Blind Randomized Control Trial Research Articles

4439 Comparing the Impact of Adding an Educational Video Presentation to Universal Self-Consent for Remnant Clinical Biospecimens: A Single Blind Randomized-Control Trial

OBJECTIVES/GOALS: BURRITO is an efficient strategy that provides full disclosure in the electronic medical record of a patient’s preference in real time. BURRITO uses printed materials only to inform patients and has a <50% rates of consent. We hypothesized that adding an informational video to the printed materials would increase donations. METHODS/STUDY POPULATION: This study was IRB-approved and was considered minimal risk. The BURRITO self-consent workflow process (Soares et. al, Biopreservation and Biobanking, IN PRINT) was developed in an outpatient cardiology clinic. In the same clinic, patients were randomized to receiving printed materials only (standard procedure) or the printed materials plus a 2.5-minute informational video (intervention) while waiting for the physician in the exam room. Randomization occurred at the level of the day in clinic. Patients were blinded to the nature of the study. Following the presentation of information, the patient’s decision on consent for donation was documented in the electronic record by ancillary clinical staff. Rates of consent were analyzed by a statistician not involved in the experiment and after completion of trial. RESULTS/ANTICIPATED RESULTS: Thirty-five clinic days were randomized to either intervention (17 days) or standard (18 days), and a total of 255 patients decided during their visit to either “opt-in” or “opt-out” to donating remnant biospecimens for future research. One hundred patients opted to defer deciding (28%). No significant demographic differences were noted between the study arms. The rate of consent was 73% vs. 58% in the intervention group and the control group, respectively (p-value = 0.014). This represents an increase in the odds of consenting with an informational video by 96% (OR = 1.96, 95% CI = 1.15 to 3.34). DISCUSSION/SIGNIFICANCE OF IMPACT: This is the first randomized trial to show that an informational video with printed materials is superior for when patients are self-consenting to opt-in for clinical remnant biospecimen donation. This result adds to the evidence that the BURRITO process plus video (BURRITOv) is an effective approach for biospecimen universal consenting.

Nutrition intervention of pregnant adolescents: a systematic review

Purpose This paper aims to evaluate the effectiveness of nutrition interventions conducted in pregnant adolescents and their implications for future research. Design/methodology/approach The papers in this systematic study were searched through PubMed, PMC, the Cochrane Library (Trial), ScienceDirect and Google Scholar that were published from 2000 to 2019. An experimental study using a randomized controlled trial (RCT) or non-RCT among pregnant adolescents aged 10-19 years were inclusion criteria for this study. While exclusion criteria were studies published before 2000, non-experimental study and non-English-language studies. Findings A total of 14 studies were identified in this review. Six studies provided interventions in the form of nutrition and health education and seven studies provided interventions in the form of nutritional supplementation (calcium, vitamin D, iron-folate, lipid-based nutrient supplements and multi-micronutrient powder. One study provided dietary intervention. The interventions in pregnant adolescents in the form of education and nutritional supplementation effectively increased the knowledge and nutrition of pregnant adolescents and decreased low birth weight (LBW) and premature birth. The impact on birth outcomes was still quite diverse. Some of the studies in this review were conducted without a comparison group, a small sample size and conducted in health-care facilities. Conclusion This systematic review implies a future nutrition intervention for pregnant adolescents is needed to improve nutritional status of pregnant adolescents and birth outcome. Future research using double blind RCT method with bigger sample size and various nutritional outcome are wide open to be developed. Originality/value Interventions in pregnant adolescents effectively increased the knowledge and nutrition of pregnant adolescents and decreased LBW and premature birth. The program implementation in the community needs to be improved so that the effectiveness of the program remains optimal as in healthcare facilities.

Effect of Addition of Dexamethasone or Clonidine to Ropivacaine on Postoperative Analgesia in Ultrasonography Guided Transversus Abdominis Plane Block for Inguinal Hernia Repair: A Prospective Double Blind Randomized Control Trial

Background: A hernia repair surgery commonly induces moderate to severe postoperative pain for 48 hours. Aim of the study was to compare 0.5% Ropivacaine with dexamethasone and 0.5% Ropivacaine with clonidine for ultrasonography guided transversus abdominis plane (TAP) block as post-operative analgesia in patients undergoing Inguinal hernia repair surgery.Subjects and Methods:A randomized prospective controlled clinical study was conducted in 64 patients undergoing Inguinal Herneoplasty. Participants were divided into two groups in which group RD (n=32) received 0.5% Ropivavacaine with Dexamethasone 8mg and those in group RC (n=32) received 0.5% Ropivacaine with Clonidine 75mcg as USG guided TAP block at the end of surgery. The postoperative pain was evaluated by visual analog scale (VAS) for pain scoring at every 2 hours for 24 hours postoperatively. Subjective assessment of duration of analgesia was done.Results:Time to first rescue analgesia was significantly less in group RC (424.53±34.13) compared to group RD (616.09±31.36min) (P < 0.001). Total tramadol consumed in 24 h was significantly higher in group RC than group RD (P < 0.001). Visual analog scale scores for both somatic and visceral pain were significantly higher in group RC than group RD at 6h, 8 h and 12 h postoperatively.Conclusion:TAP block is a safe and effective way of relieving postoperative pain in inguinal herneoplasty patients. Addition of dexamethasone to Ropivacaine significantly enhances its effect in terms of block quality and analgesia duration as compared to clonidine addition.

Postoperative morbidity after adenotonsillectomy versus adenopharyngoplasty in young children with obstructive sleep apnea: an RCT

PurposeIn our previous randomized controlled trial (RCT), comparing adenotonsillectomy (ATE) with adenopharyngoplasty (APP) in children with severe obstructive sleep apnea (OSA), there were no differences in respiratory sleep parameters or quality of life. The purpose of the present report was to evaluate postoperative morbidity from this RCT.MethodsThe study was a blinded RCT in 83 children (ATE = 47; APP = 36), 2–4 years of age, with an obstructive apnea–hypopnea index of ≥ 10. Pain was assessed from the first until the tenth day after surgery with a logbook that reported pain by child (FPS-R, Faces Pain Scale-Revised) and caregiver (visual analogue scale), analgesic use, return to normal diet, and weight change. Bleeding, infection, satisfaction with treatment, speech, and swallowing were assessed with a questionnaire and medical records 6 months after surgery.ResultsSixty-four children (77%) returned the logbook and 65 (78%) answered the questionnaire. The median (interquartile range) day the children graded themselves as pain free (FPS-R = 0) was 7 (6–10) after ATE, compared with 9 (7 to > 10) after APP (p = 0.018). There were no other significant differences between the groups regarding any other pain-related outcomes, bleeding, infection, satisfaction, swallowing, or speech, but three children (11%) reported impaired speech after APP compared to none after ATE (p = 0.067).ConclusionThe results regarding postoperative morbidity were in favor of ATE and the results from our previous report showed no advantages of APP. Therefore, APP should not be recommended in young, otherwise healthy children with OSA.

Splinting for thumb carpometacarpal osteoarthritis: protocol for a feasibility randomized controlled trial

Background: Evidence for the use of splints to reduce pain and improve function and quality of life in thumb carpometacarpal osteoarthritis (CMC OA) is sparse and poor despite recommendations by international guidelines.Objective: To outline the protocol for a study designed to determine the feasibility of conducting a fully powered pragmatic randomized controlled trial (RCT) comparing soft splint vs no splint for thumb CMC OA.Methods: The proposed pragmatic, assessor-blinded, and partial participant blinded parallel-group feasibility RCT will recruit 30 adults with thumb CMC OA and randomise to: splint intervention or usual care control. Randomization will be stratified by hand dominance. Primary feasibility outcomes are recruitment rate over a 4-month period, retention rate at 6 months, intervention acceptability, and rate of adverse events. Study costs, intervention fidelity, and clinical outcomes will also be evaluated. Measurements will be collected at baseline, 4 weeks, and 6 months post-initiation of treatment. This trial has been registered with the Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12618001639213.Major Findings: N/A.Conclusions: If shown to be effective, soft off-the shelf splints would be a good first-line non-pharmacological, non-surgical option for thumb CMC OA as prescribed by health professionals or accessed directly by patients. This feasibility study will inform a future, fully powered RCT as evaluated by success of the recruitment strategy; assessment time and acceptability; implementation and evaluation of ‘usual care’; and intervention procedures and adherence.

Randomized Controlled Trial of Tranexamic Acid’s Effect on Bleeding Length: A Study on DMPA Users with Abnormal Uterine Bleeding Who Receive Low-Dose Oral Contraceptive Pill

ABSTRACTBackground: Contraceptive injection is the most common contraception used in Indonesia. Among the contraceptive injections, depomedroxy progesterone acetate (DMPA) is the most effective method with pregnancy rate of 0,3 pregnancy in 100 women annually. Abnormal uterine bleeding (AUB) is a common side effect occurred in DMPA users which leads to the discontinuation of contraception.Objective: To explore the effect of tranexamic acid on bleeding length for DMPA users with AUB who receive low dose Oral Contraceptive Pills (OCP).Methods: We performed double blind randomized control trial between two groups to investigate the effect of tranexamic in managing AUB in DMPA users who receive low dose OCP. This study was performed in Dr. Kariadi Hospital Semarang, Indonesia. Forty-four subjects were divided into two groups, equally. Group 1 received 250 mg tranexamic acid four times a day for 5 days and OCP once a day for 28 days, while Group 2 received placebo four times a day for 5 days and OCP once a day for 28 days. Both groups were evaluated for bleeding length during treatment and were analyzed using Mann Whitney for post treatment with tranexamic acid.Results: The mean bleeding length was 5.2±3.62 days and 9.2±6.16 days in group 1 and 2 respectively. These bleeding lengths were significantly different between both groups (p=0.018). The precentage of subjects in whom bleeding was stopped during the first week after initial treatment was significantly higher in group 1 than group 2 (77,3 % vs 45,5 %, p<0,030).Conclusion: Tranexamic acid significantly reduced the bleeding length in DMPA users who use OCP.

The Effect of Vitamin C Supplementation on Chest X-Rayimprovementin Pulmonary Tuberculosis Patients During Intensive Phase in Medan

Backgrounds: Tuberculosis (TB) is still a public health problem in the world.Vitamin C is a water-soluble micronutrient, protects the host from reactive oxygen and reactive nitrogen intermediates generated during mycobacterial infection, involved in the synthesis of collagen, iron transport, and acts as physiological antioxidant. Vitamin C plays role in killing Mycobacterium tuberculosis by fenton reaction. This study was to determine the effect of vitamin C supplementation on chest X-ray (CXR) improvement in pulmonary TB patients during intensive phase.
 Methods: This was a quasy experimental study with single blind-randomized controlled trial design. Subjects were divided into 2 groups, first group was pulmonary TB patients treated with anti tuberculosis drugs (ATD) plus vitamin C and the second group was treated with ATD plus placebo. This study was conducted in several public health center in Medan City. The subjects were pulmonary TB patients with positive AFB sputum in intensive phase from December 2017 to May 2018. Data were analized using t-test dependent.
 Results: From 80 total subjects, 53 males (66%) and 27 females (34%). After 2 months of treatment, improvements in CXR images were found in the ATD plus vitamin C group, about 21 subjects (52.5%) had no more lesions on CXR, while the same condition was found on 15 subjects (37.5%) in the placebo group.
 Conclusion: Vitamin C supplementation in pulmonary TB provided better improvements of CXR images. (J Respir Indo. 2020; 40(2): 82-7)

Intervening on the Developmental Course of Children With Borderline Intellectual Functioning With a Multimodal Intervention: Results From a Randomized Controlled Trial.

An adverse social environment is a major risk factor for borderline intellectual functioning (BIF), a condition characterized by an intelligence quotient (IQ) within the low range of normality (70–85) with difficulties in the academic achievements and adaptive behavior. Children with BIF show impairments in planning, language, movement, emotion regulation, and social abilities. Moreover, the BIF condition exposes children to an increased risk of school failures and the development of mental health problems, and poverty in adulthood. Thus, an early and effective intervention capable of improving the neurodevelopmental trajectory of children with BIF is of great relevance.AimThe present work aims to report the results of a randomized controlled trial (RCT) in which an intensive, integrated and innovative intervention, the movement cognition and narration of the emotions (MCNT) was compared to standard speech therapy (SST) for the treatment of children with BIF.MethodsThis was a multicenter, interventional, single blind RCT with two groups of children with BIF: the experimental treatment (MCNT) and the treatment as usual (SST). A mixed factorial ANOVA was carried out to assess differences in the effectiveness between treatments. Primary outcome measures were: WISC III, Child Behavior Checklist (CBCL), Vineland II, and Movement ABC.ResultsMCNT proved to be more effective than SST in the increment of full-scale IQ (p = 0.0220), performance IQ (p < 0.0150), socialization abilities (p = 0.0220), and behavior (p = 0.0016). No improvement was observed in motor abilities. Both treatments were linked to improvements in verbal memory, selective attention, planning, and language comprehension. Finally, children in the SST group showed a significant worsening in their behavior.ConclusionOur data show that an intensive and multimodal treatment is more effective than a single domain treatment for improving intellectual, adaptive and behavioral functioning in children with BIF. These improvements are relevant as they might represent protective factors against the risk of school failure, poverty and psychopathology to which children with BIF are exposed in the adult age. Limitations of the study are represented by the small number of subjects and the lack of a no-treatment group.Clinical Trial RegistrationISRCTN Registry (isrctn.com), identifier ISRCTN81710297.

LBA01-03 COMPARISON OF MIRABEGRON, SOLIFENACIN AND TAMSULOSIN FOR STENT RELATED SYMPTOMS: A DOUBLE BLINDED RANDOMIZED CONTROL TRIAL

You have accessJournal of UrologyLate-Breaking Abstracts (LBA1)1 Apr 2020LBA01-03 COMPARISON OF MIRABEGRON, SOLIFENACIN AND TAMSULOSIN FOR STENT RELATED SYMPTOMS: A DOUBLE BLINDED RANDOMIZED CONTROL TRIAL Abhishek Chandna*, Santosh Kumar, Uttam Kumar Mete, Sudheer Kumar Devana, Aditya Prakash Sharma, and Samir Malhotra Abhishek Chandna*Abhishek Chandna* More articles by this author , Santosh KumarSantosh Kumar More articles by this author , Uttam Kumar MeteUttam Kumar Mete More articles by this author , Sudheer Kumar DevanaSudheer Kumar Devana More articles by this author , Aditya Prakash SharmaAditya Prakash Sharma More articles by this author , and Samir MalhotraSamir Malhotra More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000000946.03AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Introduction: Ureteral double J (DJ) stents are associated with stent related symptoms (SRSs) in up to 80% patients. Alpha blockers and anti-cholinergics have demonstrated efficacy in ameliorating SRSs. Mirabegron, a novel beta-3 receptor antagonist, demonstrated benefit in overactive bladder, with beta-3 receptors found in the ureter as well. We conducted a double blinded randomized control trial (MIRASOTA; CTRI/2019/02/017808) to evaluate the efficacy of mirabegron in ameliorating SRSs as compared to solifenacin or tamsulosin. Methods: Between October 2018 and December 2019, 150 patients undergoing DJ stent placement following ureteroscopic stone removal (URS), percutaneous nephrolithotomy (PCNL) or lap/robotic pyeloplasty were randomized in a 1:1:1 fashion into 3 groups. Patients in groups A, B and C received mirabegron 50 mg, solifenacin 5mg and tamsulosin 0.4mg once a day respectively. Stent was removed 4 weeks after surgery. Patients were followed at POD10 (I visit), 4 weeks (II visit) post surgery and 2 weeks post-stent removal. Validated vernacular version of ureteral stent symptoms questionnaire (USSQ) was evaluated at each visit. Results: Out of the 150 patients randomized, 124 patients (A; n = 42, B; n = 40 and C; n = 42) completed the study. Two patients in group C withdrew from the study due to side effects. Protocol violation was the most common reason for exclusion. Baseline demographic variables were comparable across groups. The groups were comparable in terms of urinary index score of USSQ at I and II visits (p = 0.111 and 0.084, respectively). No significant difference was observed between the groups in terms of pain index (p = 0.054 and 0.409, respectively). However, a significantly lower proportion of patients in group B persisted to have bodily pain at II visit (p = 0.035). Patients in group A demonstrated significantly better general health index scores at I visit (p = 0.021), which were not replicated at II visit (p = 0.684). No significant differences were observed in terms of sexual score or work performance. Constipation and dry mouth were noted in 14.7% patients in group B whereas headache (7.1%) was the most common side effect in group A. There was no significant association between drug group and type of surgery. Conclusions: Mirabegron has shown comparable benefit in alleviating SRSs and may be beneficial in cases where tamsulosin or solifenacin are contra-indicated or poorly tolerated. The MIRASOTA trial is first and only double blinded RCT comparing mirabegron with tamsulosin or solifenacin for SRSs. Source of Funding: None © 2020 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 203Issue Supplement 4April 2020Page: e1020-e1020 Advertisement Copyright & Permissions© 2020 by American Urological Association Education and Research, Inc.MetricsAuthor Information Abhishek Chandna* More articles by this author Santosh Kumar More articles by this author Uttam Kumar Mete More articles by this author Sudheer Kumar Devana More articles by this author Aditya Prakash Sharma More articles by this author Samir Malhotra More articles by this author Expand All Advertisement PDF downloadLoading ...

Effects of respiratory muscle therapy on obstructive sleep apnea: a systematic review and meta-analysis

The purpose of this study is to conduct a systematic review and meta-analysis evaluating the effects of respiratory muscle therapy (ie, oropharyngeal exercises, speech therapy, breathing exercises, wind musical instruments) compared with control therapy or no treatment in improving apnea-hypopnea index ([AHI] primary outcome), sleepiness, and other polysomnographic outcomes for patients diagnosed with obstructive sleep apnea (OSA). Only randomized controlled trials with a placebo therapy or no treatment searched using PubMed, EMBASE, Cochrane, and Web of Science up to November 2018 were included, and assessment of risk of bias was completed using the Cochrane Handbook. Nine studies with 394 adults and children diagnosed with mild to severe OSA were included, all assessed at high risk of bias. Eight of the 9 studies measured AHI and showed a weighted average overall AHI improvement of 39.5% versus baselines after respiratory muscle therapy. Based on our meta-analyses in adult studies, respiratory muscle therapy yielded an improvement in AHI of -7.6 events/h (95% confidence interval [CI] = -11.7 to -3.5; P ≤ .001), apnea index of -4.2 events/h (95% CI = -7.7 to -0.8; P ≤ .016), Epworth Sleepiness Scale of -2.5 of 24 (95% CI= -5.1 to -0.1; P ≤ .066), Pittsburgh Sleep Quality Index of -1.3 of 21 (95% CI= -2.4 to -0.2; P ≤ .026), snoring frequency (P = .044) in intervention groups compared with controls. This systematic review highlights respiratory muscle therapy as an adjunct management for OSA but further studies are needed due to limitations including the nature and small number of studies, heterogeneity of the interventions, and high risk of bias with low quality of evidence.

Comparison of flapped versus flapless dental implant insertion subjected to immediate functional loading protocol: A parallel group randomised control trial for radiographic bone density changes

Purpose: To evaluate and compare the hard tissue (Bone density) outcomes of flapped and flapless surgically placed dental implants in mandibular posterior region subjected to immediate functional loading protocol. Materials and Methods: Forty patients, meeting predetermined inclusion and exclusion criteria for dental implant placement in mandibular posterior region were recruited for a single center, parallel group, double blinded randomized control trial. Patients were randomly allocated in two groups on the basis of surgical method used for implant placement: flapped & flapless. Implants were loaded functionally with provisional auto-polymerizing composite resin within 48 hours of surgery and after 4 month replaced by metal- ceramic permanent restorations. Outcome Measures: Bone density was measured through cone beam computed tomography (CBCT) in patients of both groups at baseline, 4months, 8months and 12 months. Results: No drop out occurred after 12 months of implant placement. Five implants failed 3 in flapped group and 2 in flapless group. Intergroup comparison (flapped & flapless) of mean bone density in gray scale at different time intervals (baseline, 4 months, 8 months and 12 months) in falpped was lesser than flapless at 4 months [flapped 1081.1±156.66, flapless 1174.6±192.79], at 8 months [flapped 1212.2±121.67, flapless 1317.8±158.21], at 12 months [flapped 1307.9±126.27, flapless 1418.3±162.19] and difference was statistically significant (P values were .008*, Intra group comparison of mean bone density from baseline to different time intervals was higher in flapped group from baseline values and difference was statistically insignificant. (p values were .002, 0.000,.000 at 4 months, 8 months and 12 months respectively) and the mean bone density was, at 4 months [-45.27], at 8 months [-176.32], at 12 months [-272.09]. For flapless group the mean bone density was at 4 months [-42.71], at 8 months [-185.93], at 12 month s[-286.47] and difference

Mesenchymal Stem Cells for Treatment of Tendon and Ligament Injuries-clinical Evidence.

Introduction:Sport injuries, most of the time affect muscles, tendons, ligaments, cartilage and bones and range from very mild to severe, prompting different therapeutic approaches. Overuse is the most common cause of sports injuries and half of those injuries affect tendon, tendon sheet and tendon insertion to the bone. The number of ligament injuries, particularly anterior cruciate ligament (ACL) increasing.Aim:We were searching PubMed, Google Scholar and Medline focusing on human clinical studies related to stem cell therapy for tendinopathies and ligament injuries. Considering small number of published articles, we accepted papers with all level of evidence without following strict PRISMA guidelines.Results:The number of studies related to ligament injuries is very low compared to tendon injuries. In human clinical trials there have been only a few studies published so far. In double blind randomized control trial (RCT) Wang and coauthors combined allogenic precursor mesenchymal stem cells (MPC) with hyaluronic acid (HA) and compared with hyaluronic acid alone in 17 patients underwent ACL reconstruction. Intensity of pain and quality of life were assessed by Knee Injury and Osteoarthritis Outcome Score (KOOS) and SF-36v2 scores. A width of joint space, volume of cartilage and bone were recorded by magnetic resonance imaging (MRI). Moderate arthralgia and swelling were detected within 24 hours after the injection in 4 out of 11 patients in the group receiving MSC+HA. In the group receiving only HA, there were no adverse reactions. The signs of slowing down of regenerative process were presented on MRI by preserving joint space and reducing degradation of cartilage volume.Conclusion:Clinical application of MSCs for treatment of tendon and ligament injuries might be good alternative option for athletes. Published clinical studies confirmed clinical improvement and integrity of impaired tissues. However, RTCs are needed to confirm real potential of cell therapy and their advantages comparing to other treatment options.

Supplementation of Catfish (Clarias gariepinus) Oil Enriched with Omega-3 Soft Capsule Improves Oxidative Stress and Cognitive Function in Elderly.

Elderly is defined as an age group that is susceptible to various diseases. The aging process in the elderly is associated with an increase in oxidative stress activity which can lead to various health problems which are a major cause of high mortality and morbidity. This study aimed to analyze the effect of supplementation of catfish (Clarias gariepinus) oil enriched with omega-3 soft capsule on oxidative stress and cognitive function of elderly people. The design of this study was a single blind randomized control trial. A total of 29 elderly subjects were chosen following these inclusion criteria: aged >60 y; had dyslipidemia; and signed the informed consent. Subject were divided into three groups i.e. SO (soybean oil), CFO (commercial fish oil), and CO with omega-3 (catfish oil enriched with omega-3). The intervention was 1,000 mg oil/d administered for 90 d. The results showed that different supplementation groups had significant effects on oxidative stress and cognitive function (p<0.05). Supplementation of catfish oil enriched with omega-3 was able to significantly decreased malondialdehyde (MDA) level (p<0.05) and significantly increased mini mental state examination (MMSE) score (p<0.05). Overall, CO with omega-3 supplementation for 90 d was able to improve oxidative stress and cognitive function of the elderly better than other groups.

Effect of progressive muscle relaxation therapy on fatigue and psychological distress of cancer patients during radiotherapy: A randomized controlled trial

Background:Patients with cancer receiving radiotherapy experiences fatigue and psychological distress. Now a days there has been growing interest towards managing these symptoms with non-pharmacological treatments, But researches related to effect of progressive muscle relaxation therapy on fatigue and psychological distresses related to admitted patients are limited hence the aim of the study to evaluate the effect of progressive muscle relaxation therapy on fatigue and psychological distress in Cancer patients during Radiotherapy.Aims and Objectives:Aim of the study to evaluate the effect of progressive muscle relaxation therapy on fatigue and psychological distress in Cancer patients during Radiotherapy.Materials and Methods:The study design was single blinded randomized control trial. Total of 50 patients, for both intervention and control group 25 patients were included. The intervention group patients received P.M.R. therapy of 20 min. given for 3 times/week of total period of 3 weeks, whereas the control group received conventional treatment with no added intervention. Fatigue symptom inventory and hospital anxiety and depression scale used as an outcome measures.Results:Paired t-test used for FSI to compare among intervention and control group and results were showing statistical significant difference (P < 0.05), similarly pre and post improvement was observed in both the groups for HADS. Between group comparison showed no superior improvement one over the other.Conclusion:Based on the above findings, P.M.R. and conventional treatment were similarly efficacious in decreasing fatigue and psychological distress related to cancer patients who were hospitalized undergoing radiotherapy.

Effect of Resistance Training of Quadriceps Muscle in Patients with Knee Osteoarthritis: A Randomized Control Trial

Objective: To determine the effects of resistance training in quadriceps muscle in patients with knee osteoarthritis attending tertiary care hospital, Karachi. Materials and methods: This was a single blinded randomized control trial study with probability simple random sampling technique. Sampling was done in physiotherapy department of Al-Khidmat Hospital Korangi, Karachi from May to December 2018. The required sample size was found to be 74 (37 in experimental group and 37 in control group). Inclusion criteria for patients was age >45 years, moderate degree pain, ability to walk 20 to 30 meters, subject without any walking aid and chronic osteoarthritis of knee diagnosed on radiograph. Variables were observed using the Numerical Rating Scale (NRS), Western Ontario and McMaster Universities Osteoarthritis (WOMAC) index, and a strength gauge device, respectively. All observations were taken at baseline and after a week. SPSS version 23.0 was used for data analysis. Results: A total of 74 patients were recruited in this study. There were two groups Experimental and Control 37 patients were taken in each group. Strengthening of quadriceps exercises was assessed at baseline 9.13 ± 1.39 and after a week 11.36 ± 1.22 with statistically significant P-value of 0.041 in experimental group. In control group there was no statistical (difference observed at baseline and after a week routine checkup. Conclusion: Quadriceps strengthening exercises have a positive impact found in patients with knee OA. Experimental group patients gradually showed improvement after exercises of one week with good physical health status.

Comparison between dynamic oscillatory stretch technique and static stretching in reduced hamstring flexibility in healthy population: A single blind randomized control trial.

To compare the effects of dynamic oscillatory stretch and static stretching techniques in order to improve hamstring extensibility in healthy individuals with asymptomatic hamstring tightness. The single-blind randomised controlled trial was conducted from March to June 2018 at Sadiq Hospital, Sargodha Institute of Health Sciences, and District Headquarter Teaching Hospital,Sargodha, Pakistan, and comprised young healthy individuals with hamstring tightness who were randomly divided into groups 1 and 2, with the former getting exposure to oscillatory stretch technique and the latter to static stretching technique. Assessment of hamstring length was done using reliable clinical measurement test along with pain for stretch tolerance during passive straight leg raise using numeric pain rating scale. Measurements were taken at baseline, immediate (10min) and 1 hourpost-intervention. Data was analysed using SPSS 20. Of the 83 subjects, 42(%) were in group 1 with a mean age of 24.22±4.09 years, and 41(%) were in group 2 with a mean age of 25.85±6.09 years.Group1 showed significantly more improvement in all variables of hamstring flexibility and perceived pain at both post-intervention checkups compared to group 2 (p<0.05). Dynamic oscillatory stretch technique was found to be more effective in improving hamstring flexibility and perceived pain compared to static stretching technique.

Comparison of Morphine and Clonidine as Adjuncts to Bupivacaine in Spinal Anaesthesia- A Double Blind Randomised Control Trial

Introduction: Spinal anaesthesia is a preferred choice for infraumbilical surgery. Various drugs have been added intrathecally to augment analgesia in the postoperative period. Morphine an opiate was among the first to be introduced. More recently the alpha-2 agonist Clonidine. Aim: To compare Clonidine and Morphine as adjuncts to bupivacaine in spinal anaesthesia on the quality of the block, the duration of postoperative analgesia, haemodynamic changes and complication. Materials and Methods: In this randomised double blind controlled study, one hundred patients between age 20-40 years of age and American Society of Anaesthesiologists (ASA) physical status 1 and 2 undergoing lower limb Orthopaedic procedures were studied to compare the effect of preservative free morphine (100 mcg) (Group BM) and clonidine (30 mcg) (Group BC) as an adjunct to 0.5% bupivacaine in spinal anaesthesia. Group BM received a mixture of 2.6 mL (13 mg) of hyperbaric bupivacaine (0.5%) with 0.1 mL of preservative free Morphine and 0.1 mL 0.9% saline. Group BC received a mixture of 2.6 mL (13 mg) of hyperbaric bupivacaine (0.5%) with 0.2 mL of clonidine (30 mcg).Total volume of solution in both the groups was 2.8 mL. The groups were compared for the onset and duration of sensory and motor blockade. Duration of analgesia, Sedation, Haemodynamic variations viz., Pulse rate, blood pressure and complications. Data obtained was analysed using Student t-test, Pearson chi-square test and ANOVA as appropriate. Results: Onset of sensory block was faster and duration of the sensory as well as motor block was more after addition of Clonidine (30 μg) to bupivacaine in spinal anaesthesia. The duration of postoperative analgesia was significantly prolonged to 10-13 hours in patients receiving Bupivacaine and morphine combination as compared to 6-8 hours noted in patients receiving Bupivacaine and Clonidine only. Incidence of hypotension, bradycardia, shivering, nausea and vomiting was not statistically significant. None of the patients in both groups showed any other side effects like respiratory depression, hypoxia, excessive sedation or any other spinal consequences. Conclusion: Clonidine improves the quality of spinal anaesthesia in terms of faster onset of sensory block and longer duration of sensory as well as motor block compared to morphine, when added as an adjunct. However, the duration of postoperative analgesia was prolonged more with the addition of Morphine compared to Clonidine.

Comparison of Spencer muscle energy technique and Passive stretching in adhesive capsulitis: A single blind randomized control trial.

To compare the effects of Spencer muscle energy technique and passive stretching in adhesive capsulitis. The single-blind randomised control trial was conducted at the District Headquarter Hospital and Fatima Hospital, Sargodha, Pakistan, from February to May 2018, and comprised patients of either gender aged 30-55 years with idiopathic frozen shoulder stage 1 and 2 or stiff painful shoulder joint for at least 3 months. They were randomised into two equal groups using the sealed envelope method. Group 1 was exposed to muscle energy technique, while group 2 was exposed to passive stretching. Pain, shoulder range of motion and function were assessed by numeric pain rating scale, goniometer, shoulder pain and disability index and the quick version of the disabilities of the arm, shoulder and hand questionnaire. Measurements were taken at baseline, 2nd and 4th week. Data was analysed using SPSS 20. Of the 60 patients, there were 30(50%) in each of the two groups. There were 39(65%) females and 21(35%) males with an overall mean age of 45.84±5.88 years. All parameters significantly improved in group 1 compared to group 2 t post-intervention (p<0.001). Spencer technique was found to be more effective than passive stretching in treating patients with adhesive capsulitis.

CORR Synthesis: What Is the Evidence for the Clinical Use of Stem Cell-based Therapy in the Treatment of Osteoarthritis of the Knee?

CORR Synthesis: What Is the Evidence for the Clinical Use of Stem Cell-based Therapy in the Treatment of Osteoarthritis of the Knee?

U.S. Food and Drug Administration anticancer drug approval trends from 2016 to 2018 for lung, colorectal, breast, and prostate cancer.

This paper aims to describe the clinical and regulatory aspects of new drugs and indications that were approved for lung, breast, prostate, and colorectal cancer, from 2016 to 2018, in order to provide health technology assessment trends in oncology. Data were collected from the US Food and Drug Administration (FDA) online database for new medications and indications approved for the above-mentioned types of cancer. Data regarding clinical study characteristics and regulatory information were collected. From 2016 to 2018, 53 percent of the FDA approvals of new drugs and indications for the most incident cancers were for oral protein kinase inhibitor monotherapy for advanced lung cancer. Since 2018, four drugs were approved as tumor-agnostic therapies. A biomarker was included in 72 percent of indications, and 58 percent of approvals were for targeted therapies, potentially heralding an end to research into conventional cytotoxic agents. A special designation for faster approval was granted in 78 percent of new approvals. The majority of the studies were open label randomized controlled trials (RCTs) (44 percent), followed by blind RCTs, single-arm clinical trials, and cohort studies. Only 14 percent of studies used overall survival as the primary end point; the vast majority used surrogate end points, and did not use patient-important outcomes. Three biosimilars were approved in the period. Advanced lung cancer therapy, mainly targeted drugs, accounted for 53 percent of approvals. Special designations for faster approval were used in 78 percent of FDA approvals, and four drugs were approved for tumor-agnostic treatment-a new form of approval.