scholarly journals The Effect of Structured Exercise Compared with Education on Neuropathic Signs and Symptoms in People at Risk of Neuropathic Diabetic Foot Ulcers: A Randomized Clinical Trial

Medicina ◽  
2021 ◽  
Vol 58 (1) ◽  
pp. 59
Author(s):  
Byron M. Perrin ◽  
Jessica Southon ◽  
Jane McCaig ◽  
Isabelle Skinner ◽  
Timothy C. Skinner ◽  
...  

Background and Objectives: Lifestyle interventions such as exercise prescription and education may play a role in the management of peripheral neuropathy in people with diabetes. The aim of this study was to determine the effect of undertaking an exercise program in comparison with an education program on the signs and symptoms of peripheral neuropathy in people with diabetes at risk of neuropathic foot ulceration. Materials and Methods: Twenty-four adult participants with diabetes and peripheral neuropathy were enrolled in this parallel-group, assessor blinded, randomised clinical trial. Participants were randomly allocated to one of two 8-week lifestyle interventions, exercise or education. The primary outcome measures were the two-part Michigan Neuropathy Screening Instrument (MNSI) and vibratory perception threshold (VPT). Secondary outcome measures included aerobic fitness, balance and lower limb muscular endurance. Results: Participants in both lifestyle interventions significantly improved over time for MNSI clinical signs (MD: −1.04, 95% CI: −1.68 to −0.40), MNSI symptoms (MD: −1.11, 95% CI: −1.89 to −0.33) and VPT (MD: −4.22, 95% CI: −8.04 to −0.40). Although the interaction effects did not reach significance, changes in values from pre to post intervention favoured exercise in comparison to control for MNSI clinical signs (MD −0.42, 95% CI −1.72 to 0.90), MNSI clinical symptoms (MD −0.38, 95% CI −1.96 to 1.2) and VPT (MD −4.22, 95% CI −12.09 to 3.65). Conclusion: Eight weeks of exercise training or lifestyle education can improve neuropathic signs and symptoms in people with diabetes and peripheral neuropathy. These findings support a role for lifestyle interventions in the management of peripheral neuropathy.

2021 ◽  
Author(s):  
Aldo A M Lima ◽  
Erico A G Arruda ◽  
Roberto J Pires-Neto ◽  
Melissa S Medeiros ◽  
J Quirino-Filho ◽  
...  

This study aimed to evaluate the efficacy and toxicity of tenofovir (TDF) and TDF combined with emtricitabine (TDF/FTC) in patients with mild to moderate COVID-19 infections. We conducted a randomized, double-blind, placebo-controlled clinical trial in patients with clinical suspicion of mild to moderate respiratory infection caused by SARS-CoV-2 who were treated at an outpatient clinic. Patients were randomly recruited to take 10 days of TDF (300 mg/day), TDF (300 mg/day) combined with FTC (200 mg/day) or placebo Vitamin C (500 mg/day). The primary parameter was the score of symptoms and predictive signs of COVID-19, assessed on the seventh day of patient follow-up. From a total of 309 patients with clinical suspicion of SARS-CoV-2, 227 met the inclusion criteria and were randomly distributed into the following groups: (a) 75 (one did not initiate treatment) in the TDF group; (b) 74 in the TDF combined with FTC group; and (c) 77 in the Vitamin C group (placebo). Of the 226 patients, 139 (62%) were positive for SARS-CoV-2. Fever (37.8oC), ageusia or dysgeusia, anosmia or dysosmia, and two or more clinical symptoms or signs were significantly associated with SARS-CoV-2 infection. There was no significant change in clinical score based on clinical symptoms and signs between treatment groups. Patients with mild to moderate infection by SARS-CoV-2 had higher concentrations of G-CSF, IL-1β, IL-6 and TNF-α compared to patients without infection. Patients with mild to moderate respiratory infection, with fever (37.8oC), loss of smell, loss of taste and two or more symptoms, have a better prediction for the diagnosis of COVID-19. Patients with SARS-CoV-2 showed higher and more persistent proinflammatory cytokines profile compared to patients not infected with SARS-CoV-2. Pharmacological intervention with TDF or TDF combined with FTC did not change the clinical signs and symptoms score in mild to moderate respiratory infection in patients with SARS-CoV-2 compared to the Vitamin C group (placebo).


Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Mahsa Miryan ◽  
Mohammad Bagherniya ◽  
Amirhossein Sahebkar ◽  
Davood Soleimani ◽  
Mohammad Hossein Rouhani ◽  
...  

Abstract Objectives This study aims to investigate the efficacy of curcumin-piperine co-supplementation on disease duration, severity and clinical symptoms, and inflammatory mediators in patients with coronavirus (COVID-19). Trial design This is a randomized, placebo-controlled, double-blind, parallel arm clinical trial. Participants All patients aged 20-75 years with the diagnosis of Covid-19 based on the PCR test. The exclusion criteria will include an age less than 20 and more than 75 years, current use of warfarin or other anticoagulant drugs, and the presence of sensitivity to herbal products such as turmeric and pepper. This study will be conducted in academic hospitals affiliated to Isfahan University of Medical Sciences, Isfahan, Iran. Intervention and comparator Fifty outpatients will be randomly allocated in a ratio of 1:1 to receive a capsule of curcumin-piperine containing 500 mg curcumin plus 5 mg piperine or matching placebo containing 505 mg maltodextrin twice a daily, after lunch and dinner, over a period of 2 weeks. Similarly, 50 inpatients who are admitted to hospital wards excluding intensive care unit (ICU) will be randomly assigned in a ratio of 1:1 to receive a capsule curcumin-piperine or matching placebo (provided by the Sami Labs company) twice a daily, after lunch and dinner, over a period of 2 weeks. Main outcomes The main outcomes of this study are the efficacy of curcumin-piperine on coronavirus disease’s clinical symptoms, duration, severity, and inflammatory mediators after 2 weeks of curcumin-piperine co-supplementation. Randomisation Randomization sequences will be generated with the use of a random-number table with a permuted block design (block size of 4) and stratification according to the gender variable (male vs. female). These sequences will be prepared by an independent statistician and will be kept in opaque, sealed, numbered envelopes which will be opened only at the time of enrollment. The allocation ratio in intervention and control groups is 1:1. Researchers and all patients will be unaware of the study-group assignment until the completion of data analyses. Blinding (masking) This study is a double-blind clinical trial (participant, researcher). The curcumin-piperine and placebo supplements are packaged in similar numbered drug containers, and the researcher and all patients will be unaware of the study assignment until the end of the study. Numbers to be randomised (sample size) The calculated total sample size is 100 patients, with 25 patients in each group. Trial Status The protocol is Version 2.0, May 24, 2020. Recruitment began May 4, 2020, and is anticipated to be completed by April 19, 2021. Trial registration This trial has been registered by the title of “Effect of curcumin-piperine co-supplementation on disease duration, severity and clinical signs, and inflammatory factors in patients with coronavirus (COVID-19): A randomized, double-blind, placebo-controlled clinical trial study” in the Iranian Registry of Clinical Trials (IRCT) with code “IRCT20121216011763N46”, https://www.irct.ir/trial/47529. The registration date is May 4, 2020. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.


2017 ◽  
Vol 20 (03) ◽  
pp. 1750014
Author(s):  
Mahdieh Asadi ◽  
Sharareh Roshanzamir

Background: Previous studies do not agree with each other on the association between electrodiagnostic findings and clinical symptoms of Carpal tunnel syndrome (CTS). In most of these studies, many variables such as age, sex, obesity and hypothyroidism have not been taken into account. Material & methods: About 62 patients with hypothyroidism and 62 patients without hypothyroidism with sign and symptoms of CTS were included in this study. Electrodiagnostic tests were done for all patients. And relationship of the severity of CTS signs and symptoms with electrodiagnostic parameters was examined statistically in each group. Results: This study showed that distal motor latency in control group (without hypothyroidism) is significantly more prolonged than hypothyroid patients. Also there was significant correlation between clinical symptoms and electrodiagnostic findings in control group, but there was not such correlation in hypothyroid patients. In 62% of hypothyroid patients with clinical signs and symptoms of CTS, electrodiagnostic findings were normal and only in 38% of cases, electrodiagnostic findings were suggestive of CTS. Conclusion: Relationship of the severity of CTS signs and symptoms with electrodiagnostic parameters is very weak in hypothyroid patients. Many hypothyroid patients with clinical signs and symptoms of CTS have normal electrodiagnostic findings; so we need more studies for revising the para-clinic criteria of labeling patients having CTS in hypothyroid patients.


2020 ◽  
Author(s):  
Congcong Zeng ◽  
Xi Liu ◽  
Lufeng Hu ◽  
Yuan Feng ◽  
Nengzhi Xia ◽  
...  

Abstract Background: Insomnia seriously affects people’s normal lives and work. However, effective treatment strategies are scarce. The purpose of this study is to explore the efficacy and safety of Jiao-tai-wan (JTW) for ameliorating insomnia symptoms caused by disharmony of the heart and kidney. Design: This is a randomized, double-blind, placebo-controlled pilot clinical trial. One hundred twenty-four participants suffering from insomnia symptoms will randomly assigned to the JTW or placebo group in an equal ratio. The participants will be asked to take JTW or placebo granules twice a day for 1 week. All data will be gathered at baseline and at the end of drug intervention. The primary outcome measures will be the mean change in the Pittsburgh sleep quality index (PSQI) from baseline to the end of drug intervention. Secondary outcome measures will include the the altered sleep parameters in polysomnography, 1H-magnetic resonance spectroscopy (1H-MRS) evalution, the Disharmony of Heart and Kidney Scoring System score and blood tests, including the levels of serum adenosine and melatonin. A laboratory test will be taken before and after treatment to assess the safety of JTW. Discussion: The outcomes of this study will confirm the efficacy of JTW for the treatment of insomnia symptoms, and will also be used to monitor the safety of JTW. Trial registration: Chinese Clinical Trial Registry, ChiCTR1800019239.Registered on 1st November 2018- Retrospectively registered, http://www.chictr.org.cn/. Keywords: Jiao-tai-wan, Insomnia, Traditional herbal medicine, Randomized controlled trial, Study protocol, Pattern identification Protocol version: Manuscript based on study protocol version 1.3, 1 November 2018.


Author(s):  
Abdolali MOSHFE ◽  
Arash ARIA ◽  
Najme ERFANI ◽  
Ali JAMSHIDI ◽  
Bahador SARKARI ◽  
...  

Background: In the current study, we described the epidemiological features, clinical presentation, diagnosis and management of patients with suspicion of fascioliasis in Kohgiluyeh and Boyer-Ahmad Province in southwest of Iran.    Methods: Overall, 56 patients with suspicion of fascioliasis, based on their clinical signs and symptoms that referred to Clinic of Internal Medicine in Yasuj city, from 2014 to 2016 were enrolled. Demographic data, history of eating aquatic local plants, the chief complains, and laboratory findings were recorded for each patient. Stool samples were obtained from each case for detection of Fasciola eggs. Moreover, blood samples were taken from each patient and evaluated for detection of anti-Fasciola antibodies by an indirect ELISA. Patients who defined as having fascioliasis were treated with triclabendazole and were followed for at least three months for clinical improvement. Results: Serological test was positive in 5 patients. Of these 5 cases, three cases had a history of ingesting raw aquatic vegetables. The main clinical signs and symptoms in positive cases were; abdominal pain (60%), epigastric pain (40%), anemia (60%), and dermal pruritus (20%). Hypereosinophilia was seen in all of 5 positive cases. No Fasciola egg was found in stool specimens of any of the patients. The fascioliasis cases were treated by triclabendazole and clinical symptoms disappeared in all of 5 cases. Conclusion: Our observation further confirmed Yasuj district as a human endemic area for fascioliasis in Iran. The study also highlighted the importance of clinical features together with eosinophilia, as key parameters, in the diagnosis of human fascioliasis. Clinicians need to be aware of this disease and should keep in mind fascioliasis when hypereosinophilia present in patients in such endemic areas.


2021 ◽  
Vol 12 ◽  
Author(s):  
Tianye Hu ◽  
Hantong Hu ◽  
Feng Chen ◽  
Bin Jiang ◽  
Fengfei Shen ◽  
...  

Introduction: With a high incidence rate and low diagnosis rate, vestibular migraine (VM) can seriously affect the quality of life of patients, but it remains difficult to manage by current treatment options. Acupuncture may be a potential treatment option for VM prophylaxis, but the currently available evidence is still uncertain. Therefore, this trial aims to evaluate the efficacy and safety of acupuncture for VM prophylaxis.Methods: This is a 28-week parallel, randomized, controlled clinical trial including 4 weeks of baseline, 8 weeks of treatment, and 16 weeks of follow-up. A total of 72 participants will be randomly assigned to two groups. The participants will receive acupuncture in the experimental group, while the participants in the control group will be treated with venlafaxine. The primary outcome measures are change in vertigo/migraine days and vertigo/migraine attacks, vertigo severity, and migraine intensity per 4 weeks from baseline. The secondary outcome measures are change in doses of rescue medication, anxiety level, depression level, and quality of life per 4 weeks from baseline. Adverse events will be recorded for safety evaluation.Discussion: This study will investigate the efficacy and safety of acupuncture for VM prophylaxis. The results will contribute to determining whether acupuncture can serve as an optional treatment strategy for treating VM.Clinical Trial Registration:www.ClinicalTrials.gov, identifier: NCT0464088.


2020 ◽  
Vol 14 (12) ◽  
pp. e0008917
Author(s):  
Fred Bernardes Filho ◽  
Jaci Maria Santana ◽  
Regina Coeli Palma de Almeida ◽  
Glauber Voltan ◽  
Natália Aparecida de Paula ◽  
...  

Background This study evaluates an active search strategy for leprosy diagnosis based on responses to a Leprosy Suspicion Questionnaire (LSQ), and analyzing the clinical, immunoepidemiological and follow-up aspects for individuals living in a prison population. Methods A cross-sectional study based on a questionnaire posing 14 questions about leprosy symptoms and signs that was distributed to 1,400 prisoners. This was followed by dermatoneurological examination, anti-PGL-I serology and RLEP-PCR. Those without leprosy were placed in the Non-leprosy Group (NLG, n = 1,216) and those diagnosed with clinical symptoms of leprosy were placed in the Leprosy Group (LG, n = 34). Findings In total, 896 LSQ were returned (64%), and 187 (20.9%) of the responses were deemed as positive for signs/symptoms, answering 2.7 questions on average. Clinically, 1,250 (89.3%) of the prisoners were evaluated resulting in the diagnosis of 34 new cases (LG), based on well-accepted clinical signs and symptoms, a new case detection rate of 2.7% within this population, while the NLG were comprised of 1,216 individuals. The confinement time medians were 39 months in the LG while it was 36 months in the NLG (p>0.05). The 31 leprosy cases who responded to the questionnaire (LSQ+) had an average of 1.5 responses. The symptoms “anesthetized skin area” and “pain in nerves” were most commonly mentioned in the LG while “tingling, numbness in the hands/feet”, “sensation of pricks and needles”, “pain in nerves” and “spots on the skin” responses were found in more than 30% of questionnaires in the NLG. Clinically, 88.2% had dysesthetic macular skin lesions and 97.1% presented some peripheral nerve impairment, 71.9% with some degree of disability. All cases were multibacillary, confirming a late diagnosis. Anti-PGL-I results in the LG were higher than in the NLG (p<0.0001), while the RLEP-PCR was positive in 11.8% of the patients. Interpretation Our findings within the penitentiary demonstrated a hidden prevalence of leprosy, although the individuals diagnosed were likely infected while living in their former communities and not as a result of exposure in the prison. The LSQ proved to be an important screening tool to help identify leprosy cases in prisons.


Author(s):  
Hosein Yaghoubian ◽  
Hossein Niktale ◽  
Arash Peivandi Yazdi ◽  
Vahideh Ghorani ◽  
Masoud Mahdavi Rashed ◽  
...  

The antiviral effectiveness of allicin (L-cysteine) has been shown by numerous studies in both levels of clinical and animals. The aim of this study was to evaluate the therapeutic effect of allicin (L-cysteine) on clinical presentation and prognosis. In the current study, 66 patients with COVID-19 based on clinical, radiological presentations and RT-PCR results, were enrolled in two groups of placebo and allicin. In the both allicin (L-cysteine) and placebo groups (n=33 in each group), the capsules were prescribed two times a day for two weeks. Clinical signs and symptoms, blood parameters and chest CT scan were evaluated before and two weeks after treatment. The results showed that allicin (L-cysteine) could significantly impact on improvement of signs and symptoms of COVID-19 after two weeks of treatment in comparison to placebo. Allicin (L-cysteine) not only improve the clinical signs, but also ameliorate the lab and radiological data, which suggest a therapeutic effect for this agent in COVID-19. Our data suggest the therapeutic effect of allicin (L-cysteine) on COVID-19 through improvement of clinical symptoms and acceleration of the healing process.


Author(s):  
Heather Barksdale ◽  
Brittany McHugh ◽  
Wayne Hodges ◽  
Jessica Peters ◽  
Carmen Smotherman ◽  
...  

Objective: To determine the feasibility of conducting an 8-week physical therapist (PT)-guided tele-rehabilitation (TR) program for persons with multiple sclerosis (MS) and mobility deficits. Design, setting, and participants: This feasibility study had a pre–post-intervention, non-randomized design. Nine subjects with a confirmed diagnosis of MS without a clinical exacerbation in the last year were selected from the MS Center of Excellence at UF Health Jacksonville (UFHJ). Inclusion criteria included demonstrated mobility deficits on initial examination, basic computer competency, and a home with high-speed internet connection. Examinations were performed face-to-face, pre–post-intervention in the Neurology Research Clinic at UFHJ. TR was delivered to the patient’s homes in Florida and South Georgia. Intervention: An informed consent was obtained prior to initial examination. Self-reported measures included quality of life (QOL) and fatigue. Mobility measures included timed 10-m walk, five times sit to stand, and Berg balance scale. Following inclusion, home safety was evaluated and computer equipment was installed. TR intervention utilized the Jintronix® web-based platform system with a kinetic camera that demonstrated selected exercises by an avatar, allowing for real-time feedback on the quality of performance as well as tracking of adherence. The individualized exercises were assigned by the evaluating PT based on the initial assessment. Subjects participated in weekly TR visits with the prescribing PT to further monitor and adjust the therapy program. Main outcome measures: Primary outcome measures were patient satisfaction, safety, and compliance. Secondary outcome measures were projected travel cost, self-reported fatigue and QOL, and mobility testing measures. To compare the TR effect on mobility, a comparator persons with MS group was selected retrospectively. Eight persons with MS referred from the MS Center at UFHJ for outpatient (OP) PT from January 2018 through September 2019 were identified by UFHJ electronic database search for ICD 10 code G35. The inclusion criteria for mobility deficits and functional measurements were the same as those in TR group. Results: Eight subjects completed the TR program with no adverse events. They reported satisfaction, demonstrated compliance, and saved $8,487 in projected travel costs. All TR subjects noted improvement in self-reported fatigue, QOL, or mobility measures. Improvement in mobility measures had wide variability but did not differ between TR and OP groups. Conclusions: The 8-week PT-monitored TR program was shown to be feasible, safe, and well received by persons with MS. Larger studies focused on specific dysfunction leading to mobility deficits and longer intervention times will be necessary to determine efficacy.


2020 ◽  
Author(s):  
Wenjun Du ◽  
Jinhong Yu ◽  
Hui Wang ◽  
Xiaoguo Zhang ◽  
Shouwei Zhang ◽  
...  

Abstract Aims & Background: The COVID-19 outbreak spread in China and is a threat to the world. We reported on the epidemiological, clinical, laboratory, and radiological characteristics of children cases to help health workers better understand and provide timely diagnosis and treatment.Methods: Retrospectively, two research centers’ case series of 67 consecutive hospitalized cases including 14 children cases with COVID-19 between 23 Jan 2020 to 15 Feb 2020 from Jinan and Rizhao were enrolled in this study. Epidemiological, clinical, laboratory, and radiological characteristics of children and adults were analyzed and compared.Results: Most cases in children were mild(21.4%) and conventional cases(78.6%), with mild clinical signs and symptoms, and all cases were of family clusters. Fever (35.7%) and dry cough(21.4%) were described as clinical manifestations in children cases. Dry cough and phlegm were not the most common symptoms in children compared with adults(p=0.03). In the early stages of the disease, lymphocyte counts did not significantly decline but neutrophils counts did in children compared with adults(p=0.00).There was an elevated level of LDH(p=0.01) and a lower level of CRP(p=0.00)and IL-6(p=0.01) in children compared with adults. There were 8 (57.1%)asymptomatic cases and 6 (42.9%)symptomatic cases among the 14 children cases. The age of asymptomatic patients was younger than that of symptomatic patients(p=0.03). Even among asymptomatic patients, 5(62.5%)cases had pneumonia including 3 (60%) cases with bilateral pneumonia, which was not different compared with that of asymptomatic cases(p=0.58, p=0.74).Conclusions: The clinical symptoms of children are mild, and the positive indicators of laboratory tests are rare, which may easily cause clinical misdiagnoses.


Sign in / Sign up

Export Citation Format

Share Document