A Pilot Randomized Sham-Controlled Trial of MC5-A Scrambler Therapy in the Treatment of Chronic Chemotherapy-Induced Peripheral Neuropathy (CIPN)

2019 ◽  
Vol 35 (1) ◽  
pp. 53-58 ◽  
Author(s):  
Thomas J. Smith ◽  
A. Rab Razzak ◽  
Amanda L. Blackford ◽  
Jennifer Ensminger ◽  
Catherine Saiki ◽  
...  
Keyword(s):  
Peripheral Neuropathy ◽  
Rating Scale ◽  
Small Sample Size ◽  
Controlled Trial ◽  
Brief Pain Inventory ◽  
Small Sample ◽  
Sham Treatment ◽  
The Real ◽  
Average Pain ◽  
Scrambler Therapy

Background: Chemotherapy-induced peripheral neuropathy (CIPN) affects 30% to 40% of patients with cancer with long-lasting disability. Scrambler therapy (ST) appeared to benefit patients in uncontrolled trials, so we performed a randomized sham-controlled Phase II trial of ST. Methods: The primary end point was “average pain” after 28 days on the Numeric Rating Scale. Each received ten 30-minute sessions of ST on the dermatomes above the painful areas, or sham treatment on the back, typically at L3-5 where the nerve roots would enter the spinal cord. Outcomes included the Brief Pain Inventory (BPI)-CIPN and the EORTC CIPN-20 scale. Patients were evaluated before treatment (day 0), day 10, and days 28, 60, and 90. Results: Data regarding pain as a primary outcome were collected for 33 of the 35 patients. There were no significant differences between the sham and the “real” ST group at day 10, 28, 60, or 90, for average pain, the BPI, or EORTC CIPN-20. Individual responses were noted during the ST treatment on the real arm, but most dissipated by day 30. There was improvement in the sensory subscale of the CIPN-20 at 2 months in the “real” group ( P = .14). All “real” patients wanted to continue treatment if available. Discussion: We observed no difference between sham and real ST CIPN treatment. Potential reasons include at least the following: ST does not work; the sham treatment had some effect; small sample size with heterogeneous patients; misplaced electrodes on an area of nonpainful but damaged nerves; or a combination of these factors.

Abstract 3725: Simvastatin but Not Pravastatin Affects Sleep: Findings from the UCSD Statin Study

Circulation ◽  
2007 ◽  
Vol 116 (suppl_16) ◽  
Author(s):  
Beatrice A Golomb ◽  
Edwin K Kwon ◽  
Michael H Criqui ◽  
Joel E Dimsdale
Keyword(s):  
Sleep Quality ◽  
Rating Scale ◽  
Sleep Problems ◽  
Small Sample Size ◽  
Case Reports ◽  
Controlled Trial ◽  
Small Sample ◽  
T Test ◽  
Secondary Outcome ◽  
Regression Analyses

Background : Case reports have suggested possible effects of lipophilic statins on sleep in some subjects. Most randomized studies evaluating the effect of statins on sleep have had small sample size and short duration (≤ 6 weeks). Whether statins affect sleep on average, favorably or adversely, has been unclear. Goal : To assess the effects of lipophilic and hydrophilic statins on sleep. Subjects : 1016 adult men and women without diabetes or heart disease, with LDL-cholesterol 115–190mg/dL. Design : Randomized double blind placebo-controlled trial of simvastatin 20mg, pravastatin 40mg or placebo for 6 months. Sleep was a prespecified secondary outcome. It was assessed by both an adaptation of the Leeds sleep scale (a visual analog scale of sleep quality); and a rating scale of sleep problems. Both items were measured at baseline and on-treatment. Analysis : Baseline comparability of randomization groups including sleep measures was affirmed. T-test of mean on-treatment sleep scores across randomization groups was performed. This complemented regression analyses, adjusted for baseline values of the respective sleep assessment. Results : Groups were comparable at baseline on variables including both sleep measures. Simvastatin use was associated with significantly worse sleep quality, and significantly greater reported sleep problems than either pravastatin or placebo, by t-test and regression analyses. Pravastatin did not differ significantly from placebo on any sleep outcome. Conclusion : Findings were compatible with the hypothesis that statins may impair sleep in some subjects, and that this impairment may arise selectively with lipophilic statins. Table 1. Effects of Statins on Sleep: Regression Analysis

Comprehensive Geriatric Care to Improve Mobility after Hip Fracture: An RCT

Gerontology ◽  
2020 ◽  
Vol 66 (6) ◽  
pp. 542-548
Author(s):  
Wendy L. Cook ◽  
Penelope M.A. Brasher ◽  
Pierre Guy ◽  
Stirling Bryan ◽  
Meghan G. Donaldson ◽  
...  
Keyword(s):  
Hip Fracture ◽  
Small Sample Size ◽  
Controlled Trial ◽  
Geriatric Care ◽  
Small Sample ◽  
Community Dwelling ◽  
Post Discharge ◽  
Mobility Performance ◽  
Discharge Care ◽  
Comprehensive Geriatric Care

<b><i>Background:</i></b> Comprehensive geriatric care (CGC) for older adults during hospitalization for hip fracture can improve mobility, but it is unclear whether CGC delivered after a return to community living improves mobility compared with usual post-discharge care. <b><i>Objective:</i></b> To determine if an outpatient clinic-based CGC regime in the first year after hip fracture improved mobility performance at 12 months. <b><i>Methods:</i></b> A two-arm, 1:1 parallel group, pragmatic, single-blind, single-center, randomized controlled trial at 3 hospitals in Vancouver, BC, Canada. Participants were community-dwelling adults, aged ≥65 years, with a hip fracture in the previous 3–12 months, who had no dementia and walked ≥10 m before the fracture occurred. Target enrollment was 130 participants. Clinic-based CGC was delivered by a geriatrician, physiotherapist, and occupational therapist. Primary outcome was the Short Physical Performance Battery (SPPB; 0–12) at 12 months. <b><i>Results:</i></b> We randomized 53/313 eligible participants with a mean (SD) age of 79.7 (7.9) years to intervention (<i>n</i> = 26) and usual care (UC, <i>n</i> = 27), and 49/53 (92%) completed the study. Mean 12-month (SD) SPPB scores in the intervention and UC groups were 9.08 (3.03) and 8.24 (2.44). The between-group difference was 0.9 (95% CI –0.3 to 2.0, <i>p</i> = 0.13). Adverse events were similar in the 2 groups. <b><i>Conclusion:</i></b> The small sample size of less than half our recruitment target precludes definitive conclusions about the effect of our intervention. However, our results are consistent with similar studies on this population and intervention.

scholarly journals Differential response to scrambler therapy by neuropathic pain phenotypes

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Young Gi Min ◽  
Hyun Seok Baek ◽  
Kyoung-Min Lee ◽  
Yoon-Ho Hong
Keyword(s):  
Neuropathic Pain ◽  
Treatment Outcome ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Brief Pain Inventory ◽  
Differential Response ◽  
Open Label ◽  
Numerical Rating ◽  
Scrambler Therapy ◽  
Post Hoc

AbstractScrambler therapy is a noninvasive electroanalgesia technique designed to remodulate the pain system. Despite growing evidence of its efficacy in patients with neuropathic pain, little is known about the clinical factors associated with treatment outcome. We conducted a prospective, open-label, single-arm trial to assess the efficacy and safety of scrambler therapy in patients with chronic neuropathic pain of various etiologies. A post-hoc analysis was performed to investigate whether cluster analysis of the Neuropathic Pain Symptom Inventory (NPSI) profiles could identify a subgroup of patients regarding neuropathic pain phenotype and treatment outcome. Scrambler therapy resulted in a significant decrease in the pain numerical rating scale (NRS) score over 2 weeks of treatment (least squares mean of percentage change from baseline, − 15%; 95% CI − 28% to − 2.4%; p < 0.001). The mean score of Brief Pain Inventory (BPI) interference subdimension was also significantly improved (p = 0.022), while the BPI pain composite score was not. Hierarchical clustering based on the NPSI profiles partitioned the patients into 3 clusters with distinct neuropathic pain phenotypes. Linear mixed-effects model analyses revealed differential response to scrambler therapy across clusters (p = 0.003, pain NRS; p = 0.072, BPI interference subdimension). Treatment response to scrambler therapy appears different depending on the neuropathic pain phenotypes, with more favorable outcomes in patients with preferentially paroxysmal pain rather than persistent pain. Further studies are warranted to confirm that capturing neuropathic pain phenotypes can optimize the use of scrambler therapy.

scholarly journals DIAGNOSIS OF ENDOCRINE DISEASE: The diagnostic performance of adrenal biopsy: a systematic review and meta-analysis

2016 ◽  
Vol 175 (2) ◽  
pp. R65-R80 ◽  
Author(s):  
Irina Bancos ◽  
Shrikant Tamhane ◽  
Muhammad Shah ◽  
Danae A Delivanis ◽  
Fares Alahdab ◽  
...  
Keyword(s):  
Systematic Review ◽  
Diagnostic Performance ◽  
Small Sample Size ◽  
Controlled Trial ◽  
Meta Analysis ◽  
Small Sample ◽  
Cochrane Central Register ◽  
Moderate Risk ◽  
Adrenal Biopsy ◽  
Adrenocortical Carcinomas

ObjectiveTo perform a systematic review of published literature on adrenal biopsy and to assess its performance in diagnosing adrenal malignancy.MethodsMedline In-Process and Other Non-Indexed Citations, MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trial were searched from inception to February 2016. Reviewers extracted data and assessed methodological quality in duplicate.ResultsWe included 32 observational studies reporting on 2174 patients (39.4% women, mean age 59.8 years) undergoing 2190 adrenal mass biopsy procedures. Pathology was described in 1621/2190 adrenal lesions (689 metastases, 68 adrenocortical carcinomas, 64 other malignancies, 464 adenomas, 226 other benign, 36 pheochromocytomas, and 74 others). The pooled non-diagnostic rate (30 studies, 2013 adrenal biopsies) was 8.7% (95%CI: 6–11%). The pooled complication rate (25 studies, 1339 biopsies) was 2.5% (95%CI: 1.5–3.4%). Studies were at a moderate risk for bias. Most limitations related to patient selection, assessment of outcome, and adequacy of follow-up. Only eight studies (240 patients) could be included in the diagnostic performance analysis with a sensitivity and specificity of 87 and 100% for malignancy, 70 and 98% for adrenocortical carcinoma, and 87 and 96% for metastasis respectively.ConclusionsEvidence based on small sample size and moderate risk of bias suggests that adrenal biopsy appears to be most useful in the diagnosis of adrenal metastasis in patients with a history of extra-adrenal malignancy. Adrenal biopsy should only be performed if the expected findings are likely to alter the management of the individual patient and after biochemical exclusion of catecholamine-producing tumors to help prevent potentially life-threatening complications.

Three-year results of phase I retinal gene therapy trial for CNGA3-mutated achromatopsia: results of a non randomised controlled trial

2021 ◽  
pp. bjophthalmol-2021-319067
Author(s):  
Felix Friedrich Reichel ◽  
Stylianos Michalakis ◽  
Barbara Wilhelm ◽  
Ditta Zobor ◽  
Regine Muehlfriedel ◽  
...  
Keyword(s):  
Gene Therapy ◽  
Primary Endpoint ◽  
Statistical Power ◽  
Small Sample Size ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Small Sample ◽  
Functional Improvement ◽  
Limiting Factor ◽  
Serious Adverse Events

AimsTo determine long-term safety and efficacy outcomes of a subretinal gene therapy for CNGA3-associated achromatopsia. We present data from an open-label, nonrandomised controlled trial (NCT02610582).MethodsDetails of the study design have been previously described. Briefly, nine patients were treated in three escalating dose groups with subretinal AAV8.CNGA3 gene therapy between November 2015 and October 2016. After the first year, patients were seen on a yearly basis. Safety assessment constituted the primary endpoint. On a secondary level, multiple functional tests were carried out to determine efficacy of the therapy.ResultsNo adverse or serious adverse events deemed related to the study drug occurred after year 1. Safety of the therapy, as the primary endpoint of this trial, can, therefore, be confirmed. The functional benefits that were noted in the treated eye at year 1 were persistent throughout the following visits at years 2 and 3. While functional improvement in the treated eye reached statistical significance for some secondary endpoints, for most endpoints, this was not the case when the treated eye was compared with the untreated fellow eye.ConclusionThe results demonstrate a very good safety profile of the therapy even at the highest dose administered. The small sample size limits the statistical power of efficacy analyses. However, trial results inform on the most promising design and endpoints for future clinical trials. Such trials have to determine whether treatment of younger patients results in greater functional gains by avoiding amblyopia as a potential limiting factor.

A comparative assessment of orthodontic treatment outcomes using the quantitative light-induced fluorescence (QLF) method between direct bonding and indirect bonding techniques in adolescents: a single-centre, single-blind randomized controlled trial

2019 ◽  
Vol 42 (4) ◽  
pp. 441-453
Author(s):  
Aykan Onur Atilla ◽  
Taner Ozturk ◽  
Mustafa Murat Eruz ◽  
Ahmet Yagci
Keyword(s):  
Orthodontic Treatment ◽  
Small Sample Size ◽  
Controlled Trial ◽  
Small Sample ◽  
White Spot Lesion ◽  
Indirect Bonding ◽  
Signed Rank ◽  
Group 12 ◽  
Registration Number ◽  
Bonding Technique

Summary Introduction The aim of this two-arm parallel trial was to evaluate enamel demineralization in fixed orthodontic treatment using an indirect bonding technique in comparison to a direct bonding technique by the quantitative light-induced fluorescence (QLF) method. Design, settings and participants Fifty-six patients who needed fixed orthodontic treatment were randomly separated into either the direct bonding group or the indirect bonding group. The presence and extent of lesions on the buccal surfaces of all teeth, except the molar teeth, were assessed. The percentage of fluorescence loss (ΔF and ΔFmax), the degree of demineralization (ΔQ) and lesion area (WS area) were determined using the system’s software. The data were analysed with the Wilcoxon signed-rank and Mann–Whitney U-tests (P &lt; 0.05). Interventions Treatment with a direct bonding or an indirect bonding technique. Results This study was completed with 25 patients in the indirect bonding group (12 females, 13 males; mean age: 15.42 ± 1.71 years) and 26 patients in the direct bonding group (12 females, 14 males; mean age: 14.73 ± 1.65 years). In the indirect bonding technique, a few teeth (especially mandibular left canine: 50.45 ± 93.48; 95% confidence interval: −12.35 and 113.26) were found to develop significant white spot lesion (WSL) formation (P &lt; 0.05). However, the number of teeth with demineralization was higher in the direct bonding group (P &lt; 0.05). Conclusion The bonding procedures used in the indirect bonding technique contribute to reducing the degree of WSL formation. Further, the use of flowable composite adhesives in this bonding process is more effective at reducing the appearance of WSLs than in cases where conventional composite adhesives are used. Limitations The limitation of our trial may be the small sample size and the short follow-up time for the patients. Harms No harms were detected during the study. Protocol The protocol was not published before trial commencement. Registration This trial was registered post hoc at ‘Clinical Trials’ (http://www.clinicaltrials.gov), registration number (ID): NCT03738839.

scholarly journals Nutritional Support and Clinical Outcome of Severe and Critical Patients With COVID-19 Pneumonia

2020 ◽  
Vol 7 ◽  
Author(s):  
Xiangfeng Yue ◽  
Min Li ◽  
Yu Wang ◽  
Jing Zhang ◽  
Xinyi Wang ◽  
...  
Keyword(s):  
Protein Intake ◽  
Small Sample Size ◽  
Controlled Trial ◽  
Antiviral Treatment ◽  
Small Sample ◽  
Nutrition Support ◽  
Calorie Intake ◽  
Viral Shedding ◽  
Significant Difference ◽  
Critical Patients

Background: In 2020, a novel coronavirus has spread throughout the world. More than four hundred thousand people have died of SARS-CoV-2 pneumonia, most of which were severe and critical patients. No effective antiviral treatment has been verified thus far. Nutrition support has become one of the important treatments for severe and critical patients.Methods: In this retrospective study, 26 severe patients and 22 critical patients with laboratory confirmed COVID-19 were enrolled. We recorded the diet and nutritional treatments in severe and critical patients. Baseline characteristics and clinical outcomes of severe and critical patients were also collected.Results: Average calorie intake of severe patients (19.3 kcal/kg/d) was higher than critical patients (15.3 kcal/kg/d) (P = 0.04). Protein intake was similar in the two groups (0.65 and 0.62 g/kg per day, respectively; P = 0.29). There was no significant difference in the median duration of viral shedding between the severe and critical patients (P = 0.354).Conclusions: A permissive underfeeding strategy that restricts non-protein calories but preserves protein intake is feasible for critical patients with SARS-CoV-2 pneumonia. Viral shedding duration of critical patients was the same as severe patients who received standard feeding. Nevertheless, evidence of the conclusion is not sufficient because of small sample size. To show the real clinical benefit of permissive low-calorie and adequate protein intake in critical SARS-CoV-2 pneumonia patients, a large and pragmatic randomized controlled trial is needed.

scholarly journals A Randomized, Placebo-Controlled Trial Evaluating Changes in Peripheral Neuropathy and Quality of Life by Using Low-Frequency Electrostimulation on Breast Cancer Patients Treated With Chemotherapy

2020 ◽  
Vol 19 ◽  
pp. 153473542092551
Author(s):  
Si-Yeon Song ◽  
Ji-Hye Park ◽  
Jin Sun Lee ◽  
Je Ryong Kim ◽  
Eun Hee Sohn ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Peripheral Neuropathy ◽  
Rating Scale ◽  
Controlled Trial ◽  
Low Frequency ◽  
Pharmacological Intervention ◽  
European Organization ◽  
Eortc Qlq

Background: This study examined the effect of a portable low-frequency electrostimulation (ES) device on patients diagnosed with chemotherapy-induced peripheral neuropathy (CIPN) immediately after chemotherapy for breast cancer. Methods: A single-center, randomized, placebo-controlled trial was conducted. A total of 72 patients newly diagnosed with CIPN were enrolled and randomly placed into the ES (n = 36) or the sham ES group (SES; n = 36). Duloxetine or pregabalin was prescribed to all participants from the initial assessment. The devices for 14 days, at least twice a day, for at least 120 minutes. The primary outcomes were the overall intensities of the CIPN symptoms as assessed using Numerical Rating Scale (NRS). Secondary outcomes included Total Neuropathy Score (TNS), European Organization for Research and Treatment of Cancer Quality of Life (EORTC-QLQ), Chemotherapy-Induced Peripheral Neuropathy 20 (CIPN20), Functional Assessment of Cancer Therapy-Breast (FACT-B), and Instrument on Pattern Identification and Evaluation for CIPN (IPIE-CIPN). Results: No differences in NRS scores were found between the patients in the ES and the SES group ( P = 0.267). Patients in both groups showed significantly reduced CIPN intensities (ES P < .001; SES P < .001). No significant differences between the groups were found in TNS, EORTC-QLQ, CIPN20, and FACT-B. The general symptoms of CIPN diagnosed as cold arthralgia showed significance only in the ES group ( P = .006). Conclusion: Compared with a placebo, the effectiveness of the low-frequency ES device with pharmacological intervention was not significantly different, but a therapeutic effect was possible.

Effectiveness of Somatic Yoga and Meditation: A Pilot Study in a Multicultural Cancer Survivor Population with Chemotherapy-Induced Peripheral Neuropathy

2019 ◽  
Vol 30 (1) ◽  
pp. 49-61
Author(s):  
Mary Lou Galantino ◽  
Jennifer Brooks ◽  
Robyn Tiger ◽  
Shera Jang ◽  
Kim Wilson
Keyword(s):  
Standard Deviation ◽  
Health Literacy ◽  
Peripheral Neuropathy ◽  
Fear Of Falling ◽  
Controlled Trial ◽  
Brief Pain Inventory ◽  
Chemotherapeutic Agents ◽  
Feasibility Trial ◽  
Minority Population ◽  
Recruitment And Retention

Abstract Chemotherapy-induced peripheral neuropathy (CIPN) causes significant pain and is an adverse effect of treatment with chemotherapeutic agents. We explored a somatic yoga and meditation intervention in a predominantly minority population. Goals included describing strategies for minority inclusion and testing feasibility and effectiveness. Eight individuals with CIPN enrolled in a single-arm feasibility trial. Somatic yoga and meditation were provided weekly for 8 weeks, with an additional home program component. The primary outcomes were Sit and Reach, Functional Reach, and Timed Up and Go. Secondary outcomes were Patient Neurotoxicity Questionnaire, FACT-GOG-Ntx (for addressing patient concerns associated with neurological symptoms), Brief Pain Inventory, Perceived Stress Scale, Pittsburgh Sleep Quality Index, and Falls Efficacy Scale. Sensitivity to vibration was measured via biothesiometer. Participants with a mean age of 65 (49–73) years self-reported as 63% African-American and 37% Caucasian. They attended 81% of the sessions, and no adverse events we re re p o rted. CIPN symptoms (FAC T- G O G - N t x ) improved significantly (from 88.88 to 106.88, standard deviation = 20.03; p = 0.039). Fear of falling improved, approaching significance (from 39.26 to 34.38, standard deviation = 6.081; p = 0.058). Other measures showed improvement trends, with a slight increase in Brief Pain Inventory pain severity (from 3.50 to 3.75, p = 0.041) possibly reflecting comorbidities. Four qualitative themes emerged: (1) CIPN symptom variability, with musculoskeletal comorbidities; (2) utility of learned skills; (3) improvement in self-confidence, balance, and stability; and (4) social support, with CIPN experience validation and increasing health literacy. Challenges of recruitment and retention require specific outreach, community trust, and health literacy. Preliminary data suggest that somatic yoga and meditation may affect fear of falling and quality of life in cancer survivors with CIPN. A randomized controlled trial using inclusive recruitment and retention methods is indicated to establish the intervention’s efficacy.

Internet-Based Self-Help Training for Children and Adolescents with Recurrent Headache: A Pilot Study

2008 ◽  
Vol 36 (2) ◽  
pp. 241-245 ◽  
Author(s):  
Ellen Trautmann ◽  
Birgit Kröner-Herwig
Keyword(s):  
Therapeutic Potential ◽  
Pain Catastrophizing ◽  
Small Sample Size ◽  
Controlled Trial ◽  
Small Sample ◽  
Post Treatment ◽  
The Internet ◽  
Behavioural Treatment ◽  
Self Help ◽  
Cognitive Behavioural

AbstractWe report the results of a randomized controlled trial that compared the efficacy of an internet-based self-help treatment for paediatric headache including chat communication (cognitive-behavioural treatment, CBT) with an internet-based psychoeducation intervention (EDU). In the CBT group, significant pre- to post-treatment decreases were found for headache frequency and pain catastrophizing, but not for headache intensity or duration. In the EDU group none of the variables (frequency, intensity, duration, pain catastrophizing) showed improvement. No significant between group differences were found for headache variables and pain catastrophizing at post-treatment. The patients reported high satisfaction with the internet-based training and a good patient-trainer-alliance. Results were maintained at 6-month follow-up. Due to the small sample size, no general conclusions can be drawn regarding the efficacy of the internet-based training regarding the outcome variables, but the training was well accepted by patients. Further research is necessary to evaluate the therapeutic potential of such interventions.

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