scholarly journals Intramuscular versus oral diclofenac for acute pain in adults with acute musculoskeletal injuries presenting to the ED setting: a prospective, double-blind, double-dummy, randomised controlled trial

2019 ◽  
pp. emermed-2018-208214
Author(s):  
Isma Qureshi ◽  
Sameer A Pathan ◽  
Raheel Sharfeen Qureshi ◽  
Stephen H Thomas
Keyword(s):  
Randomised Controlled Trial ◽  
Pain Score ◽  
Drug Administration ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Controlled Trial ◽  
Pain Reduction ◽  
Musculoskeletal Injuries ◽  
Number Needed To Treat ◽  
Randomised Controlled

ObjectiveThe current study aimed to ascertain differences in early postmedication pain reduction in participants presenting with acute musculoskeletal injuries (MSI) to the ED receiving intramuscular (IM) versus per oral (PO) diclofenac.MethodsThis was a prospective, double-blinded, randomised controlled trial conducted between January and June 2018 at the ED of Hamad General Hospital in Doha, Qatar. Adults (18–65 years of age) presenting to the ED within 24 hours of an acute MSI, who had a triage pain score measured using numerical rating scale of at least five or above were enrolled in this trial. Participants randomised to either IM (75 mg) with oral placebo, or oral (100 mg) diclofenac group with IM placebo using a computer-generated randomised concealed list in blocks of six and eight. The primary objective was to compare the proportion of IM versus PO participants attaining a 50% reduction in pain score at 30 min from t0.Results300 participants were enrolled (150 in the IM diclofenac group and 150 in the PO diclofenac group) in the trial. The primary outcome was achieved in 99.3 (95% CI 96.3 to 100) in the IM group and 86.7 (95% CI 80.2 to 91.7) in PO group. There was an absolute risk difference of 12.7%. This corresponds to a number needed to treat of 8 cases (95% CI 6 to 14) receiving IM rather than the PO diclofenac in order to achieve one additional case of 50% pain reduction within 30 min of drug administration. There were no adverse events experienced in any treatment groups.ConclusionIM diclofenac injection provides rapid analgesia over PO administration of diclofenac. However, given the preparation needed for an IM injection, oral administration may be preferable when and if clinical circumstances allow a choice in non-steroidal anti-inflammatory drug administration route.

scholarly journals Reducing arthritis fatigue impact: two-year randomised controlled trial of cognitive behavioural approaches by rheumatology teams (RAFT)

2019 ◽  
Vol 78 (4) ◽  
pp. 465-472 ◽  
Author(s):  
Sarah Hewlett ◽  
Celia Almeida ◽  
Nicholas Ambler ◽  
Peter S Blair ◽  
Ernest H Choy ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Usual Care ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Controlled Trial ◽  
Intention To Treat ◽  
Cognitive Behavioural ◽  
Numerical Rating ◽  
Randomised Controlled ◽  
Group Programme

ObjectivesTo see if a group course delivered by rheumatology teams using cognitive-behavioural approaches, plus usual care, reduced RA fatigue impact more than usual care alone.MethodsMulticentre, 2-year randomised controlled trial in RA adults (fatigue severity>6/10, no recent major medication changes). RAFT (Reducing Arthritis Fatigue: clinical Teams using CB approaches) comprises seven sessions, codelivered by pairs of trained rheumatology occupational therapists/nurses. Usual care was Arthritis Research UK fatigue booklet. Primary 26-week outcome fatigue impact (Bristol RA Fatigue Effect Numerical Rating Scale, BRAF-NRS 0–10). Intention-to-treat regression analysis adjusted for baseline scores and centre.Results308/333 randomised patients completed 26 week data (156/175 RAFT, 152/158 Control). Mean baseline variables were similar. At 26 weeks, the adjusted difference between arms for fatigue impact change favoured RAFT (BRAF-NRS Effect −0.59, 95% CI –1.11 to -0.06), BRAF Multidimensional Questionnaire (MDQ) Total −3.42 (95% CI –6.44 to -0.39), Living with Fatigue −1.19 (95% CI –2.17 to -0.21), Emotional Fatigue −0.91 (95% CI –1.58 to -0.23); RA Self-Efficacy (RASE, +3.05, 95% CI 0.43 to 5.66) (14 secondary outcomes unchanged). Effects persisted at 2 years: BRAF-NRS Effect −0.49 (95% CI −0.83 to -0.14), BRAF MDQ Total −2.98 (95% CI −5.39 to -0.57), Living with Fatigue −0.93 (95% CI −1.75 to -0.10), Emotional Fatigue −0.90 (95% CI −1.44, to -0.37); BRAF-NRS Coping +0.42 (95% CI 0.08 to 0.77) (relevance of fatigue impact improvement uncertain). RAFT satisfaction: 89% scored > 8/10 vs 54% controls rating usual care booklet (p<0.0001).ConclusionMultiple RA fatigue impacts can be improved for 2 years by rheumatology teams delivering a group programme using cognitive behavioural approaches.Trial registration numberISRCTN52709998.

scholarly journals Participatory health through behavioural engagement and disruptive digital technology for postoperative rehabilitation: protocol of the PATHway trial

BMJ Open ◽  
2021 ◽  
Vol 11 (1) ◽  
pp. e041328
Author(s):  
Xia Wang ◽  
David J Hunter ◽  
Sarah Robbins ◽  
Sarah Capistrano ◽  
Vicky Duong ◽  
...  
Keyword(s):  
Physical Activity ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Postoperative Rehabilitation ◽  
Randomised Controlled

IntroductionPostsurgical rehabilitation is critical for optimal recovery in people undergoing orthopaedic surgery. Currently, knee and lumbar spine postsurgical care is not standardised, economically sustainable, nor based on quality evidence, contributing to substantial clinical variation, poor outcomes and increasing healthcare costs. This protocol describes the design of a randomised controlled trial aiming to evaluate the effectiveness and cost-effectiveness of a postsurgical clinical pathway augmented by disruptive technology and compared with standardised rehabilitation alone, in decreasing pain and improving function after total knee replacement (TKR) or lumbar laminectomy (with or without fusion).MethodsAn assessor-blinded, parallel group, randomised controlled trial will be conducted to recruit 204 consenting participants (102 per arm) of whom 50% are undergoing TKR and 50% lumbar surgery. The intervention group will receive a 6-month technology-enabled rehabilitation package in addition to usual postsurgical care. The package includes (1) an exercise program delivered via the Physitrack app on the iPad, (2) a health-coaching program delivered via video calls and motivational messages, (3) use of physical activity tracker with goal setting and motivational reminders (Fitbit). For those undergoing TKR, the intervention will also include knee joint range of motion self-monitoring via the Goniometer app. The control group will receive usual postsurgical care. Participants will be followed up at 3, 6 and 12 months from the enrolment date. The primary outcome is pain measured with the Numerical Rating Scale at 3 months. Secondary outcomes include pain-related disability, quality of life, computer self-efficacy, physical activity participation and sedentary behaviour. Data analysis will be blinded and by intention-to-treat. A trial-based cost-effectiveness analysis will determine the potential incremental cost per quality-adjusted life-year gained.Ethics and disseminationThis protocol is approved by the human research ethics committee of the University of Sydney. Dissemination will occur through lay summary, infographics, conferences and journal publications.Trial registration numberACTRN12618001448235.

scholarly journals Exercise and education for community-dwelling older participants with knee osteoarthritis: a video-linked programme protocol based on a randomised controlled trial

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Lin Wang ◽  
Suhang Xie ◽  
Tianjie Bao ◽  
Siyi Zhu ◽  
Qiu Liang ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Knee Osteoarthritis ◽  
Rating Scale ◽  
Controlled Trial ◽  
Pressure Pain Threshold ◽  
Estimating Equation ◽  
Community Dwelling ◽  
Self Report ◽  
Exercise Programmes ◽  
Randomised Controlled

Abstract Background Neuromuscular and quadriceps exercises have been shown to be effective approaches to relieve pain and to improve function for patients with knee osteoarthritis. In this study, we aim to provide an informative feasible model in which therapeutic exercise and education will be undertaken with physiotherapy supervision and instruction via video link. We also aim to explore the relationship between program-induced pain alleviation/functional improvements and reduction in irritability, which might be mediated through program-induced psychosocial benefits. Methods In this proposed two-parallel group (neuromuscular exercise versus quadriceps exercise), single-blinded, randomised controlled trial, participants aged ≥50 years with osteoarthritic knee pain will undergo a 12-week intervention, comprising video-linked education, supervised exercises, and a 12-week follow-up. Seven measurements will be taken to collect longitudinal data. A generalised estimating equation will be used to establish the adjusted difference in effectiveness on pain, function, irritability, and psychosocial outcomes between participants undertaking neuromuscular exercises and those undertaking quadriceps exercises. The primary outcomes are overall average pain in the knee joint during walking, as assessed through the 11-point Numerical Pain Rating Scale, and the Western Ontario and McMaster Universities osteoarthritis index physical function subscale. Furthermore, pressure pain threshold and changes in self-report pain scores pre-, during, and post-exercise were also measured as an indication of irritability. In addition, both the 6-min walk test and a timed up & go test were used to assess walking function performance. Finally, patients’ emotions (e.g., fear and catastrophising), self-trust, needs in terms of disease knowledge, mental resilience, social support and health-related quality of life were investigated. Two four-wave cross-lagged models will be used to investigate directional relationships, aiming to investigate the complex mechanisms concerning the effects of exercise programmes. Discussion Through summarising the study’s strengths and limitations, this study may provide promising insights in terms of exercise therapy optimisation for people with knee osteoarthritis and/or other chronic pain within a psychosocial framework. Trial registration ChiCTR2100041978 (chictr.org.cn), January 10, 2021.

scholarly journals Email-based promotion of self-help for subthreshold depression: Mood Memos randomised controlled trial

2012 ◽  
Vol 200 (5) ◽  
pp. 412-418 ◽  
Author(s):  
Amy J. Morgan ◽  
Anthony F. Jorm ◽  
Andrew J. Mackinnon
Keyword(s):  
Major Depression ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Active Group ◽  
Depression Symptoms ◽  
Number Needed To Treat ◽  
Subthreshold Depression ◽  
Self Help ◽  
Significant Difference ◽  
Randomised Controlled

BackgroundSubthreshold depression is common, impairs functioning and increases the risk of major depression. Improving self-help coping strategies could help subthreshold depression and prevent major depression.AimsTo test the effectiveness of an automated email-based campaign promoting self-help behaviours.MethodA randomised controlled trial was conducted through the website: www.moodmemos.com. Participants received automated emails twice weekly for 6 weeks containing advice about self-help strategies. Emails containing general information about depression served as a control. The principal outcome was depression symptom level on the nine-item Patient Health Questionnaire (PHQ-9) (trial registration: ACTRN12609000925246).ResultsThe study recruited 1326 adults with subthreshold depression. There was a small significant difference in depression symptoms at post-intervention, favouring the active group (d = 0.17, 95% CI 0.01–0.34). There was a lower, although non-significant, risk of major depression in the active group (number needed to treat (NNT) 25, 95% CI 11 to ∞ to NNT(harm) 57).ConclusionsEmails promoting self-help strategies were beneficial. Internet delivery of self-help messages affords a low-cost, easily disseminated and highly automated approach for indicated prevention of depression.

scholarly journals Effectiveness of online tailored advice to prevent running-related injuries and promote preventive behaviour in Dutch trail runners: a pragmatic randomised controlled trial

2017 ◽  
Vol 52 (13) ◽  
pp. 851-858 ◽  
Author(s):  
Luiz Carlos Hespanhol ◽  
Willem van Mechelen ◽  
Evert Verhagen
Keyword(s):  
Randomised Controlled Trial ◽  
Preventive Intervention ◽  
Absolute Risk ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Number Needed To Treat ◽  
Preventive Behaviour ◽  
Randomised Controlled ◽  
Tailored Advice

BackgroundTrail running is popular worldwide, but there is no preventive intervention for running-related injury (RRI).AimTo evaluate the effectiveness of adding online tailored advice (TrailS6) to general advice on (1) the prevention of RRIs and (2) the determinants and actual preventive behaviour in Dutch trail runners.MethodsTwo-arm randomised controlled trial over 6 months. 232 trail runners were randomly assigned to an intervention or control group. All participants received online general advice on RRI prevention 1 week after baseline. Every 2 weeks, participants in the intervention group received specific advice tailored to their RRI status. The control group received no further intervention. Bayesian mixed models were used to analyse the data.ResultsTrail runners in the intervention group sustained 13% fewer RRIs compared with those in the control group after 6 months of follow-up (absolute risk difference −13.1%, 95% Bayesian highest posterior credible interval (95% BCI) −23.3 to −3.1). A preventive benefit was observed in one out of eight trail runners who had received the online tailored advice for 6 months (number needed to treat 8, 95% BCI 3 to 22). No significant between-group difference was observed on the determinants and actual preventive behaviours.ConclusionsOnline tailored advice prevented RRIs among Dutch trail runners. Therefore, online tailored advice may be used as a preventive component in multicomponent RRI prevention programmes. No effect was observed on determinants and actual preventive behaviours.Trial registration numberThe Netherlands National Trial Register (NTR5431).

scholarly journals Promoting Independence in Dementia (PRIDE): protocol for a feasibility randomised controlled trial

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Aisha Shafayat ◽  
Emese Csipke ◽  
Lucy Bradshaw ◽  
Georgina Charlesworth ◽  
Florence Day ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Rating Scale ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Mild Dementia ◽  
Link Type ◽  
Feasibility Randomised Controlled Trial ◽  
Randomised Controlled

Abstract Background Memory services often see people with early stage dementia who are largely independent and able to participate in community activities but who run the risk of reducing activities and social networks. PRIDE is a self-management intervention designed to promote living well and enhance independence for people with mild dementia. This study aims to examine the feasibility of conducting a definitive randomised trial comparing the clinical and cost-effectiveness of the PRIDE intervention offered in addition to usual care or with usual care alone. Methods/design PRIDE is a parallel, two-arm, multicentre, feasibility, randomised controlled trial (RCT). Eligible participants aged 18 or over who have mild dementia (defined as a score of 0.5 or 1 on the Clinical Dementia Rating Scale) who can participate in the intervention and provide informed consent will be randomised (1:1) to treatment with the PRIDE intervention delivered in addition to usual care, or usual care only. Participants will be followed-up at 3 and 6 month’s post-randomisation. There will be an option for a supporter to join each participant. Each supporter will be provided with questionnaires at baseline and follow-ups at 3 to 6 months. Embedded qualitative research with both participants and supporters will explore their perspectives on the intervention investigating a range of themes including acceptability and barriers and facilitators to delivery and participation. The feasibility of conducting a full RCT associated with participant recruitment and follow-up of both conditions, intervention delivery including the recruitment, training, retention of PRIDE trained facilitators, clinical outcomes, intervention and resource use costs and the acceptability of the intervention and study related procedures will be examined. Discussion This study will assess whether a definitive randomised trial comparing the clinical and cost-effectiveness of whether the PRIDE intervention offered in addition to usual care is feasible in comparison to usual care alone, and if so, will provide data to inform the design and conduct of a future trial. Trial registration ISRCTN, ISRCTN11288961, registered on 23 October 2019, http://www.isrctn.com/ISRCTN12345678 Protocol V2.1 dated 19 June 2019.

scholarly journals SOMA-trial: surgery or medication for women with an endometrioma? Study protocol for a randomised controlled trial and cohort study

2020 ◽  
Vol 2020 (1) ◽  
Author(s):  
E van Barneveld ◽  
V B Veth ◽  
J M Sampat ◽  
A M F Schreurs ◽  
M van Wely ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Cohort Study ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Pain Reduction ◽  
Deep Endometriosis ◽  
Ovarian Endometrioma ◽  
Randomised Controlled

Abstract STUDY QUESTIONS The objective of this study is to evaluate the effectiveness and cost-effectiveness of surgical treatment of women suffering from pain due to an ovarian endometrioma when compared to treatment with medication (analgesia and/or hormones). The primary outcome is defined as successful pain reduction (−30% reduction of pain) measured by the numeric rating scale (NRS) after 6 months. Secondary outcomes include successful pain reduction after 12 and 18 months, quality of life, affective symptoms, cost-effectiveness, recurrence rate, need of adjuvant medication after surgery, ovarian reserve, adjuvant surgery and budget impact. WHAT IS KNOWN ALREADY Evidence suggests that both medication and surgical treatment of an ovarian endometrioma are effective in reducing pain and improving quality of life. However, there are no randomised studies that compare surgery to treatment with medication. STUDY DESIGN, SIZE, DURATION This study will be performed in a research network of university and teaching hospitals in the Netherlands. A multicentre randomised controlled trial and parallel prospective cohort study in patients with an ovarian endometrioma, with the exclusion of patients with deep endometriosis, will be conducted. After obtaining informed consent, eligible patients will be randomly allocated to either treatment arm (medication or surgery) by using web-based block randomisation stratified per centre. A successful pain reduction is set at a 30% decrease on the NRS at 6 months after randomisation. Based on a power of 80% and an alpha of 5% and using a continuity correction, a sample size of 69 patients in each treatment arm is needed. Accounting for a drop-out rate of 25% (i.e. loss to follow up), we need to include 92 patients in each treatment arm, i.e. 184 in total. Simultaneously, a cohort study will be performed for eligible patients who are not willing to be randomised because of a distinct preference for one of the two treatment arms. We intend to include 100 women in each treatment arm to enable standardization by inverse probability weighting, which means 200 patients in total. The expected inclusion period is 24 months with a follow-up of 18 months. PARTICIPANTS/MATERIALS, SETTING, METHODS Premenopausal women (age ≥ 18 years) with pain (dysmenorrhoea, pelvic pain or dyspareunia) and an ovarian endometrioma (cyst diameter ≥ 3 cm) who visit the outpatient clinic will make up the study population. Patients with signs of deep endometriosis will be excluded. The primary outcome is successful pain reduction, which is defined as a 30% decrease of pain on the NRS at 6 months after randomisation. Secondary outcomes include successful pain reduction after 12 and 18 months, quality of life and affective symptoms, cost-effectiveness (from a healthcare and societal perspective), number of participants needing additional surgery, need of adjuvant medication after surgery, ovarian reserve and recurrence rate of endometriomas. Measurements will be performed at baseline, 6 weeks and 6, 12 and 18 months after randomisation. STUDY FUNDING/COMPETING INTEREST(S) This study is funded by ZonMw, a Dutch organization for Health Research and Development, project number 80-85200-98-91041. The Department of Reproductive Medicine of the Amsterdam UMC location VUmc has received several research and educational grants from Guerbet, Merck KGaA and Ferring not related to the submitted work. B.W.J. Mol is supported by a NHMRC Practitioner Fellowship (GNT1082548) and reports consultancy for ObsEva, Merck KGaA and Guerbet. V. Mijatovic reports grants from Guerbet, grants from Merck and grants from Ferring outside the submitted work. All authors declare that they have no competing interests concerning this publication. TRIAL REGISTRATION NUMBER Dutch Trial Register (NTR 7447, http://www.trialregister.nl). TRIAL REGISTRATION DATE 2 January 2019 DATE OF FIRST PATIENT’S ENROLMENT First inclusion in randomised controlled trial October 4, 2019. First inclusion in cohort May 22, 2019.

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