scholarly journals Electroacupuncture for poststroke spasticity (EAPSS): protocol for a randomised controlled trial

BMJ Open ◽  
2018 ◽  
Vol 8 (2) ◽  
pp. e017912 ◽  
Author(s):  
Yiyi Cai ◽  
Claire Shuiqing Zhang ◽  
Wenwei Ouyang ◽  
Jianmin Li ◽  
Wenheng Nong ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Ethics Committees ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Control Group ◽  
Main Trial ◽  
Parallel Group ◽  
Registration Number ◽  
Randomised Controlled

IntroductionSpasticity is a common complication of stroke. Current therapies for poststroke spasticity (PSS) have been reported to be associated with high costs, lack of long-term benefit and unwanted adverse events (AEs). Electroacupuncture (EA) has been used for PSS, however, its efficacy and safety is yet to be confirmed by high-quality clinical studies. This study is designed to evaluate the add-on effects and safety profile of EA when used in combination with usual care (UC).Methods and analysisThis study is a parallel group randomised controlled trial. A total of 136 participants will be included and randomly assigned to either the treatment group (EA plus UC) or the control group (UC alone). Prior to the main trial, a pilot study involving 30 participants will be conducted to assess the feasibility of the trial protocol. EA will be administered by registered acupuncturists for 20min to 30 min, three times per week for 4 weeks. The primary outcome measure (Modified Ashworth Scale) and secondary outcome measures (Fugl-Meyer Assessment and Barthel Index) will be evaluated at baseline, the end of treatment (week 4) and the end of follow-up (week 8). AEs will be monitored, recorded and reported, and their causality will be explored.Ethics and disseminationEthics approval was obtained from the ethics committees of Guangdong Provincial Hospital of Chinese Medicine and RMIT University in December 2016. The results will be disseminated in a peer-reviewed journal, and PhD theses and might be presented at international conferences.Trial registration numberChiCTR-IOR-16010283; Pre-results.

scholarly journals Cochlear implantation for tinnitus in adults with bilateral hearing loss: protocol of a randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (5) ◽  
pp. e043288
Author(s):  
Kelly Assouly ◽  
Adriana L Smit ◽  
Inge Stegeman ◽  
Koenraad S Rhebergen ◽  
Bas van Dijk ◽  
...  
Keyword(s):  
Hearing Loss ◽  
Randomised Controlled Trial ◽  
Cochlear Implantation ◽  
Controlled Trial ◽  
Trial Registration ◽  
Secondary Outcome ◽  
Control Group ◽  
Auditory Input ◽  
Registration Number ◽  
Randomised Controlled

IntroductionTinnitus is the perception of sound without an external stimulus, often experienced as a ringing or buzzing sound. Subjective tinnitus is assumed to origin from changes in neural activity caused by reduced or lack of auditory input, for instance due to hearing loss. Since auditory deprivation is thought to be one of the causes of tinnitus, increasing the auditory input by cochlear implantation might be a possible treatment. In studies assessing cochlear implantation for patients with hearing loss, tinnitus relief was seen as a secondary outcome. Therefore, we will assess the effect of cochlear implantation in patients with primarily tinnitus complaints.Method and analysisIn this randomised controlled trial starting in January 2021 at the ENT department of the UMC Utrecht (the Netherlands), patients with a primary complaint of tinnitus will be included. Fifty patients (Tinnitus Functional Index (TFI) >32, Beck’s Depression Index <19, pure tone average at 0.5, 1, 2 and 4 kHz: bilateral threshold between 50 and ≤75 dB) will be randomised towards cochlear implantation or no intervention. Primary outcome of the study is tinnitus burden as measured by the TFI. Outcomes of interest are tinnitus severity, hearing performances (tinnitus pitch and loudness, speech perception), quality of life, depression and patient-related changes. Outcomes will be evaluated prior to implantation and at 3 and 6 months after the surgery. The control group will receive questionnaires at 3 and 6 months after randomisation. We expect a significant difference between the cochlear implant recipients and the control group for tinnitus burden.Ethics and disseminationThis research protocol was approved by the Institutional Review Board of the University Medical Center (UMC) Utrecht (NL70319.041.19, V5.0, January 2021). The trial results will be made accessible to the public in a peer-review journal.Trial registration numberTrial registration number NL8693; Pre-results.

Effects of golf training on cognition in older adults: a randomised controlled trial

2018 ◽  
Vol 72 (10) ◽  
pp. 944-950 ◽  
Author(s):  
Hiroyuki Shimada ◽  
Sangyoon Lee ◽  
Masahiro Akishita ◽  
Koichi Kozaki ◽  
Katsuya Iijima ◽  
...  
Keyword(s):  
Older Adults ◽  
Randomised Controlled Trial ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Training Group ◽  
Community Dwelling ◽  
Secondary Outcome ◽  
Control Group ◽  
Logical Memory ◽  
Randomised Controlled

BackgroundAlthough research indicates that a physically active lifestyle has the potential to prevent cognitive decline and dementia, the optimal type of physical activity/exercise remains unclear. The present study aimed to determine the cognitive benefits of a golf-training programme in community-dwelling older adults.MethodsWe conducted a randomised controlled trial between August 2016 and June 2017 at a general golf course. Participants included 106 Japanese adults aged 65 and older. Participants were randomly assigned to either a 24-week (90–120 min sessions/week) golf-training group or a health education control group. Postintervention changes in Mini-mental State Examination (MMSE) and National Centre for Geriatrics and Gerontology-Functional Assessment Tool scores were regarded as primary outcome measures. Secondary outcome measures included changes in physical performance and Geriatric Depression Scale (GDS) scores.ResultsA total of 100 participants (golf training, n=53; control, n=47) completed the assessments after the 24-week intervention period. The adherence to the golf programme was 96.2% (51/53 participants). Analysis using linear mixed models revealed that the golf training group exhibited significantly greater improvements in immediate logical memory (p=0.033), delayed logical memory (p=0.009) and composite logical memory (p=0.013) scores than the control group. However, no significant changes in MMSE, word memory, Trail Making Test or Symbol Digital Substitution Test scores were observed. In addition, no significant changes in grip strength, walking speed or GDS were observed.ConclusionsGolf-based exercise interventions may improve logical memory in older adults, but no significant changes in other cognitive tests. Further follow-up investigations are required to determine whether the observed effects are associated with delayed onset of mild cognitive impairment or Alzheimer’s disease in older adults.Trial registration numberUMIN-CTR UMIN000024797; Pre-results.

scholarly journals Open-labelled randomised controlled trial of 12 hours versus 24 hours modified Pritchard regimen in the management of eclampsia and pre-eclampsia in Ghana (MOPEP Study): study protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (10) ◽  
pp. e032799 ◽  
Author(s):  
Titus Beyuo ◽  
Emma Lawrence ◽  
Elizabeth S Langen ◽  
Samuel A Oppong
Keyword(s):  
Randomised Controlled Trial ◽  
Health Outcomes ◽  
Magnesium Sulfate ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Control Group ◽  
University Of Michigan ◽  
Clinical Trial Registry ◽  
Randomised Controlled ◽  
Study Participants

IntroductionHypertensive disorders of pregnancy continue to be a major contributor to maternal and perinatal morbidity and mortality. Magnesium sulfate therapy is the standard of care for seizure prophylaxis and treatment for pre-eclampsia and eclampsia respectively, despite wide disparities in dosing regimens and routes of administration. This study compares the clinical efficacy of magnesium sulfate in the reduction of seizure occurrence or recurrence with the 12 hours versus 24 hours modified Pritchard regimens in the management of severe pre-eclampsia and eclampsia.Methods and analysisThis study is an open labelled randomised controlled trial. The study participants are patients admitted to the Korle Bu Teaching Hospital (KBTH) in Accra, Ghana with a diagnosis of antepartum, intrapartum or postpartum eclampsia or pre-eclampsia with severe features. All study participants will be administered a loading dose of magnesium sulfate, followed by maintenance dosing. Participants in the control group will receive magnesium sulfate for 24 hours after diagnosis, while those in the treatment group will receive magnesium sulfate for 12 hours after diagnosis. The primary outcome of this study is the occurrence of a seizure any time after the completion of treatment in the assigned group. Secondary outcome measures include maternal health outcomes, magnesium sulfate toxicities and fetal health outcomes. Data collection was started in October 2018 with a target enrolment of 1245 participants with severe pre-eclampsia and 844 participants with eclampsia with a projected study period of 2–3 years.Ethics and disseminationEthical approval was obtained from the KBTH Institutional Review Board (IRB) in Ghana. University of Michigan involvement is limited to protocol development and statistical analysis of de-identified data, and has been granted a Not Regulated Determination by the University of Michigan IRB. Results of the study will be shared at clinical forums at the KBTH and will be submitted for publication in an international peer-reviewed journal.Trial registration numberPan African Clinical Trial Registry through the South African Medical Research Council (PACTR201811515303983).

scholarly journals Does tension applied in kinesio taping affect pain or function in older women with knee osteoarthritis? A randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e041121
Author(s):  
Yago Tavares Pinheiro ◽  
Germanna Medeiros Barbosa ◽  
Hilmaynne Renaly Fonseca Fialho ◽  
César Augusto Medeiros Silva ◽  
Jaciara de Oliveira Anunciação ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Knee Osteoarthritis ◽  
Older Women ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Group Differences ◽  
Control Group ◽  
Kinesio Taping ◽  
Secondary Outcomes ◽  
Randomised Controlled

ObjectiveTo analyse the short-term effects of kinesio taping (KT) with tension (KTT) or without tension (KTNT) in older women with knee osteoarthritis (KOA), and compare them to controls who did not receive KT.DesignRandomised controlled trial.SettingUniversity physiotherapy school clinic.ParticipantsForty-five older women (fifteen participants per group) with 66.8 (±5.6) years and clinical diagnosis of KOA were assessed pre, post and 3 days after intervention.InterventionsParticipants were randomly allocated to KTT, who received two simultaneous applications of KT with tension on the knee and rectus femoris; KTNT, who received the same application as the KTT group, but without tension and a control group that attended a class on KOA.Primary and secondary outcome measuresPrimary outcome was pain intensity and secondary outcomes were knee-related health status, functional capacity, muscle strength and global rating of change.ResultsNo between-group differences were observed in pain after the first intervention (KTT vs KTNT: mean difference (MD), −1.8 points; 95% CI −4.2 to 0.5; KTT vs control: MD, −1.2 points; 95% CI −3.6 to 1.2; KTNT vs control: MD, 0.66 points; 95% CI −1.7 to 3.0) or 3 days later (KTT vs KTNT: MD, −1.3 points; 95% CI −3.7 to 1.0; KTT vs control: MD, 0.13 points; 95% CI −2.2 to 2.5; KTNT vs control: MD, 1.4 points; 95% CI −0.9 to 3.8). The lack of between-group differences was also found for secondary outcomes.ConclusionThe short-term use of KT with or without tension in older woman with KOA had no beneficial effects on pain and function. These findings call into question the clinical use of KT as a non-pharmacological therapy for this population.Trial registration numberNCT03624075.

scholarly journals Randomised controlled trial of rhinothermy for treatment of the common cold: a feasibility study

BMJ Open ◽  
2018 ◽  
Vol 8 (3) ◽  
pp. e019350 ◽  
Author(s):  
Susanne van de Hei ◽  
Steven McKinstry ◽  
George Bardsley ◽  
Mark Weatherall ◽  
Richard Beasley ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Vitamin C ◽  
Feasibility Study ◽  
Common Cold ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Pcr Analysis ◽  
Control Group ◽  
The Common ◽  
Randomised Controlled

ObjectiveTo determine the feasibility of a randomised controlled trial (RCT) of rhinothermy for the common cold.DesignOpen label, randomised, controlled feasibility study.SettingSingle-centre research institute in New Zealand recruiting participants from the community.Participants30 adult participants with symptoms of a common cold, presenting within 48 hours of the onset of symptoms.InterventionsParticipants were randomly assigned 2:1 to receive either 35 L/min of 100% humidified air at 41°C via high flow nasal cannulae, 2 hours per day for up to 5 days (rhinothermy), or vitamin C 250 mg daily for 5 days (control).Primary and secondary outcome measuresThe primary outcome was the proportion of screened candidates who were randomised. Secondary outcomes included: proportion of randomised participants who completed the study; modified Jackson scores from randomisation to 10 days after initiation of randomised regimen; time until feeling ‘a lot better’ compared with study entry; time until resolution of symptoms or symptom score at 10 days postrandomisation; proportion of organisms identified by PCR analysis of nasal swabs taken at baseline; the patterns of use of the rhinothermy device; estimated adherence of the control group; and rhinothermy device tolerability.ResultsIn all 30/79 (38%, 95% CI 27% to 50%) of potential participants screened for eligibility were randomised. Rhinothermy was well tolerated, and all randomised participants completed the study (100%, 95% CI 88% to 100%). The reduction from baseline in the modified Jackson score was greater with rhinothermy compared with control at days 2, 3, 4, 5 and 6, with the maximum difference at day 4 (−6.4, 95% CI −9.4 to −3.3). The substantial clinical benefit threshold for modified Jackson score was a 5-unit change.ConclusionsThis study shows that an RCT of rhinothermy compared with low-dose vitamin C in the treatment of the common cold is feasible.Trial registration numberACTRN12616000470493; Results.

scholarly journals Rehabilitation nursing for motor functional recovery of acute ischaemic stroke: study protocol for a randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (9) ◽  
pp. e037391
Author(s):  
Jianmiao Wang ◽  
Yuanyuan Chen ◽  
Yuping Zhang ◽  
Mei Li ◽  
Jingfen Jin
Keyword(s):  
Randomised Controlled Trial ◽  
Ischaemic Stroke ◽  
Outcome Measures ◽  
Functional Recovery ◽  
Acute Ischaemic Stroke ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Control Group ◽  
Functional Impairments ◽  
Randomised Controlled

IntroductionStroke is the second-leading cause of death and disability in the world, and patients with stroke often suffer from functional impairments and need rehabilitation. Notably, there is much evidence that rehabilitation can lead to better mortality and morbidity outcomes. The evidence for the effectiveness of rehabilitation nursing, however, is limited. Thus, this study seeks to explore whether rehabilitation nursing is not inferior to usual rehabilitation for motor functional recovery in patients with acute ischaemic stroke.Methods and analysisWe will conduct an assessor-blinded parallel randomised controlled trial of patients who meet the inclusion criteria after stratification by weighted corticospinal tract lesion load. The experimental group will receive rehabilitation nursing by trained and qualified nurses (seven consecutive days, two sessions per day, 30 min each session). The control group will receive usual rehabilitation provided by therapists (seven consecutive days, two sessions per day, 30 min each session). The primary outcome measures are the Motor Assessment Scale, the Fugl-Meyer Assessment and the Action Research Arm Test. The secondary outcome measures are the modified Rankin Scale, the modified Barthel Index and the National Institute of Health Stroke Scale. Primary and secondary outcome assessment will be performed before and after the intervention, and secondary outcome be assessed at 4 and 12 weeks follow-up. We will recruit 224 patients within a period of 12–18 months from a hospital in southeastern China.Ethics and disseminationThe study was approved by the Human Research Ethics Committee from the corresponding author’s hospital (approval Number is Ethical Review Study No. 2018 - 112). Peer-reviewed journals and presentations at national and international conferences will be used to disseminate the results.Trial registration numberNCT03702452.

scholarly journals Bluebelle pilot randomised controlled trial of three wound dressing strategies to reduce surgical site infection in primary surgical wounds

BMJ Open ◽  
2020 ◽  
Vol 10 (1) ◽  
pp. e030615 ◽  
Author(s):  
Jane Blazeby
Keyword(s):  
Randomised Controlled Trial ◽  
Surgical Site Infection ◽  
Wound Closure ◽  
Controlled Trial ◽  
Response Rates ◽  
Secondary Outcome ◽  
Site Infection ◽  
Main Trial ◽  
Surgical Wounds ◽  
Randomised Controlled

ObjectiveSurgical site infection (SSI) affects up to 25% of primary surgical wounds. Dressing strategies may influence SSI risk. The Bluebelle study assessed the feasibility of a multicentre randomised controlled trial (RCT) to evaluate the effectiveness and cost-effectiveness of different dressing strategies to reduce SSI in primary surgical wounds.DesignA pilot, factorial RCT.SettingFive UK hospitals.ParticipantsAdults undergoing abdominal surgery with a primary surgical wound.InterventionsParticipants were randomised to ‘simple dressing’, ‘glue-as-a-dressing’ or ‘no dressing’, and to the time at which the treatment allocation was disclosed to the surgeon (disclosure time, before or after wound closure).Primary and secondary outcome measuresFeasibility outcomes focused on recruitment, adherence to randomised allocations, reference assessment of SSI and response rates to participant-completed and observer-completed questionnaires to assess SSI (proposed primary outcome for main trial), wound experience and symptoms, and quality of life (EQ-5D-5L).ResultsBetween March and November 2016, 1115 patients were screened; 699 (73.4%) were eligible and approached, 415 (59.4%) consented and 394 (35.3%) were randomised (simple dressing=133, glue=129 and ‘no dressing’=132). Non-adherence to dressing allocation was 2% (3/133), 6% (8/129) and 15% (20/132), respectively. Adherence to disclosure time was 99% and 86% before and after wound closure, respectively. The overall rate of SSI (reference assessment) was 18.1% (51/281). Response rates to the Wound Healing Questionnaire and other questionnaires ranged from >90% at 4 days to 68% at 4–8 weeks.ConclusionsA definitive RCT of dressing strategies including ‘no dressing’ is feasible. Further work is needed to optimise questionnaire response rates.Trial registration number49328913; Pre-results.

scholarly journals Efficacy of nature-based therapy for individuals with stress-related illnesses: randomised controlled trial

2018 ◽  
Vol 213 (1) ◽  
pp. 404-411 ◽  
Author(s):  
Ulrika Karlsson Stigsdotter ◽  
Sus Sola Corazon ◽  
Ulrik Sidenius ◽  
Patrik Karlsson Nyed ◽  
Helmer Bøving Larsen ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Well Being ◽  
Behavioural Therapy ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Significant Difference ◽  
Increasing Demand ◽  
Randomised Controlled

BackgroundStress-related illnesses are a major threat to public health, and there is increasing demand for validated treatments.AimsTo test the efficacy of nature-based therapy (NBT) for patients with stress-related illnesses.MethodRandomised controlled trial (ClinicalTrials.gov ID NCT01849718) comparing Nacadia® NBT (NNBT) with the cognitive–behavioural therapy known as Specialised Treatment for Severe Bodily Distress Syndromes (STreSS). In total, 84 participants were randomly allocated to one of the two treatments. The primary outcome measure was the mean aggregate score on the Psychological General Well-Being Index (PGWBI).ResultsBoth treatments resulted in a significant increase in the PGWBI (primary outcome) and a decrease in burnout (the Shirom–Melamed Burnout Questionnaire, secondary outcome), which were both sustained 12 months later. No significant difference in efficacy was found between NNBT and STreSS for primary outcome and secondary outcomes.ConclusionsThe study showed no statistical evidence of a difference between NNBT and STreSS for treating patients with stress-related illnesses.Declaration of interestNone.

scholarly journals Effectiveness of a mindfulness-oriented substance use prevention program for boys with mild to borderline intellectual disabilities: study protocol for a randomised controlled trial

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Lucie Waedel ◽  
Anne Daubmann ◽  
Antonia Zapf ◽  
Olaf Reis
Keyword(s):  
Substance Use ◽  
Randomised Controlled Trial ◽  
Intellectual Disabilities ◽  
Controlled Trial ◽  
Intervention Group ◽  
Secondary Outcome ◽  
Control Group ◽  
Post Intervention ◽  
Randomised Controlled

Abstract Background Boys with mild to borderline intellectual disabilities (MBID) are at particular risk to drink in harmful ways once they start to consume alcohol. Interventions based on mindfulness have been proven to be effective in preventing substance use, but mostly for adults with MBID. A mindfulness oriented intervention targeting 11–17 years old boys will be tested in a randomised controlled trial. Study aim is to investigate the benefits of this new intervention compared to an active control condition within a 12 months follow-up. Methods In this randomised controlled proof of concept study, 82 boys with MBID who consumed any alcohol during the last year will be randomised either to the 6 week mindfulness oriented intervention or the control group receiving a control intervention equal in dose and length. The intervention group undergoes mindfulness training combined with interactive drug education, while the control group completes a health training combined with the same education. In the intention-to-treat analysis the primary outcome is the self-reported delay of first post-intervention drunkeness within a 12 months follow-up time span, measured weekly with a short app-based questionnaire. Secondary outcome is the use of alcohol, tobacco and other drugs within 30 days post-intervention. Changes in neurobiological behavioural parameters, such as impulse control, reward anticipation, and decision making, are also investigated. Other secondary outcomes regard trait mindfulness, emotion regulation, psychopathological symptoms, peer networks, perceived stress, and quality of life. In addition, a prospective registry will be established to record specific data on the population of 11–17 year old boys with MBID without any alcohol experience. Discussion This study offers the opportunity to gain first evidence of the effectiveness of a mindfulness-oriented program for the prevention of substance use for boys with MBID. Trial registration German Clinical Trials Register, DRKS00014042. Registered on March 19th 2018.

scholarly journals SOLACE: A Psychosocial Stigma Protection Intervention to Improve the Mental Health of Parents of Autistic Children—A Feasibility Randomised Controlled Trial

2020 ◽  
Vol 50 (12) ◽  
pp. 4477-4491 ◽  
Author(s):  
Annemarie Lodder ◽  
Chris Papadopoulos ◽  
Gurch Randhawa
Keyword(s):  
Mental Health ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Feasibility Trial ◽  
Secondary Outcome ◽  
Control Group ◽  
Autistic Children ◽  
Self Compassion ◽  
Group Interviews ◽  
Randomised Controlled

AbstractThis study presents findings from a feasibility trial, testing an 8-week psychosocial stigma protection intervention (SOLACE) designed to improve the mental health of parents of autistic children. Seventeen parents were stratified then randomly assigned to either SOLACE (n = 9) or control group (n = 8). Retention and adherence rates were excellent with minimal missing data suggesting SOLACE had good acceptability and feasibility. Quantitative analysis revealed that mental health scores had significantly improved for those who took part in SOLACE compared to no significant changes for control group participants. In addition, changes in secondary outcome measures (e.g. stigma, self-esteem and self-compassion) were in favour of SOLACE. Focus group interviews revealed that SOLACE was acceptable to parents. Results suggest that a full randomised controlled trial is warranted.

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