Comparison of the corticosteroid injection and hyaluronate in the treatment of chronic subacromial bursitis: A randomized controlled trial

2021 ◽  
pp. 026921552110077
Author(s):  
Lin-Fen Hsieh ◽  
Yi-Jia Lin ◽  
Wei-Chun Hsu ◽  
Ying-Chen Kuo ◽  
Yu-Chia Liu ◽  
...  
Keyword(s):  
Hyaluronic Acid ◽  
Outcome Measures ◽  
Normal Saline ◽  
Corticosteroid Injection ◽  
Controlled Trial ◽  
Teaching Hospitals ◽  
Saline Injection ◽  
Group B ◽  
Randomised Controlled ◽  
Double Blinded

Objective: To analyse the effectiveness of corticosteroid (CS) and hyaluronic acid (HA) subacromial – subdeltoid (SASD) injection compared with normal saline (NS) in patients with chronic subacromial bursitis (CSB). Design: A prospective three-arm double-blinded randomised controlled trial. Setting: Rehabilitation department of two teaching hospitals. Subjects: Patients with CSB ( N = 186) divided into CS ( N = 68), HA ( N = 60), and NS ( N = 58) groups. Interventions: Three SASD injections under ultrasound guidance: group A, 20 mg of triamcinolone; group B, 2.5 mL of HA; and group C, 2.5 mL of NS. Outcome measures: The primary outcome measures were the pain visual analogue scale (VAS) score at eight weeks. The secondary outcomes were scores on the Shoulder Pain and Disability Index (SPADI) and Shoulder Disability Questionnaire. Results: At eight weeks, the pain VAS scores during activity were 2.56 ± 2.29, 3.65 ± 2.50, and 4.71 ± 2.83 in the CS, HA, and NS groups, respectively (CS vs NS, P < 0.001; HA vs NS, P = 0.013; CS vs HA, P = 0.010). SPADI scores were 40.83 ± 21.75, 36.92 ± 22.78, and 33.35 ± 23.38 in the CS, HA, and NS groups, respectively (CS vs NS, P < 0.001; HA vs NS, P = 0.197; CS vs HA, P = 0.004). Conclusion: Ultrasound-guided corticosteroid injection into the subacromial – subdeltoid bursa was proven to be effective and superior to hyaluronic acid and normal saline injection for treating CSB. Hyaluronic acid injection was only marginally more effective than normal saline injection. Trial Registration: ClinicalTrials.gov: NCT02702206

scholarly journals Arthroscopic Bankart versus open Latarjet as a primary operative treatment for traumatic anteroinferior instability in young males: a randomised controlled trial with 2-year follow-up

2021 ◽  
pp. bjsports-2021-104028
Author(s):  
Juha Kukkonen ◽  
Sami Elamo ◽  
Tapio Flinkkilä ◽  
Juha Paloneva ◽  
Miia Mäntysaari ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Outcome Measures ◽  
Shoulder Instability ◽  
Controlled Trial ◽  
Activity Level ◽  
Secondary Outcome ◽  
Young Males ◽  
Group B ◽  
Randomised Controlled

ObjectivesTo compare the success rates of arthroscopic Bankart and open Latarjet procedure in the treatment of traumatic shoulder instability in young males.DesignMulticentre randomised controlled trial.SettingOrthopaedic departments in eight public hospitals in Finland.Participants122 young males, mean age 21 years (range 16–25 years) with traumatic shoulder anteroinferior instability were randomised.InterventionsArthroscopic Bankart (group B) or open Latarjet (group L) procedure.Main outcome measuresThe primary outcome measure was the reported recurrence of instability, that is, dislocation at 2-year follow-up. The secondary outcome measures included clinical apprehension, sports activity level, the Western Ontario Shoulder Instability Index, the pain Visual Analogue Scale, the Oxford Shoulder Instability Score, the Constant Score and the Subjective Shoulder Value scores and the progression of osteoarthritic changes in plain films and MRI.Results91 patients were available for analyses at 2-year follow-up (drop-out rate 25%). There were 10 (21%) patients with redislocations in group B and 1 (2%) in group L, p=0.006. One (9%) patient in group B and five (56%) patients in group L returned to their previous top level of competitive sports (p=0.004) at follow-up. There was no statistically significant between group differences in any of the other secondary outcome measures.ConclusionsArthroscopic Bankart operation carries a significant risk for short-term postoperative redislocations compared with open Latarjet operation, in the treatment of traumatic anteroinferior instability in young males. Patients should be counselled accordingly before deciding the surgical treatment.Trial registration numberNCT01998048.

scholarly journals Normal saline flushes performed once daily maintain peripheral intravenous catheter patency: a randomised controlled trial

2015 ◽  
Vol 100 (7) ◽  
pp. 700-703 ◽  
Author(s):  
Silvana Schreiber ◽  
Chiara Zanchi ◽  
Luca Ronfani ◽  
Anna Delise ◽  
Alessandra Corbelli ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Normal Saline ◽  
Controlled Trial ◽  
Nursing Time ◽  
Catheter Patency ◽  
Registration Number ◽  
Peripheral Intravenous Catheter ◽  
Group A ◽  
Group B ◽  
Randomised Controlled

ObjectiveRecent evidence supports the use of normal saline flushes in place of heparin to maintain the patency of peripheral intravenous locks (IVLs); however, there are no data regarding the recommended flush frequency.Study designThis was an open, non-inferiority, randomised controlled trial. Children with IVLs, aged 1–17 years, were randomly assigned to receive saline flushing every 12 h (group A) or every 24 h (group B). The main outcome was the maintenance of catheter patency.ResultsFour hundred patients were randomised; 198 subjects were analysed in the 12 h group and 199 in the 24 h group (three patients were lost at follow-up). Occlusion occurred in 15 children (7.6%) in group A versus 9 (4.5%) in group B (p=0.21). The difference in catheter patency was +3.1% in favour of the 24 h group (95% CI −1.6% to 7.7%), showing the non-inferiority of the 24 h procedure (the non-inferiority margin was set at −4%). Catheter-related complications were not different between the two groups (12.1% in group A vs 9.5% in group B; p=0.42).ConclusionsA flushing procedure with one flush per day allows maintenance of catheter patency without an increase in catheter-related complications. We propose a simplification of the flushing procedure with only one flush per day, thereby reducing costs (materials use and nursing time), labour and unnecessary manipulation of the catheters which can cause distress in younger children and their parents.Trial registration numberThe study is registered in the international database ClinicalTrial.gov under registration number NCT02221024.

Efficacy of oral tranexamic acid versus triple combination for the treatment of melasma: A prospective, double blinded randomised controlled trial

2021 ◽  
Vol 7 (3) ◽  
pp. 222-227
Author(s):  
Shruti Appannavar ◽  
Rohith ◽  
Gajanan Pise
Keyword(s):  
Tranexamic Acid ◽  
Controlled Trial ◽  
Triple Combination ◽  
Once Daily ◽  
Exposed Skin ◽  
Acid Versus ◽  
Significant Difference ◽  
Group B ◽  
Randomised Controlled ◽  
Double Blinded

Melasma is a common acquired hypermelanosis characterized by irregular light to dark brown macules and patches seen mainly in women and over sun-exposed skin on the face. We have undertaken this RCT to compare the efficacy between oral Tranexamic acid and Topical Triple combination as Tranexamic acid is having good safety profile.To compare the therapeutic efficacy of oral Tranexamic acid versus Topical Triple combination for the treatment of Melasma using MASI score. To compare the adverse effects profile of each treatment modality. Total subjects (66 patients) were divided into 2 groups (A and B, each with 33 patients) by simple randomization method.Patients and analysers were blinded to treatments. Group-A received topical triple combination cream once daily (15-minutes) at night for 8 weeks followed by maintenance regimen of biweekly application of product for 4 weeks and oral placebo tablets (calcium gluconate 250mg) twice daily for 12 weeks. Group-B received oral Tranexamic acid tablets 250mg twice daily for 12 weeks with topical placebo cream (Moisturizer) once daily at night for 8 weeks followed by maintenance regimen of biweekly application of product for 4 weeks. MASI score was assessed at baseline and monthly follow-up visits along with simultaneous serial digital photographs, with the recording of side effects. Both groups showed significant decrease in MASI score in each followup visits without any statistically significant difference.In epidermal melasma topical triple combination is preferred over oral tranexamic acid. In dermal and mixed variety oral tranexamic acid is better.

scholarly journals Platelet-rich plasma versus corticosteroid injection for treatment of trigger finger: study protocol for a prospective randomized triple-blind placebo-controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Samuli Aspinen ◽  
Panu H. Nordback ◽  
Turkka Anttila ◽  
Susanna Stjernberg-Salmela ◽  
Jorma Ryhänen ◽  
...  
Keyword(s):  
Normal Saline ◽  
Platelet Rich Plasma ◽  
Corticosteroid Injection ◽  
Controlled Trial ◽  
Trigger Finger ◽  
Saline Injection ◽  
Single Center ◽  
Randomized Controlled ◽  
Local Corticosteroid Injection ◽  
A1 Pulley

Abstract Background Trigger finger is a common hand disorder that limits finger range of motion and causes pain and snapping of the affected finger. Trigger finger is caused by an imbalance of the tendon sheath and the flexor tendon. The initial treatment is generally a local corticosteroid injection around the first annular (A1) pulley. However, it is not unusual that surgical release of the A1 pulley is required. Moreover, adverse events after local corticosteroid injection or operative treatment may occur. Platelet-rich plasma (PRP) has been shown to be safe and to reduce symptoms in different tendon pathologies, such as DeQuervain’s disease. However, the effects of PRP on trigger finger have not been studied. The aim of this single-center triple-blind randomized controlled trial is to study whether PRP is non-inferior to corticosteroid injection in treating trigger finger. The secondary outcome is to assess the safety and efficacy of PRP in comparison to placebo. Methods The trial is designed as a randomized, controlled, patient-, investigator-, and outcome assessor-blinded, single-center, three-armed 1:1:1 non-inferiority trial. The patients with clinical symptoms of trigger finger will be randomly assigned to treatment with PRP, corticosteroid, or normal saline injection. The primary outcome is Patient-Rated Wrist Evaluation and symptom resolution. Secondary outcomes include Quick-Disabilities of the Arm, Shoulder and Hand; pain; grip strength; finger active range of motion; and complications. Appropriate statistical methods will be applied. Discussion We present a novel RCT study design on the use of PRP for the treatment of trigger finger compared to corticosteroid and normal saline injection. The results of the trial will indicate if PRP is appropriate for the treatment of trigger finger. Trial registration ClinicalTrials.gov NCT04167098. Registered on November 18, 2019.

scholarly journals To study and evaluate the effect of intravenous lignocaine on haemodynamic responses to intubation, extubation and post‐operative analgesia in laparoscopic cholecystectomy surgeries

2017 ◽  
Vol 4 (6) ◽  
pp. 1649
Author(s):  
Amitha S. ◽  
Vinay P. V.
Keyword(s):  
Tracheal Intubation ◽  
Normal Saline ◽  
Intravenous Infusion ◽  
Controlled Trial ◽  
Tracheal Extubation ◽  
Medical College ◽  
Arterial Blood ◽  
Group A ◽  
Group B ◽  
Double Blinded

Background: Laryngoscopy, tracheal intubation and subsequent extubation are often associated with an increase in arterial blood pressure (BP), heart rate, arrhythmias, and raised intracranial and intraocular pressure. Lignocaine as bolus I.V. dose just prior to tracheal intubation or extubation has been effectively used to decrease haemodynamic responses associated with them.Methods: Double blinded Randomized Controlled Trial was undertaken at Department of Anesthesia, Sri Siddartha Medical College for a period of one year among ASA 1 and 2 patients. Group A: 0.9% normal saline was used as placebo for perioperative intravenous infusion. Group B: Preservative free lignocaine (xylocard) diluted with normal saline and made to 1% used as intravenous infusion started at a dose of 1.5 mg per kg of lignocaine given as bolus over 10 minutes before induction followed by an infusion of 1.5mg/kg/hr till 1 hour post op.Results: There was significantly less rise in PR and MAP in Group B as compared to Group A. It was also seen that during tracheal extubation there was significantly less rise in PR and MAP in the Group B as compared to the Group A.Conclusions: Administration of lignocaine infusion attenuates the rise in PR as well as MAP duringthe peri‑intubation and peri‑extubation period. Furthermore, infusion of lignocaine significantly increases the mean pain‑free period post‑operatively.

scholarly journals Randomised controlled trial of Compensatory Cognitive Training and a Computerised Cognitive Remediation programme

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Frances Dark ◽  
Ellie Newman ◽  
Victoria Gore-Jones ◽  
Veronica De Monte ◽  
Marta I. Garrido ◽  
...  
Keyword(s):  
Cognitive Impairment ◽  
Randomised Controlled Trial ◽  
Outcome Measures ◽  
Cognitive Training ◽  
Controlled Trial ◽  
Schizophrenia Spectrum Disorders ◽  
Cognitive Interventions ◽  
Schizophrenia Spectrum ◽  
Spectrum Disorders ◽  
Randomised Controlled

Abstract Background Compensation and adaptation therapies have been developed to improve community functioning via improving neurocognitive abilities in people with schizophrenia. Various modes of delivering compensation and adaptation therapies have been found to be effective. The aim of this trial is to compare two different cognitive interventions, Compensatory Cognitive Training (CCT) and Computerised Interactive Remediation of Cognition–Training for Schizophrenia (CIRCuiTS). The trial also aims to identify if mismatch negativity (MMN) can predict an individual’s response to the compensation and adaptation programmes. Methods This study will use a randomised, controlled trial of two cognitive interventions to compare the impact of these programmes on measures of neurocognition and function. One hundred clinically stable patients aged between 18 and 65 years with a diagnosis of a schizophrenia spectrum disorder will be recruited. Participants will be randomised to either the CCT or the CIRCuiTS therapy groups. The outcome measures are neurocognition (BACS), subjective sense of cognitive impairment (SSTICS), social functioning (SFS), and MMN (measured by EEG) in people with schizophrenia spectrum disorders. Discussion This trial will determine whether different approaches to addressing the cognitive deficits found in schizophrenia spectrum disorders are of comparable benefit using the outcome measures chosen. This has implications for services where cost and lack of computer technology limit the implementation and dissemination of interventions to address cognitive impairment in routine practice. The trial will contribute to the emerging evidence of MMN as a predictor of response to cognitive interventions. Trial registration Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12618000161224. Registered on 2 February 2018. Protocol version: 4.0, 18 June 2018.

scholarly journals Mechanical bowel preparation and oral antibiotics versus mechanical bowel preparation only prior rectal surgery (MOBILE2): a multicentre, double-blinded, randomised controlled trial—study protocol

BMJ Open ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. e051269
Author(s):  
Laura Koskenvuo ◽  
Pipsa Lunkka ◽  
Pirita Varpe ◽  
Marja Hyöty ◽  
Reetta Satokari ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Bowel Preparation ◽  
Controlled Trial ◽  
Rectal Surgery ◽  
Mechanical Bowel Preparation ◽  
Oral Antibiotic ◽  
Oral Antibiotics ◽  
Number Of Patients ◽  
Randomised Controlled ◽  
Double Blinded

IntroductionMechanical bowel preparation (MBP) prior to rectal surgery is widely used. Based on retrospective data many guidelines recommend mechanical and oral antibiotic bowel preparation (MOABP) to reduce postoperative complications and specifically surgical site infections (SSIs). The primary aim of this study is to examine whether MOABP reduces complications of rectal surgery.Methods and analysisThe MOBILE2 (Mechanical Bowel Preparation and Oral Antibiotics vs Mechanical Bowel Preparation Only Prior Rectal Surgery) trial is a multicentre, double-blinded, parallel group, superiority, randomised controlled trial comparing MOABP to MBP among patients scheduled for rectal surgery with colorectal or coloanal anastomosis. The patients randomised to the MOABP group receive 1 g neomycin and 1 g metronidazole two times on a day prior to surgery and patients randomised to the MBP group receive identical placebo. Based on power calculations, 604 patients will be enrolled in the study. The primary outcome is Comprehensive Complication Index within 30 days after surgery. Secondary outcomes are SSIs within 30 days after surgery, the number and classification of anastomosis dehiscences, the length of hospital stay, mortality within 90 days after surgery and the number of patients who received adjuvant treatment if needed. Tertiary outcomes are overall survival, disease-specific survival, recurrence-free survival and difference in quality-of-life before and 1 year after surgery. In addition, the microbiota differences in colon mucosa are analysed.Ethics and disseminationThe Ethics Committee of Helsinki University Hospital approved the study. The findings will be disseminated in peer-reviewed academic journals.Trial registration numberNCT04281667.

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