Milk protein consumption improves muscle performance and total antioxidant status in young soccer athletes: a randomized controlled trial

BACKGROUND Muscle performance and antioxidant balance are closely related to an athlete achievement. Milk proteins (whey and casein) contain essential and non-essential amino acids, which benefit muscle performance through increased antioxidant levels. This study was aimed to evaluate the effects of milk protein on muscle performance and total antioxidant status (TAS) in soccer athletes. METHODS A randomized controlled trial was conducted on 20 males 16- to 18-year-old athletes at the Central Java Soccer Club in January 2018. For 28 days, the treatment group received 24 g/d of milk protein and the control group received 24 g/d of maltodextrin. Muscle performance was measured through a 20-m sprint, shuttle run, Illinois run, standing broad jump, sit-ups, push-ups, sit-and-reach test, and one-repetition maximum (1RM) leg extension. TAS was analyzed using the 2,2-azino-bis-3-ethylbenzothiazoline-6-sulfonic acid (ABTS) method. RESULTS The treatment group had a decreased shuttle run time (-0.16 [0.11] versus 0.08 [0.14] sec), greater increase in sit-ups (6.80 [2.57] versus 1.10 [2.84] times/60 sec), greater increase in push-ups (2.40 [1.78] versus 0.30 [1.77] times/60 sec), and greater increase in 1RM leg extension (32.00 [13.78] versus 3.50 [13.75] kg). After adjustments for age, energy intake, carbohydrates, and pre-interventional performance, these parameters remained significantly improved after the intervention of milk protein. The TAS increase was greater in the treatment group than in the control group (0.36 [0.32] versus -0.12 [0.20] mmol/l) before and after adjustment for age, vitamin C, iron, selenium intake, and TAS pre-treatment. CONCLUSIONS Milk protein supplementation for 28 days increased muscle performance and TAS.

Download Full-text

2021 Mark Coventry Award: Use of a smartphone-based care platform after primary partial and total knee arthroplasty: a prospective randomized controlled trial

The Bone & Joint Journal ◽

10.1302/0301-620x.103b6.bjj-2020-2352.r1 ◽

2021 ◽

Vol 103-B (6 Supple A) ◽

pp. 3-12 ◽

Cited By ~ 1

Author(s):

David A. Crawford ◽

Paul J. Duwelius ◽

Michael A. Sneller ◽

Michael J. Morris ◽

Jason M. Hurst ◽

...

Keyword(s):

Emergency Department ◽

Treatment Group ◽

Knee Arthroplasty ◽

Care Management ◽

Controlled Trial ◽

Emergency Department Visits ◽

Control Group ◽

Randomized Controlled ◽

Prospective Randomized Controlled Trial ◽

Total Knee

Aims The purpose is to determine the non-inferiority of a smartphone-based exercise educational care management system after primary knee arthroplasty compared with a traditional in-person physiotherapy rehabilitation model. Methods A multicentre prospective randomized controlled trial was conducted evaluating the use of a smartphone-based care management system for primary total knee arthroplasty (TKA) and partial knee arthroplasty (PKA). Patients in the control group (n = 244) received the respective institution’s standard of care with formal physiotherapy. The treatment group (n = 208) were provided a smartwatch and smartphone application. Early outcomes assessed included 90-day knee range of movement, EuroQoL five-dimension five-level score, Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) score, 30-day single leg stance (SLS) time, Time up and Go (TUG) time, and need for manipulation under anaesthesia (MUA). Results Overall, 90-day mean flexion was not significantly different between the control (121° (SD 11.7°)) and treatment groups (121o; p = 0.559); 90-day mean SLS was 22.7 seconds (SD 9.8) in controls and 24.3 seconds (SD 20.8) in treatment (p = 0.519); 90-day mean TUG times were 10.1 seconds (SD 4.8) in control and 9.3 seconds (SD 3.3) in treatment (p = 0.139). Mean KOOS JR scores were significantly different between control group (73.6 (SD 13.4)) and treatment group (70.4 (SD 12.6); p = 0.026). MUAs were performed in nine (3.7%) patients in the control group and four (1.9%) in the treatment group (p = 0.398). Physiotherapy was performed by 230 (94.4%) of control group and 123 (59.3%) of treatment group (p < 0.001). There were no significant differences between groups in postoperative urgent care visits, or readmissions within 90 days, with significantly fewer emergency department visits in the treatment group (16 (8.2%) vs five (2.5%), p = 0.014). Conclusion The use of the smartwatch/smartphone care platform demonstrated non-inferiority of clinically significant outcomes to traditional care models, while requiring significantly less postoperative physiotherapy and fewer emergency department visits. This platform could aid in decreasing postoperative costs, while improving patient engagement and communication with the healthcare team. Cite this article: Bone Joint J 2021;103-B(6 Supple A):3–12.

Download Full-text

Clustered Randomized Controlled Trial of a Hand Hygiene Intervention Involving Pocket-Sized Containers of Alcohol-Based Hand Rub for the Control of Infections in Long-Term Care Facilities

Infection Control and Hospital Epidemiology ◽

10.1086/657636 ◽

2011 ◽

Vol 32 (1) ◽

pp. 67-76 ◽

Cited By ~ 40

Author(s):

Wing Kin Yeung ◽

Wai San Wilson Tam ◽

Tze Wai Wong

Keyword(s):

Treatment Group ◽

Hand Hygiene ◽

Controlled Trial ◽

Control Group ◽

Term Care ◽

Randomized Controlled ◽

Serious Infections ◽

Care Facilities ◽

To Receive

Objective.To investigate the effectiveness of a multifaceted hand hygiene program involving the use of pocket-sized containers of antiseptic gel in long-term care facilities (LTCFs) with elderly residents.Methods.In this clustered randomized controlled trial, Hong Kong LTCFs for elderly persons were recruited via snowball sampling. Staff hand hygiene adherence was directly observed, and residents' infections necessitating hospitalization were recorded. After a 3-month preintervention period, LTCFs were randomized to receive pocket-sized containers of alcohol-based gel, reminder materials, and education for all HCWs (treatment group) or to receive basic life support education and workshops for all healthcare workers (HCWs) (control group). A 2-week intervention period (April 1-15, 2007) was followed by 7 months of postintervention observations.Results.In the 3 treatment LTCFs, adherence to hand rubbing increased from 5 (1.5%) of 333 to 233 (15.9%) of 1,465 hand hygiene opportunities (P = .001) and total hand hygiene adherence increased from 86 (25.8%) of 333 to 488 (33.3%) of 1,465 opportunities (P = .01) after intervention; the 3 control LTCFs showed no significant change. In the treatment group, the incidence of serious infections decreased from 31 cases in 21,862 resident-days (1.42 cases per 1,000 resident-days) to 33 cases in 50,441 resident-days (0.65 cases per 1,000 resident-days) (P = .002), whereas in the control group, it increased from 16 cases in 32,726 resident-days (0.49 cases per 1,000 resident-days) to 85 cases in 81,177 resident-days (1.05 cases per 1,000 resident-days) (P = .004). In the treatment group, the incidence of pneumonia decreased from 0.91 to 0.28 cases per 1,000 resident-days (P = .001) and the death rate due to infection decreased from 0.37 to 0.10 deaths per 1,000 resident-days (P = .01); the control group revealed no significant change.Conclusions.A hand hygiene program involving the use of pocket-sized containers of antiseptic gel and education could effectively increase adherence to hand rubbing and reduce the incidence of serious infections in LTCFs with elderly residents.

Download Full-text

Early outcomes of primary total hip arthroplasty with use of a smartphone-based care platform: a prospective randomized controlled trial

The Bone & Joint Journal ◽

10.1302/0301-620x.103b7.bjj-2020-2402.r1 ◽

2021 ◽

Vol 103-B (7 Supple B) ◽

pp. 91-97 ◽

Cited By ~ 1

Author(s):

David A. Crawford ◽

Adolph V. Lombardi ◽

Keith R. Berend ◽

James I. Huddleston ◽

Christopher L. Peters ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Treatment Group ◽

Total Hip Arthroplasty ◽

Hip Arthroplasty ◽

Care Management ◽

Controlled Trial ◽

Urgent Care ◽

Control Group ◽

Randomized Controlled ◽

Prospective Randomized Controlled Trial

Aims The purpose of this study is to evaluate early outcomes with the use of a smartphone-based exercise and educational care management system after total hip arthroplasty (THA) and demonstrate decreased use of in-person physiotherapy (PT). Methods A multicentre, prospective randomized controlled trial was conducted to evaluate a smartphone-based care platform for primary THA. Patients randomized to the control group (198) received the institution’s standard of care. Those randomized to the treatment group (167) were provided with a smartwatch and smartphone application. PT use, THA complications, readmissions, emergency department/urgent care visits, and physician office visits were evaluated. Outcome scores include the Hip disability and Osteoarthritis Outcome Score (HOOS, JR), health-related quality-of-life EuroQol five-dimension five-level score (EQ-5D-5L), single leg stance (SLS) test, and the Timed Up and Go (TUG) test. Results The control group was significantly younger by a mean 3.0 years (SD 9.8 for control, 10.4 for treatment group; p = 0.007), but there were no significant differences between groups in BMI, sex, or preoperative diagnosis. Postoperative PT use was significantly lower in the treatment group (34%) than in the control group (55.4%; p = 0.001). There were no statistically significant differences in complications, readmissions, or outpatient visits. The 90-day outcomes showed no significant differences in mean hip flexion between controls (101° (SD 10.8)) and treatment (100° (SD 11.3); p = 0.507) groups. The HOOS, JR scores were not significantly different between control group (73 points (SD 13.8)) and treatment group (73.6 points (SD 13); p = 0.660). Mean 30-day SLS time was 22.9 seconds (SD 19.8) in the control group and 20.7 seconds (SD 19.5) in the treatment group (p = 0.342). Mean TUG time was 11.8 seconds (SD 5.1) for the control group and 11.9 (SD 5) seconds for the treatment group (p = 0.859). Conclusion The use of the smartphone care management system demonstrated similar early outcomes to those achieved using traditional care models, along with a significant decrease in PT use. Noninferiority was demonstrated with regard to complications, readmissions, and ED and urgent care visits. This technology allows patients to rehabilitate on a more flexible schedule and avoid unnecessary healthcare visits, as well as potentially reducing overall healthcare costs. Cite this article: Bone Joint J 2021;103-B(7 Supple B):91–97.

Download Full-text

Total Glucosides of Paeony Capsule Plus Compound Glycyrrhizin Tablets for the Treatment of Severe Alopecia Areata in Children: A Randomized Controlled Trial

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2013/378219 ◽

2013 ◽

Vol 2013 ◽

pp. 1-5 ◽

Cited By ~ 9

Author(s):

Dingquan Yang ◽

Jingwen Zheng ◽

Yuming Zhang ◽

Yueli Jin ◽

Chaonan Gan ◽

...

Keyword(s):

Treatment Group ◽

Adverse Events ◽

Alopecia Areata ◽

Statistical Difference ◽

Controlled Trial ◽

Effective Rate ◽

Control Group ◽

Efficacy And Safety ◽

Randomized Controlled ◽

Total Glucosides Of Paeony

Total glucosides of paeony capsule (TGPC) and compound glycyrrhizin tablets (CGT) are plant extracts of glycosides. We conducted this study to examine the efficacy and safety of TGPC plus CGT for severe alopecia areata in children. 117 subjects were randomly allocated into TGPC plus CGT group or CGT group. For consecutive 12 months, subjects were given oral TGPC and CGT or oral CGT alone. The outcome measures included score of alopecia areata severity, effective rate, and adverse events observed in the 3rd, 6th, and 12th month. We found that the scores of alopecia areata severity of both groups were significantly reduced, and the scores of treatment group were lower than those of control group; for effective rate, there was no statistical difference between the two groups in the 3rd month, while in the 6th and 12th months the treatment group was superior compared with control group; the incidence rate of adverse events between the two groups was not statistically different, and no severe adverse events were observed. In conclusion, TGPC plus CGT appears effective and safe for severe alopecia areata in children.

Download Full-text

Do Relaxation Exercises Decrease Postoperative Pain after Rotator Cuff Repair? A Randomized Controlled Trial

Orthopaedic Journal of Sports Medicine ◽

10.1177/2325967119s00380 ◽

2019 ◽

Vol 7 (7_suppl5) ◽

pp. 2325967119S0038

Author(s):

Danielle G. Weekes ◽

Eric D. Wicks ◽

Richard E. Campbell ◽

Christopher Hadley ◽

Aaron Carter ◽

...

Keyword(s):

Treatment Group ◽

Controlled Trial ◽

Control Group ◽

Study Group ◽

Relaxation Techniques ◽

Randomized Controlled ◽

Breathing Techniques ◽

Relaxation Exercises ◽

Cuff Repair

Objectives: During the last decade, concern about opioid dependence and abuse has spurred an increasing interest within orthopedic surgery to decrease reliance on narcotics for pain management. Non-pharmacologic interventions, such as patient opioid education, can decrease narcotic consumption after arthroscopic rotator cuff repair (ARCR). Another non-pharmacologic intervention, the use of relaxation exercises, has been promoted for pain management following surgical procedures; however, its’ effect has not been investigated following ARCR. The purpose of this investigation was to evaluate the effects of relaxation exercises on post-operative pain and narcotics use after ARCR. Methods: This was a prospective, randomized, controlled trial evaluating 151 consecutive patients undergoing ARCR. The treatment group (n: 75) received and reviewed relaxation education materials including a 5 minute video explaining relaxation breathing techniques, while the control group (n: 75) received no relaxation education materials. Both groups received a standardized pre-operative interscalene nerve block as well as the same standardized post-op care, including oxycodone 5mg/acetaminophen 325 mg, and cryotherapy. Patients recorded a 5-day journal of their pain level and opioid consumption. Patients were then queried with the American Shoulder and Elbow Surgeons (ASES) Shoulder Score, Single Assessment Numerical Evaluation (SANE) score, and Visual Analog Score (VAS) for pain pre-operatively, and at 2, 6, 12, 18, and 24 weeks post-operatively. Additionally, patients were given a follow-up survey at 2 weeks post-operative to assess subjective pain relief efficacy of the relaxation techniques. T-test analyses were utilized to compare differences between the treatment group and the control group. Results: Ninety-five percent of patients completed the follow-up survey. Sixty-three percent (43/68) of study group patients reported that the relaxation techniques decreased their pain levels, while 37% said that it had no effect on their pain. There were no significant differences between the study and control groups in mean post-op VAS pain scores on post-op day 1 (treatment: 55.40, control: 59.5; p= 0.94), post-op day 2 (treatment: 56.15, control: 56.93; p= 0.88), post-op day 3 (treatment: 48.38, control: 47.07; p= 0.52), post-op day 4 (treatment: 40.03, control: 45.54; p= 0.79) and post-op day 5 (treatment: 38.57, control: 40.57; p= 0.71). At two weeks post-op the study group consumed significantly less narcotics than the control group (mean: 21.7 doses vs. 29.7; p= 0.016, Cohen’s d: 0.42), and 51% were still performing the relaxation techniques. There were no significant differences in ASES and SANE scores at each time point throughout the study period. Conclusion: Although nearly two-thirds of patients in the treatment group believed that the use of relaxation breathing techniques decreased their pain, there was no difference in pain measures between the treatment group and the control group. However, the treatment group did utilize less opioid medication than the control group. While the effect on post-op pain is uncertain, the use of relaxation techniques can provide an easy to implement, non-pharmacologic strategy to significantly decrease narcotics consumption after ARCR.

Download Full-text

Efficacy and Safety of Maxing Xianchang Su in the Treatment of Functional Constipation: A Randomized Controlled Trial

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2021/3685440 ◽

2021 ◽

Vol 2021 ◽

pp. 1-9

Author(s):

Mi Li ◽

Lijuan Zhao ◽

Li Ma ◽

Wen Zhang ◽

Hua Huang ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Treatment Group ◽

Controlled Trial ◽

Functional Constipation ◽

Oral Solution ◽

Controlled Study ◽

Symptom Improvement ◽

Control Group ◽

Efficacy And Safety ◽

Randomized Controlled

Background. Functional constipation (FC) is one of the prevalent gastrointestinal disorders that affect people of all ages. Long-term FC has significant effects on the quality of life of patients. Although commonly used drugs have reliable short-term effects, they are easily addictive and have side effects. Therefore, pursuing a convenient drug-food homogenous program is critical for FC patients. Maxing Xianchang Su is a functional food based on traditional Chinese medicine. To investigate the efficacy and safety of Maxing Xianchang Su in FC treatment, we conducted a randomized controlled trial. Methods. We carried out a prospective multicenter randomized parallel controlled study in three hospitals in Jiangsu Province, China, from January 2020 to March 2021, which included 206 FC patients. All patients were arbitrarily assigned into a treatment group and a control group at a ratio of 1 : 1; 103 cases in each group. The treatment group was given oral Maxing Xianchang Su, whereas the control group was treated with lactulose oral solution. The course of treatment was two weeks. The two groups of patients were evaluated after six weeks for symptom improvement before and after taking the drug. Furthermore, the safety of Maxing Xianchang Su was assessed. Results. Both groups of patients successfully completed the study without shedding cases. The effective rates of the treatment group and control group after two weeks were 90.6% and 67.0%, respectively. The treatment group had a better curative effect than the control group ( P < 0.05 ). The symptom score of the two groups improved compared with that before the treatment. The difference between the two groups was statistically significant ( P < 0.05 ). During the treatment process, neither group experienced abnormal changes in blood lipid, blood glucose, routine hematuria, or liver and kidney functions. There were no adverse reactions in both groups. Conclusion. Maxing Xianchang Su has a positive effect on FC treatment with reliable mid-term effect and a high level of safety.

Download Full-text

Safety and Efficacy of Repurposed Siddha Medicines in Mild, Moderate, and Severe COVID-19 Patients Admitted To a Government Tertiary Hospital Near Chennai, Tamil Nadu– An Open-Labeled, Randomized, Controlled Trial.

10.21203/rs.3.rs-999914/v1 ◽

2021 ◽

Author(s):

Christian G J ◽

Meenakumari Ramasamy ◽

Shanthimalar Ramalingam ◽

Sankar Ganesan ◽

Ravichandran Vadugam Muthusamy ◽

...

Keyword(s):

Treatment Group ◽

Standard Care ◽

Tamil Nadu ◽

Controlled Trial ◽

Standard Of Care ◽

Tertiary Hospital ◽

Control Group ◽

Open Label ◽

Randomized Controlled ◽

Oxygenation Status

Abstract BackgroundCOVID-19 resulted in loss of human lives owing to respiratory failure caused by dysregulated immune system. Though many treatments are evaluated, the most appropriate is yet to be established. We hypothesized accelerated recovery and reduced mortality in mild, moderate and severe COVID-19 with Siddha regimen consisting of natural products.MethodsIn a randomized, controlled open-label trial conducted on 200 hospitalized COVID-19 patients, they were allocated equally to be treated with add-on Siddha regimen with Standard care or only standard care. The primary and secondary end points were accelerated recovery (≤ 7 days) and mortality comparison between the groups respectively. Patients were followed through 90 days.ResultsIn this study the accelerated recovery was 59.0% and 27.0% in treatment and control group (ITT analyses) (p < 0.001) respectively and Odds for it were four times higher in the treatment group (OR: 3.9; 95% CI: 1.9, 8.0). The estimated median time for recovery in the treatment group was 7 days (95% CI: 6.0, 8.0; p=0.003) and 10 days (95% CI: 8.7, 11.3) in control. Hazard ratio for death in control was 2.3 times that of treatment group. No adverse reactions or alarming laboratory values were observed in response to intervention. In severe treatment group (n=80), mortality was 15.0% and 39.5% in control (n=81). The COVID stage progression was 65% less in treatment group.ConclusionSiddha regimen demonstrated that they can synergistically improve oxygenation status, enhance the recovery rate and reduce the mortality better as compared to only Standard of Care.

Download Full-text

Psychodynamic therapy for adolescents suffering from co-morbid disorders of conduct and emotions in an in-patient setting: a randomized controlled trial

Psychological Medicine ◽

10.1017/s003329171300278x ◽

2013 ◽

Vol 44 (10) ◽

pp. 2213-2222 ◽

Cited By ~ 12

Author(s):

S. Salzer ◽

C. Cropp ◽

U. Jaeger ◽

O. Masuhr ◽

A. Streeck-Fischer

Keyword(s):

Randomized Controlled Trial ◽

Treatment Group ◽

Controlled Trial ◽

Academic Failure ◽

Psychodynamic Therapy ◽

Post Treatment ◽

Control Group ◽

Global Severity Index ◽

Randomized Controlled

BackgroundCo-morbid disorders of conduct and emotions can be regarded as childhood antecedents of further negative developments (e.g. manifestation of personality disorders in adulthood). We evaluated a manualized psychodynamic therapy (PDT) for adolescents with these co-morbid disorders.MethodIn a randomized controlled trial (RCT), 66 adolescents diagnosed with mixed disorders of conduct and emotions (F92 in ICD-10) were randomly assigned to a manualized in-patient PDT group or a waiting list/treatment-as-usual (WL/TAU) control condition. Diagnoses according to DSM-IV were also documented. Patients were compared using rates of remission as the primary outcome. The Global Severity Index (GSI) and the Strengths and Difficulties Questionnaire (SDQ) were used as secondary measures. Assessments were performed at baseline, post-treatment and at the 6-month follow-up.ResultsThe sample consisted of severely impaired adolescents with high rates of further co-morbid disorders and academic failure. Patients in the treatment group had a significantly higher rate of remission [odds ratio (OR) 26.41, 95% confidence interval (CI) 6.42–108.55, p < 0.001]. Compared with the control group, the PDT group resulted in significantly better outcomes on the SDQ (p = 0.04) but not the GSI (p = 0.18), with small between-group effect sizes (SDQ: d = 0.38, GSI: d = 0.18). However, the scores of patients treated with PDT were post-treatment no longer significantly different from normative data on the GSI and within the normal range on the SDQ. The effects in the treatment group were stable at follow-up. Furthermore, most patients were reintegrated into educational processes.ConclusionPDT led to remarkable improvement and furthered necessary preconditions for long-term stabilization. In future, PDT should be compared to other strong active treatments.

Download Full-text

Feasibility Study of a Randomized Controlled Trial Investigating Renal Denervation as a Possible Treatment Option in Patients With Loin Pain Hematuria Syndrome

Canadian Journal of Kidney Health and Disease ◽

10.1177/2054358120951390 ◽

2020 ◽

Vol 7 ◽

pp. 205435812095139

Author(s):

Bhanu Prasad ◽

Maryam Jafari ◽

Kaval Kour ◽

Kunal Goyal ◽

Francisco Garcia

Keyword(s):

Treatment Group ◽

Renal Denervation ◽

Controlled Trial ◽

Feasibility Trial ◽

Control Group ◽

Single Center ◽

Randomized Controlled ◽

Loin Pain

Background: Loin Pain Hematuria Syndrome (LPHS) is a poorly understood clinical condition characterized by severe pain localized to the kidney but in the absence of identifiable urinary tract disease. There is no consensus on optimal treatment strategies for LPHS. Case reports and series have shown renal denervation via catheter-based radiofrequency ablation to be an effective therapeutic option for the treatment of LPHS. To determine whether catheter-based renal denervation is a meaningful addition to the treatment options in these often-difficult-to-treat LPHS patients, a randomized clinical trial is needed. Prior to conducting a definitive trial that focuses on patient outcomes, ensuring the feasibility of undertaking such a trial is required. As such, we will conduct a single-center randomized control feasibility trial designed to determine viability and provide framework and direction for a larger trial. Objective: The objective of the study is to determine whether conducting a randomized trial of renal denervation versus sham procedure is feasible in terms of recruitment and eligibility, and adequacy of follow-up in LPHS patients. Design: Single-center double-blinded, parallel-group, partial crossover, sham-controlled, randomized feasibility trial of 10 LPHS patients. Setting: Regina General Hospital in Regina, Saskatchewan, Canada. Patients: Ten LPHS patients who require opioid therapy. Measurements: The main feasibility outcome measures include proportion of target patients who undergo the procedure (treatment or sham) within 6 months; proportion of randomized participants (treatment or control) who entirely complete the follow-up measures at 6 weeks, 3 and 6 months; proportion of the participants who were randomized to control group, cross over after 6 months and opt-in renal denervation treatment; proportion of the crossover participants who complete the follow-up measures at 6 weeks, 3 and 6 months. Pain will be assessed using Brief Pain Inventory Score, McGill Pain Questionnaire, and a pain diary. Mood, disability, and quality of life will be measured by Center for Epidemiologic Studies Depression Scale, Oswestry Disability Index, EuroQol-5D, and Short Form Health Survey Questionnaire, respectively. Methods: Eligible participants will be randomized into either renal denervation (treatment group) or a sham treatment (control group). Data (pain, quality of life, mood, disability) will be collected from both groups at baseline, 6 weeks, 3 and 6 months after the intervention. After the initial 6-month follow-up is over, the participants who received the sham procedure will cross over into the treatment group and will be followed for an additional 6 months in the same manner as the treatment group. Descriptive statistics will be used to report outcomes for all patients. Limitations: Single-center study, small sample size. Conclusions: The lessons learnt from this trial will lay the framework and direction for conducting a multisite randomized controlled trial involving a larger cohort of patients. Trial registration: ClinicalTrials.gov (NCT04332731).

Download Full-text

Clinical Effect of Acupuncture on Endemic Skeletal Fluorosis: A Randomized Controlled Trial

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2013/839132 ◽

2013 ◽

Vol 2013 ◽

pp. 1-5

Author(s):

Zhou Jincao ◽

Wu Zhongchao ◽

Chen Zhongjie ◽

Zhao Xiaoguang ◽

Hu Jing ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Treatment Group ◽

Serum Calcium ◽

Controlled Trial ◽

Control Group ◽

Skeletal Fluorosis ◽

Randomized Controlled ◽

Relieve Pain ◽

Urinary Fluoride ◽

Before And After

Objective. To evaluate the effect of acupuncture on endemic skeletal fluorosis (ESF) through the randomized controlled trial.Methods. Ninety-nine cases were divided into the treatment group (68 cases) and the control group (31 cases) randomly. Normal acupuncture combined with electroacupuncture was used in treatment group, while Caltrate with vitamin D tablets were applied in control group. After 2 courses, the VAS, urinary fluoride, serum calcium, and serum phosphate were evaluated before and after treatment.Results. Both of these two methods could relieve pain effectively and the effect of acupuncture was better (P<0.05). In treatment group, the content of urinary fluoride after treatment was higher than before (P<0.05), while the content of serum calcium and phosphate was lower (P<0.05).Conclusion. The effect of acupuncture on relieving pain and promoting discharge of urinary fluoride is better than that of western medicine. Acupuncture can reduce the content of serum calcium and phosphate.

Download Full-text