Exploratory Randomized Double-Blind Placebo-Controlled Trial of Botulinum Therapy on Grasp Release After Stroke (PrOMBiS)

Background. OnabotulinumtoxinA injections improve upper-limb spasticity after stroke, but their effect on arm function remains uncertain. Objective. To determine whether a single treatment with onabotulinumtoxinA injections combined with upper-limb physiotherapy improves grasp release compared with physiotherapy alone after stroke. Methods. A total of 28 patients, at least 1 month poststroke, were randomized to receive either onabotulinumtoxinA or placebo injections to the affected upper limb followed by standardized upper-limb physiotherapy (10 sessions over 4 weeks). The primary outcome was time to release grasp during a functionally relevant standardized task. Secondary outcomes included measures of wrist and finger spasticity and strength using a customized servomotor, clinical assessments of stiffness (modified Ashworth Scale), arm function (Action Research Arm Test [ARAT], Nine Hole Peg Test), arm use (Arm Measure of Activity), Goal Attainment Scale, and quality of life (EQ5D). Results. There was no significant difference between treatment groups in grasp release time 5 weeks post injection (placebo median = 3.0 s, treatment median = 2.0 s; t(24) = 1.20; P = .24; treatment effect = −0.44, 95% CI = −1.19 to 0.31). None of the secondary measures passed significance after correcting for multiple comparisons. Both groups achieved their treatment goals (placebo = 65%; treatment = 71%), and made improvements on the ARAT (placebo +3, treatment +5) and in active wrist extension (placebo +9°, treatment +11°). Conclusions. In this group of stroke patients with mild to moderate spastic hemiparesis, a single treatment with onabotulinumtoxinA did not augment the improvements seen in grasp release time after a standardized upper-limb physiotherapy program.

Download Full-text

Relief of pain and trismus in patients treated with naproxen or acetylsalicylic acid after tonsillectomy

The Journal of Laryngology & Otology ◽

10.1017/s0022215100103913 ◽

1988 ◽

Vol 102 (1) ◽

pp. 39-42 ◽

Cited By ~ 5

Author(s):

S. Kristensen ◽

K. Tveteraas ◽

P. Hein ◽

H. B. Poulsen ◽

K. E. Outzen

Keyword(s):

Clinical Trial ◽

Acetylsalicylic Acid ◽

Pain Intensity ◽

Sleep Disturbances ◽

Significant Positive Correlation ◽

Controlled Trial ◽

Double Blind ◽

Treatment Groups ◽

Significant Difference ◽

Therapeutic Gain

AbstractThe pain-relieving efficacy of naproxen and acetylsalicylic acid (ASA) in tonsillectomized patients was compared in a double blind parallel clinical trial comprising 83 patients, among whom 42 were treated with naproxen and 41 with ASA. The patients were treated post-operatively for two days with either naproxen suppositories 500 mg. twice, or ASA effervescent tablets 1000 mg. three times, daily.The therapeutic gain was evaluated by recording the intensity of pain, reduced ability to open the mouth (trismus), consumption of supplementary analgesic (parcetamol), and pain-related sleep disturbances.The statistical analysis of the results revealed no differences in pain intensity, consumption of additional analgesics or pain-related sleep disturbances in the two treatment groups. A considerable degree of trismus was demonstrated in most of the tonsillectomized patients. This reduced ability to open the mouth was gradually overcome in the naproxen group while it remained unchanged in the ASA group, however, no statistical significant difference could be demonstrated. Additionally, no significant positive correlation between pain intensity and trismus was proven. The pain-relieving effect, however, was unsatisfactory in both the naproxen and the ASA group, and clinical controlled trial studies of alternative analgetics in tonsillectomized patients are still to be encouraged.

Download Full-text

Double-blind placebo-controlled trial of etanercept in the prevention of work disability in ankylosing spondylitis: Table 1

Annals of the Rheumatic Diseases ◽

10.1136/ard.2009.121327 ◽

2010 ◽

Vol 69 (11) ◽

pp. 1926-1928 ◽

Cited By ~ 46

Author(s):

Nick Barkham ◽

Laura C Coates ◽

Helen Keen ◽

Elizabeth Hensor ◽

Alexander Fraser ◽

...

Keyword(s):

Placebo Group ◽

Ankylosing Spondylitis ◽

Clinical Outcomes ◽

Job Loss ◽

Controlled Trial ◽

Controlled Study ◽

Double Blind ◽

Treatment Groups ◽

Gait Parameters ◽

Significant Difference

ObjectivesEtanercept has been shown to be rapidly effective in suppressing disease activity in ankylosing spondylitis (AS). The aim of this study was to determine whether etanercept improves work instability as measured by the Ankylosing Spondylitis Work Instability Scale (AS-WIS).MethodForty patients with active AS who were in work but were work unstable were recruited. Patients were randomised to receive 25 mg etanercept or placebo twice weekly for 12 weeks. The primary outcome was change in AS-WIS at week 12. The AS-WIS is a patient-derived outcome measure which allows stratification of the risk of job loss. Secondary outcomes included clinical outcomes and gait parameters.ResultsThe mean improvement in AS-WIS score at week 12 was 2.75 in the etanercept group and 0.68 in the placebo group (p=0.125). The risk of job loss decreased for 11 (55%) of the etanercept group compared with 7 (35%) in the placebo group. Conversely, the risk of job loss increased in 3 (15%) of the placebo group compared with 1 (5%) in the etanercept group. There was no statistically significant difference between treatment groups in change in WIS categories (Mann–Whitney U test=0.153, p=0.160). Significant improvement with etanercept was seen at week 12 in clinical outcomes and gait parameters. Etanercept was well tolerated, with no dropouts due to adverse events.ConclusionThis small study confirms the efficacy of etanercept on clinical outcome measures in patients with AS and suggests an effect on work instability which needs to be replicated in a larger controlled study.

Download Full-text

Effectiveness of Levodropropizine on Post-Operative Sore Throat After Endotracheal Intubation for Head and Neck Surgery: A Double-Blind Randomized Controlled Trial

Philippine Journal of Otolaryngology Head and Neck Surgery ◽

10.32412/pjohns.v35i2.1501 ◽

2020 ◽

Vol 35 (2) ◽

pp. 6

Author(s):

Ivabelle Ducto ◽

Joseph Cachuela

Keyword(s):

Head And Neck ◽

Sore Throat ◽

Medical Center ◽

Controlled Trial ◽

Neck Surgery ◽

Orotracheal Intubation ◽

Control Group ◽

Double Blind ◽

Treatment Groups ◽

Significant Difference

ABSTRACT Objective: To determine the effectiveness of levodropropizine in reducing the incidence of post-operative sore throat (POST) among ear, nose, throat, head and neck (ENT-HNS) patients undergoing general endotracheal anesthesia. Methods:Design: Double-Blind, Randomized, Placebo Controlled TrialSetting: Tertiary Government Training Hospital Participants: Sixty (60) ENT-HNS patients aged between 19 to 60 years old admitted to the Southern Philippines Medical Center from January to March 2019 for surgeries on benign thyroid tumors, benign submandibular gland tumors and tonsils requiring orotracheal intubation were randomized into control and treatment groups of 30 patients each. Results: There was a statistically significant difference (p=.0016) in the incidence of POST 6 hours after surgery between control (25/30; 83%) and treatment (16/30; 53.33%) groups. However, confounders such as length and type of surgery (more females and tonsillectomy cases in the control group) were not fully eliminated by randomization. Conclusion: Perioperative levodropropizine significantly decreases the incidence of moderate (as well as mild) postoperative sore throat. It was not shown to decrease the incidence of severe sore throat. A larger cohort (adjusted for other confounders) may better describe the benefit of this treatment.

Download Full-text

Intrauterine lidocaine and naproxen for analgesia during intrauterine device insertion: randomized controlled trial

Contraception and Reproductive Medicine ◽

10.1186/s40834-019-0094-0 ◽

2019 ◽

Vol 4 (1) ◽

Cited By ~ 1

Author(s):

Shana M. Miles ◽

Katerina Shvartsman ◽

Susan Dunlow

Keyword(s):

Pain Assessment ◽

Controlled Trial ◽

Intrauterine Device ◽

Self Medication ◽

Double Blind ◽

Clinical Trial Registration ◽

Treatment Groups ◽

Pain Scores ◽

Post Procedure ◽

Treatment Medication

Abstract Background This study evaluates oral naproxen and intrauterine instillation of lidocaine for analgesia with intrauterine device (IUD) placement as compared to placebo. Methods This was a randomized, double-blind, placebo-controlled trial. Patients desiring levonorgestrel 52 mg IUD or Copper T380A IUD were randomized into treatment groups. Patients received either oral naproxen 375 mg or placebo approximately 1 h prior to procedure in conjunction with 5 mL of 2% lidocaine or 5 mL of intrauterine saline. The primary outcome was pain with IUD insertion measured on a visual analog scale immediately following the procedure. Prespecified secondary outcomes included physician pain assessment, post procedure analgesia, satisfaction with procedure, satisfaction with IUD, and pain assessment related to IUD type. Results From June 4, 2014 to October 28, 2016 a total of 160 women desiring Copper T380A or levonorgestrel 52 mg intrauterine device insertion and meeting study criteria were enrolled and randomized in the study. Of these, 157 (78 in the Copper T380A arm, 79 in the levonorgestrel 52 mg) received study treatment medication. There were 39 in naproxen/lidocaine arm, 39 in placebo/lidocaine arm, 40 in naproxen/placebo arm, and 39 in placebo/placebo arm. There were no differences in the mean pain scores for IUD placement between treatment groups (naproxen/lidocaine 3.38 ± 2.49; lidocaine only 2.87 ± 2.13; naproxen only 3.09 ± 2.18; placebo 3.62 ± 2.45). There was no difference in self-medication post procedure or in satisfaction with the procedure and IUD among women in the treatment arms or by type of IUD. Conclusion Naproxen with or without intrauterine lidocaine does not reduce pain with IUD placement. Clinical trial registration Clinicaltrials.gov, NCT02769247. Registered May 11, 2016, Retrospectively registered

Download Full-text

Capsular closure versus unrepaired interportal capsulotomy after hip arthroscopy in patients with femoroacetabular impingement, results of a patient-blinded randomised controlled trial

Hip International ◽

10.1177/11207000211005762 ◽

2021 ◽

pp. 112070002110057

Author(s):

Niels H Bech ◽

Inger N Sierevelt ◽

Sheryl de Waard ◽

Boudijn S H Joling ◽

Gino M M J Kerkhoffs ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Femoroacetabular Impingement ◽

Hip Arthroscopy ◽

Controlled Trial ◽

Poor Quality ◽

Control Group ◽

Treatment Groups ◽

Significant Difference ◽

Randomised Controlled

Background: Hip capsular management after hip arthroscopy remains a topic of debate. Most available current literature is of poor quality and are retrospective or cohort studies. As of today, no clear consensus exists on capsular management after hip arthroscopy. Purpose: To evaluate the effect of routine capsular closure versus unrepaired capsulotomy after interportal capsulotomy measured with NRS pain and the Copenhagen Hip and Groin Outcome Score (HAGOS). Materials and methods: All eligible patients with femoroacetabular impingement who opt for hip arthroscopy ( n = 116) were randomly assigned to one of both treatment groups and were operated by a single surgeon. Postoperative pain was measured with the NRS score weekly the first 12 weeks after surgery. The HAGOS questionnaire was measured at 12 and 52 weeks postoperatively. Results: Baseline characteristics and operation details were comparable between treatment groups. Regarding the NRS pain no significant difference was found between groups at any point the first 12 weeks after surgery ( p = 0.67). Both groups significantly improved after surgery ( p < 0.001). After 3 months follow-up there were no differences between groups for the HAGOS questionnaire except for the domain sport ( p = 0.02) in favour of the control group. After 12 months follow-up there were no differences between both treatment groups on all HAGOS domains ( p > 0.05). Conclusions: The results of this randomised controlled trial show highest possible evidence that there is no reason for routinely capsular closure after interportal capsulotomy at the end of hip arthroscopy. Trial Registration: This trial was registered at the CCMO Dutch Trial Register: NL55669.048.15.

Download Full-text

Effects of Fermented Milk Containing Lacticaseibacillus paracasei Strain Shirota on Constipation in Patients with Depression: A Randomized, Double-Blind, Placebo-Controlled Trial

Nutrients ◽

10.3390/nu13072238 ◽

2021 ◽

Vol 13 (7) ◽

pp. 2238

Author(s):

Xiaomei Zhang ◽

Shanbin Chen ◽

Ming Zhang ◽

Fazheng Ren ◽

Yimei Ren ◽

...

Keyword(s):

Mental Illness ◽

Placebo Group ◽

Rating Scale ◽

Controlled Trial ◽

Fermented Milk ◽

Daily Consumption ◽

Double Blind ◽

Tnf Α ◽

Significant Difference ◽

Factor Α

Probiotics have been shown to benefit patients with constipation and depression, but whether they specifically alleviate constipation in patients with depression remains unclear. The aim of this study was to investigate the effect of Lacticaseibacillus paracasei strain Shirota (LcS), formerly Lactobacillus casei strain Shirota, on constipation in patients with depression with specific etiology and gut microbiota and on depressive regimens. Eighty-two patients with constipation were recruited. The subjects consumed 100 mL of a LcS beverage (108 CFU/mL) or placebo every day for 9 weeks. After ingesting beverages for this period, we observed no significant differences in the total patient constipation-symptom (PAC-SYM) scores in the LcS group when compared with the placebo group. However, symptoms/scores in item 7 (rectal tearing or bleeding after a bowel movement) and items 8–12 (stool symptom subscale) were more alleviated in the LcS group than in the placebo group. The Beck Depression Index (BDI) and Hamilton Depression Rating Scale (HAMD) scores were all significantly decreased, and the degree of depression was significantly improved in both the placebo and LcS groups (p < 0.05), but there was no significant difference between the groups. The LcS intervention increased the beneficial Adlercreutzia, Megasphaera and Veillonella levels and decreased the bacterial levels related to mental illness, such as Rikenellaceae_RC9_gut_group, Sutterella and Oscillibacter. Additionally, the interleukin (IL)-1β, IL-6, and tumor necrosis factor-α (TNF-α) levels were significantly decreased in both the placebo and LcS groups (p < 0.05). In particular, the IL-6 levels were significantly lower in the LcS group than the placebo group after the ingestion period (p < 0.05). In conclusion, the daily consumption of LcS for 9 weeks appeared to relieve constipation and improve the potentially depressive symptoms in patients with depression and significantly decrease the IL-6 levels. In addition, the LcS supplementation also appeared to regulate the intestinal microbiota related to mental illness.

Download Full-text

Randomized, controlled trial of lasmiditan over four migraine attacks: Findings from the CENTURION study

Cephalalgia ◽

10.1177/0333102421989232 ◽

2021 ◽

Vol 41 (3) ◽

pp. 294-304 ◽

Cited By ~ 2

Author(s):

Messoud Ashina ◽

Uwe Reuter ◽

Timothy Smith ◽

Judith Krikke-Workel ◽

Suzanne R Klise ◽

...

Keyword(s):

Controlled Trial ◽

Study Drug ◽

Statistical Testing ◽

Control Group ◽

Double Blind ◽

Treatment Groups ◽

Primary Endpoints ◽

Registration Number ◽

Secondary Endpoints ◽

Common Teaes

Background We present findings from the multicenter, double-blind Phase 3 study, CENTURION. This study was designed to assess the efficacy of and consistency of response to lasmiditan in the acute treatment of migraine across four attacks. Methods Patients were randomized 1:1:1 to one of three treatment groups – lasmiditan 200 mg; lasmiditan 100 mg; or a control group that received placebo for three attacks and lasmiditan 50 mg for either the third or fourth attack. The primary endpoints were pain freedom at 2 h (first attack) and pain freedom at 2 h in ≥2/3 attacks. Secondary endpoints included pain relief, sustained pain freedom and disability freedom. Statistical testing used a logistic regression model and graphical methodology to control for multiplicity. Results Overall, 1471 patients treated ≥1 migraine attack with the study drug. Both primary endpoints were met for lasmiditan 100 mg and 200 mg ( p < 0.001). All gated secondary endpoints were met. The incidence of treatment-emergent adverse events (TEAEs) was highest during the first attack. The most common TEAEs with lasmiditan were dizziness, paresthesia, fatigue, and nausea; these were generally mild or moderate in severity. Conclusions These results confirm the early and sustained efficacy of lasmiditan 100 mg and 200 mg and demonstrate consistency of response across multiple attacks. Trial Registration Number: NCT03670810

Download Full-text

Stroke early supported discharge: the impact of patients' characteristics and clinical profile on rehabilitation goal attainment and clinical outcomes

International Journal of Therapy and Rehabilitation ◽

10.12968/ijtr.2020.0009 ◽

2021 ◽

Vol 28 (3) ◽

pp. 1-11

Author(s):

Ehab Georgy

Keyword(s):

Clinical Outcomes ◽

Functional Outcomes ◽

Goal Attainment ◽

Clinical Profile ◽

Specific Patient ◽

Early Supported Discharge ◽

Significant Difference ◽

Clinical Profiles ◽

Goal Attainment Scale ◽

The Impact

Background/aims Stroke early supported discharge services were introduced to provide a comprehensive stroke specialist therapy input, while reducing cost of acute care. Early supported discharge services resulted in better health-related outcomes. A consensus has not yet been established regarding specific early supported discharge patient characteristics and clinical profile. The main aim of this study was to establish evidence to support the development of an early supported discharge patient profile (demographics and clinical) and eligibility criteria to enable early supported discharge services achieve their purposes of reducing post-stroke disability and institutionalisation rates. This article outlines the relationship between early supported discharge patients' clinical profiles and clinical outcomes, in terms of disability, goal attainment and institutionalisation rates. Methods A retrospective review of data was implemented to determine whether specific early supported discharge patients' clinical profiles and characteristics correlate with clinical outcomes. Data were collected for patients admitted to the Suffolk Stroke Early Supported Discharge Service between August and October 2016, comprising patients' demographics and clinical profiles, including stroke type, Barthel Index and Modified Rankin Scale. Performance data were collected at the end of the early supported discharge service including therapy frequency and intensity, as well as clinical outcomes including the Goal Attainment Scale. Results Data were collected for 53 patients. Data were analysed for all patients in three groups: goals not achieved; goals achieved; and goals achieved to a higher level), according to the Goal Attainment Scale. A Chi-square test showed no significant difference with regard to sex and stroke side (P=0.27). Analysis of variance revealed no significant difference in age. Conversely, results showed a significant association between goal attainment and the stroke subtype, severity and length of hospital stay. Conclusions Specific clinical characteristics and disease profiles correlate with functional outcomes and could influence goal attainment and functional status. A specific patient cohort seems to benefit the most from early supported discharge services in terms of optimised functional outcomes and recovery.

Download Full-text

TOP-PRO study: A randomized double-blind controlled trial of topiramate versus propranolol for prevention of chronic migraine

Cephalalgia ◽

10.1177/03331024211047454 ◽

2021 ◽

pp. 033310242110474

Author(s):

Debashish Chowdhury ◽

Luv Bansal ◽

Ashish Duggal ◽

Debabrata Datta ◽

Ankit Mundra ◽

...

Keyword(s):

Adverse Events ◽

Chronic Migraine ◽

Virus Disease ◽

Controlled Trial ◽

Preventive Treatment ◽

Point Estimate ◽

Tolerability Profile ◽

Double Blind ◽

Significant Difference ◽

The Mean

Objective The aim of the TOP-PRO-study, a double-blind randomized controlled trial, was to assess the efficacy (non-inferiority) and tolerability of propranolol compared to topiramate for the prevention of chronic migraine. Background Except for topiramate, oral preventive treatment for chronic migraine lacks credible evidence. Methods Chronic migraine patients aged above 18 years and less than 65 years of age, not on any preventive treatment were randomly allocated to receive topiramate (100 mg/day) or propranolol (160 mg/day). The primary efficacy outcome was the mean change in migraine days per 28 days at the end of 24 weeks from baseline. A mean difference of 1.5 days per four weeks was chosen as the cut-off delta value. Multiple secondary efficacy outcomes and treatment emergent adverse events were also assessed. Results As against the planned sample size of 244, only 175 patients could be enrolled before the spread of the corona virus disease-2019 pandemic and enforcement of lockdown in India. Of the 175 randomized patients, 95 (topiramate 46 and propranolol 49) completed the trial. The mean change in migraine days was −5.3 ± 1.2 vs −7.3 ± 1.1 days (p = 0.226) for topiramate and propranolol groups respectively. Propranolol was found to be non-inferior and not superior to topiramate (point estimate of −1.99 with a 95% confidence interval of −5.23 to 1.25 days). Multiple secondary outcomes also did not differ between the two groups. Intention to treat analysis of 175 patients and per-protocol analysis of 95 patients yielded concordant results. There was no significant difference in the incidence of adverse events between the two groups. Conclusion Propranolol (160mg/day) was non-inferior, non-superior to topiramate (100mg/day) for the preventive treatment of chronic migraine and had a comparable tolerability profile. Trial Registration: Clinical Trials Registry-India CTRI/2019/05/018997)

Download Full-text

A double-blind randomized controlled trial of topical Curcuma xanthorrhiza Roxb. on mild psoriasis: clinical manifestations, histopathological features, and K6 expressions

Medical Journal of Indonesia ◽

10.13181/mji.v27i3.2511 ◽

2018 ◽

Vol 27 (3) ◽

pp. 178-84 ◽

Cited By ~ 1

Author(s):

Githa Rahmayunita ◽

Tjut N.A. Jacoeb ◽

Endi Novianto ◽

Wresti Indriatmi ◽

Rahadi Rihatmadja ◽

...

Keyword(s):

Controlled Trial ◽

Clinical Manifestations ◽

Effective Treatment Option ◽

Psoriasis Area Severity Index ◽

Double Blind ◽

Old Patients ◽

Mean Values ◽

Significant Difference ◽

Curcuma Xanthorrhiza ◽

The Difference

Background: Curcuma xanthorrhiza Roxb. exerts its anti-inflammatory effects by reducing the concentration of IL-6, IL-8, and phosphorylase kinase, which has role in keratinocyte proliferation. Our study aimed to evaluate the efficacy of C. xanthorrhiza in psoriasis.Methods: From 18 to 59 year-old patients with mild psoriasis, 2 similar lesions were selected. The severity assessment was based on the psoriasis area severity index (PASI), Trozak score, and K6 expression. Using a double-blinded randomized method, lesion was treated with 1% C. xanthorrhiza ointment vs placebo for 4 weeks. The results were analyzed by the chi-square test using STATATM V.12 software (Stata Corp.).Results: The study was conducted in 2010 to 2012 with 17 subjects participated. The median of PASI score were reduced significantly in both lesions, either treated with 1% C. xanthorrhiza ointment vs placebo; however when compared between the group, it was not significant (p=0.520). The Trozak score were reduced in lesions treated with 1% C. xanthorrhiza ointment; but it was not significant (p = 0.306). In lesions treated with placebo, the Trozak score was increased significantly. The difference of Trozak score between lesions treated with C. xanthorrhiza and placebo was significant (p=0.024). There was no significant difference of K6 expression in lesions treated with 1% C. xanthorrhiza ointments or placebo as well as on the difference of mean values of K6 expression between the group (p=0.827).Conclusion: Based on the results, 1% C. xanthorrhiza ointment is effective treatment option for mild psoriasis, but longer follow-up period is suggested to confirm this results. C. xanthorrhiza ointment is safe for topical administration as there were no side effects reported in this study.

Download Full-text