scholarly journals A Multicenter, Prospective, Randomized, Placebo-Controlled, Double-Blind Study of a Novel Pain Management Device, AT-02, in Patients with Fibromyalgia

Pain Medicine ◽  
2019 ◽  
Vol 21 (2) ◽  
pp. 326-332 ◽  
Author(s):  
Hiroshi Oka ◽  
Kenji Miki ◽  
Iwao Kishita ◽  
David F Kong ◽  
Takahiro Uchida
Keyword(s):  
Rating Scale ◽  
Numerical Rating Scale ◽  
Repeated Measure ◽  
Controlled Clinical Trial ◽  
Double Blind Study ◽  
Double Blind ◽  
Point Change ◽  
Entire Treatment Period ◽  
Magnetic Field Therapy ◽  
Significant Difference

Abstract Objectives Existing treatments for fibromyalgia have limited efficacy, and only a minority of individuals clinically respond to any single intervention. This study was a prospective, multicenter, randomized, double-blind, controlled clinical trial to evaluate the feasibility of alternating magnetic field therapy in fibromyalgia patients by comparing the Angel Touch device (AT-02) with a sham control (S-01). Methods Two sites enrolled 44 subjects with diagnosed fibromyalgia. After informed consent, subjects taking prohibited concomitant drugs underwent a washout period of two or more weeks. All subjects then began a one-week run-in period. Numerical rating scale (NRS) pain scores were collected without device intervention for one day, followed by S-01 application to four or more painful sites for 10 minutes at each site, twice daily for six days. Subjects were then randomized to AT-02 or S-01, applied to four or more painful sites for 10 minutes at each site, twice daily for eight weeks. NRS scores were obtained twice daily during the entire treatment period. Results The primary end point (change in NRS ± SD at week 8 vs baseline) was –0.94 ± 1.33 in the AT-02 group and –0.22 ± 1.38 in the S-01 group. A trend toward a between-group difference in eight-week NRS scores favored the AT-02 group (–0.73, 95% confidence interval = –1.56 to 0.11, P = 0.086). An adjusted repeated measure analysis detected a significant difference in NRS scores (P = 0.039). Conclusions The reduction in NRS scores for AT-02 relative to sham was comparable to reductions observed in meta-analyses of fibromyalgia drug therapy. The unadjusted results and the persistence of the pain score reductions remain encouraging.

Duloxetine augmentation in resistant obsessive compulsive disorder: Surveying a new medication for challenges in treatment of OCD

2017 ◽  
Vol 41 (S1) ◽  
pp. S415-S415
Author(s):  
A. Mowla
Keyword(s):  
Obsessive Compulsive Disorder ◽  
Primary Outcome Measure ◽  
Controlled Clinical Trial ◽  
Double Blind Study ◽  
Obsessive Compulsive ◽  
Double Blind ◽  
Compulsive Disorder ◽  
Significant Difference ◽  
Competing Interest ◽  
To Receive

IntroductionUp to 50% of patients with OCD have failed to respond in SSRI trials, so looking for pharmacological alternatives in treatment of obsessive compulsive disorder (OCD) seems necessary.ObjectivesSurveying duloxetine augmentation in treatment of resistant OCD.AimsStudy the effects of serotonin-norepinephrine enhancers for treatment of OCD.MethodsThis augmentation trial was designed as an 8-week randomized controlled, double blind study. Forty-six patients suffering from OCD who had failed to respond to at least 12 weeks of treatment with a selective serotonin reuptake inhibitor (fluoxetine, citalopram or fluvoxamine) were randomly allocated to receive duloxetine or sertraline plus their current anti OCD treatment. Yale-Brown Obsessive Compulsive Scale (Y-BOCS) was the primary outcome measure.ResultsForty-six patients (24 of 30 in duloxetine group and 22 of 27 in sertraline group) completed the trial. Both groups showed improvement over the 8-week study period (mean Y-BOCS total score at week 8 as compared with baseline: P < 0.001 and P < 0.001) without significant difference (P = 0.861). Those receiving duloxetine plus their initial medications experienced a mean decrease of 33.0% in Y-BOCS score and the patients with sertraline added to their initial medication experienced a mean decrease of 34.5% in Y-BOCS.ConclusionsOur double blind controlled clinical trial showed duloxetine to be as effective as sertraline in reducing obsessive and compulsive symptoms in resistant OCD patients. However, it needs to be noted that our study is preliminary and larger double blind placebo controlled studies are necessary to confirm the results.Disclosure of interestThe authors have not supplied their declaration of competing interest.

Oxcarbazepine as an Adjunct of Antipsychotic Therapy in Acute Schizophrenia: A Double-blind, Randomised Placebo-controlled Clinical Trial

2009 ◽  
Vol 24 (S1) ◽  
pp. 1-1
Author(s):  
D. Koethe ◽  
L. Kranaster ◽  
M. Hellmich ◽  
B.M. Nolden ◽  
J. Klosterkoetter
Keyword(s):  
Rating Scale ◽  
Rate Of Change ◽  
Controlled Clinical Trial ◽  
Antipsychotic Therapy ◽  
Double Blind ◽  
Parallel Group ◽  
Significant Difference ◽  
Mixed Regression ◽  
Psychiatric Rating ◽  
Psychiatric Rating Scale

The outcome in treatment of schizophrenia is still not satisfactorily, and using the adjunctive administration of various anticonvulsant drugs adjunctive to antipsychotics has become widely distributed. This study determines the efficacy of oxcarbazepine combined to olanzapine in treatment of schizophrenia in a double-blind, randomized, placebo-controlled, parallel-group, add-on therapy, 7 week study in 54 patients suffering schizophreniform disorder or schizophrenia. Patients were randomized to oxcarbazepine or placebo and titrated up to 1800 mg/ day in week 1 and maintained at that dose for another 6 weeks. Treatment of olanzapine started at week 2 with 5 mg/day. According to weekly improvement in Brief Psychiatric Rating Scale (BPRS), olanzapine dose was maintained constant or escalated in regular steps of 2.5 mg. Main outcome measure was the cumulative olanzapine dose from beginning administration of oxcarbazepine/placebo for a period of 42 days. Comparing treatment of oxcarbazepine and olanzapine with placebo and olanzapine, there was no difference in cumulative olanzapine doses in both groups. in the oxcarbazepine group was not significantly more rescue medication given. A mixed regression model was used to assess time trends in BPRS over the treatment period: the differences in the rate of change of BPRS in the two treatment groups suggested that the scores sank more rapidly in the oxcarbazepine group (p=0.063). Mean post-treatment aggression score also showed no significant difference. Results from this study do not support the use of OXC as an adjunct to atypical antipsychotics in patients with schizophrenia.

scholarly journals Levodopa+carbidopa in X-linked Dystonia Parkinsonism (XDP/DYT3/Lubag): A Randomized, Double-blind, Placebo-controlled Trial

2018 ◽  
Vol 52 (6) ◽  
Author(s):  
Roland Dominic G. Jamora ◽  
Rosalia A. Teleg ◽  
Cynthia P. Cordero ◽  
Rodelyn F. Villareal-Jordan ◽  
Lillian V. Lee ◽  
...  
Keyword(s):  
Rating Scale ◽  
Botulinum Toxin A ◽  
Controlled Trial ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Efficacy Analysis ◽  
Intention To Treat ◽  
Oral Medications ◽  
Significant Difference ◽  
Scale Scores

Objective. X-linked dystonia parkinsonism (XDP) is an adult-onset, progressive and debilitating movement disorder described among Filipino males from Panay Island. The available oral medications have been ineffective. While chemodenervation with botulinum toxin A works and deep brain stimulation surgery is promising, these are not affordable for the vast majority of patients. Thus, we decided to look into the efficacy, safety and tolerability of levodopa+carbidopa (levodopa) versus placebo among patients with XDP. Methods. This was a double blind, randomized, placebo-controlled clinical trial. Patients were randomized to receive levodopa or placebo for 6 months. The dose was increased gradually until 1000 mg levodopa/day is reached or until side effects appear. Results. A total of 86 out of 94 randomized patients (91.5%) were included in the intention-to-treat cohort for the primary efficacy analysis. Nineteen patients (9 in levodopa, 10 in placebo) dropped out or were lost to follow up. There was no significant difference in the baseline and last visit Burke Fahn Marsden Dystonia Rating Scale and the part III of the Unified Parkinson’s Disease Rating Scale scores between levodopa and placebo. The most common adverse events in the levodopa group were increased movements, pain and nausea/ vomiting. Conclusion. While levodopa is safe and well-tolerated, it does not have any effect in alleviating the dystonia or parkinsonism in XDP

Switching from long-term benzodiazepine therapy to pregabalin in patients with generalized anxiety disorder: a double-blind, placebo-controlled trial

2011 ◽  
Vol 26 (4) ◽  
pp. 461-470 ◽  
Author(s):  
Sallie J Hadley ◽  
Francine S Mandel ◽  
Edward Schweizer
Keyword(s):  
Anxiety Disorder ◽  
Generalized Anxiety Disorder ◽  
Rating Scale ◽  
Controlled Trial ◽  
Generalized Anxiety ◽  
Double Blind Study ◽  
Double Blind ◽  
Significant Difference ◽  
Hamilton Anxiety Rating Scale

To evaluate the efficacy of pregabalin in facilitating taper off chronic benzodiazepines, outpatients ( N = 106) with a lifetime diagnosis of generalized anxiety disorder (current diagnosis could be subthreshold) who had been treated with a benzodiazepine for 8–52 weeks were stabilized for 2–4 weeks on alprazolam in the range of 1–4 mg/day. Patients were then randomized to 12 weeks of double-blind treatment with either pregabalin 300–600 mg/day or placebo while undergoing a gradual benzodiazepine taper at a rate of 25% per week, followed by a 6-week benzodiazepine-free phase during which they continued double-blind study treatment. Outcome measures included ability to remain benzodiazepine-free (primary) as well as changes in Hamilton Anxiety Rating Scale (HAM)-A and Physician Withdrawal Checklist (PWC). At endpoint, a non-significant higher proportion of patients remained benzodiazepine-free receiving pregabalin compared with placebo (51.4% vs 37.0%). Treatment with pregabalin was associated with significantly greater endpoint reduction in the HAM-A total score versus placebo (−2.5 vs +1.3; p < 0.001), and lower endpoint mean PWC scores (6.5 vs 10.3; p = 0.012). Thirty patients (53%) in the pregabalin group and 19 patients (37%) in the placebo group completed the study, reducing the power to detect a significant difference on the primary outcome. The results on the anxiety and withdrawal severity measures suggest that switching to pregabalin may be a safe and effective method for discontinuing long-term benzodiazepine therapy.

Comparison of Pimozide and Chlorpromazine in Acute Schizophrenia

1982 ◽  
Vol 27 (3) ◽  
pp. 208-212 ◽  
Author(s):  
J.C. Pecknold ◽  
D.J. Mcclure ◽  
T. Allan ◽  
L. Wrzesinski
Keyword(s):  
Dopamine Receptor ◽  
Adverse Reactions ◽  
Rating Scale ◽  
Double Blind Study ◽  
Onset Of Action ◽  
Double Blind ◽  
Acute Schizophrenia ◽  
Significant Difference ◽  
Psychiatric Rating ◽  
Psychiatric Rating Scale

A four week double-blind study comparing pimozide and chlorpromazine was designed to test the hypothesis that pimozide, a powerful dopamine receptor blocker, is more effective in the treatment of acute schizophrenia than chlorpromazine. Twenty patients, 13 males and 7 females ranging in age from 21 to 53 years (mean age 33 years) admitted to St. Mary's Hospital with acute schizophrenia were placed on the study. They were treated on an individual titrated dosage of either chlorpromazine 300 mg to 2100 mg, or pimozide 10 to 70 mg. The results revealed that on the Brief Psychiatric Rating Scale, the chlorpromazine group significantly improved after one week, whereas the pimozide group showed no statistical improvement until the third week. By the end of the study no significant differences were apparent between the two groups. In the Clinical Global Impression Scale, a significant difference between the two groups was found at week 4 showing a greater improvement in the chlorpromazine group. In terms of adverse reactions, the chlorpromazine group had significantly fewer extrapyramidal symptoms than the pimozide group (Simpson and Angus Scale) and in addition 15 adverse reactions were noted for the pimozide group as compared with 8 for the chlorpromazine group. This study shows that chlorpromazine has an earlier onset of action than pimozide in the acute schizophrenic patient despite the fact that it has a weaker effect on the dopamine receptor than has pimozide. In view of this finding, the dopamine theory of schizophrenia should be critically re-examined.

scholarly journals Neurokinin-1 antagonist orvepitant for EGFRI-induced pruritus in patients with cancer: a randomised, placebo-controlled phase II trial

BMJ Open ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. e030114 ◽  
Author(s):  
Bruno Vincenzi ◽  
Mike Trower ◽  
Ajay Duggal ◽  
Pamela Guglielmini ◽  
Peter Harris ◽  
...  
Keyword(s):  
Outcome Measures ◽  
Primary Endpoint ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Secondary Outcome ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Once Daily ◽  
Intense Pruritus ◽  
Neurokinin 1

ObjectiveTo evaluate the efficacy of orvepitant (10 or 30 mg given once daily, orally for 4 weeks), a neurokinin-1 receptor antagonist, compared with placebo in reducing the intensity of epidermal growth factor receptor inhibitor (EGFRI)-induced intense pruritus.DesignRandomised, double-blind, placebo-controlled clinical trial.Setting15 hospitals in Italy and five hospitals in the UK.Participants44 patients aged ≥18 years receiving an EGFRI for a histologically confirmed malignant solid tumour and experiencing moderate or intense pruritus after EGFRI treatment.Intervention30 or 10 mg orvepitant or placebo tablets once daily for 4 weeks (randomised 1:1:1).Primary and secondary outcome measuresThe primary endpoint was change from baseline in mean patient-recorded numerical rating scale (NRS) score (over the last three recordings) at week 4. Secondary outcome measures were NRS score, verbal rating scale score, Skindex-16 and Leeds Sleep Evaluation Questionnaire at each study visit (baseline, weeks 1, 4, 8); rescue medication use; EGFRI dose reduction; and study withdrawal because of intense uncontrolled pruritus.ResultsThe trial was terminated early because of recruitment challenges; only 44 of the planned 90 patients were randomised. All patients were analysed for efficacy and safety. Mean NRS score change from baseline to week 4 was −2.78 (SD: 2.64) points in the 30 mg group, −3.04 (SD: 3.06) points in the 10 mg group and −3.21 (SD: 1.77) points in the placebo group; the difference between orvepitant and placebo was not statistically significant. No safety signal was detected. Adverse events related to orvepitant (asthenia, dizziness, dry mouth, hyperhidrosis) were all of mild or moderate severity.ConclusionsOrvepitant was safe and well tolerated. No difference in NRS score between the orvepitant and placebo groups was observed at the week 4 primary endpoint. A number of explanations for this outcome are possible.Trial registration numberEudraCT2013-002763-25.

scholarly journals Neurodynamic mobilization and foam rolling improved delayed-onset muscle soreness in a healthy adult population: a randomized controlled clinical trial

PeerJ ◽  
2017 ◽  
Vol 5 ◽  
pp. e3908 ◽  
Author(s):  
Blanca Romero-Moraleda ◽  
Roy La Touche ◽  
Sergio Lerma-Lara ◽  
Raúl Ferrer-Peña ◽  
Víctor Paredes ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Muscle Soreness ◽  
Pain Perception ◽  
Rating Scale ◽  
Adult Population ◽  
Rectus Femoris ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Maximum Voluntary Isometric Contraction ◽  
Significant Difference

Objectives Compare the immediate effects of a Neurodynamic Mobilization (NM) treatment or foam roller (FR) treatment after DOMS. Design Double blind randomised clinical trial. Setting The participants performed 100 drop jumps (5 sets of 20 repetitions, separated by 2 min rests) from a 0.5-m high box in a University biomechanics laboratory to induce muscle soreness. The participants were randomly assigned in a counter-balanced fashion to either a FR or NM treatment group. Participants Thirty-two healthy subjects (21 males and 11 females, mean age 22.6 ± 2.2 years) were randomly assigned into the NM group (n = 16) or the FR group (n = 16). Main Outcome Measures The numeric pain rating scale (NPRS; 0–10), isometric leg strength with dynamometry, surface electromyography at maximum voluntary isometric contraction (MVIC) and muscle peak activation (MPA) upon landing after a test jump were measured at baseline, 48 h after baseline before treatment, and immediately after treatment. Results Both groups showed significant reduction in NPRS scores after treatment (NM: 59%, p < .01; FR: 45%, p < .01), but no difference was found between them (p > .05). The percentage change improvement in the MVIC for the rectus femoris was the only significant difference between the groups (p < 0.05) at post-treatment. After treatment, only the FR group had a statistically significant improvement (p < 0.01) in strength compared to pre-treatment. Conclusion Our results illustrate that both treatments are effective in reducing pain perception after DOMS whereas only FR application showed differences for the MVIC in the rectus femoris and strength.

scholarly journals The Efficacy of Lingual Laser Frenectomy in Pediatric OSAS: A Randomized Double-Blinded and Controlled Clinical Study

2021 ◽  
Vol 18 (11) ◽  
pp. 6112
Author(s):  
Miriam Fioravanti ◽  
Francesca Zara ◽  
Iole Vozza ◽  
Antonella Polimeni ◽  
Gian Luca Sfasciotti
Keyword(s):  
Diode Laser ◽  
Speech Therapy ◽  
Pediatric Patients ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Sleep Apnea Syndrome ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Obstructive Sleep

This randomized, double-blind and controlled clinical trial investigates how a diode laser lingual frenectomy can improve obstructive sleep apnea syndrome (OSAS) in pediatric patients. Background: Several authors have shown that a short lingual frenulum causes a reduction in incoming air flow and the relationship between OSAS and a short lingual frenulum. Methods: Thirty-two pediatric patients were equally randomly divided into a Study Group (SG) and a Control Group (CG). On each SG patient a polysomnography 1 (PSG1) and a lingual frenectomy were performed using a diode laser via Doctor Smile Wiser technology, power 7 W. After three months, a new polysomnography (PSG2) was performed to evaluate the lingual frenectomy efficacy in pediatric patients. The pain was assessed by a numerical rating scale (NRS) before and after surgery. The CG followed the same protocol without a lingual frenectomy but myofunctional and speech therapy were conducted to qualitatively and quantitatively improve the lingual functionality. In the SG, eight subjects (50%) had severe OSAS and eight had moderate (50%) while in the CG, three subjects had severe OSAS (18.8%) and thirteen had moderate (81.2%). Results: In the SG, 93.8% were classified as mild OSAS and 6.2% as moderate. In contrast, in the CG, 18.75% were classified as mild OSAS, 62.5% as moderate and 18.75% as severe. Conclusion: The study demonstrates how a lingual laser frenectomy can improve OSAS in pediatric patients.

Intracuff Pressures Do Not Predict Laryngopharyngeal Discomfort after Use of the Laryngeal Mask Airway 

1997 ◽  
Vol 87 (1) ◽  
pp. 63-67 ◽  
Author(s):  
Armin Rieger ◽  
Bergit Brunne ◽  
Hans Walter Striebel
Keyword(s):  
High Pressure ◽  
Laryngeal Mask Airway ◽  
Sore Throat ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Low Pressure ◽  
Laryngeal Mask ◽  
Double Blind Study ◽  
Pressure Group ◽  
Significant Difference

Background The laryngeal mask airway (LMA) is a large foreign body that exerts pressure on the pharyngeal mucosa, which may lead to throat discomfort. To determine whether intracuff pressures are associated with such discomfort, a randomized, double-blind study was performed to determine the effect of high versus low intracuff pressures. Methods Seventy healthy women were randomly allocated to two groups with different LMA intracuff pressures: 30 mmHg (low pressure) or 180 mmHg (high pressure). Pressures were controlled with a microprocessor-controlled monitor. Insertion of the LMA was performed by one investigator and facilitated with propofol and verified fiberoptically. Anesthesia was maintained with enflurane and nitrous oxide. The LMAs were removed while the patients were still asleep. Patients assessed their laryngopharyngeal complaints (sore throat, dysphagia, hoarseness) at 8, 24, and 48 h after operation on a 101-point numerical rating scale. Results No significant difference was found in the overall incidence of complaints between both groups (low pressure: 50%; high pressure: 42%). On the day of surgery, dysphagia (38%) was more frequent than sore throat (16%) or hoarseness (6%) (P &lt; 0.05) within the high-pressure group. In the low-pressure group, the incidence of these complaints was not significantly different (33%, 20%, and 23%, respectively). On the following day, dysphagia was still present in 20% of the women in both groups, and other symptoms comprised 10% or less of the reported complaints. Conclusions Differences in LMA intracuff pressures did not influence either the incidence or severity of laryngopharyngeal complaints.

scholarly journals Multi-Modal Analgesic Technique for Pain Control in Patients Undergoing Diagnostic Gynecological Laparoscopy: Randomized Controlled Clinical Trial

2019 ◽  
Vol 7 (8) ◽  
pp. 1324-1329 ◽  
Author(s):  
Sherin Refaat ◽  
Ashraf Ali Mawgood ◽  
Mohamed Al Sonbaty ◽  
Maged Gamal ◽  
Abdelrazik Ahmed
Keyword(s):  
Recruitment Maneuver ◽  
Controlled Clinical Trial ◽  
P Value ◽  
Double Blind Study ◽  
Double Blind ◽  
Rescue Analgesia ◽  
Gynaecological Laparoscopy ◽  
Significant Difference ◽  
Analgesic Technique ◽  
Pulmonary Recruitment Maneuver

BACKGROUND: Advancement in minimally invasive laparoscopic surgeries make it one of the best choices for both the surgeon and the patient. The anesthesiologist had to improve the techniques used to control post-operative pain. AIM: In this study, we hyposethized that multi-modal analgesic technique which is a combination of two simple techniques (intraperitoneal lidocaine and pulmonary recruitment) allow better result than using only one of them. PATIENTS AND METHOD: This randomised controlled, double-blind study was conducted in Kasr-Alainy hospital, faculty of medicine, Cairo University, Egypt from September 2017 till February 2018. Fifty female patients, scheduled for diagnostic gynecologic laparoscopy were included in the study. Patients were randomly allocated using random computer allocation with numbered closed opaque envelopes into four study group. GM (n = 12): Patients received pulmonary recruitment maneuver and intra-peritoneal Lidocaine, GL (n = 13): Patients received intra-peritoneal Lidocaine, GP (n = 13): Patients received Pulmonary Recruitment Maneuver, GC (n = 12): Patients received passive exsufflation through the port site. In the ward, patients were asked to fulfil a questionnaire about pain severity using (VAS) at 1, 3, 6-hour post-operative both the patients and the anesthesiologist that assess the (VAS) were blind of the patient group RESULTS: Regarding pain score between groups VAS 1 (the primary outcome) was lowest in GM {4.5 (3-5)} in comparison with other groups (P value = 0.015). While VAS 3 & VAS 6 wasn’t statistically significant between groups. Regarding Time of first rescue analgesia; GM {3 (1.75-4)} showed the longest time in between groups (P-value = 0.042). As regard nausea and vomiting; there was no statistically significant difference in in-between groups. CONCLUSION: Application of Multi-modal analgesic technique allows better analgesia for a longer duration than the use of the sole technique for control of abdominal pain in patients undergoing diagnostic gynaecological laparoscopy.

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