral density (BMD), the secondary outcome is Bone-derived alkaline phosphatase(BALP), bone glaprotein(BGP), visual pain scale score(VAS),Traditional Chinese Medicine (TCM) syndrome scores, quality of daily life score(QOL) and adverse events. Outcome measures (including primary and secondary outcome measures) are collected at baseline,3 months of the intervention, Causes and number of falls are collected at 6 months and one year after the intervention.Discussion: This study will provide clinical evidence for the treatment of primary osteoporosis with holistic adjustment acupuncture. This study will evaluate the synergistic effect of acupuncture treatment for primary osteoporosis and provide evidence for clinical treatment.Trial registration: This trial was registed at Chinese Clinical Trial Registry, registration date: 5 August 2018.URL:http://www.chictr.org.cn,registration number:ChiCTR1800017581.

scholarly journals Effectiveness of Hydrogalvanic Bath on Improving Pain, Disability, and Quality of Life in Individuals with Chronic Nonspecific Neck Pain: A Randomized Controlled Trial

2020 ◽  
Vol 2020 ◽  
pp. 1-7
Author(s):  
Mastour Saeed Alshahrani ◽  
Jaya Shanker Tedla ◽  
Ravi Shankar Reddy ◽  
Faisal Asiri
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Pain Disability ◽  
Sf 36 ◽  
Neck Disability ◽  
Experimental Group

Background. Neck pain is one of the world’s leading factors in years lived with disability. Ambiguity in the effect of electrotherapy modalities for the treatment of chronic nonspecific neck pains (CNSNP) needs to be examined further. This study sought to elucidate the effectiveness of hydrogalvanic bath on improving pain, disability, and quality of life among individuals with CNSNP. Methods. Thirty-four individuals with a diagnosis of CNSNP were selected through convenient sampling and randomly divided into two groups by block randomization. The control group treatment underwent low Transcutaneous Electrical Nerve Stimulation (TENS) and exercise, and the experimental group was subjected to hydrogalvanic bath therapy (HGBT) and exercise. Individuals were evaluated for pain using a visual analog scale (VAS), disability with the Neck Disability Index (NDI), and quality of life with Short Form-36 (SF-36). These measures were applied at baseline and after 12 weeks of treatment. Results. The pretreatment and posttreatment results for VAS, NDI, and SF-36 were compared for both control and experimental groups. We found that all the three variables showed significant differences between the two time points with p < 0.05 in both the groups but the experimental group improvements were more significant than the control group with p < 0.05 . Conclusion. Twelve weeks of low TENS or HGBT along with exercises can decrease pain and neck disability and increase the quality of life in individuals with CNSNP. However, HGBT along with exercise has superior effects relative to low TENS along with exercise. This randomized controlled trial was registered in the International Standard Randomized Controlled Trials Number-ISRCTN29695190 and registered on 05/02/2020. This study is a retrospective registration.

scholarly journals Effects of Virtual Reality Associated With Serious Games for Upper Limb Rehabilitation in Patients With Multiple Sclerosis. a Randomized Controlled Trial

2020 ◽  
Author(s):  
Alicia Cuesta-Gómez ◽  
Patricia Sanchez-Herrera Baeza ◽  
Edwin Daniel Oña-Simbaña ◽  
Alicia Martínez-Medina ◽  
Carmen Ortiz-Comino ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Multiple Sclerosis ◽  
Randomized Controlled Trial ◽  
Serious Games ◽  
Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Experimental Group

Abstract Background: Dexterity and activities of daily living limitations on the upper limb (UL) represent one of the most common problems in patients with multiple sclerosis (MS). The aim of this study was to evaluate the effectiveness of the specially developed Serious Games that make use of the Leap Motion Controller (LMC) as main user interface for improving UL grip muscle strength, dexterity, fatigue, quality of life, satisfaction and compliance. Methods: A single-blinded randomized controlled trial was conducted. The sample was randomized into two groups: an experimental group who received treatment based on serious games designed by the research team using the developed LMC based Serious Games for the UL plus conventional rehabilitation, and a control group who received the same conventional rehabilitation for the UL. Both groups received two 60 min sessions per week over a ten-week period. Grip muscle strength, coordination, speed of movements, fine and gross UL dexterity, fatigue, quality of life, satisfaction and compliance were assessed in both groups pre-treatment, post-treatment and in a follow-up period of one month without receiving any treatment. Results : In the experimental group compared to the control group, significant improvements were observed in the post-treatment assessment for coordination, speed of movements, fine and gross UL dexterity. Also, significant results were found in the follow-up in coordination, speed of movements, fine and gross for the more affected side. Conclusions: An experimental protocol using an LMC based Serious Games designed for UL rehabilitation showed improvements for unilateral gross manual dexterity, fine manual dexterity, and coordination in MS patients with high satisfaction and excellent compliance.

The effectiveness of a non-guided mindfulness application on perceived stress in a non-clinical Dutch population: a Randomized Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Leonieke W Kranenburg ◽  
Jamie Gillis ◽  
Birgit Mayer ◽  
Witte JG Hoogendijk
Keyword(s):  
Randomized Controlled Trial ◽  
Perceived Stress ◽  
Psychological Symptoms ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Control Group ◽  
Dutch Population ◽  
Randomized Controlled ◽  
Experimental Group

BACKGROUND Mindfulness has become increasingly popular and positive outcomes have been reported for mindfulness-based interventions (MBIs) to reduce stress. These findings make room for innovative perspectives on how MBIs could be applied, for instance through mHealth. OBJECTIVE The aim of this study is to investigate if a non-guided mindfulness mobile phone application can decrease perceived stress in a non-clinical Dutch population over the course of eight weeks, with follow-up at six months. METHODS A randomized controlled trial (RCT) was performed, comparing the experimental group that made use of a structured 8-week mHealth mindfulness program and a control group after 8 weeks, with follow-up after six months. Participants were recruited via a national television program. The primary outcome measure was perceived stress as measured by the Perceived Stress scale (PSS), secondary outcomes were symptoms of burnout (VAS) and psychological symptoms (measured by the four-dimensional symptom questionnaire ; 4DSQ at follow-up). Outcomes were analyzed using a multilevel regression model. RESULTS At baseline, 587 respondents were included. Results showed no differences between groups for the level of perceived stress. With regard to the secondary outcome measures, the VAS for emotional exhaustion and physical exhaustion showed statistically significant lower scores for the experimental group after 8 weeks (resp. p=.04 and p= .01), but not at follow-up. There were also no differences between groups found for psychological symptoms. CONCLUSIONS These findings do not support our hypothesis that using the mindfulness app would reduce stress levels. However, findings with regard to diminished exhaustion at 8 weeks are encouraging and require further investigation.

scholarly journals Effects of virtual reality associated with serious games for upper limb rehabilitation in patients with multiple sclerosis. A randomized controlled trial

2020 ◽  
Author(s):  
Alicia Cuesta-Gómez ◽  
Patricia Sanchez-Herrera Baeza ◽  
Edwin Daniel Oña-Simbaña ◽  
Alicia Martínez-Medina ◽  
Carmen Ortiz-Comino ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Multiple Sclerosis ◽  
Randomized Controlled Trial ◽  
Serious Games ◽  
Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Experimental Group

Abstract Background: Dexterity and activities of daily living limitations on the upper limb (UL) represent one of the most common problems in patients with multiple sclerosis (MS). The aim of this study was to evaluate the effectiveness of the specially developed Serious Games that make use of the Leap Motion Controller (LMC) as main user interface for improving UL grip muscle strength, dexterity, fatigue, quality of life, satisfaction and compliance.Methods: A single-blinded randomized controlled trial was conducted. The sample was randomized into two groups: an experimental group who received treatment based on serious games designed by the research team using the developed LMC based Serious Games for the UL plus conventional rehabilitation, and a control group who received the same conventional rehabilitation for the UL. Both groups received two 60 min sessions per week over a ten-week period. Grip muscle strength, coordination, speed of movements, fine and gross UL dexterity, fatigue, quality of life, satisfaction and compliance were assessed in both groups pre-treatment, post-treatment and in a follow-up period of one month without receiving any treatment.Results: In the experimental group compared to the control group, significant improvements were observed in the post-treatment assessment for coordination, speed of movements, fine and gross UL dexterity. Also, significant results were found in the follow-up in coordination, speed of movements, fine and gross for the more affected side. Conclusions: An experimental protocol using an LMC based Serious Games designed for UL rehabilitation showed improvements for unilateral gross manual dexterity, fine manual dexterity, and coordination in MS patients with high satisfaction and excellent compliance. Trial registration: This randomized controlled trial has been registered at ClinicalTrials.gov Identifier: NCT04171908, Nov 2019.

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 Effects of Virtual Reality Associated With Serious Games for Upper Limb Rehabilitation in Patients With Multiple Sclerosis. a Randomized Controlled Trial

2020 ◽  
Author(s):  
Alicia Cuesta-Gómez ◽  
Patricia Sanchez-Herrera Baeza ◽  
Edwin Daniel Oña-Simbaña ◽  
Alicia Martínez-Medina ◽  
Carmen Ortiz-Comino ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Multiple Sclerosis ◽  
Randomized Controlled Trial ◽  
Serious Games ◽  
Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Experimental Group

Abstract Background: Dexterity and activities of daily living limitations on the upper limb (UL) represent one of the most common problems in patients with multiple sclerosis (MS). The aim of this study was to evaluate the effectiveness of the specially developed Serious Games that make use of the Leap Motion Controller (LMC) as main user interface for improving UL grip muscle strength, dexterity, fatigue, quality of life, satisfaction and compliance. Methods: A single-blinded randomized controlled trial was conducted. The sample was randomized into two groups: an experimental group who received treatment based on serious games designed by the research team using the developed LMC based Serious Games for the UL plus conventional rehabilitation, and a control group who received the same conventional rehabilitation for the UL. Both groups received two 60 min sessions per week over a ten-week period. Grip muscle strength, coordination, speed of movements, fine and gross UL dexterity, fatigue, quality of life, satisfaction and compliance were assessed in both groups pre-treatment, post-treatment and in a follow-up period of one month without receiving any treatment. Results : In the experimental group compared to the control group, significant improvements were observed in the post-treatment assessment for coordination, speed of movements, fine and gross UL dexterity. Also, significant results were found in the follow-up in coordination, speed of movements, fine and gross for the more affected side. Conclusions: An experimental protocol using an LMC based Serious Games designed for UL rehabilitation showed improvements for unilateral gross manual dexterity, fine manual dexterity, and coordination in MS patients with high satisfaction and excellent compliance.

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 Laser Acupuncture Alleviates Symptoms and Improves Quality of Life in Women with Overactive Bladder: A Double-Blind, Pilot Randomized Controlled Trial

2020 ◽  
Vol 2020 ◽  
pp. 1-11
Author(s):  
Yu-Wei Chang ◽  
Tsia-Shu Lo ◽  
Hsin-Ning Chang ◽  
Yi-Hsien Shiao ◽  
Yuan-Chieh Yeh
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Overactive Bladder ◽  
Controlled Trial ◽  
Laser Acupuncture ◽  
Control Group ◽  
Double Blind ◽  
Randomized Controlled ◽  
Experimental Group

Objective. The aim of this study was to investigate the clinical efficacy of laser acupuncture for the treatment of women with overactive bladder (OAB) in Taiwan. Methods. A double-blind randomized controlled trial was conducted on female patients with OAB symptoms referred from gynecologists, and subjects were divided into two groups using blocked randomization. LaserPan (RJ-Laser, Germany) was applied to seven selected acupuncture points. The subjects received laser acupuncture 3 times per week for 3 weeks, 9 sessions in total. Basic patient data, Overactive Bladder Symptom Score (OABSS), Incontinence Impact Questionnaire (IIQ-7), and Urogenital Distress Inventory (UDI-6) scores were recorded prior to first treatment and at the end of 3rd, 6th, and 9th treatments. Results. Thirty patients were enrolled, and twenty-seven patients completed all treatments in this study. The OABSS total score of the experimental group decreased significantly by 3.13 (p≤0.001), 4.60 (p≤0.001), and 3.79 (p≤0.001) after 3rd, 6th, and 9th treatments, respectively, compared with that of the control group. The IIQ-7 score declined significantly from baseline by 4.57 (p=0.003) and 3.63 (p=0.023) after 3rd and 6th treatments, respectively, compared with that of the control group. Similarly, the UDI-6 score of the experimental group exhibited a significant decrease from baseline by 1.90 (p=0.042) and 2.25 (p=0.025) after 6th and 9th interventions, respectively, compared with that of the control group. Conclusions. This study demonstrates that laser acupuncture can alleviate OAB symptoms and improve quality of life. This noninvasive device could be an effective therapy for women with OAB.

scholarly journals Effect of Customized Insoles on Gait in Post-Stroke Hemiparetic Individuals: A Randomized Controlled Trial

Biology ◽  
2021 ◽  
Vol 10 (11) ◽  
pp. 1187
Author(s):  
Jie Wang ◽  
Lei Qiao ◽  
Long Yu ◽  
Yanmin Wang ◽  
Redha Taiar ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Stance Phase ◽  
Controlled Trial ◽  
Weight Bearing ◽  
Gait Training ◽  
Secondary Outcome ◽  
Control Group ◽  
Stroke Patients ◽  
Randomized Controlled ◽  
Experimental Group

Background: Insoles have been widely applied to many diseases, but stroke involves complex problems and there is a paucity of research on the application of insoles in stroke patients. Aim: To evaluate the effect of customized insoles on gait in patients with hemiplegia. Design: A randomized controlled trial. Setting: Rehabilitation department of a hospital. Population: A total of 50 stroke patients were randomized into an experimental group (n = 25) or a control group (n = 25). Methods: Both groups received conventional gait training, which was conducted five times a week, every 40 min for four weeks and patients in the experimental group were required to wear customized insoles for at least 1 h per day for four weeks. The primary outcome measure was the Tinetti Gait Scale (TGS) and the secondary outcome measures were the plantar pressure test, 6-min walking test (6MWT), lower extremity Fugl–Meyer assessment (FMA-LE), Berg Balance Scale (BBS), and the modified Barthel index (MBI). Results: Compared to the control group, there were significant increases in the experimental group after four weeks (p = 0.014) and at the four week follow-up (p = 0.001) in the change in TGS, weight-bearing on the involved side (p = 0.012) or forefoot (p = 0.028) when standing, weight-bearing on the involved side (p = 0.01 6) or forefoot (p = 0.043) when walking, early stance phase (p = 0.023) and mid stance phase (p = 0.013) on the involved side, FMA-LE (p = 0.029), BBS (p = 0.005), and MBI (p = 0.009), but there were no differences in the late stance phase (p = 0.472) on the involved side when walking or in the 6MWT (p = 0.069). Conclusions: Customized insoles had great efficacy in enhancing gait performance in stroke patients.

scholarly journals Individualized Diet and Lifestyle Modifications Reverse Symptoms of Systemic Lupus Erythematosus (Preprint)

2018 ◽  
Author(s):  
Daniel Rothman ◽  
Faiz Khan ◽  
Vanessa Rudin
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Effect Size ◽  
Controlled Trial ◽  
Health Coaching ◽  
Control Group ◽  
Sustained Remission ◽  
Randomized Controlled ◽  
Experimental Group

BACKGROUND There is increasing evidence that digital therapeutic tools can bring personalized medicine to the masses improving outcomes and decreasing cost. Many factors influence the expression of autoimmune disease, and understanding and removing these underlying triggers provides an opportunity to minimize use of medications and some patients can achieve sustained remission if the right triggers for a patient are identified. This randomized controlled trial is the first to test the efficacy of a digital therapeutic intervention which combines adaptive patient generated health data tracking with health coaching to identify factors triggering lupus and to evaluate reductions in symptoms, and improvements in quality of life. OBJECTIVE Evaluate impact of personalized dietary and environmental interventions on quality of life and health care costs. METHODS This a randomized controlled trial using a convenience sample. The Mann-Whitney U test determined that a sample size of 40 patients (20 intervention and 20 control) provides a power of 80% for continuous and ordinal variables. The Bonferroni Correction was used to ensure that the probability of a type 1 error is less than 5% even with the large number of hypotheses being tested. Subjects in both groups received standard of care from their physicians. All subjects repeated the online questionnaires (Fatigue Scale - FACIT, Lupus QOL, and BPI-SF) at weeks 4, 8, 12, and 16. The experimental group going through the mymee protocol received health coaching (weekly calls to educate and implement changes based on data analysis). Digital data collection and tracking was used to correlate dietary/lifestyle/environmental patterns with symptoms. The control group completed the same assessments during the 16 week intervention period but did not receive any additional coaching. The intervention uses correlations between symptoms and triggers that are reported daily to create an iterative cycle of hypotheses tailored to each individual. With 5 min of tracking a day using the app, patients easily report what they have eaten, other triggers, and their symptoms. Using our machine learning platform, coaches identify each patient’s personal disease triggers and help patients implement changes to remove them. RESULTS The interim results of the study showed that 78% improved in the experimental group and 36% in the control group with a P<.01. Furthermore, 67% of the patients have gone off some or all of their drugs after consulting with their doctors. CONCLUSIONS Results show a significant improvement for lupus patients who completed the protocol, demonstrating the potential for digital therapeutics to dramatically improve the quality of life for patients diagnosed not only with lupus, but other chronic diseases (80% of the trial patients also had rheumatoid arthritis). Broad adoption of the mymee intervention could assist in building a database of lupus triggers and symptoms that could lead to further understanding the causes of lupus. Based on interim results, a 78/36 effect size is competitive if not more effective than current drugs in the pipeline like Stelara which shows a 60/31 effect size and includes potential side effects of drug-induced MS and cancer.

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