scholarly journals Effects of One-Fifth, One-Third, and One-Half of the Bodyweight Lumbar Traction on the Straight Leg Raise Test and Pain in Prolapsed Intervertebral Disc Patients: A Randomized Controlled Trial

2021 ◽  
Vol 2021 ◽  
pp. 1-8
Author(s):  
Anita Kumari ◽  
Nishat Quddus ◽  
Prachi Raj Meena ◽  
Ahmad H. Alghadir ◽  
Masood Khan
Keyword(s):  
Intervertebral Disc ◽  
Controlled Trial ◽  
Traction Forces ◽  
Significant Difference ◽  
Common Causes ◽  
Lumbar Traction ◽  
Prolapsed Intervertebral Disc ◽  
Straight Leg Raise ◽  
Study Participants ◽  
Pain Improvement

The prolapsed intervertebral disc (PIVD) at the lumbar spine is one of the most common causes of low back pain (LBP) affecting humans worldwide. Lumbar traction is widely used as a part of physiotherapeutic modalities for its treatment; however, reports on its effectiveness and dosage are conflicting. This study is aimed at comparing the acute effects of three traction forces on the straight leg raise (SLR) test and LBP intensity. A total of 45 (age 35.53 yrs., ±3.09) participants with 15 participants in each group were recruited for the study. Participants were divided into groups A, B, and C wherein traction forces equal to one-fifth, one-third, and one-half of their bodyweight were applied, respectively. SLR range of motion (ROM) and pain were examined before and immediately after the application of traction. Significant improvement was observed in SLR ROM in all three groups ( p < 0.05 ). However, for pain, significant improvement ( p < 0.05 ) was observed only in the group with one-half of bodyweight force. There was no significant difference ( p > 0.05 ) between the three groups for both variables. All three forces were equally effective in immediately improving SLR ROM in patients suffering from lumbar PIVD; however, pain improvement was observed with one-half of bodyweight only.

scholarly journals Efficacy of manual therapy interventions in management of lumbar prolapsed intervertebral disc: A pilot randomized controlled trial

2021 ◽  
Vol 20 (3) ◽  
pp. 373-378
Author(s):  
Varun Singh ◽  
◽  
Manoj Malik ◽  
Keyword(s):  
Randomized Controlled Trial ◽  
Intervertebral Disc ◽  
Manual Therapy ◽  
Retention Rate ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Assessment Procedure ◽  
Randomized Controlled ◽  
Prolapsed Intervertebral Disc ◽  
Therapy Interventions

Background. This pilot trial reports the initial estimates of the efficacy of manual therapy interventions in lumbar prolapsed intervertebral disc and determines the feasibility and acceptability of full powered “randomized controlled trial” on efficacy of “spinal mobilization with leg movement (SMWLM)”, high velocity low amplitude thrust (HVLA) and neural mobilization (NM) in lumbar PIVD (Prolapsed Inter-Vertebral Disc) and pilot data will be used to perform sample size calculation for full trial. Material and methods. 48 subjects diagnosed lumbar PIVD were randomly distributed into 4 groups. The primary outcomes were feasibility, assessment procedure, retention rate, adherence and acceptability to the intervention. The secondary outcomes measures were pain, disability and straight leg raise (SLR) range of motion. Results. 90 subjects were screened based on selection criteria. Out of them, 50 (55.55%) were eligible. 48(96%) subjects accepted to participate in study. Baseline data of all the groups was similar but post-intervention score were significant when compared the data between the groups. Highest mean change for visual analog scale (VAS), oswestry disability index (ODI) and SLR were found in SMWLM group. No adverse effects were reported by subjects. Results also suggest that the outcome measures were feasible and acceptable and the treatment considered as the beneficial approach. Conclusions. Present study suggests that it is feasible and acceptable to do a fully powered “randomized controlled trial (RCT)” to evaluate the efficacy of manual therapy interventions in management of lumbar PIVD. This study also reveals that manual therapy interventions are effective in management of lumbar PIVD.

Primary and secondary endpoint analysis of N08C9 (Alliance): A phase III randomized study of sulfasalazine versus placebo in the prevention of acute radiation enteritis.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 562-562
Author(s):  
Matthew J. Iott
Keyword(s):  
Controlled Trial ◽  
Randomized Study ◽  
Bowel Function ◽  
Phase Iii ◽  
Radiation Enteritis ◽  
Significant Difference ◽  
Early Closure ◽  
Secondary Endpoints ◽  
Full Analysis ◽  
Study Participants

562 Background: An interim futility analysis at ASTRO 2013 led to early closure of N08C9 (Alliance), a randomized controlled trial (RCT) comparing sulfasalazine (SSZ) versus placebo (PBO) in the prevention of radiation enteritis during pelvic RT. This is the full analysis of the primary endpoint (PE) and secondary endpoints (SEs) of the trial. Methods: A multi-institutional RCT conducted by the Alliance for Clinical Trials in Oncology assessed the effect of 1000 mg SSZ b.i.d. versus PBO b.i.d. in the treatment of pelvic RT related enteritis. Study participants (SPs) received the study agents during RT and for 4 weeks afterwards. The PEwas the maximal severity of diarrhea toxicity (CTCAE version 4.0) during and up to 6 weeks after RT. SEs, including the maximum severity of diarrhea (MSD) and the duration of MSD, rectal bleeding, abdominal cramping, tenesmus, and constipation, were graded weekly during RT by a health care provider. Bowel function was assessed using a self-administered bowel function questionnaire weekly during RT, afterwards at 6 weeks, and at 12 and 24 months. A two-sided 0.05-level Wilcoxon rank-sum test was used to test the equality of the distributions of MSD grades. The planned study size was 128 SPs. Results: 87 SPs were enrolled in the study between 4/29/2011 and 5/13/2013, with evenly distributed baseline factors. Toxicity data were available in 84 SPs during RT and in 54 SPs in the 6 weeks following RT. There was no significant difference in the distribution of MSD grades between the SSZ and PBO arms (p=0.41 regardless of attribution; p=0.09 at least possibly attributed to the study agent). No significant differences were observed in SEs during RT and after RT, except the abdominal pain occurring after completion of RT was higher in SPs receiving SSZ (p=0.02). More SPs required antidiarrheal agents on the SSZ arm (49% vs. 29%, p=0.06). Conclusions: Despite prior single institution RCT’s suggesting a benefit for SSZ (Kilic 2001; Pal 2013) in this clinical context, the results of this large, multi-institutional trial demonstrate that SSZ does not reduce the risk of enteritis and may worsen acute GI toxicity during pelvic RT. Clinical trial information: NCT01198145.

scholarly journals Impact of a Digital Intervention for Literacy in Depression among Portuguese University Students: A Randomized Controlled Trial

Healthcare ◽  
2022 ◽  
Vol 10 (1) ◽  
pp. 165
Author(s):  
Lersi D. Durán ◽  
Ana Margarida Almeida ◽  
Ana Cristina Lopes ◽  
Margarida Figueiredo-Braga
Keyword(s):  
University Students ◽  
Controlled Trial ◽  
Study Groups ◽  
The Other ◽  
Control Group ◽  
Post Intervention ◽  
Text Format ◽  
Significant Difference ◽  
Study Participants ◽  
The Impact

Digital interventions are important tools to promote mental health literacy among university students. “Depression in Portuguese University Students” (Depressão em Estudantes Universitários Portugueses, DEEP) is an audiovisual intervention describing how symptoms can be identified and what possible treatments can be applied. The aim of this study was to evaluate the impact of this intervention. A random sample of 98 students, aged 20–38 years old, participated in a 12-week study. Participants were recruited through social media by the academic services and institutional emails of two Portuguese universities. Participants were contacted and distributed into four study groups (G1, G2, G3 and G4): G1 received the DEEP intervention in audiovisual format; G2 was given the DEEP in text format; G3 received four news articles on depression; G4 was the control group. A questionnaire was shared to collect socio-demographic and depression knowledge data as a pre-intervention method; content was then distributed to each group following a set schedule; the depression knowledge questionnaire was then administered to compare pre-intervention, post-intervention and follow-up literacy levels. Using the Scheffé and Least Significant Difference (LSD) multiple comparisons test, it was found that G1, which received the DEEP audiovisual intervention, differed significantly from the other groups, with higher depression knowledge scores in post-intervention stages. The DEEP audiovisual intervention, compared to the other formats used (narrative text format; news format), proved to be an effective tool for increasing depression knowledge in university students.

scholarly journals Effect of Balloon-Blowing on Dyspnea and Oxygenation in Noncritical Adult Covid19 Patients: A Pilot Study

2021 ◽  
Author(s):  
Mohammad Bargahi ◽  
Soheil Soltani ◽  
Nafiseh Rastgoo ◽  
Farzane Aryanejad ◽  
Sohrab Esmaielzade ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Scientific Evidence ◽  
Intervention Group ◽  
Chest Physiotherapy ◽  
Peripheral Oxygen Saturation ◽  
Breathing Exercise ◽  
Breathing Exercises ◽  
Significant Difference ◽  
Common Causes ◽  
And Control

Dyspnea and decreased O2 saturation are the most common causes of hospitalization in noncritical covid-19 patients. Breathing exercises and chest physiotherapy are used for managing the patients. These treatments are however not well supported by scientific evidence. In a randomized controlled trial, 80 patients were randomly assigned to planned breathing-exercise (n=40) and control groups (n=40). The participants in the intervention group were instructed to blow into a balloon five times a day while lying down. Other therapies were similar in both groups. The severity of dyspnea at rest/after activity and peripheral oxygen saturation (SpO2) with/without O2 therapy were compared between the two groups on the first, second, and third days. The study findings showed no statistically significant difference in SpO2 with/without O2 therapy on the first, second, and third days between the two groups. Although the severity of dyspnea showed no significant difference between the two groups, the mean score of dyspnea at rest (2.72+-2.25 vs. 1.6+-1.21, p=0.007) and after activity (4.53+-2.04 vs. 3.52+-1.66, P=0.017) improved in the intervention group on the third day. Balloon-blowing exercise improves dyspnea in noncritical Covid-19 patients, but it does not significantly improve oxygenation. Keywords: breathing exercises, balloon-blowing, BBE, chest physiotherapy, covid-19, dyspnea, oxygenation, pulmonary rehabilitation.

scholarly journals Efficacy and safety of Levamisole treatment in clinical presentations of non-hospitalized patients with COVID-19: a double-blind, randomized, controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Amirreza Roostaei Firozabad ◽  
Zohreh Akhoundi Meybodi ◽  
Seyed Ruhollah Mousavinasab ◽  
Adeleh Sahebnasagh ◽  
Mohsen Gholinataj Jelodar ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Clinical Status ◽  
Clinical Importance ◽  
Standard Of Care ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Clinical Benefits ◽  
Study Participants

Abstract Background Levamisole has shown clinical benefits in the management of COVID-19 via its immunomodulatory effect. However, the exact role of Levamisole effect in clinical status of COVID-19 patients is unknown. We aimed to evaluate the efficacy of Levamisole on clinical status of patients with COVID-19 during their course of the disease. Methods This prospective, double-blind, randomized controlled clinical trial was performed in adult patients with mild to moderate COVID-19 (room-air oxygen saturation > 94%) from late April 2020 to mid-August 2020. Patients were randomly assigned to receive a 3-day course of Levamisole or placebo in combination with routine standard of care. Results With 25 patients in each arm, 50 patients with COVID-19 were enrolled in the study. Most of the study participants were men (60%). On days 3 and 14, patients in Levamisole group had significantly better cough status distribution when compared to the placebo group (P-value = 0.034 and 0.005, respectively). Moreover, there was significant differences between the two groups in dyspnea at follow-up intervals of 7 (P-value = 0.015) and 14 (P-value = 0.010) days after receiving the interventions. However, no significant difference in fever status was observed on days 1, 3, 7, and 14 in both groups (P-value > 0.05). Conclusion The results of the current study suggest that Levamisole may improve most of clinical status of patients with COVID-19. The patients receiving Levamisole had significantly better chance of clinical status including cough and dyspnea on day 14 when compared to the placebo. However, the effect-size of this finding has uncertain clinical importance. Trial registration The trial was registered as IRCT20190810044500N7 (19/09/2020).

Reducing the Social Stigma Associated with Obsessive Compulsive Disorder: A Controlled Trial of an Intervention Program in a Turkish Community Sample

2020 ◽  
Vol 20 (2) ◽  
pp. 101-120
Author(s):  
Ayça Aktaç Gürbüz ◽  
Orçun YORULMAZ ◽  
Gülşah DURNA
Keyword(s):  
Obsessive Compulsive Disorder ◽  
Intervention Program ◽  
Controlled Trial ◽  
Community Sample ◽  
Case Vignette ◽  
Control Group ◽  
Obsessive Compulsive ◽  
Compulsive Disorder ◽  
Significant Difference ◽  
The Impact

Scientific research into the reduction of stigmatization, particularly related to specific problems such as Obsessive-Compulsive Disorder (OCD), is scarce. In the present study, we examine the impact of a video-based antistigma intervention program for OCD in a pretest-posttest control group research. After being randomly assigned to either an intervention (n= 101) or control group (n= 96), the participants reported their attitudes on a hypothetical case vignette before and after OCD vs. Multiple Sclerosis (MS) videos, and again six months later as a follow up assessment. The mixed design analyses for the group comparisons indicated that although there was no significant difference in the measures of the control group, the participants watching the anti-stigma OCD video, in which the focus was psychoeducation and interaction strategies, reported significantly lower scores on social distances and negative beliefs for the case vignettes they read, and this difference was maintained six months later. Then, the present results indicate the effectiveness of our anti-stigma intervention program for OCD. Interventions to reduce stigmatization can also be viewed as effective tools for changing the attitudes of people toward OCD, although further research and applications are needed related to specific disorders if a longlasting impact is to be achieved.

Breastfeeding Training through Role-Play and Effects on Mother-infant Attachment Behaviours: A Randomised Controlled Trial

2020 ◽  
Vol 22 (1) ◽  
Author(s):  
Farokh Saljughi ◽  
Mitra Savabi-Esfahani ◽  
Shahnaz Kohan ◽  
Soheila Ehsanpour
Keyword(s):  
Pregnant Women ◽  
Maternal Employment ◽  
Controlled Trial ◽  
Role Play ◽  
Intervention Group ◽  
Control Group ◽  
Maternal Behaviour ◽  
Infant Attachment ◽  
Significant Difference ◽  
History Of

Mother-infant attachment is an intimate, lasting and satisfying relationship that leads to better cognitive, emotional and social growth of the infant. The aim of this study was to determine the effects of breastfeeding training by role-play on mother-infant attachment behaviours. This research was a randomised clinical trial (parallel design). Inclusion criteria were: no history of mental disorders; ability to read and write the Persian language to complete the questionnaire; no history of drug and tobacco intake in primigravida women. The sample comprised 100 pregnant women (in 2 groups), selected through simple random sampling at healthcare centres. The researcher reviewed prenatal care registries of selected healthcare centres and extracted the names of pregnant women in their early third trimester. The data were imported into randomisation software. The control group received routine breastfeeding training, while the intervention group received routine training together with training through role-play. The data collection tool was the Maternal Behaviour Inventory Questionnaire. Consequently 75 samples were analysed in SPSS16. Independent t-tests and chi-square tests were used to examine the difference between the two groups. Results showed that the mean score of mother-infant attachment one week after delivery was significantly higher in the intervention group in comparison to that in the control group (p<0.001). No significant difference was observed between the two groups in maternal age, age of marriage, neonatal gender, maternal employment and education, number of parity, and number of abortions (P>0.05). Since breastfeeding training through role-play could affect mother-infant attachment, it is suggested that this type of training should be provided for pregnant women to promote mother-infant attachment and exclusive breastfeeding.

Comparative Study between Endoscopic Aided Septoplasty with Two Handed Technique using Endoholder and Conventional Septoplasty

2020 ◽  
Vol 16 (3) ◽  
Author(s):  
Apar Pokharel ◽  
Naganawalachullu Jaya Prakash Mayya ◽  
Nabin Gautam
Keyword(s):  
Comparative Study ◽  
Nasal Septum ◽  
Deviated Nasal Septum ◽  
Endoscopic Septoplasty ◽  
Septal Surgery ◽  
Significant Difference ◽  
Common Causes ◽  
Prospective Comparative Study ◽  
Evolutionary Step ◽  
One Year

Introduction: Deviated nasal septum is one of the most common causes for the nasal obstruction. The objective of this study is to compare the surgical outcomes in patients undergoing conventional septoplasty and endoscopic septoplasty in the management of deviated nasal septum. Methods:  Prospective comparative study was conducted on 60 patients who presented to the Department of ENT, College of Medical sciences, during a period of one year. The severity of the symptoms was subjectively assessed using NOSE score and objectively assessed using modified Gertner plate. Results: There was significant improvement in functional outcome like NOSE Score and area over the Gertner plate among patients who underwent endoscopic septoplasty. Significant difference in incidence of post-operative nasal synechae and haemorrhage was seen in conventional group compared to endoscopic group. Conclusions: Endoscopic surgery is an evolutionary step towards solving the problems related to deviated nasal septum. It is safe, effective and conservative, alternative to conventional septal surgery.

The Effect of Reflexology on Labor Pain and Length Among Primiparous Women: A Randomized Controlled Trial

2018 ◽  
Vol 7 ◽  
Author(s):  
Azita Kamjoo
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
Active Phase ◽  
Labor Pain ◽  
Control Group ◽  
Singleton Pregnancy ◽  
Group Data ◽  
Significant Difference ◽  
Labor Length ◽  
Primiparous Women

Background: Pain control is considered as the key issue in modern midwifery. Along with medical painkillers, reflexology is viewed as a non-medical and noninvasive method. Hence, we aimed to investigate the effect of reflexology on the intensity of pain and length of labor. Materials and Methods: In this clinical trial, participants included 240 Iranian primiparous women with term and singleton pregnancy. Having a 3-4 cm cervical dilatation once they visited the hospital. Through a convenient sampling method, they were selected and then randomly divided into two groups. In the intervention group, reflexology was performed, and the intensity of pain during the active phase of labor along with the length of labor in the active phase was measured by visual analog scale (VAS) and compared with the control group. Data were analyzed using descriptive statistics, t-test, and Mann-Whitney U-test. Result: Data analysis showed a statistically significant difference between the intensity of pain in the 5-7 and 8-10 cm dilatation in the two groups (P=0.01). Moreover, the labor length in the active phase was found to be significantly shorter in the intervention group (P<0.001). Conclusion: It appears that reflexology can lead to a reduction in the pain and length of labor. Therefore, through instructing this technique, a goal of midwifery, which is reducing labor pain and its length can be achieved. Keywords: Reflexology, Labor Pain, Labor Length, Primiparous Women

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