Effectiveness of physical therapy in addition to occlusal splint in myogenic temporomandibular disorders: protocol of a randomised controlled trial

IntroductionTemporomandibular disorders (TMDs) are considered a collection of musculoskeletal conditions involving the masticatory muscles, the temporomandibular joint and associated structures. The myogenous group appears to represent the most frequently diagnosed category. In the context of a multimodal approach, splint therapy and musculoskeletal physiotherapy are often considered as a preferred therapy. The purpose of this study will be to investigate the effects of musculoskeletal physiotherapy combined with occlusal splint and education versus occlusal splint and education alone in the treatment of chronic myogenous TMD on pain and mandibular range of motion.Methods and analysisAll consecutive adults complaining of TMDs presented to the Department of Biomedical and Neuromotor Sciences of the University of Bologna will be considered eligible. Inclusion criteria shall be based on the presence of myogenous TMDs, as diagnosed through clinical examination in reference to the international diagnostic criteria of TMDs. Randomisation, concealed allocation, blinded assessment and intention-to-treat analysis will be employed. The splint therapy will consist of the use of the splint every night and concurrent delivery of an educational programme; the protocol shall have a duration of three consecutive months. The combined musculoskeletal physiotherapy, splint therapy and education will additionally consist of manual therapy techniques and exercise; such protocol shall consist of a duration of three consecutive months, inclusive of 10 sessions for the enhanced elements. All outcome measures will be collected at baseline, after treatment and at a 6 months follow-up.Ethics and disseminationEthical approval has been obtained from the Independent Ethic Committee in Clinical Research of AUSL Bologna-Italy (47/2018/SPER/AUSLBO). Pursuant to applicable rules,we will obtain informed consent from each participant and collect data anonymously to maintain privacy. Results will be disseminated to clinicians and researchers through peer-reviewed publications and conferences.Trial registration numberNCT03726060

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UTAH: Using Telemedicine to improve early medical Abortion at Home: a protocol for a randomised controlled trial comparing face-to-face with telephone consultations for women seeking early medical abortion

BMJ Open ◽

10.1136/bmjopen-2020-046628 ◽

2021 ◽

Vol 11 (6) ◽

pp. e046628

Author(s):

John Joseph Reynolds-Wright ◽

John Norrie ◽

Sharon Tracey Cameron

Keyword(s):

Controlled Trial ◽

Medical Abortion ◽

Is Success ◽

Face To Face ◽

Intention To Treat ◽

Ethical Approval ◽

Registration Number ◽

Low Sensitivity ◽

Randomised Controlled ◽

The Uk

IntroductionEarly medical abortion (EMA) is a two-stage process of terminating pregnancy using oral mifepristone (a progesterone-receptor antagonist) followed usually 1–2 days later by sublingual, vaginal or buccal misoprostol (a prostaglandin analogue). There are no published randomised controlled trials (RCTs) on the use of telemedicine for EMA. Our proposed research will determine if telephone consultations for EMA (the most common method of abortion in the UK) is non-inferior to standard face-to-face consultations with regard to the efficacy of EMA.Methods and analysisThis study will be conducted as an RCT. The recruitment target is 1222 participants.The primary outcome is success of EMA (complete abortion rate). This will be determined based on a negative low-sensitivity urine pregnancy test result (2 weeks after misoprostol use) and absence of surgical intervention or diagnosis of ongoing pregnancy (within 6 weeks of misoprostol).Secondary outcomes include total time spent at a clinic appointment to receive EMA, self-reported preparedness for EMA, level of satisfaction with consultation and effective contraception uptake compared with when women attend for a face-to-face consultation.The main analysis will be a modified intention-to-treat analysis. This will include all randomised women (with a viable pregnancy) using EMA and follow-up for the main outcome. The study initiated on 13 January 2020 and is anticipated to finish in late 2021.Ethics and disseminationEthical approval was given by the South East Scotland NHS Research Ethics Committee, reference: 19/SS/0111. Results will be published in peer-reviewed journals, presented at clinical and academic meetings, and shared with participants via the clinic website.Trial registration numberNCT04139382.

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Involving clinical experts in prioritising topics for health technology assessment: a randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2017-016104 ◽

2017 ◽

Vol 7 (8) ◽

pp. e016104 ◽

Cited By ~ 1

Author(s):

Andrew Cook ◽

Elke Streit ◽

Gill Davage

Keyword(s):

Controlled Trial ◽

Free Text ◽

Intention To Treat ◽

Cohen’S D ◽

Registration Number ◽

Review Form ◽

Response Modes ◽

Randomised Controlled ◽

Scoring Tool ◽

Cohen's D

ObjectivesThe objective of this study was to explore whether reducing the material supplied to external experts during peer review and decreasing the burden of response would maintain review quality into prioritising research questions for a major research funder.Methods and analysisClinical experts who agreed to review documents outlining research for potential commissioning were screened for eligibility and randomised in a factorial design to two types of review materials (long document versus short document) and response modes (structured review form versus free text email response). Previous and current members of the funder’s programme groups were excluded. Response quality was assessed by use of a four-point scoring tool and analysed by intention to treat.Results554 consecutive experts were screened for eligibility and 460 were randomised (232 and 228 to long document or short document, respectively; 230 each to structured response or free text). 356 participants provided reviews, 90 did not respond and 14 were excluded after randomisation as not eligible.The pooled mean quality score was 2.4 (SD=0.95). The short document scored 0.037 (Cohen’s d=0.039) extra quality points over the long document arm, and the structured response scored 0.335 (Cohen’s d=0.353) over free text. The allocation did not appear to have any effect on the experts' willingness to engage with the task.ConclusionsNeither providing a short or a long document outlining suggested research was shown to be superior. However, providing a structured form to guide the expert response provided more useful information than allowing free text. The funder should continue to use a structured form to gather responses. It would be acceptable to provide shorter documents to reviewers, if there were reasons to do so.Trial registration numberANZCTR12614000167662.

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Using feeding to reduce pain during vaccination of formula-fed infants: a randomised controlled trial

Archives of Disease in Childhood ◽

10.1136/archdischild-2017-313488 ◽

2018 ◽

Vol 103 (12) ◽

pp. 1132-1137 ◽

Cited By ~ 3

Author(s):

Netty G P Bos-Veneman ◽

Marrit Otter ◽

Sijmen A Reijneveld

Keyword(s):

Side Effects ◽

Controlled Trial ◽

Recovery Phase ◽

Pain Scale ◽

Formula Feeding ◽

Full Term ◽

Intention To Treat ◽

Registration Number ◽

The Face ◽

Randomised Controlled

ObjectivesTo assess the effectiveness and potential side effects of formula feeding to reduce pain during vaccination among infants.Study designIn the setting of well-baby clinics we recruited a community-based sample of full-term born infants who were already formula fed by the choice of the parents (n=48, aged 4–10 weeks) and received their first DTaP-IPV-HepB-Hib and pneumococcal vaccinations and randomised them into two groups. To evaluate pain experienced during vaccination we compared infants who drank formula feeding before, during and after vaccination with infants who did not. Outcomes were observed cry duration and pain scores measured by means of the Neonatal Infant Pain Scale (NIPS) and the Face, Legs, Activity, Cry and Consolability (FLACC) scale. Side effects of drinking during vaccination were recorded. We performed intention-to-treat analyses using regression models, crude and adjusted for sex and age of the infant.ResultsPain at the moment of the second injection did not differ between groups. Drinking infants cried 33.5 s shorter (−56.6; −10.3). In the first minute after injection drinking infants experienced a faster pain reduction on the NIPSΔt: regression coefficient 3.86 (95% CI 2.70 to 5.02) and FLACCΔt: 4.42 (95% CI 2.85 to 5.99).ConclusionsIn line with findings of previous studies regarding breast feeding, formula feeding reduced vaccination pain in the recovery phase in full-term born infants receiving their first vaccinations between ages 4 and 10 weeks with no adverse effects. Professionals should discuss this non-costly and feasible pain-reducing intervention with parents of infants who receive vaccinations.Trial registration numberIRCTN 31383, post-results

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Maximising trichiasis surgery success (MTSS) trial: rationale and design of a randomised controlled trial to improve trachomatous trichiasis surgical outcomes

BMJ Open ◽

10.1136/bmjopen-2019-036327 ◽

2020 ◽

Vol 10 (3) ◽

pp. e036327 ◽

Cited By ~ 1

Author(s):

Belay Bayissasse ◽

Kristin M Sullivan ◽

Shannath L Merbs ◽

Beatriz Munoz ◽

Alexander Keil ◽

...

Keyword(s):

Surgical Outcomes ◽

Controlled Trial ◽

Randomised Clinical Trial ◽

Upper Eyelid ◽

Intention To Treat ◽

Research Ethics Review ◽

Registration Number ◽

Randomised Controlled ◽

The Impact ◽

Trachomatous Trichiasis

IntroductionTrachomatous trichiasis (TT) is a condition in which the eyelid turns inward and eyelashes abrade the front part of the eye. To prevent eventual blindness, surgery is recommended. Two surgical procedures are commonly used, bilamellar tarsal rotation (BLTR) and posterior lamellar tarsal rotation (PLTR). Evidence suggests that incision height and surgery type may affect the risk of postoperative TT (PTT) and other surgical outcomes. However, these studies have not prospectively compared the impact of incision height on surgical outcomes.Methods and analysisMaximising trichiasis surgery Success (MTSS) is a three-arm, randomised clinical trial being conducted in Ethiopia. Participants will be randomly assigned on a 1:1:1 basis to BLTR with a 3 mm incision height, BLTR with a 5 mm incision height, or PLTR 3 mm incision height. Patients are eligible for the trial if they have previously unoperated upper eyelid TT. Follow-up visits will be conducted by trained eye examiners at 1 day, 2 weeks, 6 weeks and 12 months after surgery. The primary outcome is incident PTT within 1 year following surgery. Logistic regression will be used in an intention-to-treat analysis to assess outcome incidence by surgical approach.Ethics and disseminationThe University of North Carolina and Johns Hopkins School of Medicine institution review boards, Ethiopian National Research Ethics Review Committee and Ethiopian Food, Medicine, Healthcare and Administration and Control Authority provided ethics approval for the trial. On completion, trial results will be disseminated at local and international meetings and in peer-reviewed journals.Trial registration numberNCT03100747.

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Supervised pulmonary tele-rehabilitation versus pulmonary rehabilitation in severe COPD: a randomised multicentre trial

Thorax ◽

10.1136/thoraxjnl-2019-214246 ◽

2020 ◽

Vol 75 (5) ◽

pp. 413-421 ◽

Cited By ~ 5

Author(s):

Henrik Hansen ◽

Theresa Bieler ◽

Nina Beyer ◽

Thomas Kallemose ◽

Jon Torgny Wilcke ◽

...

Keyword(s):

Pulmonary Rehabilitation ◽

Controlled Trial ◽

Drop Out ◽

Group Differences ◽

Primary Analysis ◽

Intention To Treat ◽

Registration Number ◽

Randomised Controlled

RationalePulmonary rehabilitation (PR) is an effective, key standard treatment for people with COPD. Nevertheless, low participant uptake, insufficient attendance and high drop-out rates are reported. Investigation is warranted of the benefits achieved through alternative approaches, such as pulmonary tele-rehabilitation (PTR).ObjectiveTo investigate whether PTR is superior to conventional PR on 6 min walk distance (6MWD) and secondarily on respiratory symptoms, quality of life, physical activity and lower limb muscle function in patients with COPD and FEV1 <50% eligible for routine hospital-based, outpatient PR.MethodsIn this single-blinded, multicentre, superiority randomised controlled trial, patients were assigned 1:1 to 10 weeks of groups-based PTR (60 min, three times weekly) or conventional PR (90 min, two times weekly). Assessments were performed by blinded assessors at baseline, end of intervention and at 22 weeks’ follow-up from baseline. The primary analysis was based on the intention-to-treat principle.Measurements and main resultsThe primary outcome was change in 6MWD from baseline to 10 weeks; 134 participants (74 females, mean±SD age 68±9 years, FEV1 33%±9% predicted, 6MWD 327±103 metres) were included and randomised. The analysis showed no between-group differences for changes in 6MWD after intervention (9.2 metres (95% CI: −6.6 to 24.9)) or at 22 weeks’ follow-up (−5.3 metres (95% CI: −28.9 to 18.3)). More participants completed the PTR intervention (n=57) than conventional PR (n=43) (χ2 test p<0.01).ConclusionPTR was not superior to conventional PR on the 6MWD and we found no differences between groups. As more participants completed PTR, supervised PTR would be relevant to compare with conventional PR in a non-inferiority design.Trial registration numberClinicalTrials.gov (NCT02667171), 28 January 2016.

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A Case Series of Temporomandibular Disorders Treated with Acupuncture, Occlusal Splint and Point Injection Therapy

Acupuncture in Medicine ◽

10.1136/aim.21.4.138 ◽

2003 ◽

Vol 21 (4) ◽

pp. 138-149 ◽

Cited By ~ 14

Author(s):

Yiu-kai Wong ◽

Jason Cheng

Keyword(s):

Temporomandibular Disorders ◽

Acupuncture Treatment ◽

Case Series ◽

Injection Therapy ◽

Treatment Modalities ◽

Occlusal Splint ◽

Treatment Results ◽

Splint Therapy ◽

Point Injection ◽

Randomised Controlled

A treatment regime combining acupuncture, occlusal splint and point injection therapy for temporomandibular disorders (TMD) is presented. There were 89 consecutive patients treated by the regime in this case series but four patients dropped out after two to three visits. Data and treatment results of the remaining 85 patients who had treatment completed were analysed. It was found that 73 (85%) of patients with TMD had symptoms relieved within six visits under this regime. Complications were rare and minor. Acupuncture treatment, in combination with splint therapy and point injection therapy, appears to be effective for managing TMD. However, further research, using randomised controlled trials should be conducted to ascertain its effectiveness over other treatment modalities.

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Convalescent plasma for treatment of COVID-19: study protocol for an open randomised controlled trial in Sweden

BMJ Open ◽

10.1136/bmjopen-2020-048337 ◽

2021 ◽

Vol 11 (12) ◽

pp. e048337

Author(s):

Joakim Dillner ◽

Johan Ursing

Keyword(s):

Randomised Controlled Trial ◽

Standard Care ◽

Controlled Trial ◽

Ethical Review ◽

Block Randomisation ◽

Ethical Approval ◽

Registration Number ◽

Secondary Endpoints ◽

Randomised Controlled ◽

Antibody Levels

IntroductionAlthough there are many studies on the use of convalescent plasma (CP) for treatment of COVID-19, it is not clear (1) which groups of patients may benefit, (2) what dose of plasma to give, or (3) which antibody levels the plasma should contain. Previous phase I/II studies and literature review suggest that CP should only be given to patients with viraemia, that a daily infusion should be given until the patient becomes virus free and that the neutralising antibody titre should preferably be >1:640Methods and analysisAn open randomised controlled trial enrolling patients with COVID-19, who must be SARS-CoV-2 positive in both airway and blood samples and admitted to a study hospital. Block randomisation 2:1 is to either 200 mL CP (preferably titre ≥1/640) daily for up to 10 days (until virus negative in blood) plus standard care or standard care only (control arm). The primary endpoint is mortality by day 28 after study inclusion. Secondary endpoints include mortality by day 60 and doses of plasma needed to clear viraemia. Assuming a reduced mortality of approximately 30% by the CP therapy and 85%–88% survival in the control arm, approximately 600 participants will be enrolled to the CP therapy arm and 300 participants to the control arm.Ethics and disseminationEthical approval has been granted by the Swedish Ethical Review Authority (reference: 2020-06277). Results from this trial will be compiled in a clinical study report, disseminated via journal articles and communicated to stakeholders.Trial registration numberNCT04649879.

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Effect of tranexamic acid on the prognosis of patients with traumatic brain injury undergoing craniotomy: study protocol for a randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2021-049839 ◽

2021 ◽

Vol 11 (11) ◽

pp. e049839

Author(s):

Bei Wu ◽

Yu Lu ◽

Yun Yu ◽

Hongli Yue ◽

Jie Wang ◽

...

Keyword(s):

Traumatic Brain Injury ◽

Brain Injury ◽

Tranexamic Acid ◽

Controlled Trial ◽

Perioperative Period ◽

Double Blind ◽

Ethical Approval ◽

Registration Number ◽

Randomised Controlled ◽

Medical University

IntroductionAbnormal coagulation function aggravates the prognosis of patients with traumatic brain injury (TBI). It was reported that the antifibrinolytic drug tranexamic acid (TXA) could reduce intracranial haemorrhage and mortality in non-operative patients with TBI. However, there is a lack of evaluation of TXA in patients with TBI undergoing craniotomy.Methods and analysisThis is a single-centre randomised controlled, double-blind, parallel study aiming to investigate the effectiveness and safety of TXA in patients with TBI during the perioperative period. Blood loss and transfusion, neurological function, adverse events, mortality and serum immune-inflammatory cytokines will be collected and analysed.Ethics and disseminationEthical approval has been granted by the Medical Ethics Committee of Beijing Tian Tan Hospital, Capital Medical University (reference number KY 2020-136-03). The results of this study will be disseminated through presentations at scientific conferences and publication in peer-reviewed journals.Trial registration numberChiCTR2100041911.

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Comparison of two dose escalation strategies of methotrexate in active rheumatoid arthritis: a multicentre, parallel group, randomised controlled trial

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2021-220512 ◽

2021 ◽

pp. annrheumdis-2021-220512

Author(s):

Siddharth Jain ◽

Varun Dhir ◽

Amita Aggarwal ◽

Ranjan Gupta ◽

Bidyalaxmi Leishangthem ◽

...

Keyword(s):

Dose Escalation ◽

Controlled Trial ◽

Group Differences ◽

Drug Discontinuation ◽

Open Label ◽

Intention To Treat ◽

Parallel Group ◽

Registration Number ◽

Randomised Controlled

ObjectivesThere are no head-to-head trials of different dose escalation strategies of methotrexate (MTX) in RA. We compared the efficacy, safety and tolerability of ‘usual’ (5 mg every 4 weeks) versus ‘fast’ (5 mg every 2 weeks) escalation of oral MTX.MethodsThis multicentre, open-label (assessor blinded) RCT included patients 18-55 years of age having active RA with disease duration <5 years, and not on DMARDs. Patients were randomized 1:1 into usual or fast escalation groups, both groups starting MTX at 15 mg/week till a maximum of 25 mg/week. Primary outcome was EULAR good response at 16 weeks, secondary outcomes were ΔDAS28 and adverse effects (AE). Analyses were intention-to-treat.Results178 patients with mean DAS28-CRP of 5.4(1.1) were randomized to usual (n=89) or fast escalation groups (n=89). At 16 weeks, there was no difference in good EULAR response in the usual (28.1%) or fast escalation (22.5%) groups (p=0.8). There was no difference in mean ΔDAS28-CRP at 8 weeks (-0.9, -0.8, p=0.72) or 16 weeks (-1.3, -1.3, p=0.98). Even at 24 weeks (extended follow-up), responses were similar. There were no inter-group differences in ΔHAQ, or MTX-polyglutamates 1-3 levels at 8 or 16 weeks. Gastrointestinal AE were higher in the fast escalation group over initial 8 weeks (27%, 40%, p=0.048), but not over 16 weeks. There was no difference in cytopenias, transaminitis, or drug discontinuation/dose reduction between the groups. No serious AE were seen.ConclusionA faster MTX escalation strategy in RA was not more efficacious over 16-24 weeks, and did not significantly increase AE, except higher gastrointestinal AE initially.Trial registration numberCTRI/2018/12/016549

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Transnasal Humidified Rapid Insufflation Ventilatory Exchange in children requiring emergent intubation (Kids THRIVE): a protocol for a randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2018-025997 ◽

2019 ◽

Vol 9 (2) ◽

pp. e025997 ◽

Cited By ~ 5

Author(s):

Shane George ◽

Susan Humphreys ◽

Tara Williams ◽

Ben Gelbart ◽

Arjun Chavan ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Controlled Trial ◽

Cost Effective ◽

Intubation Attempt ◽

Emergency Intubation ◽

Intention To Treat ◽

High Incidence ◽

Registration Number ◽

Randomised Controlled ◽

Paediatric Intensive Care Units

IntroductionEmergency intubation of children with abnormal respiratory or cardiac physiology is a high-risk procedure and associated with a high incidence of adverse events including hypoxemia. Successful emergency intubation is dependent on inter-related patient and operator factors. Preoxygenation has been used to maximise oxygen reserves in the patient and to prolong the safe apnoeic time during the intubation phase. Transnasal Humidified Rapid Insufflation Ventilatory Exchange (THRIVE) prolongs the safe apnoeic window for a safe intubation during elective intubation. We designed a clinical trial to test the hypothesis that THRIVE reduces the frequency of adverse and hypoxemic events during emergency intubation in children and to test the hypothesis that this treatment is cost-effective compared with standard care.Methods and analysisThe Kids THRIVE trial is a multicentre randomised controlled trial performed in participating emergency departments and paediatric intensive care units. 960 infants and children aged 0–16 years requiring emergency intubation for all reasons will be enrolled and allocated to THRIVE or control in a 1:1 allocation with stratification by site, age (<1, 1–7 and >7 years) and operator (junior and senior). Children allocated to THRIVE will receive weight appropriate transnasal flow rates with 100% oxygen, whereas children in the control arm will not receive any transnasal oxygen insufflation. The primary outcomes are defined as follows: (1) hypoxemic event during the intubation phase defined as SpO2<90% (patient-dependent variable) and (2) first intubation attempt success without hypoxemia (operator-dependent variable). Analyses will be conducted on an intention-to-treat basis.Ethics and disseminationEthics approval for the protocol and consent process has been obtained (HREC/16/QRCH/81). The trial has been actively recruiting since May 2017. The study findings will be submitted for publication in a peer-reviewed journal.Trial registration numberACTRN12617000147381.

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