scholarly journals A randomized controlled trial comparing autologous cranioplasty with custom-made titanium cranioplasty

2017 ◽  
Vol 126 (1) ◽  
pp. 81-90 ◽  
Author(s):  
Stephen Honeybul ◽  
David Anthony Morrison ◽  
Kwok M. Ho ◽  
Christopher R. P. Lind ◽  
Elizabeth Geelhoed
Keyword(s):  
Controlled Trial ◽  
Secondary Infection ◽  
Young Patients ◽  
Cost Effective ◽  
Secondary Outcome ◽  
Clinical Trial Registration ◽  
Skull Defects ◽  
Custom Made ◽  
Autologous Bone ◽  
Titanium Cranioplasty

OBJECTIVE Autologous bone is usually used to reconstruct skull defects following decompressive surgery. However, it is associated with a high failure rate due to infection and resorption. The aim of this study was to see whether it would be cost-effective to use titanium as a primary reconstructive material. METHODS Sixty-four patients were enrolled and randomized to receive either their own bone or a primary titanium cranioplasty. All surgical procedures were performed by the senior surgeon. Primary and secondary outcome measures were assessed at 1 year after cranioplasty. RESULTS There were no primary infections in either arm of the trial. There was one secondary infection of a titanium cranioplasty that had replaced a resorbed autologous cranioplasty. In the titanium group, no patient was considered to have partial or complete cranioplasty failure at 12 months of follow-up (p = 0.002) and none needed revision (p = 0.053). There were 2 deaths unrelated to the cranioplasty, one in each arm of the trial. Among the 31 patients who had an autologous cranioplasty, 7 patients (22%) had complete resorption of the autologous bone such that it was deemed a complete failure. Partial or complete autologous bone resorption appeared to be more common among young patients than older patients (32 vs 45 years old, p = 0.013). The total cumulative cost between the 2 groups was not significantly different (mean difference A$3281, 95% CI $−9869 to $3308; p = 0.327). CONCLUSIONS Primary titanium cranioplasty should be seriously considered for young patients who require reconstruction of the skull vault following decompressive craniectomy. Clinical trial registration no.: ACTRN12612000353897 (anzctr.org.au)

scholarly journals Effectiveness of custom-made foot orthoses in patients with systemic lupus erythaematosus: protocol for a randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e042627
Author(s):  
María Reina-Bueno ◽  
María del Carmen Vázquez-Bautista ◽  
Inmaculada C Palomo-Toucedo ◽  
Gabriel Domínguez-Maldonado ◽  
José Manuel Castillo-López ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomised Controlled Trial ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Foot Orthoses ◽  
Systemic Lupus ◽  
Custom Made ◽  
Randomised Controlled

IntroductionSystemic lupus erythaematosus (SLE) is a chronic autoimmune disease of heterogeneous involvement. The disease may affect feet with a high prevalence of symptoms such as, for example, pain, forefoot and rearfoot deformities, and biomechanics dysfunctions. Custom-made foot orthoses (CMFO) have been previously reported to be effective in patients with other rheumatic diseases. However, as far as the authors know, there exist no studies about their effectiveness in SLE. This study aims at determining the effect of CMFO versus placebo flat cushioning insoles on pain, foot functionality, fatigue and quality of life in patients with SLE.Methods and analysisA randomised controlled trial would compare the effects of (1) CMFO and group B, which received a placebo, flat cushioning insoles, for 3 months. The main outcome measures are foot pain, foot functionality and foot-related disability. The secondary outcome measures are fatigue and quality of life.Ethics and disseminationThe study has been approved by the Portal de Ética de la Investigación Biomédica de Andalucía ethical committee 1494-N-19. The results will be disseminated regardless of the magnitude or direction of effect.Trial registartion numberClinicaltrials.gov identifier NCT04098055.

scholarly journals Effectiveness of a primary care-based group educational intervention in the management of patients with migraine: a randomized controlled trial

2019 ◽  
Vol 20 ◽  
Author(s):  
Iñaki Aguirrezabal ◽  
Maria Soledad Pérez de San Román ◽  
Raquel Cobos-Campos ◽  
Estibalitz Orruño ◽  
Arturo Goicoechea ◽  
...  
Keyword(s):  
Primary Care ◽  
Educational Intervention ◽  
Controlled Trial ◽  
Basque Country ◽  
Intervention Group ◽  
Cost Effective ◽  
Response To Treatment ◽  
Secondary Outcome ◽  
Control Group ◽  
Randomised Controlled

Abstract Aim: The aim of this study was to assess the effectiveness of a primary care-based group educational intervention about concepts of pain neuroscience for the management of migraine compared to the routine medical care delivered to patients with this condition. Background: The way pain is understood has been radically changed in recent decades, thanks to developments in the field of neuroscience. Thus, migraine may develop as a result of an exaggerated perception of threat that activates the pain neuromatrix, which might be modifiable, from a learning perspective, by adjusting the beliefs and behaviours that favour the onset of an attack. Methods: A randomised controlled trial was carried out in five primary care health centres of Vitoria-Gasteiz (Basque Country, Spain). The follow-up period was 12 months. The main outcome measure was the reduction in days lost due to migraine-related disability according to the Migraine Disability Assessment Test (MIDAS) score. Secondary outcome measures included the intensity and frequency of the pain and the number of analgesic drugs taken in the previous three months. A positive response to treatment was considered when the MIDAS score decreased by at least 50% from baseline. Findings: Days lost due to migraine-related disability decreased by at least 50% in 68.9% (n = 37) of patients in the intervention group and 34.6% of patients in the control group (n = 18) (P < 0.001). The intensity of the headache [odds ratio (OR) 9.116; P = 0.005] and the medication intake (OR 13.267; P < 0.001) were also significantly reduced with the intervention. Conclusions: The provision of suitable information through a group educational intervention delivered in primary care appears to be effective in preventing migraine attacks. Moreover, the intervention could offer a new cost-effective management alternative that seems to reduce the need for pharmacological treatment in patients with migraine.

scholarly journals Behavioral interventions for pediatric insomnia: one treatment may not fit all

SLEEP ◽  
2019 ◽  
Vol 43 (4) ◽  
Author(s):  
Michal Kahn ◽  
Michal Juda-Hanael ◽  
Efrat Livne-Karp ◽  
Liat Tikotzky ◽  
Thomas F Anders ◽  
...  
Keyword(s):  
Behavioral Interventions ◽  
Separation Anxiety ◽  
Sleep Problems ◽  
Controlled Trial ◽  
Cost Effective ◽  
Parental Presence ◽  
Clinical Trial Registration ◽  
Specific Patient ◽  
Pediatric Insomnia

Abstract Study Objectives Behavioral interventions for pediatric insomnia are cost-effective and benefit most families, but there is no evidence indicating which treatments are most suitable for specific patient populations. This randomized controlled trial evaluated the moderating role of infant separation anxiety in two brief interventions for infant sleep problems. Methods Ninety-one infants aged 9–18 months (61% boys) with pediatric insomnia were randomized to either Checking-in, a Graduated extinction protocol which involves gradual separation from parents, or to the Camping-out intervention, in which parental presence is maintained. Sleep was measured using actigraphy and parent reports. Infant separation anxiety was observed in the laboratory. Assessments were completed at baseline, post-treatment and 6-month follow-up. Results Improvement in sleep was demonstrated following both interventions and maintained at follow-up. Separation anxiety did not change significantly following treatment. Infant separation anxiety moderated treatment efficacy, with greater benefit for infants with high separation anxiety in the Camping-out compared to the Checking-in intervention. Conclusions This study provides support for considering infant separation anxiety in the effort to personalize treatment for pediatric insomnia. Pediatricians should incorporate evaluation of infant separation anxiety to assessment processes, and favor more gentle treatment approaches, such as Camping-out, over Graduated extinction for highly anxious infants. Clinical Trial Registration NCT01489215.

scholarly journals Early mobilization and quality of life after stroke

Neurology ◽  
2019 ◽  
Vol 93 (7) ◽  
pp. e717-e728
Author(s):  
Toby B. Cumming ◽  
Leonid Churilov ◽  
Janice Collier ◽  
Geoffrey Donnan ◽  
Fiona Ellery ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Usual Care ◽  
Recurrent Stroke ◽  
Controlled Trial ◽  
Early Mobilization ◽  
Care Quality ◽  
Secondary Outcome ◽  
Clinical Trial Registration ◽  
Significant Difference

ObjectiveTo determine whether early and more frequent mobilization after stroke affects health-related quality of life.MethodsA Very Early Rehabilitation Trial (AVERT) was an international, multicenter (56 sites), phase 3 randomized controlled trial, spanning 2006–2015. People were included if they were aged ≥18 years, presented within 24 hours of a first or recurrent stroke (ischemic or hemorrhagic), and satisfied preordained physiologic criteria. Participants were randomized to usual care alone or very early and more frequent mobilization in addition to usual care. Quality of life at 12 months was a prespecified secondary outcome, evaluated using the Assessment of Quality of Life 4D (AQoL-4D). This utility-weighted scale has scores ranging from −0.04 (worse than death) to 1 (perfect health). Participants who died were assigned an AQoL-4D score of 0.ResultsNo significant difference in quality of life at 12 months between intervention (median 0.47, interquartile range [IQR] 0.07–0.81) and usual care (median 0.49, IQR 0.08–0.81) groups was identified (p = 0.86), nor were there any group differences across the 4 AQoL-4D domains. The same lack of group difference in quality of life was observed at 3 months. When cohort data were analyzed (both groups together), quality of life was strongly associated with acute length of stay, independence in activities of daily living, cognitive function, depressive symptoms, and anxiety symptoms (all p < 0.001). Quality of life in AVERT participants was substantially lower than population norms, and the gap increased with age.ConclusionsEarlier and more frequent mobilization after stroke did not influence quality of life.Clinical trial registrationanzctr.org.au; ACTRN12606000185561Classification of evidenceThis study provides Class II evidence that for people with stroke, earlier and more frequent mobilization did not influence quality of life over the subsequent year.

scholarly journals The Clinical Efficacy, Safety and Biomechanical Mechanism of Tai Chi in Patients with Knee Osteoarthritis: Study Protocol for a Randomized Controlled Trial

2021 ◽  
Author(s):  
PAN FUWEI ◽  
Min Zhang ◽  
Guoqing Du ◽  
Yuanchuan Chen ◽  
Guangyue Yang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Knee Osteoarthritis ◽  
Tai Chi ◽  
Controlled Trial ◽  
Joint Disease ◽  
Secondary Outcome ◽  
Control Group ◽  
Clinical Trial Registration ◽  
Randomized Controlled ◽  
Biomechanical Effect

Abstract Background: Knee osteoarthritis (KOA), one of the most common degenerative joint disease, is the leading cause of disability among elder people. Many previous studies demonstrated that Tai chi is an effective treatment in the management of KOA, but there has been a lack of study evaluated the effect of Tai chi on both clinical and biomechanical outcomes in individuals with KOA. The purpose of the study is to identify the clinical and biomechanical effect of the Tai chi, the results will help to improve the understanding of possible underlying biomechanical effects of the Tai chi. Methods: We will conduct a prospective, randomized controlled trials of 72 individuals with medial KOA. The participants with medial KOA will be randomly divided into Tai chi group or a control group. The Tai chi group will participant in Tai chi twice a week for eight weeks. The control group will receive health care education. After the 8-week intervention period there will be a 16-week follow-period with no active intervention in either group. The primary and secondary outcomes will be assessed at baseline, 4 weeks, 8 weeks, 12 weeks and 24 weeks. The primary measure will be Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The secondary outcome measures will include the kinetics, kinematics changing of the knee joint at sagittal, frontal, and transverse plane, the muscle co-contraction.Discussion: This study aims to investigate the clinical and biomechanical effect of the Tai chi, and the results will help to improve the understanding of possible underlying biomechanical effects of the Tai chi in the management of KOA. Trail Registration: The study was approved by China registered clinical trial ethics review committee with No.ChiECRCT20200335. The study plan was registered on the website of China Registered Clinical Trial Registration Center with No.ChiCTR2000040769 .Registered 09 December 2020, http://www.chictr.org.cn/showprojen.aspx?proj=65571

scholarly journals Acupuncture for comorbid mild-moderate depression and chronic musculoskeletal pain: study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Sheng Li ◽  
Jing Liu ◽  
Jianpeng Huang ◽  
Ding Luo ◽  
Qian Wu ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Effective Treatment ◽  
Musculoskeletal Pain ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Cost Effective ◽  
Sham Acupuncture ◽  
Chronic Musculoskeletal Pain ◽  
Secondary Outcome

Abstract Background Depression and chronic musculoskeletal pain (CMSP) are the leading causes of years lived with disabling diseases worldwide. Moreover, they often commonly coexist, which makes diagnosis and treatment difficult. A safe and effective treatment is urgently needed. Previous studies have shown that acupuncture is a cost-effective treatment for simple depression or CMSP. However, there is limited evidence that acupuncture is effective for depression comorbid with CMSP. Methods This is a randomized, sham acupuncture-controlled trial with three arms: real acupuncture (RA), sham acupuncture (SA), and healthy control (HC). Forty-eight depression combined CMSP participants and 12 healthy people will be recruited from GDTCM hospital and randomized 2:2:1 to the RA, SA, and HC groups. The patients will receive RA or SA intervention for 8 weeks, and HC will not receive any intervention. Upon completion of the intervention, there will be a 4-week follow-up. The primary outcome measures will be the severity of depression and pain, which will be assessed by the Hamilton Depression Rating Scale (HAMD-17) and Brief Pain Inventory (BPI), respectively. The secondary outcome measures will be cognitive function and quality of life, which will be measured by the Montreal Cognitive Assessment (MoCA), P300, and World Health Organization Quality of Life (WHOQOL-BREF). In addition, the correlation between brain-derived neurotrophic factor (BDNF) and symptoms will also be determined. Discussion The aim of this study is to evaluate the clinical efficacy and underlying mechanism of acupuncture in depression comorbid with CMSP. This study could provide evidence for a convenient and cost-effective means of future prevention and treatment of combined depression and CMSP. Trial registration Chinese Clinical Trial Registry ChiCTR1800014754. Preregistered on 2 February 2018. The study is currently recruiting.

scholarly journals Efficacy of McKenzie Manipulative Therapy on Pain, Functional Activity and Disability for Lumbar Disc Herniation

2021 ◽  
Vol 14 (1) ◽  
pp. 14-24
Author(s):  
Mohammad Anwar Hossain ◽  
Iqbal Kabir Jahid ◽  
Md. Forhad Hossain ◽  
Zakir Uddin ◽  
Md. Feroz Kabir ◽  
...  
Keyword(s):  
Lumbar Disc Herniation ◽  
Disc Herniation ◽  
Lumbar Disc ◽  
Cost Effective ◽  
Secondary Outcome ◽  
Control Group ◽  
Mri Findings ◽  
Clinical Trial Registration ◽  
Manipulative Therapy ◽  
Pain Disability

Introduction: Lumbar disc herniation (LDH) is a common determinant of low back pain (LBP) and priority for cost-effective therapeutic approach is necessary. The objective of the study was to explore the effectiveness of McKenzie Manipulative Therapy (MMT) for patients with LDH. Methodology: This was an assessor blinded, 36-month RCT, at Center for Rehabilitation of the Paralyzed (CRP) in Savaar, Bangladesh. Seventy-two subjects, ages 28-47 years and clinically diagnosed with MRI findings of LDH, were randomly recruited from hospital records and sixty-eight found eligible. The control group received stretching exercise and graded oscillatory mobilization, and the experimental group received McKenzie manipulative therapy for 12 sessions in 4 weeks, both groups received a standard set of care also. The pain was the primary outcome and the secondary outcome was participation in functional activities and disability. Results: Pain and Disability found significant improvement in both groups, with the McKenzie approach significantly superior to the control group (p<.05). Bothersome in Activities (SBI) reported significantly lower post report compared to baseline for both groups (p<.01). McKenzie showed significantly superior outcomes for fear avoidance (FABQ) total and SBI feeling of abnormal sensation in leg compared to the control group (p <.05). Conclusion: The McKenzie manipulative therapy approach was found to be effective for pain, disability and participation in activities for single or multiple level LDH patients in a short time from day 1 to week 4, and the treatment effect extends after 6 months. Clinical Trial Registration No.: CTRI/2020/ 04/024667.

A randomised controlled trial comparing autologous cranioplasty with custom-made titanium cranioplasty: long-term follow-up

2018 ◽  
Vol 160 (5) ◽  
pp. 885-891 ◽  
Author(s):  
Stephen Honeybul ◽  
David Anthony Morrison ◽  
Kwok M. Ho ◽  
Christopher R. P. Lind ◽  
Elizabeth Geelhoed
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Custom Made ◽  
Long Term Follow Up ◽  
Randomised Controlled ◽  
Titanium Cranioplasty

scholarly journals Comparison of two different titanium cranioplasty methods: Custom-made titanium prostheses versus precurved titanium mesh

2020 ◽  
Vol 11 ◽  
pp. 148
Author(s):  
Domenico Policicchio ◽  
Gina Casu ◽  
Giosuè Dipellegrini ◽  
Artan Doda ◽  
Giampiero Muggianu ◽  
...  
Keyword(s):  
Young Patients ◽  
Single Stage ◽  
Mesh Exposure ◽  
Titanium Mesh ◽  
Cosmetic Results ◽  
First Choice ◽  
Custom Made ◽  
Duration Of Surgery ◽  
Custom Made Prostheses ◽  
Titanium Cranioplasty

Background: The aim of this study was to compare the results of two different titanium cranioplasties for reconstructing skull defects: standard precurved mesh versus custom-made prostheses. Methods: Retrospective analysis of 23 patients submitted to titanium cranioplasty between January 2014 and January 2019. Ten patients underwent delayed cranioplasty using custom-made prostheses; and 13 patients were treated using precurved titanium mesh (ten delayed cranioplasties, and three single-stage resection- reconstructions). Demographic, clinical, and radiological data were recorded. Results and complications of the two methods were compared, including duration of surgery, cosmetic results (visual analog scale for cosmesis [VASC]), and costs of the implants. Results: Complications: one epidural hematoma in the custom-made group, one delayed failure in precurved group due to wound dehiscence with mesh exposure. There were no infections in either group. All custom-made prostheses perfectly fitted on the defect; eight of 13 precurved mesh prostheses incompletely covered the defect. Custom-made cranioplasty obtained better cosmetic results (average VASC 94 vs. 68), shorter surgical time (141min vs. 186min), and -fewer screws was needed to fix the prostheses in place (6 vs. 15). However, satisfactory results were obtained using precurved mesh in cases of small defects and in single-stage reconstruction. Precurved mesh was found to be cheaper (€1,500 vs. €5,500). Conclusion: Custom-made cranioplasty obtained better results and we would suggest that this should be a first choice, particularly for young patients with a large cranial defect. Precurved mesh was cheaper and useful for single-stage resection-reconstruction. Depending on the individual conditions, both prostheses have their place in cranioplasty therapies.

An Evaluation of an Innovative Multimedia Educational Software Program for Asthma Management: Report of a Randomized, Controlled Trial

PEDIATRICS ◽  
2000 ◽  
Vol 106 (Supplement_1) ◽  
pp. 210-215
Author(s):  
Charles Homer ◽  
Oded Susskind ◽  
Hillel R. Alpert ◽  
MPM§; Celestina Owusu ◽  
Lynda Schneider ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Computer Program ◽  
Outcome Measures ◽  
Educational Software ◽  
Controlled Trial ◽  
Cost Effective ◽  
Substantial Improvement ◽  
Secondary Outcome ◽  
Randomized Controlled ◽  
Software Program

Background. Asthma continues to be a substantial cause of morbidity in pediatric populations. New strategies are needed to provide cost-effective educational interventions for children with asthma, particularly those in the inner city. Objective. To assess the effectiveness of a multimedia educational software program about asthma. Setting. A hospital-based primary care clinic and an affiliated neighborhood health center. Design. Randomized, controlled trial. Population. Children 3 to 12 years old with physician-diagnosed asthma. Intervention. An interactive educational computer program, Asthma Control, designed to teach children about asthma and its management. Using a graphic display of a child going through simulated daily events, the game emphasizes: 1) monitoring; 2) allergen identification; 3) use of medications; 4) use of health services; and 5) maintenance of normal activity. Control group participants reviewed printed educational materials with a research assistant. Outcomes. Acute health care use (emergency department and outpatient) was the primary outcome. Secondary outcome measures included maternal report of asthma symptom severity, child functional status and school absences, satisfaction with care, and parental and child knowledge of asthma. Results. A total of 137 families were enrolled in the study (76 intervention, 61 control). Both intervention and control groups showed substantial improvement in all outcomes during the 12-month follow-up period. Aside from improvement in knowledge after use of the computer program, no differences were demonstrated between the 2 groups in primary or secondary outcome measures. Children reported enjoyment of program use. Conclusions. This trial of an educational software program found that it did not produce greater improvement than occurred with review of traditional written materials. Because both groups showed substantial improvement over baseline, computer-based education may be more cost-effective. Alternatively, improvements in illness severity over time may overshadow the effects of such interventions. Rigorous comprehensive evaluations such as this are necessary to assess new interventions intended to improve management and outcomes of asthma.

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