A Comparison of Acupuncture with Advice and Exercises on the Symptomatic Treatment of Osteoarthritis of the Hip – a Randomised Controlled Trial

Acupuncture is becoming a common technique within the physiotherapy profession as a treatment modality for pain relief; however, few randomised controlled trials have been undertaken to assess the effectiveness of acupuncture, particularly in the treatment of osteoarthritis (OA) of the hip. Therefore, a randomised trial to compare the effectiveness of acupuncture with advice and exercises on the symptomatic treatment of OA of the hip was carried out. Thirty-two patients awaiting a total hip arthroplasty were randomly allocated to either the experimental group, (A), to have six sessions of acupuncture each lasting up to 25 minutes, or the control group, (B), to be given advice and exercises for their hip over a six week period. Group A consisted of three men and 13 women, and group B consisted of four men and eight women. The average age in group A was 66 years and in group B it was 68 years. Patients were assessed for pain and functional ability, using a modified version of the WOMAC questionnaire, pre-treatment, immediately post-treatment and at eight weeks post-treatment. The pre-treatment WOMAC scores in the two groups were similar (p=0.85). There was a significant improvement in group A (decrease in WOMAC score) immediately post-treatment (p=0.002) and this was maintained at the eight-week follow-up (p=0.03). There were no significant changes in group B. When the changes in WOMAC scores were compared between groups, a significantly greater improvement was found between pre-treatment and immediately post-treatment in group A, compared with group B (p=0.02). The changes between pre-treatment and the eight-week follow-up also showed a significant improvement in group A compared with group B (p=0.03). In conclusion, this trial supports the hypothesis that acupuncture is more effective than advice and exercises in the symptomatic treatment of OA of the hip.

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Gamification as an entrepreneur well-being intervention: A study protocol for a single-blinded randomised controlled trial

10.21203/rs.3.pex-1323/v1 ◽

2021 ◽

Author(s):

Waqar M. Naqvi

Keyword(s):

Controlled Trial ◽

Life Quality ◽

Well Being ◽

Likert Scale ◽

Control Group ◽

Group A ◽

Measuring Scale ◽

Group B ◽

Randomised Controlled

Abstract Entrepreneurs usually work for long hours resulting in exhaustion, stress, and burnout. The prevalent symptoms of burnout are reduced levels of physical and mental energy, reduced job efficiency and diminished productivity. Therefore, it is important to improve the health of entrepreneurs. Gamification has a positive relationship with improvements in health and well-being as it influences positive experiences and satisfaction. This trial aims to study how 30-minutes of virtual reality game use via Kinect Azure and Oculus platforms 3-times per week, for 4 weeks, relates to differences in entrepreneur stress, burnout, subjective life quality, and downstream firm performance. We will recruit entrepreneurs over the age of 18 for the gamification analysis. Analysis of previous power using G*Power will determine the sample size. We will divide the participants into 3 groups, wherein Group A will undergo gamification on the Kinect platform, Group B will undergo the Oculus Quest intervention, and Group C will be the control group. We will conduct the study at two sites, one at the HuMen research. The outcome measures include a five-point Likert scale for measuring entrepreneurial stress, burnout-measuring scale (BMS) for burnout, five-point Likert scale for performance and SF-12 for Quality of life. Since current strains pave ways to future accomplishment, entrepreneurs' eudemonic well-being might particularly relate to forward-looking challenge stressors and burnouts. The results will provide an insight into how gamification could help entrepreneurs to deal with work stress and maintain high well-being.

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Knowledge transfer and retention of simulation-based learning for neurosurgical instruments: a randomised trial of perioperative nurses

BMJ Simulation and Technology Enhanced Learning ◽

10.1136/bmjstel-2019-000576 ◽

2020 ◽

pp. bmjstel-2019-000576

Author(s):

David B Clarke ◽

Alena I Galilee ◽

Nelofar Kureshi ◽

Murray Hong ◽

Lynne Fenerty ◽

...

Keyword(s):

Nursing Education ◽

Simulation Training ◽

Controlled Trial ◽

Randomised Trial ◽

Control Group ◽

Perioperative Nurses ◽

Instrument Recognition ◽

Simulation Based ◽

Group A ◽

Group B

IntroductionPrevious studies have shown that simulation is an acceptable method of training in nursing education. The objectives of this study were to determine the effectiveness of tablet-based simulation in learning neurosurgical instruments and to assess whether skills learnt in the simulation environment are transferred to a real clinical task and retained over time.MethodsA randomised controlled trial was conducted. Perioperative nurses completed three consecutive sessions of a simulation. Group A performed simulation tasks prior to identifying real instruments, whereas Group B (control group) was asked to identify real instruments prior to the simulation tasks. Both groups were reassessed for knowledge recall after 1 week.ResultsNinety-three nurses completed the study. Participants in Group A, who had received tablet-based simulation, were 23% quicker in identifying real instruments and did so with better accuracy (93.2% vs 80.6%, p<0.0001) than Group B. Furthermore, the simulation-based learning was retained at 7 days with 97.8% correct instrument recognition in Group A and 96.2% in Group B while maintaining both speed and accuracy.ConclusionThis is the first study to assess the effectiveness of tablet-based simulation training for instrument recognition by perioperative nurses. Our results demonstrate that instrument knowledge acquired through tablet-based simulation training results in improved identification and retained recognition of real instruments.

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Endoscopic sutured gastroplasty in addition to lifestyle modification: short-term efficacy in a controlled randomised trial

Gut ◽

10.1136/gutjnl-2020-322026 ◽

2020 ◽

pp. gutjnl-2020-322026

Author(s):

Vincent Huberty ◽

Ivo Boskoski ◽

Vincenzo Bove ◽

Pauline Van Ouytsel ◽

Guido Costamagna ◽

...

Keyword(s):

Weight Loss ◽

Lifestyle Modification ◽

Controlled Trial ◽

Randomised Trial ◽

Body Weight Loss ◽

Total Body Weight ◽

Control Group ◽

Short Term ◽

Randomised Controlled

ObjectiveEndoscopic suture gastroplasty (ESG) has been developed as an alternative treatment for moderately obese patients. We present our results of a short-term randomised controlled trial on a new suturing technique, the Endomina system (E-ESG, Endo Tools therapeutics, Belgium).DesignEligible patients (body mass index 30–40 kg/m2) were randomised in a 2:1 ratio to receive lifestyle modification plus E-ESG or lifestyle modification alone (control group); dietetic counselling and follow-up were identical. Endpoints included a mean excess weight loss (EWL) of more than 25% 12 months after E-ESG and a 15% EWL difference at 6 months between groups. At 6 months, a cross-over to E-ESG was offered to the control group. All patients were followed for a total of 12 months after E-ESG.ResultsOf the 71 patients included (five male, mean age 40 years), mean EWL at 6 months was significantly higher in the treatment (38.6%, n=45) than in the control group (13.4%, n=21; p<0.001). At 6 months, satiety tests demonstrated a higher decrease in mean volume (41% vs 2.5%, p<0.001), and mean quality of life (QoL) was also higher in the treatment group (52.8 vs 45.1 p<0.05). No procedure-related or device-related severe adverse events were observed. Twelve months follow-up after E-ESG showed a mean EWL of 45.1%, which translated into a total body weight loss of 11.8%.ConclusionsThis study demonstrates that E-ESG is safe and effective, providing a 25% better EWL at 6 months than lifestyle modification alone. This weight loss was maintained and resulted in a significant improvement in QoL up to 18 months after treatment.Trial registration numberNCT03255005.

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Testing the Efficacy of ‘Unlearning’, a Mindfulness and Compassion-Based Programme for Cultivating Nonviolence in Teenagers: A Randomised Controlled Trial

Frontiers in Psychology ◽

10.3389/fpsyg.2021.717736 ◽

2021 ◽

Vol 12 ◽

Author(s):

Irene Delgado-Suárez ◽

Yolanda López-del-Hoyo ◽

Javier García-Campayo ◽

Adrián Pérez-Aranda ◽

Marta Modrego-Alarcón ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Controlled Trial ◽

Multiple Comparisons ◽

Post Treatment ◽

Control Group ◽

Self Compassion ◽

Baseline Levels ◽

Secondary Outcomes ◽

Randomised Controlled

Background: Most programmes developed to reduce aggressive attitudes among teenagers are based on cultivating nonviolence, a construct that has been related to compassion and, more indirectly, mindfulness. This study aims at testing the efficacy of ‘Unlearning’, a mindfulness and compassion-based programme, for reducing aggressive attitudes in adolescents.Method: A sample of 164 students from three high schools in Zaragoza (Spain) participated in the study. They were randomly assigned to (1) ‘Unlearning’, or (2) relaxation programme. Three assessment points were established: baseline, post-treatment and a 4-month follow-up. The outcome variables were the subscales of the ‘Attitudes Toward Social Aggression Scale’. Mindfulness and compassion were assessed as secondary outcomes.Results: ‘Unlearning’ did not produce changes in the primary outcomes, but significant effects were observed post-treatment in self-compassion; and in the follow-up, in self-compassion and mindfulness. The control group did not experience any change post-treatment, but a significant effect in mindfulness was observed in the follow-up. The intergroup analyses indicated that ‘Unlearning’ improved self-compassion, both post-treatment (t = −2.48, p = 0.014) and after 4-months (t = −2.03, p = 0.044), although these results were not statistically significant after correcting for multiple comparisons.Conclusion: ‘Unlearning’ did not produce significant reductions in aggressive attitudes compared to the control group. The low baseline levels may have hindered the efficacy of the interventions. ‘Unlearning’ showed potential to improve self-compassion, which is related to nonviolence, and this may have positive implications for the adolescents. Future interventions should include teachers and families to enhance the effectiveness of the programmes.

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Comparison of nasal douching with isotonic saline versus Ringer lactate in chronic rhinosinusitis: a randomized controlled trial

International Journal of Otorhinolaryngology and Head and Neck Surgery ◽

10.18203/issn.2454-5929.ijohns20202075 ◽

2020 ◽

Vol 6 (6) ◽

pp. 1064

Author(s):

K. Paventhan ◽

Pradeep Krishna R. ◽

Ramya Shree C.

Keyword(s):

Chronic Rhinosinusitis ◽

Controlled Trial ◽

Isotonic Saline ◽

Post Treatment ◽

Ringer Lactate ◽

Treatment Data ◽

Group A ◽

Pre Treatment ◽

Group B ◽

Lactate Solution

Background: Nasal douching is a best effective and simple treatment procedure for chronic rhinosinusitis. This study compares the efficacy of nasal douching with isotonic saline solution versus ringer lactate solution in patients suffering from chronic rhinosinusitis.Methods: This randomized control trial was conducted among the patients with chronic rhinosinusitis who were attending the outpatient department of Otorhinolaryngology in Chettinad Hospital and Research Institute, Chennai, during the study period from June 2019 to December 2019. After randomization group A and B includes thirty cases of chronic rhinosinusitis each and they received nasal douching with saline and Ringer lactate two times a day for a period of three weeks and assessed using sino-nasal outcome test (SNOT) 20 during pre-treatment and post treatment. Data was entered in Microsoft excel and data analysis was done using SPSS version 17. Results: On assessing the overall SNOT 20 mean score, in both group A and group B, there was statistically significant improvement post treatment score when compare to pre-treatment scores. But the differences in improvement between the two groups were not found to be significant.Conclusions: Though isotonic saline and ringer lactate solution showed significant improvement after treatment both these are same with respect to efficacy in the treatment of douching for chronic rhinosinusitis with no difference in outcome.

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Sustained effects of a brief and standardised acupuncture approach on menopausal symptoms: post hoc analysis of the ACOM randomised controlled trial

Acupuncture in Medicine ◽

10.1177/0964528420920280 ◽

2020 ◽

Vol 38 (6) ◽

pp. 396-406

Author(s):

Kamma Sundgaard Lund ◽

Volkert Siersma ◽

Christine Winther Bang ◽

John Brodersen ◽

Frans Boch Waldorff

Keyword(s):

Treatment Effect ◽

Acupuncture Treatment ◽

Controlled Trial ◽

Intervention Group ◽

Post Treatment ◽

Menopausal Symptoms ◽

Scale Scores ◽

Pre Treatment ◽

Randomised Controlled

Background Our objective was to investigate whether the effect of a brief and standardised acupuncture approach persists after the end of the acupuncture treatment (post-treatment effect) and whether the anticipation of future acupuncture treatment affects menopausal symptoms (pre-treatment effect). Method This study is a post hoc analysis of data from a randomised controlled trial where women with moderate to severe menopausal symptoms were offered weekly acupuncture treatment over five consecutive weeks and randomised (1:1) to an early intervention group that received treatment immediately and a late intervention group with a 6-week delay. The acupuncture style was Western medical, administered at CV3, CV4 and bilateral LR8, SP6 and SP9. Acupuncturists were general practitioners. The effect was evaluated repeatedly during and after the interventions using scales from the validated MenoScores Questionnaire (MSQ) for hot flushes (HF), day and night sweats (DNS), general sweating (GS) and menopausal-specific sleeping problems (MSSP) with a 26-week follow-up period (corresponding to 21 or 15 weeks post-treatment for the early and late intervention groups, respectively). Multivariable linear mixed models were used to analyse the extent and duration of effects. Results Seventy participants were included in the study. Four participants dropped out. Furthermore, one participant was excluded from the short- and long-term follow-up analyses after the insertion of a hormonal intrauterine device, and nine participants were excluded from the long-term follow-up analysis due to the initiation of co-interventions. For each of the four outcomes, the effect was sustained up to 21 weeks post-treatment with an effect size that was only slightly diminished. A small, but significant, pre-treatment effect was observed in the HF scale scores. The same trend, although not significant, was observed in the DNS and MSSP scale scores. No serious harms were reported. Conclusion This study demonstrated that the overall effect of a brief and standardised acupuncture treatment on menopause-relevant outcomes was sustained up to 21 weeks post-treatment and that there was a small pre-treatment effect.

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Web-based Oral Reading for Language in Aphasia (Web ORLA®): A pilot randomized control trial

Clinical Rehabilitation ◽

10.1177/0269215520988475 ◽

2021 ◽

pp. 026921552098847

Author(s):

Leora R Cherney ◽

Jaime B Lee ◽

Kwang-Youn A Kim ◽

Sarel van Vuuren

Keyword(s):

Oral Reading ◽

Controlled Trial ◽

Post Treatment ◽

Control Group ◽

Web Based ◽

End Of Treatment ◽

Significant Difference ◽

Pre Treatment ◽

The Web

Objective: To investigate an intensive asynchronous computer-based treatment delivered remotely with clinician oversight to people with aphasia. Design: Single-blind, randomized placebo-controlled trial. Setting: Free-standing urban rehabilitation hospital. Participants: Adults with aphasia (at least six months post-onset). Interventions: Experimental treatment was Web ORLA® (Oral Reading for Language in Aphasia) which provides repeated choral and independent reading aloud of sentences with a virtual therapist. Placebo was a commercially available computer game. Participants were instructed to practice 90 minutes/day, six days/week for six weeks. Main measures: Change in Language Quotient of the Western Aphasia Battery-Revised from pre-treatment to post-treatment and pre-treatment to six weeks following the end of treatment. Results: 32 participants (19 Web ORLA®, 13 Control) completed the intervention and post-treatment assessment; 27 participants (16 Web ORLA®, 11 Control) completed the follow-up assessment six weeks after treatment had ended. Web ORLA® treatment resulted in significant improvements in language performance from pre-treatment to immediately post-treatment ( X = 2.96; SD = 4.32; P < 0.01; ES = 0.68) and from pre-treatment to six weeks following the end of treatment ( X = 4.53; SD = 3.16; P < 0.001; ES = 1.43). There was no significant difference in the gain from pre-treatment to post-treatment for the Web ORLA® versus Control groups. However, the Web ORLA® group showed significantly greater gains at the six-week follow-up than the control group ( X = 2.70; SD = 1.01; P = 0.013; ES = 1.92). Conclusion: Results provide evidence for improved language outcomes following intensive, web-based delivery of ORLA® to individuals with chronic aphasia. Findings underscore the value of combining clinician oversight with the flexibility of asynchronous practice.

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The effect of giving verbal feedback during neck stabilisation exercise as an addition to physical therapy in patients with chronic neck pain: A randomised controlled trial

Clinical Rehabilitation ◽

10.1177/02692155211044138 ◽

2021 ◽

pp. 026921552110441

Author(s):

Yi-Jia Lin ◽

Wei-Chun Hsu ◽

Lin-Fen Hsieh ◽

Kae-Chwen Chang ◽

Ying-Chen Kuo ◽

...

Keyword(s):

Physical Therapy ◽

Neck Pain ◽

Controlled Trial ◽

Neck Disability Index ◽

Chronic Neck Pain ◽

Group A ◽

Group B ◽

Randomised Controlled ◽

Neck Disability

Objectives To study the addition of feedback-guided neck strength home exercise to physical therapy as an enhanced rehabilitation programme in the treatment of patients with chronic neck pain. Design A prospective randomised controlled trial. Setting Rehabilitation department of an academic hospital. Subjects Patients with chronic neck pain. Interventions The patients in both groups received supervised physical therapy sessions 3 times a week for 12 weeks. Patients in Group A ( N = 38) used the neck strengthening exerciser device for 20 min daily at home for 6 weeks and patients in Group B ( N = 20) performed 20 min of daily regular neck exercise at home for 6 weeks. Outcome measures Neck disability index, pain visual analogue scale, active range of motion of the neck, Patient Global Assessment and patient evaluation of treatment effect. All subjects were assessed at baseline as well as at 6- and 12-week follow-ups. Results At the 6-week follow-up, Group A exhibited significantly greater improvements ( P < 0.05) in pain Visual Analogue Scale (Group A: 2.97 ± 1.57; Group B: 4.20 ± 1.82), neck disability index (Group A: 13.95 ± 8.07; Group B: 20.07 ± 9.14) and active cervical extension (Group A: 65.26 ± 12.76; Group B: 51.45 ± 11.78). At 12-week follow-up, Group A also exhibited significantly greater active cervical extension (Group A: 67.74 ± 11.94; Group B: 53.85 ± 14.09; P < 0.05). Conclusion Adding neck strengthening exerciser home training to physical therapy was demonstrated to be more effective than physical therapy alone for patients with chronic neck pain.

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Oral Tranexamic Acid for the Treatment of Melasma

Kathmandu University Medical Journal ◽

10.3126/kumj.v10i4.10993 ◽

2014 ◽

Vol 10 (4) ◽

pp. 40-43 ◽

Cited By ~ 26

Author(s):

D Karn ◽

S KC ◽

A Amatya ◽

EA Razouria ◽

M Timalsina

Keyword(s):

Tranexamic Acid ◽

Controlled Trial ◽

Severity Index ◽

Sustained Improvement ◽

Treatment Measures ◽

Group A ◽

Group B ◽

Novel Concept ◽

High Treatment

Background Melasma poses a great challenge as its treatment is unsatisfactory and recurrence is high. Treatment of melasma using tranexamic acid (oral, topical or intralesional) is a novel concept. Objective To compare the efficacy of oral tranexamic acid with routine topical therapies for the treatment of melasma. Methods It is a prospective, interventional, randomized controlled trial conducted among 260 melasma patients. Patients were divided into two groups consisting of 130 patients each. First group (Group A) was given routine treatment measures and oral Tranexamic Acid while second group (Group B) was treated only with routine topical measures. Capsule Tranexamic Acid was prescribed at a dose of 250 mg twice a day for three months and cases were followed for three months. Response was evaluated on the basis of Melasma Assessment Severity Index (MASI). Mean scores between the two groups were then compared. Results Statistically significant decrease in the mean Melasma Assessment Severity Index from baseline to 8 and 12 weeks was observed among group A patients (11.08±2.91 vs 8.95±2.08 at week 8 and vs. 7.84±2.44 at week 12; p<0.05 for both). While among group B patients the decrease in mean score was significant at 8 weeks and insignificant at 12 weeks follow up (11.60±3.40 vs 9.9±2.61 at 8 weeks and vs. 9.26±3 at 12 weeks; p<0.05 for former but p>0.05 for later). Conclusion Addition of oral tranexamic acid provides rapid and sustained improvement in the treatment of melasma. DOI: http://dx.doi.org/10.3126/kumj.v10i4.10993 Kathmandu Univ Med J 2012;10(4):40-43

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Anti-adhesion Gel versus No gel following Operative Hysteroscopy prior to Subsequent fertility Treatment or timed InterCourse (AGNOHSTIC), a randomised controlled trial: protocol

Human Reproduction Open ◽

10.1093/hropen/hoab001 ◽

2021 ◽

Vol 2021 (1) ◽

Author(s):

S van Wessel ◽

T Hamerlynck ◽

V Schutyser ◽

C Tomassetti ◽

C Wyns ◽

...

Keyword(s):

Live Birth ◽

Financial Support ◽

Controlled Trial ◽

Reproductive Age ◽

Fertility Treatment ◽

Control Group ◽

Women Of Reproductive Age ◽

Operative Hysteroscopy ◽

Randomised Controlled

Abstract STUDY QUESTIONS Does the application of anti-adhesion gel, compared to no gel, following operative hysteroscopy to treat intrauterine pathology in women wishing to conceive increase the chance of conception leading to live birth? WHAT IS KNOWN ALREADY Intrauterine adhesions (IUAs) following operative hysteroscopy may impair reproductive success in women of reproductive age. Anti-adhesion barrier gels may decrease the occurrence of IUAs, but the evidence on their effectiveness to improve reproductive outcomes is sparse and of low quality. STUDY DESIGN, SIZE, DURATION This multicentre, parallel group, superiority, blinded and pragmatic randomised controlled trial is being carried out in seven participating centres in Belgium. Recruitment started in April 2019. Women will be randomly allocated to treatment with anti-adhesion gel (intervention group) or no gel (control group). Sterile ultrasound gel will be applied into the vagina as a mock-procedure in both treatment arms. The patient, fertility physician and gynaecologist performing the second-look hysteroscopy are unaware of the allocated treatment. Power analysis, based on a target improvement of 15% in conception leading to live birth using anti-adhesion gel, a power of 85%, a significance level of 5%, and a drop-out rate of 10%, yielded a number of 444 patients to be randomised. The baseline rate of conception leading to live birth in the control group is expected to be 45%. PARTICIPANTS/MATERIALS, SETTING, METHODS Women of reproductive age (18–47 years), wishing to conceive (spontaneously or by fertility treatment) and scheduled for operative hysteroscopy to treat intrauterine pathology (endometrial polyps, myomas with uterine cavity deformation, uterine septa, IUAs or retained products of conception) are eligible for recruitment. Women may try to conceive from 3 to 6 weeks after receiving allocated treatment with follow-up ending at 30 weeks after treatment. If the woman fails to conceive within this timeframe, a second-look hysteroscopy will be scheduled within 2–6 weeks to check for IUAs. The primary endpoint is conception leading to live birth, measured at 30 weeks after randomisation. The secondary endpoints are time to conception, clinical pregnancy, miscarriage and ectopic pregnancy rates, measured at 30 weeks after receiving allocated treatment. The long-term follow-up starts when the patient is pregnant and she will be contacted every trimester. STUDY FUNDING/COMPETING INTEREST(S) This work is funded by the Belgian Healthcare Knowledge Centre (KCE). The anti-adhesion gel is supplied at no cost by Nordic Pharma and without conditions. Dr. Tomassetti reports grants and non-financial support from Merck SA, non-financial support from Ferring SA, personal fees and non-financial support from Gedeon-Richter, outside the submitted work. None of the other authors have a conflict of interest.

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