Jane Hsieh

Spasticity outcome measures in spinal cord injury: psychometric properties and clinical utility

Study design:Comprehensive review and systematic analyses.Objectives:Assess published psychometric evidence for spinal cord injury (SCI) spasticity outcome measures. Considerations about the influence of spasticity on function have also been identified to understand treatment effects and guide service delivery.Setting:London, Ontario and Vancouver, British Columbia, Canada.Method:Review of measures was based on availability of psychometric data, application in clinical settings and evaluated in SCI patients.Results:Ashworth and Modified Ashworth Scales (AS, MAS), Penn Spasm Frequency Scale (PSFS), Spinal Cord Assessment Tool for Spasticity (SCATS), Visual Analogue Scale self-rated scale of spasticity (VAS) and the Wartenberg Pendulum Test (WPT) were included in this review. The most frequently used tools for SCI spasticity measurement include the AS, MAS, PSFS and VAS, of which the latter two are self-report spasticity measures. The SCATS has been partially validated for SCI, but is not widely used. The WPT has been minimally validated despite its use in a large-scale SCI spasticity randomized controlled trial.Conclusions:Since spasticity is multidimensional, focusing on one or two spasticity outcome measures can misrepresent the extent and influence of spasticity on SCI patients. Different scales measure different aspects of spasticity and individual tools correlate weakly with each other. Spasticity may be better measured with an appropriate battery of tests, including the AS or MAS, along with PSFS. These tools would benefit from further reliability and responsiveness testing. Tools that assess the influence of spasticity on patient activities, participation and quality of life are important, but lacking.

Ofloxacin for the treatment of urinary tract infections and biofilms in spinal cord injury.

Forty two paraplegic and quadriplegic hospitalized spinal cord injured patients with urinary tract infections (UTI) were included in a double blind, randomized treatment study comparing 7 days ofloxacin (300 mg bd) with trimethoprim-sulphamethoxazole (TMPSMX; 160-800 mg bd) or an alternative, chosen because of resistance to TMPSMX. The 4-day clinical cure rate, defined as an asymptomatic patient with sterile urine, was 90% (19/21) with ofloxacin, significantly greater than 48% (10/21) for the comparison group (P=0.003) and the rate at end of therapy was 90% (19/21) with ofloxacin, against 57% (12/21) (P=0.015). Bacterial biofilms were detected on bladder epithelial cells in 39/41 (95%) patients. The biofilm score fell significantly following ofloxacin therapy (P < 0.001) or alternative therapy (P < 0.001). Ofloxacin treatment led to significantly more biofilm eradication than the other antibiotic group on day 4 (62 vs. 24%) (P=0.005) and day 7 (67 vs. 35%) (P=0.014). The study showed that ofloxacin was better than TMPSMX and alternatives at relieving clinical infection and eradicating bladder cell biofilms.

A Meta-Analysis of Botulinum Toxin Sphincteric Injections in the Treatment of Incomplete Voiding After Spinal Cord Injury

OBJECTIVE To conduct a systematic review and meta-analysis to examine the effect of injecting botulinum toxin A (BTX-A) into the detrusor sphincter on improving bladder emptying in individuals with spinal cord injury (SCI). DATA SOURCES MEDLINE, CINAHL, EMBASE, and PsycINFO databases were searched for all relevant articles published from 1980 to September 2011. DATA SELECTION All trials examining the use of BTX-A injections into the detrusor sphincter for the treatment for incomplete bladder emptying after SCI were included if at least 50% of the study sample comprised subjects with SCI, and if the SCI sample size was 3 or greater. DATA EXTRACTION A standardized mean difference (SMD) ± SE and 95% confidence interval (CI) were calculated for each outcome of interest, and the results were pooled using a fixed or random effects model, as appropriate. Outcomes assessed included postvoid residual urine volume (PRV), detrusor pressure (PDet), and urethral pressure (UP). Effect sizes were interpreted as small, 0.2; moderate, 0.5; and large, 0.8. DATA SYNTHESIS A relatively limited number of studies (2 randomized controlled trials, 6 uncontrolled trials) were identified. The 8 studies included results from 129 subjects. There was a statistically significant decrease in PRV at 1 month (SMD=1.119±.140; 95% CI, .844-1.394; P<.001), with a pooled mean PRV decrease from 251.8 to 153.0 mL. There was a moderate statistical effect on PDet (SMD=.570±.217; 95% CI, .145-.995; P=.009); pooled PDet decreased from 88.7 to 20.5 cmH(2)O. A large statistical effect size on UP (SMD=.896±.291; 95% CI, .327-1.466; P=.002) and an improvement from 119.7 to 102.3 cmH(2)O were seen. The systematic review also indicated a 50% reduction in urinary tract infections based on 3 studies. Discontinuation or reduction in catheter usage was reported in 4 studies after BTX-A. CONCLUSIONS Results of the meta-analysis indicate that BTX-A is effective in reducing PRV and demonstrating a statistically significant reduction in PDet and UP 1 month postinjection. However, the clinical utility of BTX-A is yet to be determined.

Meta-Analysis of Botulinum Toxin A Detrusor Injections in the Treatment of Neurogenic Detrusor Overactivity After Spinal Cord Injury

OBJECTIVE To examine the effectiveness of botulinum toxin type A (BTX-A) on neurogenic detrusor overactivity (NDO) in individuals with spinal cord injury (SCI). DATA SOURCES MEDLINE, CINAHL, EMBASE, and PsycINFO databases were searched for all relevant articles published from 1980 to June 2012. STUDY SELECTION Trials examining the use of BTX-A injections into the detrusor wall in the treatment of NDO after SCI were included if (1) ≥ 50% of study sample comprised subjects post-SCI; (2) outcomes of interest were assessed before and after treatment with a single injection of BTX-A; and (3) the sample size was ≥ 3. DATA EXTRACTION A standardized mean difference ± SE (95% confidence interval) was calculated for at least 1 of the following outcomes in every study: postvoid residual urine volume, reflex detrusor volume, bladder capacity, bladder compliance, catheterization frequency, and maximum flow rate. Results from all studies were then pooled using a random-effects model. Treatment effect sizes were interpreted as small, >0.2; moderate, >0.5; or large, >0.8. DATA SYNTHESIS Fourteen studies representing data from 734 subjects were included. After BTX-A injection, large treatment effects were observed in postvoid residual urine volume, reflex detrusor volume, bladder capacity, bladder compliance, and catheterization frequency (P<.01). Rate of incontinence episodes was reduced from 23% to 1.31% after BTX-A treatment. No significant decrease in max flow rate was observed (P=.403). CONCLUSIONS Results of the meta-analysis indicate BTX-A is effective in treating NDO after SCI. The use of BTX-A was associated with a decrease in incontinence episodes, catheter use, and bladder pressures.

Examining the effectiveness of intrathecal baclofen on spasticity in individuals with chronic spinal cord injury: A systematic review

Abstract Objective To review the available evidence on the effectiveness of intrathecal baclofen in the treatment of spasticity in individuals with spinal cord injuries (SCIs) at least 6 months post-injury or diagnosis. Data sources A literature search of multiple databases (Pub Med, CINAHL, EMBASE) was conducted to identify articles published in the English language. Study selection Studies were included for review if: (1) more than 50% of the sample size had suffered a traumatic or non-traumatic SCI; (2) there were more than three subjects; (3) subjects received continuous intrathecal baclofen via an implantable pump aimed at improving spasticity; and (4) all subjects were ≥6 months post-SCI, at the time of the intervention. Data extraction Data extracted from the studies included patient and treatment characteristics, study design, method of assessment, and outcomes of the intervention. Data synthesis Methodological quality was assessed using the PEDro for randomized-controlled trials (RCTs) and the Downs and Black (D&B) tool for non-RCTs. A level of evidence was assigned to each intervention using a modified Sackett scale. Conclusion The literature search resulted in 677 articles. No RCTs and eight non-RCTs (D&B scores 13–24) met criteria for inclusion, providing a pooled sample size of 162 individuals. There was substantial level 4 evidence that intrathecal baclofen is effective in reducing spasticity. Mean Ashworth scores reduced from 3.1–4.5 at baseline to 1.0–2.0 (P < 0.005) at follow-up (range 2–41 months). Average dosing increased from 57–187 µg/day at baseline to 218.7–535.9 µg/day at follow-up. Several complications from the use of intrathecal baclofen or pump and catheter malfunction were reported.

Effectiveness of 4-Aminopyridine for the Management of Spasticity in Spinal Cord Injury: A Systematic Review

Background: Spasticity is a common secondary complication of spinal cord injury (SCI), which can severely impact functional independence and quality of life. 4-Aminopyridine (4-AP) is a potassium channel blocker that has been studied as an intervention for spasticity in individuals with SCI. Objective: To conduct a systematic review of the available evidence regarding the effectiveness of 4-AP for the management of spasticity in individuals with SCI. Methods: A comprehensive literature search was conducted on five electronic databases for articles published in English up to January 2017. Studies were included if (1) the sample size was three or more subjects, (2) the population was ≥50% SCI, (3) the subjects were ≥18 years old, (4) the treatment was 4-AP via any route, and (5) spasticity was assessed before and after the intervention. Subject characteristics, study design, intervention protocol, assessment methods, side effects, adverse events, and outcomes were extracted from selected studies. Randomized controlled trials (RCTs) were evaluated for methodological quality using the Physiotherapy Evidence Database (PEDro) tool. Levels of evidence were assigned using a modified Sackett scale. Results: Nine studies met inclusion criteria with a pooled sample size of 591 subjects. Six studies were RCTs (PEDro = 6-10, Level 1 evidence) and three studies were pre-post tests (Level 4 evidence). There was a wide range in duration, severity, and level of SCI across subjects. Oral 4-AP was investigated in five studies; one study reported significant improvements on the Ashworth Scale (AS), while the remaining four studies found no improvement. Three studies found no significant improvements on the Spasm Frequency Scale. Intravenous 4-AP was investigated in three studies; no significant improvements were found on the AS or in the Reflex Score. Intrathecal 4-AP was investigated in one study, which did not find significant improvements on the AS. Conclusion: There is weak evidence supporting the effectiveness of 4-AP in reducing spasticity post SCI. Future research should utilize contemporary measures of spasticity and address methodological limitations such as small sample sizes.