METHODS: The study was an interventional and crossover comparison. Twenty-one patients with TN were administered with LTG in comparison to CBZ. The clinical trials comprised two phases of 40 days each, with an intervening three-day washout period. The final titration in dose for LTG was 400 mg and 1,200 mg for CBZ. Efficacy of the medications involved was determined by visual analog scale (VAS) and verbal rating scale (VRS). Side effects were recorded through marking of the profiles of side effects encountered on administration of LTG and CBZ, together with baseline haematological, hepatic and renal investigations.
RESULTS: Both on VAS and VRS assessments, in terms of proportion of patients, CBZ benefitted 90.5% (19/21) of the patients with pain relief (p pain relief from LTG and 19 from CBZ, 77% (10/13) obtained a "complete" degree of pain relief from LTG, as compared with 21% (4/19) from CBZ. On VRS assessment, with LTG, 84% (11/13) of the patients accomplished "much better" degree of pain relief, as compared with 26% (5/19) with CBZ. On LTG, 67% (14/21) of patients endured general pharmacological side effects, as compared with 57% (12/21) of patients on CBZ (p > 0.05). Meanwhile, LTG inflicted 14% (3/21) of the patients with haematological, hepatic and renal derangements, as compared with 48% (10/21) on CBZ.
CONCLUSION: LTG is generally an effective and safe treatment for management of TN, compared to CBZ.
METHODS: Patients aged 18 years old or above and who were scheduled for gynecology surgery were selected. Three different models with a combination of latent factors were based on a priori hypotheses from previous studies. The root-mean-squared error of approximation, comparative fit index, Tucker-Lewis Index, Chi-squared test, and change in Chi-squared statistic given a change in degrees of freedom between models were used to assess the model fit to the present data.
RESULTS: A total of 302 patients completed the questionnaire. The five-factor model which was based on Gordon's study has an acceptable fit for the data and was superior when compared to the one-factor baseline model. Although the four-factor model, which originated from Botti's study, also demonstrates a good model fit, the "perception of care" construct was excluded in this model. The "perception of care" construct is conceptually important as patient-centered care has become the focus of quality improvement of pain service.
CONCLUSIONS: The APS-POQ-R is easy to administer and is useful for quality evaluation in postoperative pain management. The present study demonstrates that a five-factor structure of the APS-POQ-R is the best fitting model in our patient sample. The results of this study provide further evidence to support the use of APS-POQ-R as a measurement tool for pain management evaluation in acute postoperative patients with a multi-cultural background.
METHODS: This is an observational, cross-sectional analysis of 486 women who presented to a tertiary urogynecological center between May 2013 and August 2014. They underwent a standardized interview and an examination that involved 3-dimensional/4-dimensional TPUS. The SMIS and VAS were administered if they answered positively to a question on AI. The association between defects of the EAS and symptoms of AI was evaluated using bivariate tests, as well as adjusting for pertinent covariates using multiple linear regression modeling.
RESULTS: Of the included patients, 17.1% reported AI, and 15.2% had significant EAS defects (≥4 slices) on TPUS imaging. A significant sonographic defect was diagnosed in 23% of women with AI versus 14% of those without (P = 0.033). Women with symptoms of AI were more likely to have a significant defect on TPUS (odds ratio, 1.878; 95% confidence interval, 1.05-3.37). No significant findings were seen when analyzing SMIS, its components, and VAS against sonographic EAS defects.
CONCLUSIONS: The symptom of AI is associated with significant EAS defects detected on TPUS. However, this study failed to show an association between significant EAS defects and the SMIS and VAS.
FUNDING: Pfizer.
STUDY DESIGN: In total, 282 patients with oral submucous fibrosis were treated with topical corticosteroid and oral antioxidant and the ice-cream stick exercise regimen. Patients in subgroups A1, A2, and A3 were additionally given a new MED. Patients in subgroups A1 and B1 patients with interincisal distance (IID) of 20 to 35 mm were managed without any additional therapy; patients in subgroups A2 and B2 with IID of 20 to 35 mm were additionally managed with intralesional injections; and those in subgroups A3 and B3 with IID less than 20 mm were managed surgically. Subjective evaluation of decrease in the oral mucosal burning was measured on a visual analogue scale (VAS). Analysis of variance and Tukey's multiple post hoc analysis were carried out to present the results.
RESULTS: Patients using the MED, that is, subgroups A1, A2, and A3, showed reduction in burning sensation in the range of 64.8% to 71.1% and 27.8% to 30.9%, whereas in subgroups B1, B2, and B3, reduction in burning sensation ranged from 64.7% to 69.9% and from 29.3% to 38.6% after 6 months. The wo-way analysis of variance indicated statistically significant results in changes in initial VAS scores to 6-monthly VAS scores between MED users and non-MED users.
CONCLUSIONS: The MED helps to enhance the rate of reduction of mucosal burning sensation, in addition to the conventional ice-cream stick regimen, as an adjunct to local and surgical treatment.
METHODS: Parents whose children aged below 12 years and were scheduled for elective surgery in a teaching hospital, were approached to participate in this survey. The reliability of the modified version of revised American Pain Society Patient Outcome Questionnaire was evaluated using Cronbach's alpha test, while the construct validity was assessed with a principal component analysis using a varimax rotation. The parental satisfaction with pain treatment received was measured.
RESULTS: A total of 108 parents completed the questionnaire. The internal consistency of the questionnaire shows a Cronbach's alpha of 0.798. Principal component analysis revealed a four-factor structure of the 12 items which explained 69.7% of the total variance. The factors are "Interference of sleep and activity," "Pain severity and drowsiness," "Perception of care," and "Adverse effects," respectively. Our study showed that this questionnaire is a valid and reliable measure for "Interference of sleep and activity" and "Pain severity and drowsiness" factors, but not for "Perception of care" and "Adverse effects." The results for "Perception of care" and "Adverse effects," therefore, should be reported as individual items instead of total score. The parental satisfaction with pain treatment given was good (median 8.0; IQR 3.0).
CONCLUSION: The modified version of revised American Pain Society Patient Outcome Questionnaire is a feasible and easy instrument to administer. The questionnaire can be used to obtain feedback from parents about the outcomes and experiences of pain management and is helpful in continuous quality evaluation and improvement in the postoperative care in a pediatric setting.
METHODS: This study enrolled patients (N = 36) who required root canal retreatment (RCR) on mandibular molar teeth, presented with periapical lesions with periapical index scores of 2 or 3, and had a pain visual analog scale (VAS) <50 and a percussion pain VAS <50. The participants were divided into 2 groups: (1) patients scheduled for RCR followed by LLLT (n = 18) and (2) patients scheduled for RCR followed by a mock LLLT (placebo) (n = 18). Postoperative pain was assessed using the VAS. Data were collected and statistically analyzed with the chi-square test, the independent sample t test, and the Mann-Whitney U test (P = .05).
RESULTS: On the first 4 days, postoperative pain significantly reduced in the LLLT group compared with the placebo group (P pain were found between the 2 groups after 5 and 7 days (P > .05). The number of patients who needed analgesics was lower in the LLLT group than in the placebo group (P pain during LLLT application.
CONCLUSIONS: LLLT may reduce postoperative pain after RCR of mandibular molars.
METHODS: This study will be a pilot, interventional, randomized, 2-armed, parallel, singled-masked, controlled trial. A total of 40 diabetes mellitus patients with peripheral neuropathy will be recruited and assigned randomly into 2 groups (moxibustion group and waiting group) at a 1:1 ratio. This trial consists of an 8-week intervention period and a 4-week follow-up period. During the intervention period, the moxibustion group will take 3 moxibustion sessions per week, whereas no intervention will be done on the waiting group to act as the control group. The outcome will be assessed by an outcome assessor who is unaware of the group assignment. The primary outcome will be pain assessment measured with algometry, Leeds Assessment of Neuropathic Symptoms and Signs pain scale, visual analogue scale, and neuropathy pain scale. The secondary outcome will be an evaluation of functional performance capacity with 6 minutes walking test, evaluation of the Foot and Ankle Ability Measure, and serum HbA1c and albumin levels.
DISCUSSION: We hope that this trial will provide valuable insights on the efficacy of moxibustion in the management of diabetic peripheral neuropathy.
TRIAL REGISTRATION: ClinicalTrials.gov Registry No.: NCT04894461 (URL: https://clinicaltrials.gov/ct2/show/NCT04894461?term=NCT04894461&draw=2&rank=1) Registered on May 20, 2021.
OBJECTIVES: To assess the effects on mother and baby of a policy of selective episiotomy ('only if needed') compared with a policy of routine episiotomy ('part of routine management') for vaginal births.
SEARCH METHODS: We searched Cochrane Pregnancy and Childbirth's Trials Register (14 September 2016) and reference lists of retrieved studies.
SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing selective versus routine use of episiotomy, irrespective of parity, setting or surgical type of episiotomy. We included trials where either unassisted or assisted vaginal births were intended. Quasi-RCTs, trials using a cross-over design or those published in abstract form only were not eligible for inclusion in this review.
DATA COLLECTION AND ANALYSIS: Two authors independently screened studies, extracted data, and assessed risk of bias. A third author mediated where there was no clear consensus. We observed good practice for data analysis and interpretation where trialists were review authors. We used fixed-effect models unless heterogeneity precluded this, expressed results as risk ratios (RR) and 95% confidence intervals (CI), and assessed the certainty of the evidence using GRADE.
MAIN RESULTS: This updated review includes 12 studies (6177 women), 11 in women in labour for whom a vaginal birth was intended, and one in women where an assisted birth was anticipated. Two were trials each with more than 1000 women (Argentina and the UK), and the rest were smaller (from Canada, Germany, Spain, Ireland, Malaysia, Pakistan, Columbia and Saudi Arabia). Eight trials included primiparous women only, and four trials were in both primiparous and multiparous women. For risk of bias, allocation was adequately concealed and reported in nine trials; sequence generation random and adequately reported in three trials; blinding of outcomes adequate and reported in one trial, blinding of participants and personnel reported in one trial.For women where an unassisted vaginal birth was anticipated, a policy of selective episiotomy may result in 30% fewer women experiencing severe perineal/vaginal trauma (RR 0.70, 95% CI 0.52 to 0.94; 5375 women; eight RCTs; low-certainty evidence). We do not know if there is a difference for blood loss at delivery (an average of 27 mL less with selective episiotomy, 95% CI from 75 mL less to 20 mL more; two trials, 336 women, very low-certainty evidence). Both selective and routine episiotomy have little or no effect on infants with Apgar score less than seven at five minutes (four trials, no events; 3908 women, moderate-certainty evidence); and there may be little or no difference in perineal infection (RR 0.90, 95% CI 0.45 to 1.82, three trials, 1467 participants, low-certainty evidence).For pain, we do not know if selective episiotomy compared with routine results in fewer women with moderate or severe perineal pain (measured on a visual analogue scale) at three days postpartum (RR 0.71, 95% CI 0.48 to 1.05, one trial, 165 participants, very low-certainty evidence). There is probably little or no difference for long-term (six months or more) dyspareunia (RR1.14, 95% CI 0.84 to 1.53, three trials, 1107 participants, moderate-certainty evidence); and there may be little or no difference for long-term (six months or more) urinary incontinence (average RR 0.98, 95% CI 0.67 to 1.44, three trials, 1107 participants, low-certainty evidence). One trial reported genital prolapse at three years postpartum. There was no clear difference between the two groups (RR 0.30, 95% CI 0.06 to 1.41; 365 women; one trial, low certainty evidence). Other outcomes relating to long-term effects were not reported (urinary fistula, rectal fistula, and faecal incontinence). Subgroup analyses by parity (primiparae versus multiparae) and by surgical method (midline versus mediolateral episiotomy) did not identify any modifying effects. Pain was not well assessed, and women's preferences were not reported.One trial examined selective episiotomy compared with routine episiotomy in women where an operative vaginal delivery was intended in 175 women, and did not show clear difference on severe perineal trauma between the restrictive and routine use of episiotomy, but the analysis was underpowered.
AUTHORS' CONCLUSIONS: In women where no instrumental delivery is intended, selective episiotomy policies result in fewer women with severe perineal/vaginal trauma. Other findings, both in the short or long term, provide no clear evidence that selective episiotomy policies results in harm to mother or baby.The review thus demonstrates that believing that routine episiotomy reduces perineal/vaginal trauma is not justified by current evidence. Further research in women where instrumental delivery is intended may help clarify if routine episiotomy is useful in this particular group. These trials should use better, standardised outcome assessment methods.
DESIGN: A meta-analysis was conducted to determine the potential impact of blood flow restriction on patients with knee injuries. PubMed, EBSCO, and Web of Science databases were searched for eligible studies from January 2000 until January 2020. The mean differences of the data were analyzed using Revman 5.3 software with a 95% confidence interval.
RESULTS: Nine studies fulfilled the inclusion criteria. These studies involved 179 patients who received L-BFR, 96 patients who underwent high-load resistance training, and another 94 patients who underwent low-load resistance training. The analysis of pooled data showed that patients in both the L-BFR (standardized mean difference, 0.83 [0.53, 1.14], P < 0.01) and high-load resistance training (standardized mean difference, -0.09 [-0.43, 0.24], P = 0.58) groups experienced an increase in muscle strength after the training. In addition, pain score was significantly reduced in the L-BFR group compared with the other two groups (standardized mean difference, -0.61 [-1.19, -0.03], P = 0.04).
CONCLUSIONS: Muscle strength increased after L-BFR and high-load resistance training compared with low-load resistance training. Furthermore, pain score was significantly reduced after L-BFR. Hence, L-BFR is a potential intervention to be applied in rehabilitation of knee injuries.
METHODS: This single-blinded, randomized controlled trial was conducted in a single emergency department. Patients with acute long bone fractures and numerical rating scale (NRS) pain scores ≥ 6 following an initial dose of intravenous morphine were assigned to receive either a LDK (0.3 mg/kg) over 15 min or intravenous MOR at a dose of 0.1 mg/kg administered over 5 min. Throughout a 120-min observation period, patients were regularly evaluated for pain level (0-10), side effects, and the need for additional rescue analgesia.
RESULTS: A total of 58 subjects participated, with 27 in the MOR group and 31 in the LDK group. Demographic variables and baseline NRS scores were comparable between the MOR (8.3 ± 1.3) and LDK (8.9 ± 1.2) groups. At 30 min, the LDK group showed a significantly greater mean reduction in NRS scores (3.1 ± 2.03) compared to the MOR group (1.8 ± 1.59) (p = 0.009). Similarly, at 60 min, there were significant differences in mean NRS score reductions (LDK 3.5 ± 2.17; MOR mean reduction = 2.4, ± 1.84) with a p-value of 0.04. No significant differences were observed at other time intervals. The incidence of dizziness was higher in the LDK group at 19.4% (p = 0.026).
CONCLUSION: Short infusion low-dose ketamine, as an adjunct to morphine, is effective in reducing pain during the initial 30 to 60 min and demonstrated comparability to intravenous morphine alone in reducing pain over the subsequent 60 min for acute long bone fractures. However, it was associated with a higher incidence of dizziness.
TRIAL REGISTRATION: NMRR17318438970 (2 May 2018; www.nmrr.gov.my ).
OBJECTIVE: To evaluate the efficacy of exercise and its potential determinants for pain, function, performance, and quality of life (QoL) in knee and hip osteoarthritis (OA).
METHODS: We searched 9 electronic databases (AMED, CENTRAL, CINAHL, EMBASE, MEDLINE Ovid, PEDro, PubMed, SPORTDiscus and Google Scholar) for reports of randomised controlled trials (RCTs) comparing exercise-only interventions with usual care. The search was performed from inception up to December 2017 with no language restriction. The effect size (ES), with its 95% confidence interval (CI), was calculated on the basis of between-group standardised mean differences. The primary endpoint was at or nearest to 8 weeks. Other outcome time points were grouped into intervals, from<1 month to≥18 months, for time-dependent effects analysis. Potential determinants were explored by subgroup analyses. Level of significance was set at P≤0.10.
RESULTS: Data from 77 RCTs (6472 participants) confirmed statistically significant exercise benefits for pain (ES 0.56, 95% CI 0.44-0.68), function (0.50, 0.38-0.63), performance (0.46, 0.35-0.57), and QoL (0.21, 0.11-0.31) at or nearest to 8 weeks. Across all outcomes, the effects appeared to peak around 2 months and then gradually decreased and became no better than usual care after 9 months. Better pain relief was reported by trials investigating participants who were younger (mean age<60 years), had knee OA, and were not awaiting joint replacement surgery.
CONCLUSIONS: Exercise significantly reduces pain and improves function, performance and QoL in people with knee and hip OA as compared with usual care at 8 weeks. The effects are maximal around 2 months and thereafter slowly diminish, being no better than usual care at 9 to 18 months. Participants with younger age, knee OA and not awaiting joint replacement may benefit more from exercise therapy. These potential determinants, identified by study-level analyses, may have implied ecological bias and need to be confirmed with individual patient data.