scholarly journals A Randomized, Double-Blind, Placebo-Controlled Clinical Trial Using a Low-Frequency Magnetic Field in the Treatment of Musculoskeletal Chronic Pain

2007 ◽  
Vol 12 (4) ◽  
pp. 249-258 ◽  
Author(s):  
Alex W Thomas ◽  
Karissa Graham ◽  
Frank S Prato ◽  
Julia McKay ◽  
Patricia Morley Forster ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Statistical Significance ◽  
Low Frequency ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Sham Treatment ◽  
Double Blind Clinical Trial ◽  
Antinociceptive Effects ◽  
Frequency Magnetic Field ◽  
Pulsed Electromagnetic

Exposure to a specific pulsed electromagnetic field (PEMF) has been shown to produce analgesic (antinociceptive) effects in many organisms. In a randomized, double-blind, sham-controlled clinical trial, patients with either chronic generalized pain from fibromyalgia (FM) or chronic localized musculoskeletal or inflammatory pain were exposed to a PEMF (400 μT) through a portable device fitted to their head during twice-daily 40 min treatments over seven days. The effect of this PEMF on pain reduction was recorded using a visual analogue scale. A differential effect of PEMF over sham treatment was noticed in patients with FM, which approached statistical significance (P=0.06) despite low numbers (n=17); this effect was not evident in those without FM (P=0.93; n=15). PEMF may be a novel, safe and effective therapeutic tool for use in at least certain subsets of patients with chronic, nonmalignant pain. Clearly, however, a larger randomized, double-blind clinical trial with just FM patients is warranted.

scholarly journals A Double-Blind, Active-Controlled Clinical Trial of Sodium Bicarbonate and Calcium Gluconate in the Treatment of Bilateral Osteoarthritis of the Knee

2017 ◽  
Vol 10 ◽  
pp. 117954411668889 ◽  
Author(s):  
María del Carmen Caamaño ◽  
Sandra García-Padilla ◽  
Miguel Ángel Duarte-Vázquez ◽  
Karla Elena González-Romero ◽  
Jorge L Rosado
Keyword(s):  
Clinical Trial ◽  
Sodium Bicarbonate ◽  
Knee Osteoarthritis ◽  
Calcium Gluconate ◽  
Controlled Clinical Trial ◽  
Osteoarthritis Of The Knee ◽  
Short Term ◽  
Double Blind ◽  
Knee Oa ◽  
Double Blind Clinical Trial

Objective: To evaluate the effect of intra-articular injections of sodium bicarbonate with a single (SBCG1) or double dose (SBCG2) of calcium gluconate administered monthly compared with methylprednisolone (MP) for treatment of knee osteoarthritis. Methods: A 3-month, randomized, double-blind clinical trial with patients diagnosed with knee osteoarthritis (OA). The outcome variables were the Western Ontario-McMaster University Osteoarthritis Index (WOMAC) and the Lequesne functional index. Results: After 3 months, all treatments significantly improved in overall WOMAC and Lequesne scores. Mean changes (95% confidence interval) in WOMAC total score and the Lequesne index, respectively, for SBCG1 (−12.5 [−14.3, −10.7]; −9.0 [−11.4, −6.7]) and SBCG2 (−12.3 [−14.3, −10.4]; −8.9 [−10.4, −7.4]) were significantly greater than for MP (−5.0 [−7.2, −2.8]; −3.2 [−4.9, −1.5]) ( P < .001). Conclusions: Intra-articular injections of sodium bicarbonate and calcium gluconate are useful for short-term relief of OA symptoms in patients with bilateral knee osteoarthritis. Both treatments are more effective than MP injections in the reduction of knee OA symptoms. Trial Registration: Clinicaltrials.gov NCT00977444

scholarly journals Delirium treatment in intoxicated patients in ICU: A randomized, double-blind clinical trial

2020 ◽  
Vol 7 (2) ◽  
pp. 93-96
Author(s):  
Javad Mesbahi ◽  
Shahin Shadnia ◽  
Hossein Hassanian-Moghaddam ◽  
Nasim Zamani ◽  
Peyman Erfan Talab Evini ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Total Sample ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Delirium Assessment ◽  
Diagnostic And Statistical Manual ◽  
Double Blind Clinical Trial ◽  
Dsm V ◽  
Significant Difference ◽  
Hospital Stays

Objective: Delirium is one of the most common complications in patients admitted to intensive care units (ICUs). Delirium is a definite cause for more extended hospital stays, higher mortality rates, and possibly persistent cognitive decline in the future. Antipsychotics have been frequently evaluated as first drugs of choice, but the most appropriate, evidence-based treatment is yet to be discovered. This study aims to compare the efficacy of haloperidol and olanzapine in patients admitted to our toxicology ICU. Methods: This double-blind, randomized controlled clinical trial was undertaken on 35 ICU admitted patients with delirium in Loghman Hakim hospital in Tehran, Iran. The diagnosis was based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria for delirium, and clinical toxicologists included the patients according to the study’s inclusion and exclusion criteria. Patients received either haloperidol or olanzapine based on computerized randomization. The severity of delirium was measured with the Memorial Delirium Assessment Scale (MDAS) scoring on days 0 and 3 of ICU-admission. Results: The total sample size was 35 in which 16 patients received haloperidol, and 19 patients received olanzapine. The doses of haloperidol and olanzapine were 3 mg three times a day and 5 mg three times a day, respectively. There was no significant difference in baseline characteristics and the scores of MDAS between groups. Conclusion: Olanzapine and haloperidol have the same efficacy in the management of delirium in toxicology ICU-admitted patients. They can be interchangeably used for delirium treatment in these patients.

scholarly journals Treatment of patients with Schistosomiasis mansoni: a double blind clinical trial comparing praziquantel with oxamniquine

1986 ◽  
Vol 28 (3) ◽  
pp. 174-180 ◽  
Author(s):  
Luiz Caetano da Silva ◽  
José Murilo R. Zeitune ◽  
Lucia Maria F. Rosa-Eid ◽  
Dirce Mary C. Lima ◽  
Rita H. Antonelli ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Side Effects ◽  
Statistical Significance ◽  
Double Blind ◽  
Chemical Structures ◽  
Double Blind Clinical Trial ◽  
Negative Findings ◽  
Rectal Biopsies ◽  
Cure Rates

A double-blind clinical trial involving 120 patients with chronic schistosomiasis was carried out to compare the tolerability and efficacy of praziquantel and oxamniquine. The patients were randomly allocated into two groups. One was treated with praziquantel, 55 mg/kg of body weight CBWT), and the other one with oxamniquine, 15mg/kg bwt, administered in a single oral dose. The diagnosis and the parasitological follow-up was based on stool examinations by quantitative Kato-Katz method and on rectal biopsies. Side-effects — mainly dizziness, sleepness, abdominal distress, headache, nausea and diarrhea — were observed in 87% of the cases. Their incidence, intensity and duration were similar for both drugs but abdominal pain was significantly more frequent after praziquantel intake and severe dizziness was more commonly reported after oxamniquine. A significant increase of alanine-aminotransferase and y-glutamyltransferase was found with the latter drug and of total bilirubin with the former one. A total of 48 patients treated with praziquantel and 46 with oxamniquine completed with negative findings the required three post-treatment parasitological controls — three slides of each stool sample on the first, third and sixth month. The achieved cure rates were 79.2% and 84.8%, respectively, a difference without statistical significance. The non-cured cases showed a mean reduction in the number of eggs per gram of feces of 93.5% after praziquantel and of 84.1% after oxamniquine. This diference also was not significant. Five patients retreated with praziquantel were cured but only one out of three treated a second time with oxamniquine. These findings show that both drugs — despite their different chemical structures, pharmacological properties and mechanisms-of-action — induce similar side-effects as well as a comparable therapeutical efficacy, in agreement with the results reported from analogous investigations.

scholarly journals Usage of Calendula officinalis in the prevention and treatment of radiodermatitis: a randomized double-blind controlled clinical trial

2015 ◽  
Vol 49 (2) ◽  
pp. 0221-0228 ◽  
Author(s):  
Franciane Schneider ◽  
Mitzy Tannia Reichembach Danski ◽  
Stela Adami Vayego
Keyword(s):  
Clinical Trial ◽  
Fatty Acids ◽  
Survival Curve ◽  
Essential Fatty Acids ◽  
Statistical Significance ◽  
Controlled Clinical Trial ◽  
P Value ◽  
Calendula Officinalis ◽  
Double Blind ◽  
Prevention And Treatment

OBJECTIVE To evaluate the efficacy of Calendula officinalis in relation to Essential Fatty Acids for the prevention and treatment of radiodermatitis. METHOD This is a randomized double-blind controlled clinical trial with 51 patients with head and neck cancer in radiotherapy treatment divided into two groups: control (27) and experimental (24). RESULTS There is statistically significant evidence (p-value = 0.0120) that the proportion of radiodermatitis grade 2 in Essential Fatty Acids group is higher than Calendula group. Through the Kaplan-Meier survival curve we observed that Essential Fatty Acids group has always remained below the Calendula group survival curve, due to the lower risk of developing radiodermatitis grade 1, which makes the usage of Calendula more effective, with statistical significance (p-value = 0.00402). CONCLUSION Calendula showed better therapeutic response than the Essential Fatty Acids in the prevention and treatment of radiodermatitis. Brazilian Registry of Clinical Trials: RBR-237v4b.

Controlled Clinical Trial with Fentiazac Cream in Sport Microtraumatology

1981 ◽  
Vol 9 (4) ◽  
pp. 300-302 ◽  
Author(s):  
M Sinniger ◽  
P Blanchard
Keyword(s):  
Clinical Trial ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Inflammatory Lesions ◽  
Double Blind Clinical Trial ◽  
Spontaneous Course

Fentiazac 5% cream was applied topically on limited articular and extraarticular inflammatory lesions in the course of a double-blind clinical trial versus placebo. The drug proved to be satisfactorily tolerated and also therapeutically effective since it changed significantly (p < 0.05 — < 0.01) the spontaneous course of the microtraumatic pathologic pattern producing an early attenuation and resolution of the painful and functional symptomatic pattern.

scholarly journals Randomized, Double-Blind, Placebo-Controlled Parallel Clinical Trial Assessing the Effect of Fructooligosaccharides in Infants with Constipation

Nutrients ◽  
2018 ◽  
Vol 10 (11) ◽  
pp. 1602 ◽  
Author(s):  
Daniela Souza ◽  
Soraia Tahan ◽  
Thabata Weber ◽  
Humberto Araujo-Filho ◽  
Mauro de Morais
Keyword(s):  
Clinical Trial ◽  
Transit Time ◽  
Statistical Significance ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
First Year ◽  
Therapeutic Success ◽  
Double Blind ◽  
Double Blind Placebo ◽  
First Year Of Life

Constipation often begins in the first year of life. The aim of this study was to assess the effect of fructooligosaccharides (FOS) in the treatment of infants with constipation. This randomized, double-blind, placebo-controlled clinical trial included infants with constipation who were randomly assigned to one of two parallel groups: FOS or placebo. Either the FOS supplement or the placebo was added to the infant formula. Thirty-six infants completed the 4-week intervention. Therapeutic success occurred in 83.3% of the FOS group infants and in 55.6% of the control group infants (p = 0.073; one-tailed test). Compared with the control group, the FOS group exhibited a higher frequency of softer stools (p = 0.035) and fewer episodes of straining and/or difficulty passing stools (p = 0.041). At the end of the intervention, the mouth-to-anus transit time was shorter (22.4 and 24.5 h, p = 0.035), and the Bifidobacterium sp. count was higher (p = 0.006) in the FOS group. In conclusion, the use of FOS in infants with constipation was associated with significant improvement in symptoms, but the results showed no statistical significance regarding the success of the therapy compared with the control group. FOS was associated with reduced bowel transit time and higher counts of the genus Bifidobacterium in the stool.

Efficacy of homeopathic treatment of skin reactions during radiotherapy for breast cancer: a randomised, double-blind clinical trial

2000 ◽  
Vol 89 (01) ◽  
pp. 8-12 ◽  
Author(s):  
A Balzarini ◽  
E Felisi ◽  
A Martini ◽  
F De Conno
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Skin Reactions ◽  
Double Blind Placebo ◽  
X Ray ◽  
Homeopathic Treatment ◽  
Double Blind Clinical Trial ◽  
Number Of Patients

AbstractThe aim of this study was to assess the effects of Belladonna 7cH and X-ray 15cH associated in the treatment of acute radiodermatitis. A randomized double-blind placebo-controlled clinical trial involving 66 patients who had been operated on for breast cancer and were undergoing radiotherapy was conducted. The following parameters were assessed over ten weeks: breast skin colour, warmth, swelling and pigmentation.The efficacy of the treatment was assessed by the comparison of these parameters taken individually and by calculating an Index of Total Severity (sum of the scores of the four parameters) during radiotherapy, and during recovery, 15 and 30 d after the end of the radiotherapy.The differences of the scores of the Index of Total Severity during Radiotherapy were not statistically significant, but showed a trend towards a better activity of the homoeopathic medicine compared to placebo. Analysis of the data on Total Severity during recovery, showed a statistically significant benefit of the active medicines over placebo. The homeopathic medicines had particular effectiveness on the heat of the skin.The limited number of patients observed and the posology employed could have interfered with the significance of the results. Chemotherapy and hormonotherapy do not seem to affect the results.

scholarly journals Evaluation of microkinesitherapy effectiveness in post-traumatic cervicalgia: a new approach applied to previous data

2020 ◽  
pp. 1-4
Author(s):  
Pierre Baconnier ◽  
Bruno Vial ◽  
Gérard Vaudaux ◽  
Geneviève Vaudaux ◽  
Jean-Luc Bosson
Keyword(s):  
Clinical Trial ◽  
Clinical Significance ◽  
Secondary Analysis ◽  
Cervical Trauma ◽  
Double Blind ◽  
Sham Treatment ◽  
Double Blind Clinical Trial ◽  
Significant Difference ◽  
Chi Squared ◽  
Post Traumatic

Background. Cervicalgia from traumatic events such as road traffic accidents and falls can lead to musculoskeletal and soft tissue injuries with the development of pain and headache. Microkinesitherapy is a manual therapy technique that normalizes soft tissue tensions and articular range of motion throughout micropalpation. Objective. This study is a secondary analysis with a clinical significance approach to data collected in a previously published study. These data were obtained during a randomized double-blind clinical trial to evaluate the effectiveness of microkinesitherapy treatment in cervical trauma. Methods. The authors performed a secondary analysis of a previous randomized, double-blind clinical trial, using the Minimal Clinically Important Difference (MCID). This study was conducted at the Faculty of medicine of the Université Grenoble Alpes (Grenoble, FRA), and analyzed 29 patients with cervical trauma less than three months of trauma. This is a secondary analysis of data collected in a previously published randomized double-blind clinical trial where the treated group received a microkinesitherapy treatment (n= 15, 8 females) and the other group received a sham treatment (n=14, 7 females). To look at the clinical significance of those results, it was used the MCID of the instantaneous pain and cervical articular mobility, before and after the treatment or sham treatment. The clinical significance of the treatment was obtained through an inter-group comparison (Pearson’s chi-squared test) based on MCID. Results. With both threshold values, the Pearson’s chi-squared test provide a significant difference in the treatment result compared to sham group. Conclusion. The use of the MCID concept and its value is drawn from recent studies on neck pain allowed us to demonstrate, on an intergroup analysis basis, that there is a clinically significant difference in the effect of a microkinesitherapy treatment on post-traumatic neck pain as compared to a sham treatment.

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