scholarly journals Electromagnetic stimulation as coadjuvant in the healing of diaphyseal femoral fractures: a randomized controlled trial

2014 ◽  
pp. 67-71 ◽  
Author(s):  
Alfredo Martinez Rondanelli ◽  
Juan Pablo Martinez ◽  
María Elena Moncada ◽  
Eliana Manzi ◽  
Carlos Rafael Pinedo ◽  
...  
Keyword(s):  
Electromagnetic Field ◽  
Bone Healing ◽  
Controlled Trial ◽  
Weight Bearing ◽  
Femoral Fractures ◽  
Femoral Diaphysis ◽  
Randomized Controlled ◽  
Electromagnetic Stimulation ◽  
Diaphyseal Fractures ◽  
The Mean

Introduction: There is controversy in medical literature regarding the use of electromagnetic fields to promote bone healing. Methods: After designing and building devices capable of generating an electromagnetic field for this study, their safety was confirmed and the electromagnetic therapy was randomly allocated and compared to placebo in patients with fracture of the femoral diaphysis. Treatment began six weeks after the fracture and it was administered once a day, during 1 h, for eight consecutive weeks. Twenty devices were built, 10 of which were placebo-devices. Between June 2008 and October 2009, 64 patients were randomized in two different hospitals and were followed for 24 weeks. The mean age was 30 years (18-59) and 81% were males. Results: Healing observed at week 12 was 75% vs. 58% (p= 0.1); at week 18, it was 94% vs. 80% (p= 0.15); and at week 24, it was 94% vs. 87% (p= 0.43) for the device group and the placebo group, respectively. Discussion: This study suggests that an electromagnetic field stimulus can promote earlier bone healing compared to placebo in femoral diaphyseal fractures. Faster bone healing translates into sooner weight bearing, which – in turn – permits quicker return to normal daily activities.

scholarly journals Comparative outcomes of foot cast and short leg cast in pseudo-Jones avulsion fracture: a single blinded randomized controlled trial

2019 ◽  
Vol 12 (1) ◽  
Author(s):  
Peerapong Piyapittayanun ◽  
Kanakij Mutthakalin ◽  
Alisara Arirachakaran ◽  
Jatupon Kongtharvonskul
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Weight Bearing ◽  
Randomized Controlled ◽  
Metatarsal Bones ◽  
Significant Difference ◽  
Metatarsal Fractures ◽  
The Mean ◽  
Foot Fractures ◽  
To Receive

Abstract Background Fractures of the metatarsal bones account for 35% of all foot fractures. Conservative management of fractures proximal to the metaphyseal-diaphyseal junction of the fifth metatarsal bone (pseudo-Jones) is by protected weight bearing. The methods of protected weight bearing include short-leg casting and splinting (boot cast, Jones’s bandage and elastic bandage). However, currently there is no consensus as to which method is the most suitable. Method We have conducted a randomized controlled trial to compare outcomes of foot casting (FC) and short leg casting (SLC) to assess pain, function and complication outcomes for the treatment of pseudo-jones metatarsal fractures. This single-center, single blind,randomized controlled trial was conducted between 1 June 2016–1 July 2018 at Police General Hospital, Bangkok, Thailand. Result A total of 72 pseudo-jones metatarsal fracture participants were randomly allocated to treatment by foot cast or short leg cast. The primary outcomes were pain VAS, AOFAS and complications measured at 2, 4, 6 and 8 weeks after receiving the treatment. Seventy-two patients (36 paticipants per group) were enrolled to receive either FC or SLC. The mean VAS measured at baseline, 2 weeks, 4 weeks, 6 weeks and 8 weeks were 7.36, 1.97, 0.58, 0.17 and 0.08 respectively in the FC group; and 6.09, 2.91, 1.23, 0.37 and 0.11 respectively in the SLC group. The mean AOFAS at baseline, 2, 4, 6 and 8 weeks were 33.60, 68.22, 82.72, 91.75 and 98.11 respectively in the FC group; and 32.60, 60.20, 70.20, 92.24 and 99.13 in the SLC group. The estimated mean difference of pain VAS and AOFAS at 2 weeks and 4 weeks were − 0.94 (95% CI: − 1.53, − 0.34), − 0.65 (95%CI: − 1.24, − 0.05), 8.02 (95%CI: 3.74, 12.10) and 12.52 (95%CI: 8.27, 16.78), which were statistically significantly better in the FC groups when compared to the SLC groups. However, there were no statistically significant difference between the two groups at 6 and 8 weeks. Conclusion This study demonstrated that the application of foot casting can improve pain VAS and AOFAS function at 2 and 4 weeks in the treatment of pseudo-jones metatarsal fractures when compared to short leg casting. However, at 6 and 8 weeks, there were no statistically significantly different between the two groups.

scholarly journals Knee Fix or Replace Trial (KFORT): a randomized controlled feasibility study

2019 ◽  
Vol 101-B (11) ◽  
pp. 1408-1415 ◽  
Author(s):  
Peter D. Hull ◽  
Daud T. S. Chou ◽  
Sophie Lewis ◽  
Andrew D. Carrothers ◽  
Joseph M. Queally ◽  
...  
Keyword(s):  
Sample Size ◽  
Controlled Trial ◽  
Sample Size Calculation ◽  
Femoral Fractures ◽  
Full Scale ◽  
Willingness To Participate ◽  
Randomized Controlled ◽  
The Mean ◽  
Mean Cost

Aims The aim of this study was to assess the feasibility of conducting a full-scale, appropriately powered, randomized controlled trial (RCT) comparing internal fracture fixation and distal femoral replacement (DFR) for distal femoral fractures in older patients. Patients and Methods Seven centres recruited patients into the study. Patients were eligible if they were greater than 65 years of age with a distal femoral fracture, and if the surgeon felt that they were suitable for either form of treatment. Outcome measures included the patients’ willingness to participate, clinicians’ willingness to recruit, rates of loss to follow-up, the ability to capture data, estimates of standard deviation to inform the sample size calculation, and the main determinants of cost. The primary clinical outcome measure was the EuroQol five-dimensional index (EQ-5D) at six months following injury. Results Of 36 patients who met the inclusion criteria, five declined to participate and eight were not recruited, leaving 23 patients to be randomized. One patient withdrew before surgery. Of the remaining patients, five (23%) withdrew during the follow-up period and six (26%) died. A 100% response rate was achieved for the EQ-5D at each follow-up point, excluding one missing datapoint at baseline. In the DFR group, the mean cost of the implant outweighed the mean cost of many other items, including theatre time, length of stay, and readmissions. For a powered RCT, a total sample size of 1400 would be required with 234 centres recruiting over three years. At six months, the EQ-5D utility index was lower in the DFR group. Conclusion This study found that running a full-scale trial in this country would not be feasible. However, it may be feasible to undertake an international multicentre trial, and our findings provide some guidance about the power of such a study, the numbers required, and some challenges that should be anticipated and addressed. Cite this article: Bone Joint J 2019;101-B:1408–1415.

scholarly journals The impact of vildagliptin on the daily glucose profile and coronary plaque stability in impaired glucose tolerance patients with coronary artery disease: VOGUE—A multicenter randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Hiroyuki Yamamoto ◽  
Akihide Konishi ◽  
Toshiro Shinke ◽  
Hiromasa Otake ◽  
Masaru Kuroda ◽  
...  
Keyword(s):  
Coronary Artery Disease ◽  
Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Fibrous Cap ◽  
Multicenter Randomized Controlled Trial ◽  
The Mean ◽  
Artery Disease ◽  
Fibrous Cap Thickness ◽  
The Impact

Abstract Background The impact of reduction in glycemic excursion on coronary plaques remains unknown. This study aimed to elucidate whether a dipeptidyl peptidase 4 inhibitor could reduce the glycemic excursion and stabilize the coronary plaques compared with conventional management in coronary artery disease (CAD) patients with impaired glucose tolerance (IGT). Methods This was a multicenter, randomized controlled trial including CAD patients with IGT under lipid-lowering therapy receiving either vildagliptin (50 mg once a day) or no medication (control group) regarding glycemic treatment. The primary endpoint was changes in the minimum fibrous cap thickness and lipid arc in non-significant native coronary plaques detected by optical coherence tomography at 6 months after intervention. Glycemic variability expressed as the mean amplitude of glycemic excursion (MAGE) measured with a continuous glucose monitoring system was evaluated before and 6 months after intervention. Results A total of 20 participants with 47 lesions were allocated to either the vildagliptin group (10 participants, 22 lesions) or the control group (10 participants, 25 lesions). The adjusted difference of mean changes between the groups was − 18.8 mg/dl (95% confidence interval, − 30.8 to − 6.8) (p = 0.0064) for the MAGE (vildagliptin, − 20.1 ± 18.0 mg/dl vs. control, 2.6 ± 12.7 mg/dl), − 22.8° (− 40.6° to − 5.1°) (p = 0.0012) for the mean lipid arc (vildagliptin, − 9.0° ± 25.5° vs. control, 15.8° ± 16.8°), and 42.7 μm (15.3 to 70.1 μm) (p = 0.0022) for the minimum fibrous cap thickness (vildagliptin, 35.7 ± 50.8 μm vs. control, − 15.1 ± 25.2 μm). Conclusions Vildagliptin could reduce the MAGE at 6 months and may be associated with the decreased lipid arc and increased minimum FCT of the coronary plaques in CAD patients with IGT as compared with the control group. These findings may represent its potential stabilization effect on coronary plaques, which are characteristic in this patient subset. Trial registration Registered in the UMIN clinical trial registry (UMIN000008620), Name of the registry: VOGUE trial, Date of registration: Aug 6, 2012, URL: https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000010058

scholarly journals Manual Therapy in Cervical and Lumbar Radiculopathy: A Systematic Review of the Literature

2021 ◽  
Vol 18 (11) ◽  
pp. 6176
Author(s):  
Tomasz Kuligowski ◽  
Anna Skrzek ◽  
Błażej Cieślik
Keyword(s):  
Manual Therapy ◽  
Functional Outcomes ◽  
Web Of Science ◽  
Current Knowledge ◽  
Controlled Trial ◽  
Future Research ◽  
Lumbar Radiculopathy ◽  
Inclusion Criteria ◽  
Randomized Controlled ◽  
The Mean

The aim of this study was to describe and update current knowledge of manual therapy accuracy in treating cervical and lumbar radiculopathy, to identify the limitations in current studies, and to suggest areas for future research. The study was conducted according to PRISMA guidelines for systematic reviews. A comprehensive literature review was conducted using PubMed and Web of Science databases up to April 2020. The following inclusion criteria were used: (1) presence of radiculopathy; (2) treatment defined as manual therapy (i.e., traction, manipulation, mobilization); and (3) publication defined as a Randomized Controlled Trial. The electronic literature search resulted in 473 potentially relevant articles. Finally, 27 articles were accepted: 21 on cervical (CR) and 6 in lumbar radiculopathy (LR). The mean PEDro score for CR was 6.6 (SD 1.3), and for LR 6.7 (SD 1.6). Traction-oriented techniques are the most frequently chosen treatment form for CR and are efficient in reducing pain and improving functional outcomes. In LR, each of the included publications used a different form of manual therapy, which makes it challenging to summarize knowledge in this group. Of included publications, 93% were either of moderate or low quality, which indicates that quality improvement is necessary for this type of research.

The effectiveness of emotional freedom techniques (EFT) on depression of postmenopausal women: a randomized controlled trial

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Asieh Mehdipour ◽  
Parvin Abedi ◽  
Somayeh Ansari ◽  
Maryam Dastoorpoor
Keyword(s):  
Randomized Controlled Trial ◽  
Postmenopausal Women ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Moderate Depression ◽  
Before And After ◽  
The Mean ◽  
And Control

Abstract Objectives Postmenopausal women are at greater risk of depression. Depression may negatively affect the quality of life of women. An emotional freedom technique (EFT) is an evidence-based therapy combining cognitive and exposure components with acupressure. This study aimed to evaluate the effect of EFT on depression in postmenopausal women. Methods This was a randomized controlled trial in which 88 women with mild to moderate depression recruited from a menopausal clinic in Ahvaz, Iran, and randomly assigned into two groups of EFT (n=44) and control for sham therapy (n=44). Women in the EFT group received two sessions of training and asked to continue EFT for 8 weeks, one time per day. The Beck Depression Inventory (BDI2) completed by women before and after the intervention. The control group received training on sham acupressure points similar to the intervention group. Data collected using a demographic and BDI2. Women requested to complete the BDI2 before and after the intervention. The independent t-test, chi-square, and ANCOVA were used to analyze data. Results The mean depression score in the intervention group reduced from 20.93 ± 4.6 to 10.96 ± 4.38 in comparison to the control group that reduced from 19.18 ± 2.79 to 17.01 ± 6.05 after intervention (p=0.001). After the 8 week intervention, the frequency of moderate depression decreased from 56.8 to 9.35% in the intervention and from 50 to 29.5% in the control group. In total, 63.4 and 34.15% in the intervention and control groups were free of depression respectively after the intervention (p<0.001). Conclusions The results of this study showed that using EFT for 8 weeks could significantly reduce the mean score of depression in postmenopausal women. Using this method in public health centers for postmenopausal women is recommended.

Effect of Delayed Cord Clamping Reduced Anemic Outcome in Preterm Neonate

2021 ◽  
Vol 104 (5) ◽  
pp. 695-700
Keyword(s):  
Intraventricular Hemorrhage ◽  
Preterm Neonate ◽  
Controlled Trial ◽  
Preterm Neonates ◽  
Maternal Outcomes ◽  
Delayed Cord Clamping ◽  
Randomized Controlled ◽  
Cord Clamping ◽  
Significant Difference ◽  
The Mean

Objective: To compare the effects of immediate versus delayed cord clamping on neonatal outcomes in preterm neonates of gestational age of 32 to 36⁺⁶ weeks, and maternal outcomes. Materials and Methods: A randomized controlled trial was conducted in the Obstetrics and Gynecology Department at Bhumibol Adulyadej Hospital, in Bangkok, Thailand. The study compared the effects of immediate to delayed cord clamping at 60 seconds among preterm neonates born between 32 weeks, 0 day and 36 weeks, 6 days of gestation between August and October 2018. Results: The mean age of the participants was 26 years old, and half of the cases were nulliparous. One hundred ten women were randomly separated into two equal groups (n=55). Delayed cord clamping at 60 seconds increased hematocrit levels (Hct) in both two (p=0.004) and 48 (p<0.001) hours after delivery compared to the immediate cord clamping group. There were no differences in exposing the neonate to hypothermia, hypoxemia, Apgar score at 1-minute, polycythemia, intraventricular hemorrhage, hyperbilirubinemia, length of stay in hospital, and affecting the process of resuscitation. There were no statistical differences between the two groups in maternal outcomes such as retained placenta and postpartum hemorrhage. Conclusion: Delayed cord clamping at 60 seconds increased Hct in the newborn at two to 48 hours after birth. There was no significant difference in adverse maternal and neonatal complications within both groups. Keywords: Delayed cord clamping, Hematocrit, Preterm

scholarly journals Results Are Similar Two Years After Acute or Delayed Anterior Cruciate Ligament Reconstruction. A Randomized Controlled Trial

2017 ◽  
Vol 5 (5_suppl5) ◽  
pp. 2325967117S0017
Author(s):  
Karl Eriksson ◽  
Christoffer von Essen ◽  
Björn Barenius
Keyword(s):  
Randomized Controlled Trial ◽  
Primary Endpoint ◽  
Pivot Shift ◽  
Controlled Trial ◽  
Acl Injury ◽  
Activity Level ◽  
Randomized Controlled ◽  
Delayed Group ◽  
The Mean

Objectives: Acute ACLR has been avoided since the 1990’s due to reports of postoperative stiffness. But are these risks still valid with modern arthroscopic techniques? The aim of this randomized controlled trial was to assess the impact of the time between injury and reconstruction on the outcome after ACLR. Our hypothesis was that acute ACLR with semitendinosus graft can be performed safely. Methods: The primary endpoint was ROM at three months after surgery. A power calculation revealed the need for 64 patients to detect a ROM difference of 5 degrees between the groups (5% significance level). 70 patients with a high recreational activity level (Tegner ≥6) who presented with an acute ACL injury were randomized to an acute reconstruction within 8 days from the injury or delayed reconstruction (after normalized ROM) 6-10 weeks after the injury. Fixation was with Endobutton in femur and a metallic interference screw in tibia. The rehabilitation was performed at the same physiotherapy center for all patients. Follow up assessment was performed by a physiotherapist not involved with the rehabilitation. The follow up at 24 months included ROM, Lachman, instrumented laxity with Rolimeter, pivot shift, one leg hop index, Biodex, IKDC, KOOS, Lysholm and Tegner Activity level, and a VAS question regarding knee function and the knee function’s effect on activity level. Results: Seventy percent of the patients were males, mean age at the time of surgery was 27 years (18 -41) and the median pre-injury Tegner level was 9 (6-10) with no differences between the groups. 64 (91%) patients were assessed at three months with no difference according to the primary endpoint. Median Tegner level was restored to pre-injury levels in both groups after one year, and did not change between one and two years. 63 (90%) patients were available for the 2-year follow up. There was one graft rupture and one contralateral ACL injury in both groups. There was additional surgery in 15% of the acute patients and in 31% in the delayed (n.s.). The mean instrumented laxity was 1.8 mm in the acute and 2.0 in the delayed group. There were no positive pivot shift in the acute group and 6 patients with grade 1 or not possible to perform in the delayed group (p=0.039). IKDC revealed no significant differences between the groups. Lysholm score was 87 in both groups. KOOS values showed no significant difference between the groups. VAS response to the question “How is your knee working on a scale from 0-100? (100 = best)” was 81 in the acute and 71 in the delayed group (p=0.1) and “How does your knee affect your activity level? (100 = no affection)” the mean score was 75 in the acute and 67 in the delayed group (p=0.3). Functional strength (one leg hop index >90%) was 85% in the acute and 67% in the delayed group (n.s). Conclusion: We found no increased risk of arthrofibrosis after acute ACLR. Good results can be achieved at two years regardless of ROM and swelling in the acute stage.

scholarly journals Clinical Efficacy Of Ceftriaxone Versus Ciprofloxacin In Paediatric Enteric Fever

2018 ◽  
Vol 08 (02) ◽  
pp. 67-71
Author(s):  
Anila Farhat ◽  
Asma Shaukat ◽  
Tariq Mahmood Khan
Keyword(s):  
Enteric Fever ◽  
Research Study ◽  
Controlled Trial ◽  
Clinical Effectiveness ◽  
Randomized Controlled ◽  
Group A ◽  
The Mean ◽  
Group B ◽  
Objective Determination

Objective: Determination of the clinical effectiveness of ciprofloxacin versus ceftriaxone in children with enteric fever on the basis of defervescence within 72 hours of commencement of treatment. Duration and Place of Study: This randomized controlled trial was carried out from 15th May to 15th November 2017 in pediatrics units of Benazir Bhutto Shaheed Teaching Hospital Abbottabad and Jinnah International Hospital Abbottabad. Methodology: 90 children with uncomplicated enteric fever were admitted and divided randomly into two groups, Group A was administered I/V Ceftriaxone 75mg/kg OD and Group B was given I/V Ciprofloxacin 10mg/kg BD for seven days. Response to drug was taken as defervescence within 72 hours while continued fever after 72 hours was taken as no response. The data was analyzed by using SPSS Version 21.00. Results: In our research study 53(58.9%) children were male and 37(41.1%) patients were female. The mean age was 8.43±3.17 years encompassing 4 to 14 years, mean weight of the patients in kg was 29.54±10.8 kg. Efficacy of ceftriaxone group was 93.3% while in ciprofloxacin group 62.2% patients became afebrile in 72 hours. The proportion of achieving defervescence within 72 hours was higher with ceftriaxone than with ciprofloxacin Conclusion: Ceftriaxone is more efficacious in terms of achieving defervescence than ciprofloxacin in children having enteric fever.

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