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

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.

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Lovastatin as an Adjuvant to Lithium for Treating Manic Phase of Bipolar Disorder: A 4-Week, Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Depression Research and Treatment ◽

10.1155/2014/730505 ◽

2014 ◽

Vol 2014 ◽

pp. 1-6 ◽

Cited By ~ 3

Author(s):

Ahmad Ghanizadeh ◽

Motahhar OmraniSigaroodi ◽

Ali Javadpour ◽

Mohammad Hossein Dabbaghmanesh ◽

Sara Shafiee

Keyword(s):

Clinical Trial ◽

Bipolar Disorder ◽

Placebo Group ◽

Adverse Effects ◽

Rating Scale ◽

Clinical Symptoms ◽

Controlled Clinical Trial ◽

Young Mania ◽

Double Blind ◽

Significant Difference

Objectives. Many patients with bipolar disorder suffer from metabolic disorder. Lovastatin is effective for treating major depression. This double-blind randomized placebo controlled clinical trial investigates whether lovastatin is a useful adjuvant to lithium for treating mania.Methods. Fifty-four patients with bipolar disorder-manic phase were randomly allocated into lovastatin or placebo group. The clinical symptoms were assessed at baseline, week 2, and week 4 using Young Mania Rating Scale. Adverse effects were checked.Results. Forty-six out of 54 patients completed this trial. The mania score in the lovastatin group decreased from 40.6 (11.1) at baseline to 12.9 (8.7) and 4.1 (5.4) at weeks 2 and 4, respectively. The score in the placebo group decreased from 41.0 (11.2) at baseline to 12.8 (8.07) and 5.8 (4.6) at weeks 2 and 4, respectively. However, there was no significant difference between groups at week 2 and week 4. The adverse effects rates were comparable between the two groups. No serious adverse effect was found. Tremor and nausea were the most common adverse effects.Conclusions. Lovastatin neither exacerbated nor decreased the symptoms of mania in patients with bipolar disorder. Current results support that the combination of lovastatin with lithium is tolerated well in bipolar disorder. The trial was registered with the Iranian Clinical Trials Registry (IRCT201302203930N18).

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Adjunctive Therapy to Manage Neuropsychiatric Symptoms in Moderate and Severe Dementia: Randomized Clinical Trial Using an Outpatient Version of Tailored Activity Program

Journal of Alzheimer s Disease ◽

10.3233/jad-210142 ◽

2021 ◽

pp. 1-12

Author(s):

Alexandra Martini Oliveira ◽

Marcia Radanovic ◽

Patricia Cotting Homem de Mello ◽

Patricia Cardoso Buchain ◽

Adriana Dias Barbosa Vizzotto ◽

...

Keyword(s):

Clinical Trial ◽

Sleep Disturbances ◽

Rating Scale ◽

Neuropsychiatric Symptoms ◽

Caregiver Training ◽

Controlled Clinical Trial ◽

Post Intervention ◽

Double Blind ◽

Activity Program ◽

Experimental Group

Background: Neuropsychiatric symptoms (NPS) such as aggression, apathy, agitation, and wandering may occur in up to 90%of dementia cases. International guidelines have suggested that non-pharmacological interventions are as effective as pharmacological treatments, however without the side effects and risks of medications. An occupational therapy method, called Tailored Activity Program (TAP), was developed with the objective to treat NPS in the elderly with dementia and has been shown to be effective. Objective: Evaluate the efficacy of the TAP method (outpatient version) in the treatment of NPS in individuals with dementia and in the burden reduction of their caregivers. Methods: This is a randomized, double-blind, controlled clinical trial for the treatment of NPS in dementia. Outcome measures consisted of assessing the NPS of individuals with dementia, through the Neuropsychiatric Inventory-Clinician rating scale (NPI-C), and assessing the burden on their caregivers, using the Zarit Scale. All the participants were evaluated pre-and post-intervention. Results: 54 individuals with dementia and caregivers were allocated to the experimental (n = 28) and control (n = 26) groups. There was improvement of the following NPS in the experimental group: delusions, agitation, aggressiveness, depression, anxiety, euphoria, apathy, disinhibition, irritability, motor disturbance, and aberrant vocalization. No improvement was observed in hallucinations, sleep disturbances, and appetite disorders. The TAP method for outpatient settings was also clinically effective in reducing burden between caregivers of the experimental group. Conclusion: The use of personalized prescribed activities, coupled with the caregiver training, may be a clinically effective approach to reduce NPS and caregiver burden of individuals with dementia.

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

Pain Medicine ◽

10.1093/pm/pnz064 ◽

2019 ◽

Vol 21 (2) ◽

pp. 326-332 ◽

Cited By ~ 1

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.

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Pramipexole in peritoneal dialysis patients with restless legs syndrome (RLS): a protocol for a multicentre double-blind randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2019-033815 ◽

2020 ◽

Vol 10 (2) ◽

pp. e033815

Author(s):

Tian-tian Ma ◽

Zhikai Yang ◽

Sainan Zhu ◽

Jing-hong Zhao ◽

Yi Li ◽

...

Keyword(s):

Clinical Trial ◽

Peritoneal Dialysis ◽

Restless Legs Syndrome ◽

Rating Scale ◽

Controlled Trial ◽

Psychological Status ◽

Controlled Clinical Trial ◽

Double Blind ◽

Restless Legs ◽

Peking University

IntroductionRestless legs syndrome (RLS) is a common neurological sensorimotor disorder among patients with end stage renal disease. This clinical trial aimed to provide evidence on the efficacy and safety of pramipexole in patients with uremic RLS receiving peritoneal dialysis (PD).Methods and analysisThis is a 12-week, multicentre, randomised, double-blind, placebo-controlled clinical trial. In total, 104 patients with uremic RLS receiving PD will be enrolled from four hospitals and randomly assigned in a 1:1 ratio to either placebo or pramipexole. We will determine the efficacy of pramipexole in the improvement of International RLS Study Group Rating Scale as the primary outcome, while responder rates for other RLS scales at week 12, change from baseline to week 12 for psychological status, sleep disorder and quality of life and blood pressure represent the secondary outcomes.Ethics and disseminationThe study was approved by the ethics committees of Peking University First Hospital, Xinqiao hospital of Army Medical University, Cangzhou Center Hospital and Peking University Shenzhen Hospital. The results will be disseminated in peer-reviewed journals.Trial registration numberNCT03817554

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

European Psychiatry ◽

10.1016/s0924-9338(09)71388-4 ◽

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.

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A Multicenter Randomized Double-blind Controlled Clinical Trial of Fiber Post Cementation Strategies

Operative Dentistry ◽

10.2341/16-278-c ◽

2018 ◽

Vol 43 (2) ◽

pp. 128-135 ◽

Cited By ~ 4

Author(s):

CD Bergoli ◽

LP Brondani ◽

VF Wandscher ◽

GKR Pereira ◽

MS Cenci ◽

...

Keyword(s):

Clinical Trial ◽

Survival Rate ◽

Glass Fiber ◽

Survival Rates ◽

The Self ◽

Controlled Clinical Trial ◽

Fiber Post ◽

Resin Cements ◽

Double Blind ◽

Significant Difference

SUMMARY Objectives: The aim of this prospective randomized multicenter clinical trial was to evaluate the survival rate of glass fiber–reinforced posts cemented with self-adhesive or regular resin cements. Methods: The sample was comprised of 152 teeth randomized within two centers and in accordance with the adhesive strategies for RelyX U100/U200 (3M ESPE) or Single Bond and RelyX ARC (3M ESPE). The cementation procedures were standardized and performed by previously trained operators. The primary outcome evaluated was post debonding. A trained evaluator, one for each center, assessed all subjects at intervals of 12 months for up to 6 years. Statistical analysis was performed using the Kaplan-Meier method. Results: There was no statistically significant difference in survival rates between the two strategies assessed (p=0.991), with a 92.7% survival rate for the self-adhesive cement and 93.8% for the regular cement. Conclusion: Both the self-adhesive and the regular resin cements are good alternatives for glass fiber post cementation.

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OscillococcinumR in patients with influenza-like syndromes: A placebo-controlled double-blind evaluation

British Homeopathic Journal ◽

10.1054/homp.1999.0208 ◽

1998 ◽

Vol 87 (02) ◽

pp. 69-76 ◽

Cited By ~ 39

Author(s):

Rosemarie Papp ◽

Gert Schuback ◽

Elmar Beck ◽

Georg Burkard ◽

Jürgen Bengel ◽

...

Keyword(s):

Clinical Trial ◽

Placebo Group ◽

Rectal Temperature ◽

Muscle Pain ◽

Rating Scale ◽

Controlled Clinical Trial ◽

Double Blind ◽

Duration Of Symptoms ◽

Number Of Patients ◽

Positive Effect

AbstractA controlled clinical trial was conducted to assess the effectiveness of OscillococcinumR in the treatment of patients with influenza-like syndromes. 188 patients received the test drug and 184 patients were assigned to the placebo. Data were recorded by the participating physicians at the beginning of the treatment, after 48 hours and after 7–10 days. During the first few days, the patients recorded their rectal temperature twice a day (mornings and evenings), 9 symptoms on a rating scale (cough, catarrh, sore throat, muscle pain, etc.), and use of medication. Recovery was defined as follows: ‘rectal temperature < 37.5°C and no headache or muscle pain’. Effectiveness was defined as a statistically significant greater decrease in symptoms after 48 hours in the verum group or a shorter duration of symptoms in comparison to the placebo group. After 48 hours the symptoms of the patients in the verum group were significantly milder (P=0.023) than in the placebo group. The number of patients with no symptoms was significantly higher in the verum group from the second day onwards (verum: 17.4%, placebo: 6.6%) until the end of the patients’ recording (day 5 in the evening: verum: 73.7%, placebo: 67.7%). The biggest group difference was recorded for the time between the evening of the second day (10.6% more patients with no symptoms) and the morning of the fourth day (10.2% more patients with no symptoms). The clinical trial showed that treatment of influenza-like syndromes with OscillococcinumR has a positive effect on the decline of symptoms and on the duration of the disease.

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Effectiveness of the addition of tadalafil to tamsulosin in the treatment of acute urinary retention in patients with benign prostatic hyperplasia: A randomized clinical trial

Urologia Journal ◽

10.1177/0391560317749427 ◽

2018 ◽

Vol 85 (2) ◽

pp. 51-54

Author(s):

Hamidreza Baghani Aval ◽

Zeinab Ameli ◽

Mojtaba Ameli

Keyword(s):

Clinical Trial ◽

Benign Prostatic Hyperplasia ◽

Urinary Retention ◽

Acute Urinary Retention ◽

Retention Volume ◽

Prostatic Hyperplasia ◽

Controlled Clinical Trial ◽

Urine Retention ◽

Double Blind ◽

Significant Difference

Introduction: Acute urinary retention is one of the most significant complications of benign prostatic hyperplasia. Until now, standard treatments include catheterization and use of α-blockers. Tadalafil has been recently seen to also play a role in the treatment of urinary symptoms caused by benign prostatic hyperplasia. The aim of this study was to survey the addition of tadalafil to tamsulosin in the treatment of acute urinary retention in patients with benign prostatic hyperplasia. Materials and Methods: This is a randomized, double-blind placebo-controlled clinical trial. In all, 80 patients with benign prostatic hyperplasia–related acute urinary retention referred to the emergency department of the hospital were divided into two groups of 40 each and randomly assigned to receive either 0.4 mg tamsulosin plus placebo or 0.4 mg tamsulosin plus 10 mg tadalafil daily for 7 days. At the same first visit, the catheter was removed and the ability to void in 24 h and 1 week later was assessed in each group. Results: The differences in age, urine retention volume, history of drug use, lower urinary tract symptoms, and previous acute urinary retention were not significant between the two groups ( p = 0.619, 0.149, 0.501, 0.284, and 0.371, respectively). After catheter removal, 23 (57.5%) patients in the placebo group and 26 (65%) in the tadalafil group voided successfully at 24 h ( p = 0.491). After 1 week, 29 (72.5%) patients taking placebo and 26 (65%) taking tadalafil could void, yet indicating no significant difference ( p = 0.469). Conclusion: Addition of tadalafil to α-blockers has no significant advantage in improving benign prostatic hyperplasia–related acute urinary retention versus tamsulosin alone.

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Preemptive Analgesia in Total Knee Arthroplasty: Comparing the Effects of Single Dose Combining Celecoxib with Pregabalin and Repetition Dose Combining Celecoxib with Pregabalin: Double-Blind Controlled Clinical Trial

Pain Research and Treatment ◽

10.1155/2018/3807217 ◽

2018 ◽

Vol 2018 ◽

pp. 1-6 ◽

Cited By ~ 1

Author(s):

Andri M. T. Lubis ◽

Rangga B. V. Rawung ◽

Aida R. Tantri

Keyword(s):

Clinical Trial ◽

Total Knee Arthroplasty ◽

Knee Arthroplasty ◽

Preemptive Analgesia ◽

Controlled Clinical Trial ◽

Double Blind ◽

Significant Difference ◽

Total Knee ◽

Group 2 ◽

Group 1

Acute pain is the most common early complication after total knee arthroplasty causing delayed mobilization and increased demands of morphine, leading to higher operative cost. Several studies have assessed the effectiveness, side-effects, and ease of use of various analgesics. Preemptive analgesia with combined celecoxib and pregabalin has been reported to yield positive outcomes. In this randomized, double-blind controlled clinical trial, 30 subjects underwent surgery for total knee arthroplasty using 15-20mg bupivacaine 5% epidural anesthesia. All subjects were divided into three groups. Group 1 was given celecoxib 400mg and pregabalin 150mg 1 hour before the operation, Group 2 was given celecoxib 200mg and pregabalin 75mg twice daily starting from 3 days before the operation, and Group 3 was given a placebo. The outcome was measured with Visual Analog Scale, knee range of motion, and postoperative mobilization. There was a significant difference in postoperative morphine usage between the groups that were administered with preemptive analgesia and the placebo group, but no significant difference was found between Group 1 and Group 2 that were given preemptive analgesia at different doses. ROM and postoperative mobilization were not significantly different among the three groups. Two patients in the first group, one patient in the second group, and one patient in the third group developed nausea. Preemptive analgesia is proven to reduce postoperative usage of morphine independent of the dosage. We recommend the use of combined celecoxib and pregabalin as preemptive analgesia after the total knee arthroplasty procedure. This trial is registered with NCT03523832 (ClinicalTrials.gov).

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

Journal of Emergency Practice and Trauma ◽

10.34172/jept.2020.41 ◽

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.

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