Comparative Effectiveness of Ultrasound-Guided Intratendinous Prolotherapy Injection with Conventional Treatment to Treat Focal Supraspinatus Tendinosis

Objective. To evaluate the efficacy of dextrose prolotherapy injection for focal supraspinatus rotator cuff tendinosis via outcomes such as functional score, range of movement, and real-time ultrasound parameters. Materials and Methods. 12 adult patients with focal supraspinatus tendinosis recruited after they had less than 30% improvement in functional (DASH) scores after one month of physiotherapy following initial presentation. Seven patients had 0.5–1.0 ml of prolotherapy injection (12.5% dextrose, 0.5% lignocaine) injected into the area of focal tendinosis under ultrasound guidance. Meanwhile, five patients continued standard physiotherapy with no intervention performed. Regional area of echogenicity in decibels, DASH, range of movements of the shoulder, pain, and sleep scores were measured at baseline and at 12 weeks. Results. The prolotherapy group showed significant improvement in shoulder abduction (p=0.030) and an improvement in sleep score (p=0.027). The echogenicity of area of tendinosis significantly increases at the end of treatment (p=0.009). However, there was a nonsignificant reduction in pain score in the injection group (43.5%) and in the control group (25%) at 12 weeks (p>0.005). Conclusion. Ultrasound-guided intratendinous prolotherapy injection significantly improves patient’s range of abduction and improves sleep within 12 weeks of treatment compared to conventional physiotherapy management. Trial Registration. This study was registered under Current Controlled Trials (UK) and given International Standard Randomised Controlled Trial Number (ISRCTN) of 43520960.

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Comparison of the efficacy of Acupuncture and Conventional Physiotherapy treatment in the management of SIJ dysfunction- A Randomised controlled trial (RCT)

Nigerian Journal of Medical Rehabilitation ◽

10.34058/njmr.v18i2.121 ◽

2016 ◽

Author(s):

Ganiyu Oluwaleke Sokunbi ◽

Fatima Gujba Kachalla

Keyword(s):

Pain Intensity ◽

Functional Disability ◽

Controlled Trial ◽

Control Group ◽

Invasive Treatment ◽

Pain Scores ◽

Significant Difference ◽

Conventional Physiotherapy ◽

Randomised Controlled

Background: The question of what form of non-invasive treatment is most effective for sacroiliac joint (SIJ) dysfunction has not been sufficiently addressed. The quality of evidence regarding the efficacy of a conservative treatment approach is low, and there is no evidence for sustained benefits.Objectives: To compare the efficacy of acupuncture and conventional physiotherapy in the management of pain and functional disability in patients with SIJ dysfunction.Methods: Forty women with SIJ dysfunction with a mean age of 29.3± 4.3 years participated in the study. Ten participants were randomised into each of three intervention groups (acupuncture (ACT); conventional physiotherapy (CPT); and acupuncture combined with conventional physiotherapy (ACPT)) and a control group (CG) (education and advice). Treatment interventions were provided three times a week for five weeks. The main outcome measures were pain intensity measured with visual analogue scale (VAS) and functional disability measured with Roland Morris Disability Questionnaire (RMDQ). Assessments were carried out by an independent examiner before and after the intervention and at 3 months follow-up.Results: Baseline VAS and RMDQ scores did not show significant differences among the groups. After treatment, the participants in all the intervention groups had reduced pain scores on the VAS scale (ACT= 3.5±0.06, CPT =3.0±0.08 and ACPT=1.2±0.98) and improved function on RMDQ scores (ACT =7.0±1.53, CPT = 6.0±.01, ACPT = 3.0± 0.08) compared to those in the control group, who recorded 7.4±0.08 and 17.5± 4.32 for pain intensity and functional disability, respectively. However, pain reduction and improvement in function was greatest in the ACPT at the end of the 5-week treatment and at 3-month follow-up (VAS=1.0±0.04, RMDQ =2.0± 0.07) compared with the other intervention groups (VAS: ACT= 4.0±0.97, CPT = 3.5±1.00 and RMDQ: ACT=7.0±1.6, CPT=5.0±0.87). There was a significant difference in the pain scores on VAS (F =67.171, P=0.000) and functional disability on RMDQ scores (F=62.467, P=0.000) among the groups after 5 weeks of treatment and at 3-month post-treatment follow-up assessment VAS (F =79.903, P=0.000) and RMDQ (F =75.301, P=0.000), which was not present at the baseline.Conclusion: Findings from this study showed that acupuncture or conventional physiotherapy alone or in combination is more effective than advice and education. The combination of acupuncture and conventional therapy is more effective than both treatments alone.

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Effectiveness of Child to Parent Communication Using Information Package on Food Hygiene

International Journal of Innovative Research in Medical Science ◽

10.23958/ijirms/vol03-i07/02 ◽

2018 ◽

Vol 3 (07) ◽

Author(s):

Ms. Sonam Yangchen Bhutia ◽

Dr. Sushma Kumari Saini ◽

Dr. Manmeet Kaur ◽

Dr. Sandhya Ghai

Keyword(s):

School Children ◽

Home Visit ◽

Controlled Trial ◽

Family Members ◽

Sampling Technique ◽

Control Group ◽

Food Hygiene ◽

Parent Communication ◽

Post Test ◽

Randomised Controlled

School children can act as change agent not only for families but for community. The study aimed to assess effectiveness of information package on knowledge and practices of parents/family members of school children studying in Govt. Sr. Sec. School on food hygiene in Dhanas and Daddu Majra Colony, UT, Chandigarh. A non-randomised controlled trial was conducted on 201 school children studying in VIIth standard and their parents/family members. Purposive sampling technique was utilised to enrol 101 in case and 100 participants in control group. Interview schedule for knowledge assessment and observation checklist for assessing the practices of parents/ family members was used. Pre assessment of both the groups was done by a home visit. Experimental group school children were educated on food hygiene as per the protocol. Pre and post-test knowledge of school children on food hygiene was assessed and were asked to disseminate the information to their parents/family members. After 15 days, second time home visit was done to the parents/family members of both the groups for the post assessment of knowledge and practices. Significant improvement in knowledge and practices of parents/family members related to food hygiene was observed. Hence, school children can be an effective tool in health related knowledge dissemination which can further promote healthy practices.

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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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Supported progressive resistance exercise training to counter the adverse side effects of robot-assisted radical prostatectomy: a randomised controlled trial

Supportive Care in Cancer ◽

10.1007/s00520-021-06002-5 ◽

2021 ◽

Author(s):

Ruth E. Ashton ◽

Jonathan J. Aning ◽

Garry A. Tew ◽

Wendy A Robson ◽

John M Saxton

Keyword(s):

Randomised Controlled Trial ◽

Radical Prostatectomy ◽

Muscular Strength ◽

Controlled Trial ◽

Control Group ◽

Robot Assisted ◽

Resistance Exercise Training ◽

Home Based ◽

Aerobic Exercise Capacity ◽

Randomised Controlled

Abstract Purpose To investigate the effects of a supported home-based progressive resistance exercise training (RET) programme on indices of cardiovascular health, muscular strength and health-related quality of life (HR-QoL) in prostate cancer (PCa) patients after treatment with robot-assisted radical prostatectomy (RARP). Methods This study was a single-site, two-arm randomised controlled trial, with 40 participants randomised to either the intervention or control group over a 10-month period. In addition to receiving usual care, the intervention group completed three weekly RET sessions using resistance bands for 6 months. Participants performed 3 sets of 12–15 repetitions for each exercise, targeting each major muscle group. The control group received usual care only. Brachial artery flow-mediated dilatation (FMD) was the primary outcome and assessed at baseline, 3 and 6 months. Secondary outcomes included body weight, body fat, aerobic fitness, strength and blood-borne biomarkers associated with cardiometabolic risk. Results There was no significant difference between the groups in FMD at 3 or 6 months. However, there were improvements in aerobic exercise capacity (P < 0.01) and upper- (P < 0.01) and lower-limb (P = 0.01) strength in favour of the RET group at 6 months, accompanied by greater weight loss (P = 0.04) and a reduction in body fat (P = 0.02). Improvements in HRQoL were evident in the RET group at 3 and 6 months via the PCa-specific component of the FACT-P questionnaire (both P < 0.01). Five adverse events and one serious adverse event were reported throughout the trial duration. Conclusion This study demonstrates that home-based RET is an effective and safe mode of exercise that elicits beneficial effects on aerobic exercise capacity, muscular strength and HR-QoL in men who have undergone RARP. Trial registration ISRCTN10490647.

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Nurse-based secondary preventive follow-up by telephone reduced recurrence of cardiovascular events: a randomised controlled trial

Scientific Reports ◽

10.1038/s41598-021-94892-0 ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Anna-Lotta Irewall ◽

Anders Ulvenstam ◽

Anna Graipe ◽

Joachim Ögren ◽

Thomas Mooe

Keyword(s):

Randomised Controlled Trial ◽

Primary Endpoint ◽

Cardiovascular Events ◽

Controlled Trial ◽

Control Group ◽

Coronary Syndrome ◽

Secondary Endpoints ◽

Randomised Controlled

AbstractEnhanced follow-up is needed to improve the results of secondary preventive care in patients with established cardiovascular disease. We examined the effect of long-term, nurse-based, secondary preventive follow-up by telephone on the recurrence of cardiovascular events. Open, randomised, controlled trial with two parallel groups. Between 1 January 2010 and 31 December 2014, consecutive patients (n = 1890) admitted to hospital due to stroke, transient ischaemic attack (TIA), or acute coronary syndrome (ACS) were included. Participants were randomised (1:1) to nurse-based telephone follow-up (intervention, n = 944) or usual care (control, n = 946) and followed until 31 December 2017. The primary endpoint was a composite of stroke, myocardial infarction, cardiac revascularisation, and cardiovascular death. The individual components of the primary endpoint, TIA, and all-cause mortality were analysed as secondary endpoints. The assessment of outcome events was blinded to study group assignment. After a mean follow-up of 4.5 years, 22.7% (n = 214) of patients in the intervention group and 27.1% (n = 256) in the control group reached the primary composite endpoint (HR 0.81, 95% CI 0.68–0.97; ARR 4.4%, 95% CI 0.5–8.3). Secondary endpoints did not differ significantly between groups. Nurse-based secondary preventive follow-up by telephone reduced the recurrence of cardiovascular events during long-term follow-up.

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A Short Mindfulness Retreat for Students to Reduce Stress and Promote Self-Compassion: Pilot Randomised Controlled Trial Exploring Both an Indoor and a Natural Outdoor Retreat Setting

Healthcare ◽

10.3390/healthcare9070910 ◽

2021 ◽

Vol 9 (7) ◽

pp. 910

Author(s):

Dorthe Djernis ◽

Mia S. O’Toole ◽

Lone O. Fjorback ◽

Helle Svenningsen ◽

Mimi Y. Mehlsen ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Controlled Trial ◽

Effect Sizes ◽

Medium Effect ◽

Control Group ◽

Post Intervention ◽

Pilot Randomised Controlled Trial ◽

Self Compassion ◽

Randomised Controlled

Here, we developed and examined a new way of disseminating mindfulness in nature to people without meditation experience, based on the finding that mindfulness conducted in natural settings may have added benefits. We evaluated a 5-day residential programme aiming to reduce stress and improve mental health outcomes. We compared an indoor and an outdoor version of the programme to a control group in a pilot randomised controlled trial (RCT). Sixty Danish university students experiencing moderate to high levels of stress were randomised into a residential mindfulness programme indoors (n = 20), in nature (n = 22), or a control group (n = 18). Participants completed the Perceived Stress Scale and the Self-Compassion Scale (primary outcomes) along with additional secondary outcome measures at the start and end of the program and 3 months after. Stress was decreased with small to medium effect sizes post-intervention, although not statistically significant. Self-compassion increased post-intervention, but effect sizes were small and not significant. At follow-up, changes in stress were not significant, however self-compassion increased for both interventions with medium-sized effects. For the intervention groups, medium- to large-sized positive effects on trait mindfulness after a behavioural task were found post-intervention, and small- to medium-sized effects in self-reported mindfulness were seen at follow-up. Connectedness to Nature was the only outcome measure with an incremental effect in nature, exceeding the control with a medium-sized effect at follow-up. All participants in the nature arm completed the intervention, and so did 97% of the participants in all three arms. Overall, the results encourage the conduct of a larger-scale RCT, but only after adjusting some elements of the programme to better fit and take advantage of the potential benefits of the natural environment.

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Feasibility of a specific task-oriented training versus its combination with manual therapy on balance and mobility in people post stroke at the chronic stage: study protocol for a pilot randomised controlled trial

Pilot and Feasibility Studies ◽

10.1186/s40814-021-00886-0 ◽

2021 ◽

Vol 7 (1) ◽

Author(s):

Kristina Traxler ◽

Franz Schinabeck ◽

Eva Baum ◽

Edith Klotz ◽

Barbara Seebacher

Keyword(s):

Randomised Controlled Trial ◽

Ankle Joint ◽

Manual Therapy ◽

Controlled Trial ◽

Daily Activities ◽

Control Group ◽

Chronic Stage ◽

Post Stroke ◽

Randomised Controlled ◽

Task Oriented

Abstract Background Large studies have shown that stroke is among the most relevant causes of acquired adult disability. Walking and balance impairment in stroke survivors often contribute to a restriction in daily activities and social participation. Task-oriented training (TOT) is an effective treatment strategy and manual therapy (MT) is used successfully to enhance ankle joint flexibility in this population. No study, however, has compared TOT against its combination with MT in a randomised controlled trial. Aims of this pilot study are therefore to explore the feasibility of a full-scale RCT using predefined feasibility criteria. Secondary aims are to explore the preliminary effects of specific TOT with a combined specific TOT-MT versus a control group in people post stroke. Methods This is a protocol of a 4-week prospective randomised controlled parallel pilot trial in people post stroke at the chronic stage with limited upper ankle joint mobility and an impairment in balance and mobility. At a German outpatient therapy centre using 1:1:1 allocation, 36 patients will be randomised into one of three groups: 15-min talocrural joint MT plus 30-min specific TOT (group A), 45-min specific TOT (group B), and controls (group C). Training will be goal-oriented including tasks that are based on daily activities and increased in difficulty utilising predefined progression criteria based on patients’ skill levels. Interventions will be provided face-to-face 2 times per week, for 4 weeks, in addition to 20-min concurrent x4 weekly home-based training sessions. Data will be collected by blinded assessors at baseline, post-intervention and 4-week follow-up. The primary outcome will be feasibility assessed by recruitment, retention and adherence rates, compliance, adverse events, falls and the acceptability of the intervention. Secondary outcomes will be walking speed, single and dual tasking functional mobility, ankle range of motion, disability and health-related quality of life. Discussion Feasibility provided, results from this study will be used to calculate the sample size of a larger randomised controlled trial to investigate the effects of specific TOT and specific TOT-MT compared to a post stroke control group. Trial registration German Clinical Trials Register, DRKS00023068. Registered on 21.09.2020, https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00023068.

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Functional electrical stimulation‐assisted cycle ergometry-based progressive mobility programme for mechanically ventilated patients: randomised controlled trial with 6 months follow-up

Thorax ◽

10.1136/thoraxjnl-2020-215755 ◽

2021 ◽

pp. thoraxjnl-2020-215755

Author(s):

Petr Waldauf ◽

Natália Hrušková ◽

Barbora Blahutova ◽

Jan Gojda ◽

Tomáš Urban ◽

...

Keyword(s):

Electrical Stimulation ◽

Randomised Controlled Trial ◽

Functional Electrical Stimulation ◽

Controlled Trial ◽

Cycle Ergometry ◽

Control Group ◽

Mechanically Ventilated ◽

Icu Discharge ◽

Randomised Controlled

PurposeFunctional electrical stimulation-assisted cycle ergometry (FESCE) enables in-bed leg exercise independently of patients’ volition. We hypothesised that early use of FESCE-based progressive mobility programme improves physical function in survivors of critical care after 6 months.MethodsWe enrolled mechanically ventilated adults estimated to need >7 days of intensive care unit (ICU) stay into an assessor-blinded single centre randomised controlled trial to receive either FESCE-based protocolised or standard rehabilitation that continued up to day 28 or ICU discharge.ResultsWe randomised in 1:1 ratio 150 patients (age 61±15 years, Acute Physiology and Chronic Health Evaluation II 21±7) at a median of 21 (IQR 19–43) hours after admission to ICU. Mean rehabilitation duration of rehabilitation delivered to intervention versus control group was 82 (IQR 66–97) versus 53 (IQR 50–57) min per treatment day, p<0.001. At 6 months 42 (56%) and 46 (61%) patients in interventional and control groups, respectively, were alive and available to follow-up (81.5% of prespecified sample size). Their Physical Component Summary of SF-36 (primary outcome) was not different at 6 months (50 (IQR 21–69) vs 49 (IQR 26–77); p=0.26). At ICU discharge, there were no differences in the ICU length of stay, functional performance, rectus femoris cross-sectional diameter or muscle power despite the daily nitrogen balance was being 0.6 (95% CI 0.2 to 1.0; p=0.004) gN/m2 less negative in the intervention group.ConclusionEarly delivery of FESCE-based protocolised rehabilitation to ICU patients does not improve physical functioning at 6 months in survivors.Trial registration numberNCT02864745.

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Study protocol: randomised controlled trial evaluating exercise therapy as a supplemental treatment strategy in early multiple sclerosis: the Early Multiple Sclerosis Exercise Study (EMSES)

BMJ Open ◽

10.1136/bmjopen-2020-043699 ◽

2021 ◽

Vol 11 (1) ◽

pp. e043699

Author(s):

Morten Riemenschneider ◽

Lars G Hvid ◽

Steffen Ringgaard ◽

Mikkel K E Nygaard ◽

Simon F Eskildsen ◽

...

Keyword(s):

Multiple Sclerosis ◽

Randomised Controlled Trial ◽

Usual Care ◽

Treatment Strategy ◽

Controlled Trial ◽

Treatment Strategies ◽

Control Group ◽

Disease Course ◽

Disability Progression ◽

Randomised Controlled

IntroductionIn the relapsing remitting type of multiple sclerosis (MS) reducing relapses and neurodegeneration is crucial in halting the long-term impact of the disease. Medical disease-modifying treatments have proven effective, especially when introduced early in the disease course. However, patients still experience disease activity and disability progression, and therefore, supplemental early treatment strategies are warranted. Exercise appear to be one of the most promising supplemental treatment strategies, but a somewhat overlooked ‘window of opportunity’ exist early in the disease course. The objective of this study is to investigate exercise as a supplementary treatment strategy early in the disease course of MS.Methods and analysisThe presented Early Multiple Sclerosis Exercise Study is a 48-week (plus 1-year follow-up) national multicentre single-blinded parallel group randomised controlled trial comparing two groups receiving usual care plus supervised high-intense exercise or plus health education (active control). Additionally, data will be compared with a population-based control group receiving usual care only obtained from the Danish MS Registry. The primary outcomes are annual relapse rate and MRI derived global brain atrophy. The secondary outcomes are disability progression, physical and cognitive function, MS-related symptoms, and exploratory MRI outcomes. All analyses will be performed as intention to treat.Ethics and disseminationThe study is approved by The Central Denmark Region Committees on Health Research Ethics (1-10-72-388-17) and registered at the Danish Data Protection Agency (2016-051-000001 (706)). All study findings will be published in scientific peer-reviewed journals and presented at relevant scientific conferences.Trial registration numberNCT03322761.

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Capsular closure versus unrepaired interportal capsulotomy after hip arthroscopy in patients with femoroacetabular impingement, results of a patient-blinded randomised controlled trial

Hip International ◽

10.1177/11207000211005762 ◽

2021 ◽

pp. 112070002110057

Author(s):

Niels H Bech ◽

Inger N Sierevelt ◽

Sheryl de Waard ◽

Boudijn S H Joling ◽

Gino M M J Kerkhoffs ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Femoroacetabular Impingement ◽

Hip Arthroscopy ◽

Controlled Trial ◽

Poor Quality ◽

Control Group ◽

Treatment Groups ◽

Significant Difference ◽

Randomised Controlled

Background: Hip capsular management after hip arthroscopy remains a topic of debate. Most available current literature is of poor quality and are retrospective or cohort studies. As of today, no clear consensus exists on capsular management after hip arthroscopy. Purpose: To evaluate the effect of routine capsular closure versus unrepaired capsulotomy after interportal capsulotomy measured with NRS pain and the Copenhagen Hip and Groin Outcome Score (HAGOS). Materials and methods: All eligible patients with femoroacetabular impingement who opt for hip arthroscopy ( n = 116) were randomly assigned to one of both treatment groups and were operated by a single surgeon. Postoperative pain was measured with the NRS score weekly the first 12 weeks after surgery. The HAGOS questionnaire was measured at 12 and 52 weeks postoperatively. Results: Baseline characteristics and operation details were comparable between treatment groups. Regarding the NRS pain no significant difference was found between groups at any point the first 12 weeks after surgery ( p = 0.67). Both groups significantly improved after surgery ( p < 0.001). After 3 months follow-up there were no differences between groups for the HAGOS questionnaire except for the domain sport ( p = 0.02) in favour of the control group. After 12 months follow-up there were no differences between both treatment groups on all HAGOS domains ( p > 0.05). Conclusions: The results of this randomised controlled trial show highest possible evidence that there is no reason for routinely capsular closure after interportal capsulotomy at the end of hip arthroscopy. Trial Registration: This trial was registered at the CCMO Dutch Trial Register: NL55669.048.15.

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