Transcutaneous electrical nerve stimulation effects on pain-intensity and endogenous opioids levels among chronic low-back pain patients: A randomised controlled trial.

BACKGROUND: Transcutaneous electrical nerve stimulation (TENS) is a promising non-pharmacological modality for the management of chronic low back pain (CLBP), but its efficacy and mode of action have not been clearly established. OBJECTIVE: To evaluate the responses of plasma beta-endorphin (ßE), met-enkephalin (ME), and pain intensity (PI) among patients with CLBP exposed to TENS or sham-TENS. METHODS: This double-blind trial involved 62 participants (aged 53.29 ± 5.07 years) randomised into TENS group (frequency 100 Hz, burst-rate 2 Hz, burst-width 150 µs, intensity 40 mA, duration 30 min), and sham-TENS group. The PI and plasma concentrations of ßE and ME were measured at baseline, immediately (0 hr), 1 hr, 24 hrs, and 48 hrs post-intervention. Data were analysed using general linear model repeated measures, ordinal regression, one-way analysis of variance, Kruskal-Wallis test, independent and paired samples t-tests, Mann-Whitney U test, Wilcoxon signed-rank test, and Kendall's tau coefficient. RESULTS: There was a significant temporal difference in PI between groups, F (1, 58) = 18.83, p< 0.001; the TENS group had better pain relief. The relative analgesic effect of TENS started immediately after the intervention (median difference [M⁢D] =-3, p< 0.001), peaked at 1 hr (M⁢D=-4, p< 0.001), and worn out by 24 hrs (M⁢D=-1, p= 0.029). However, there was no significant difference in ßE and ME between the groups from 0 hr to 24 hrs post interventions, and no significant correlation between the PI, and ßE, or ME. CONCLUSION: TENS significantly reduced PI up to 24 hrs after treatment.

Efficacy and safety of dual intravenous artesunate plus quinine compared to intravenous artesunate for cerebral malaria in a triple blinded parallel multisite randomized controlled trial in Nigerian children: DUAL PAQ TRIAL Protocol.

BACKGROUND: Evidence exists as to the criticality of the first 24 h in the management of cerebral malaria. The morbidity and the mortality rate (35%) with the current intravenous monotherapy for the initial treatment of cerebral malaria are unacceptably high. Combination therapy and a shorter course of effective medication have been shown to improve outcomes in human participants in the treatment of other diseases. This study outlines a protocol to conduct a triple blinded parallel randomized controlled trial on cerebral malaria using dual intravenous medications compared to the current standard of monotherapy. METHODS: This is a parallel multi-site randomized controlled superiority triple blinded trial consisting of intravenous artesunate plus quinine and a control arm of intravenous artesunate only. Eligible and assenting children aged 6 months to 17 years will be recruited from 4 tertiary hospitals by random selection from the list of tertiary hospitals in Nigeria. Participants will be randomized and assigned in parallel into two arms using random numbers generated from GraphPad Prism (version 9) by a clinical pharmacologist who has no link with the investigators, the patients, or the statistician. The primary measurable outcome is survival at 12, 24, and 48 h post-randomization. A composite secondary outcome consists of the number of children that regained consciousness, parasitaemia and defervescence at 12 and 24 h post-randomization and haematological and inflammatory markers at 24 and 48 h post-randomization. Adverse events both solicited and unsolicited are recorded all through the study post-randomization. The study is approved by the State Research Ethics Review Committee. Data analysis will be performed in GraphPad Prism version 9. DISCUSSION: The outcome of this analysis will give insight into the efficacy and safety of dual intravenous antimalaria in the treatment of cerebral malaria among Nigerian children compared with the standard of care. The safety profile of this intervention will also be highlighted. This may help inform physicians on the optimal treatment for cerebral malaria to improve outcomes and reduce recrudescence and treatment failure. TRIAL REGISTRATION: Pan Africa Clinical Trial Registry PACTR202102893629864 . 23/02/2021.

Effectiveness of Faith-Based Interventions on the Rate of Discharged Against Medical Advice in Tertiary Newborn Units in Nigeria: A Protocol for an Open Label Randomized Control Trial.

BACKGROUND: Discharged against medical advice (DAMA) is a risk factor that often leads to adverse outcomes and hospital readmissions in neonatal units. A few studies have shown that spiritual/faith-based interventions (FBIs) tend to have a lower incidence of DAMA compared with public hospitals. Perhaps, a holistic approach to patient care that addresses the spiritual needs, the soul and the body component of a being in this setting may account for the observed lower incidence of DAMA. Limited randomized control trials (RCTs) exist on FBIs with regard to DAMA in the published literature. This study seeks to compare the effectiveness of FBI, social support, religiosity, and types of FBI on neonatal DAMA against standard of care in tertiary hospitals in Nigeria. METHODS: This RCT will be conducted in two public tertiary teaching hospitals in two of the six geopolitical zones in Nigeria. The sociodemographic and clinical details of all patients admitted to the neonatal wards during the study period will be documented. Study participants will be selected through a multistage sampling technique. Subjects will be randomized and allocated to treatment and control arms having the established baseline measure of social support and religiosity. Ethical approval was obtained from the State Research Ethics Review Committee. A written informed consent will be obtained from the parents/caregivers prior to patient enrolment. The study will be conducted in line with the Declaration of Hesinki 2000. Appropriate statistical tools will be used for data collection and analysis. DISCUSSION: The outcome of this analysis will give insights into the effectiveness of FBI on DAMA. It will also predict the effect of the mediators of parents/caregivers' religiosity, spirituality, forms of FBI, the religious sect of parents/caregivers, and social support on the rate of DAMA on neonatal admission in tertiary hospitals in Nigeria. This could help Public Health Institutions and Governments make decisions about the determinants of neonatal DAMA and how to mitigate such outcomes. It is hoped that the evidence from this study may guide policy formulation and guidelines on enhancing hospital retention of sick neonates until they are fit for discharge. TRIAL REGISTRATION: This study was registered at the Pan Africa Clinical Trial Registry (PACTR202102670906630).

Hemoglobin SS Nigerian Woman First Diagnosed at the Age of 52 years with Manifestation Mimicking Tuberculosis of the Spine.

Sickle cell anemia (SCA) is an inherited disorder of hemoglobin due to the presence of abnormal hemoglobin in a homozygous state. Manifestation is usually in infancy or early childhood due to gradual decrease in hemoglobin F level as age advances. Diagnosis in middle age is unusual. We present a woman who was diagnosed of SCA for the first time at middle age. The aim was to bring to the knowledge of physicians that patients with SCA can also present late so high index of suspicion is required to make diagnosis. A 52-year-old woman presented to orthopedic clinic with complaints of generalized bone pain and low back pain. There was no history of trauma prior to the onset of the pain. There was no associated fever, weight loss, loss of appetite, nor weakness of the lower limbs. X-ray of the spine done showed wedge collapse of the 12th thoracic and first lumbar vertebrae with posterior angulation of the thoracolumbar junction giving dorsal kyphosis. Her mode of presentation raised a suspicion of tuberculosis of the spine to rule out multiple myeloma. However, investigations for tuberculosis and multiple myeloma were all negative. This necessitated the investigation for SCA and the diagnosis was confirmed. The diagnosis of SCA is usually made in infancy or early childhood. High index of suspicion is required to make the diagnosis at middle age.

The Effect of an Aerobic Exercise Programme on Blood Glucose Level, Cardiovascular Parameters, Peripheral Oxygen Saturation, and Body Mass Index among Southern Nigerians with Type 2 Diabetes Mellitus, Undergoing Concurrent Sulfonylurea and Metformin Treatment.

BACKGROUND: Diabetes mellitus increases the risk of cardiovascular diseases and all-cause mortality. The present study investigated the effect of an eight-week aerobics programme on fasting blood sugar (FBS), cardiovascular parameters, peripheral oxygen saturation (SpO2), and body mass index (BMI) among subjects with type-2 diabetes mellitus (T2DM). METHODS: A pretest-posttest experimental design was employed. Fifty subjects, diagnosed with T2DM, attending the Diabetes Clinic of the University of Nigeria Teaching Hospital, Enugu, were conveniently recruited, gender and age-matched, and randomised into exercise and control groups. The intervention included an eight-week aerobic exercise at 60%-79% HRmax for 45 min-60 min, 3-days per week. The FBS, SpO2, BMI, resting heart rate (RHR), and systolic (SBP) and diastolic blood pressure (DBP) of the subjects were measured before and after the intervention. The paired and independent t-test(s) were used for the analyses within and between the groups, respectively (P ≤ 0.05). RESULTS: The exercise group had a significantly lower SBP (15.0 mmHg, P = 0.001), DBP (7.9 mmHg, P = 0.001), RHR (4.8 bpm, P = 0.001), FBS (34.9 mg/dl, P = 0.001), and BMI (2.3, P = 0.001), while the SpO2 improved by 3.9% with P = 0.001, relative to the control group. CONCLUSION: Aerobics is an efficacious adjunct therapy in controlling the FBS level, blood pressure, BMI, and improving SpO2 among T2DM subjects.

Burden of care amongst caregivers who are first degree relatives of patients with schizophrenia.

INTRODUCTION: Caring for a mentally ill family member is a challenging task. Caregivers who are first-degree relatives (FDR) are at a higher risk of experiencing the negative consequences of caregiving. This study was aimed at determining burden of care and its correlates in caregivers who are first-degree relatives of patients with schizophrenia. METHODS: A dyad of 255 patients and caregivers was recruited. A socio-demographic questionnaire was administered to both. The GHQ-12 was used to screen for psychiatric morbidity in the FDRs. Caregiver's burden was assessed with the Zarit Burden Interview. Patients' illness severity and level of functioning were assessed using the Brief Psychiatric Rating Scale and the Global Assessment of Functioning scales respectively. RESULTS: The mean ± SD age of caregivers and patients were 45.1 ±12.3 and 36.7 ±13.4 years respectively. About 49% of caregivers experienced high burden of care. Older caregiver's age (r = 0.179; p < 0.004) and greater illness severity (r = 0.332; p < 0.0001) in the patient had weak to moderate positive correlation with burden of care. Caregiver's burden also increased with poorer functioning of the patient (r = -0.467 p < 0.0001). Independent predictors of caregiver burden were low level of education of the caregiver (OR 2.45; 95% CI 1.27-4.73), psychiatric morbidity in the caregiver (OR 6.74; 95% CI 2.51-18.15) and poor patient functioning (OR 2.81; 95% CI 1.27-6.18). CONCLUSION: Caregivers who are first-degree relatives of patients with schizophrenia experience varying degrees of burden of care during caregiving. Routine screening and early psychological intervention would help to ameliorate these negative consequences of caregiving.