Explore the vast range of titles available.

Study designProspective multi-center trial.ObjectivesTo characterize the complication profile associated with modest systemic hypothermia after acute cervical SCI in a prospective multi-center study.SettingFive trauma centers in the United States.MethodsWe analyzed data from a prospective, multi-center trial on the use of modest systemic hypothermia for acute cervical SCI. Patients with acute cervical SCI were assigned to receive modest systemic hypothermia (33 C) or standard of care medical treatment. Patients in the hypothermia group were cooled to 33 C and maintained at the target temperature for 48 h. Complication profile and the rate of complications within the first 6 weeks after injury were compared between the two groups. Multiple regression analysis was performed to determine risk factors for complications after injury.ResultsFifty patients (hypothermia: 27, control: 23) were analyzed for this study. Median age was significantly lower in the hypothermia arm (39 vs 59 years, p = 0.02). Respiratory complications were the most common (hypothermia: 55.6% vs control: 52.2%, p = 0.81). The rate of deep vein thrombosis was not significantly different between the two groups (hypothermia: 14.8% vs control 17.4%, p = 0.71). The rate of complications was not statistically different between the two groups.ConclusionIn this prospective multi-center controlled trial, preliminary data show that modest systemic hypothermia was not associated with increased risk of complications within the first 6 weeks after acute cervical SCI.Trial informationThe study is registered on clinicaltrials.gov NCT02991690. University of Miami IRB (Central IRB) approval No.: 20160758. Emory University IRB #IRB00093786.

Study design: Randomized controlled trial with single-blinded primary outcome assessment. Objectives: To determine the efficacy and safety of autologous incubated macrophage treatment for improving neurological outcome in patients with acute, complete spinal cord injury (SCI). Setting: Six SCI treatment centers in the United States and Israel. Methods: Participants with traumatic complete SCI between C5 motor and T11 neurological levels who could receive macrophage therapy within 14 days of injury were randomly assigned in a 2:1 ratio to the treatment (autologous incubated macrophages) or control (standard of care) groups. Treatment group participants underwent macrophage injection into the caudal boundary of the SCI. The primary outcome measure was American Spinal Injury Association (ASIA) Impairment Scale (AIS) A–B or better at ⩾6 months. Safety was assessed by analysis of adverse events (AEs). Results: Of 43 participants (26 treatment, 17 control) having sufficient data for efficacy analysis, AIS A to B or better conversion was experienced by 7 treatment and 10 control participants; AIS A to C conversion was experienced by 2 treatment and 2 control participants. The primary outcome analysis for subjects with at least 6 months follow-up showed a trend favoring the control group that did not achieve statistical significance ( P =0.053). The mean number of AEs reported per participant was not significantly different between the groups ( P =0.942). Conclusion: The analysis failed to show a significant difference in primary outcome between the two groups. The study results do not support treatment of acute complete SCI with autologous incubated macrophage therapy as specified in this protocol.

Study designPsychometric study.ObjectiveThis study sought to analyze the psychometric properties of the Italian version of the General Sleep Disturbance Scale (GSDS-IT) in a population of individuals with spinal cord injury (SCI).SettingItaly.MethodsIts reliability was assessed using the Cronbach’s alpha and intraclass correlation coefficient (ICC), while its concurrent validity was assessed using the Pearson’s correlation coefficient in relation to the Pittsburgh Sleep Quality Index (PSQI). The obtained scores were compared with the cut-off score for the GSDS-IT among a healthy Italian population (38.5).ResultsThe GSDS-IT was administered to 57 participants with SCI who were recruited from all over Italy. The GSDS-IT was found to have good internal consistency (Cronbach’s α of 0.76) and good test-retest reliability (ICC of 0.7), and it showed positive and significant values for all the PSQI domains. Based on the cut-off score of 38.5, 56% of participants tested positive for sleep disturbances upon admission (t0), while among the randomized participants submitted for the test-retest after 24 h (t1), 75% tested positive for sleep disturbances.ConclusionThe GSDS-IT is a valid, reliable, and time-efficient tool for measuring sleep disturbances over the past week in a population with SCI.

Study design: Retrospective investigation. Objectives: To investigate the association of patient and injury characteristics, as well as bladder management, with the occurrence of patient-reported, symptomatic urinary tract infection(s) UTI(s) in patients with chronic neurogenic lower urinary tract dysfunction (NLUTD). Setting: Tertiary urologic referral center. Methods: The patient database was screened for patients with chronic (>12 months) NLUTD who had presented between 2008 and 2012. Patient characteristics, bladder evacuation management, the annual number of patient-reported, symptomatic UTIs and the type of prophylactic treatment to prevent UTIs were collected. Binary logistic regression analysis was used to investigate the effects of the investigated risk factors on the occurrence of symptomatic UTI(s) and recurrent symptomatic UTIs (⩾3 annual UTIs). Results: The data of 1104 patients with a mean NLTUD duration of 20.3±11.6 years were investigated. The evacuation method was a significant ( P ⩽0.004) predictor for the occurrence of symptomatic UTI and recurrent symptomatic UTIs. The greatest annual number of symptomatic UTIs was observed in patients using transurethral indwelling catheters, and the odds of experiencing a UTI and recurrent UTIs were increased more than 10- and 4-fold, respectively. The odds of a UTI or recurrent UTIs were also increased significantly ( P ⩽0.014) in patients using intermittent catheterization (IC). Botulinum toxin injections into the detrusor increased the odds of a UTI ~10-fold ( P =0.03). Conclusions: The bladder evacuation method is the main predictor for symptomatic UTIs in individuals with NLUTD. Transurethral catheters showed the highest odds of symptomatic UTI and should be avoided whenever possible.

Study design: A multicentre, prospective, assessor-blinded, parallel randomised controlled trial. Objectives: The objective of the trial was to determine the effectiveness of telephone-based management of pressure ulcers in people with spinal cord injury (SCI) in low- and middle-income countries. Methods: One hundred and twenty people with SCI living in the community were recruited through three hospitals in India and Bangladesh between November 2013 and March 2016. Participants had sustained an SCI >3 months prior and had a pressure ulcer. Participants were randomly allocated (1:1) to a control or intervention group. Participants in the control group received no intervention. Participants in the intervention group received weekly advice by telephone for 12 weeks about the management of their pressure ulcers from a trained health-care professional. Outcomes were measured by a blinded assessor at baseline and 12 weeks. There was one primary outcome, namely, the size of the pressure ulcer and 13 secondary outcomes. Results: The mean between-group difference for the size of the pressure ulcer at 12 weeks was 2.3 cm 2 (95% confidence interval −0.3 to 4.9; favouring the intervention group). Eight of the 13 secondary outcomes were statistically significant. Conclusion: The results of our primary outcome (that is, size of pressure ulcer) do not provide conclusive evidence that people with SCI can be supported at home to manage their pressure ulcers through regular telephone-based advice. However, the results from the secondary outcomes are sufficiently positive to provide hope that this simple intervention may provide some relief from this insidious problem in the future.

Study designCross-sectional study.ObjectivesTo determine the degree of impoverishment of people with spinal cord injury (SCI) and their families in Bangladesh caused by loss of work-related income following injury.SettingSpinal cord injury centre, Bangladesh.MethodsA total of 410 wheelchair-dependent people with recent SCI about to be discharged from a hospital in Bangladesh were interviewed to determine the size of their families, their incomes from paid work prior to injury and the incomes of their family members. These data were used to calculate income per family unit and per family member prior to and immediately after injury.ResultsNinety percent of the participants were men, 98% were from rural areas of Bangladesh and 58% were manual labours prior to injury. Median (interquartile range, IQR) family size was 5 (4–6) people. Prior to injury, 74% of participants were the main income earners for their families and 50% provided the only source of income for their families. Participants’ median (IQR) monthly income prior to injury was US $106 (US$ 60–US $180) per person and family members’ income was US$ 30 (US $19–US$ 48) per person. After injury, the median income (IQR) of each family member dropped to US $0 (US$ 0–US $18) placing 91% of families below the extreme poverty line of US$ 37.50 per person per month (equivalent to US$1.25 per day).ConclusionIn Bangladesh, SCI have profound financial implications for individuals and their families and causes extreme poverty. This is because those most often injured are young and the main income earners for their families.

Spinal cord injury (SCI) severely impairs the physical and mental health of patients, decreasing their self-efficacy in coping with daily life and quality of life (QOL). In China, a large gap remains between the complex long-term health needs of SCI patients and the current community care system. With the prevalence of mobile terminals, the usage of mobile health apps has the potential to fill this gap by extending qualified medical resources to the families of SCI patients. Our team developed the app Together for the transitional care of home-dwelling SCI patients in China. This study aimed to evaluate the effects of app-based transitional care on the self-efficacy and QOL of SCI patients. Through a three-round Delphi process, an Android app was designed. Both medical staff and patients could access the app. Medical staff used it for providing remote transitional care to SCI patients. Patients used it to view transitional care time and send messages to medical staff. Thereafter, a multicenter and assessor-blinded randomized controlled trial was conducted. Participants (n=98) who had SCI and lived at home following discharge were recruited and randomly assigned to a study group (n=49) and control group (n=49) using a randomized number list in four research centers. Patients in both groups received systematic discharge education before discharge. The study group received five follow-ups conducted by trained nurses through the app, which had four core functions, namely remote assessment, health education, interdisciplinary referral, and patient interaction, at weeks 2, 4, 6, 8, and 12 following discharge. The control group received a routine telephone follow-up conducted by nurses at week 12 following discharge. The outcome measures were the Moorong Self-Efficacy Scale (MSES) and 36-item Short-Form Health Survey (SF-36) scores. Data were collected before discharge (T ) and at weeks 12 (T ) and 24 following discharge (T ). Differences between the groups were tested by repeated measures analysis of variance and simple effect analysis. After the follow-up, the total MSES scores in the study group improved over time (T =67.80, T =71.90, and T =76.29) and were higher than those in the control group (T =64.49) at 24 weeks following discharge (simple effect analysis: F =8.506, P=.004). Regarding the total SF-36 score, although it was higher in patients from the study group (T =65.36) than those from the control group (T =58.77) at 24 weeks following discharge, only time effects were significant (F =6.671, P=.002) and neither the group effects nor the interaction effects influenced the change in QOL (group effects: F =0.082, P=.78; interaction effects: F =3.059, P=.052). This study confirmed that app-based transitional care improves the self-efficacy of SCI patients. Nevertheless, QOL improvement is not yet evident. Future investigations with larger sample sizes and longer observation periods are warranted to further verify the effects. Chinese Clinical Trial Registry ChiCTR-IPR-17012317; http://www.chictr.org.cn/showproj.aspx?proj=19828.

Objective: To investigate the impact of upper extremity deficit in subjects with tetraplegia. Setting: The United Kingdom and The Netherlands. Study design: Survey among the members of the Dutch and UK Spinal Cord Injury (SCI) Associations. Main outcome parameter: Indication of expected improvement in quality of life (QOL) on a 5-point scale in relation to improvement in hand function and seven other SCI-related impairments. Results: In all, 565 subjects with tetraplegia returned the questionnaire (overall response of 42%). Results in the Dutch and the UK group were comparable. A total of 77% of the tetraplegics expected an important or very important improvement in QOL if their hand function improved. This is comparable to their expectations with regard to improvement in bladder and bowel function. All other items were scored lower. Conclusion: This is the first study in which the impact of upper extremity impairment has been assessed in a large sample of tetraplegic subjects and compared to other SCI-related impairments that have a major impact on the life of subjects with SCI. The present study indicates a high impact as well as a high priority for improvement in hand function in tetraplegics.

Study design: A randomized controlled trial (RCT). Objectives: To determine the efficacy of massage therapy (MT) as a treatment that could be implemented to reduce pain and fatigue in people with chronic spinal cord injury (SCI). Setting: Laboratory setting in Sydney, Australia. Methods: Participants included 40 people with SCI living in the community who were randomly assigned into one of two RCT arms: MT (Swedish massage to upper body) or an active concurrent control (guided imagery (GI) relaxation). All participants received 30 min once a week of either massage or GI over 5 consecutive weeks. In addition to sociodemographic and injury factors, assessments and reliable measures including the short-form McGill Pain Questionnaire and Chalder’s Fatigue Scale were validated. Results: Chronic pain and fatigue were significantly reduced in the massage group when assessed at the end of 5 weeks ( P <0.05), with large effect sizes. Interestingly, GI was as effective as MT in reducing pain and fatigue. Pain scores were reduced significantly over time in both MT and GI groups ( P =0.049 and P =0.032, respectively). Total fatigue scores were also reduced in both MT and GI groups ( P =0004 and P =0.037, respectively.) Conclusions: Massage and GI are both active treatments that provide potential clinical benefits for adults with SCI. Future research should clarify the role of massage and GI in managing pain and fatigue in SCI and assess outcomes into the longer-term.

Study designSimulations using data from a prospective cohort study.ObjectivesTo illustrate how prospective cohort data can be employed in randomized controlled trial (RCT) planning to assess feasibility and operational challenges, using TASCI (Transcutaneous tibial nerve stimulation in patients with Acute Spinal Cord Injury to prevent neurogenic detrusor overactivity: a nationwide randomized, sham-controlled, double-blind clinical trial) as a case study.SettingSpinal cord injury (SCI) rehabilitation centers in Switzerland.MethodsTASCI is nested in the multicenter Swiss Spinal Cord Injury Cohort Study (SwiSCI), which prospectively includes patients with acute SCI. In simulations, data from 640 patients, collected by SwiSCI, were used to investigate different scenarios of patient eligibility and study consent, as well as the performance of the randomization list. Descriptive analysis was used to describe the population of interest and the simulation results; multivariable logistic regression analysis was performed to identify predictors of discharge within the TASCI intervention time period.ResultsThe recruitment target of 114 patients is obtainable within the originally envisioned 3-year time period under the most favorable recruitment scenario examined. The distribution of the primary prognostic factor produced imbalance in the randomization lists and informed further discussion of the cut-off values used in stratification. Influxes of patients resulted in overlapping intervention periods for multiple participants, which guided resource allocation. Early discharge was related to the primary prognostic factor and study center, but is only anticipated in about 8% of participants.ConclusionsProspective cohort data are a very valuable resource for planning RCTs.