Multiple Sclerosis Spasticity Scale Research Articles

Stretching is not essential for managing MS spasticity: A randomized controlled trial

Background: Clinical practice, expert opinion, and evidence-based guidelines recommend daily stretching as first-line treatment for multiple sclerosis (MS) spasticity, but this has not been evaluated by fully powered clinical trials. Objective: To determine whether MS Spasticity: Take Control (STC), a guideline-based program of spasticity education and stretching exercises has different effects on the impact of spasticity than a control program of different spasticity education and range of motion (ROM) exercises. Methods: Ambulatory people with self-reported MS spasticity were randomly assigned to STC or ROM, delivered in same duration, facilitator-led, group classes, face-to-face (F2F) initially and later virtually, due to coronavirus disease 2019 (COVID-19). Multiple Sclerosis Spasticity Scale (MSSS) scores were compared between groups at 1 (primary outcome) and 6 months after interventions. Results: A total of 231 people enrolled. There was no significant difference in MSSS scores between STC and ROM at 1 month (mean difference = 0.28, 95% (confidence interval (CI)) = [−9.45 to 10.01], p = 0.955). There were significant group mean improvements in MSSS scores and most other outcomes at 1 and 6 months. Conclusion: Education with stretching exercises, the first-line recommended treatment for MS spasticity, and education with ROM exercises may both improve MS spasticity to a similar degree. This study debunks the belief that stretching is essential to managing MS spasticity.

Assessment of Impact of Spasticity on Activities of Daily Living in Multiple Sclerosis Patients from Saudi Arabia: A Cross-sectional Study

Introduction: Multiple sclerosis (MS) is a chronic progressive autoimmune disease with several symptoms, including spasticity. This study aimed to illustrate the impact of spasticity on the daily activities of MS patients. Subjects and Methods: A cross-sectional study was conducted using a self-administered questionnaire consisting of demographic, clinical characteristics, and MS spasticity scale. A total of 286 patients from Saudi Arabia participated in this study. Results: Muscle stiffness occurring due to spasticity in most cases does not bother the patient, except for muscle tightness (32.9%) and stiffness when staying in the same position for a long time (36.7%), which cause extreme discomfort to the patients. Five items of pain and discomfort have been reported to extremely bother the patients (28.0-33.6%). The highest percentage of patients claimed not to be affected by muscle spasm items (29.4%-66.1%), including activities of dressing and sleeping (36.7%-57.7%). More than 30% of the patients found spasticity to affect their walking speed and going up/downstairs. About 36% to 49% did not experience any difficulties with their body movements. The patients also did not exhibit any feelings of discomfort, except for irritation (30.4%) and nervousness (29.4%). Conclusion: MS patients are significantly affected by spasticity, and a considerable percentage of these patients experience problems with their movements and activities.

Effect of Dynamic Neuromuscular Stabilization on Balance, Trunk Function, Falling, and Spasticity in People With Multiple Sclerosis: A Randomized Controlled Trial

ObjectiveTo compare the effects of core stabilization (CS) and dynamic neuromuscular stabilization (DNS) on balance, trunk function, mobility, falling, and spasticity, in people with multiple sclerosis (PWMS). DesignTwo-group randomized controlled trial. SettingGeneral community and referral center. ParticipantsA total of 64 PWMS, between 30 and 50 years old, and an expanded disability status scale between 2 and 5, participated in this study (N=64). InterventionsParticipants were randomly assigned to CS (n=32) and DNS (n=32) groups. Both groups received a total of 15 sessions of CS or DNS exercises, 60 minutes per session, 3 times a week during the 5 weeks. Outcome MeasuresBalance function was measured as the primary outcome measure. Trunk function, postural stability, falling rate, fear of falling, falling index, mobility, and spasticity were measured as secondary outcomes. ResultsDNS group had significant improvement in Berg balance scale, trunk impairment scale, postural stability, activities-specific balance confidence, reduced falling rate, the timed Up and Go (TUG), multiple sclerosis walking scale-12, and multiple sclerosis spasticity scale in PWMS compared with the CS group, (P<.0001) after 5 weeks of intervention and 17 weeks of follow-up. Except for the modified Ashworth scale (MAS), significant improvements were seen in all outcome measures in both groups after 5 weeks of intervention. ConclusionThis is the first clinical evidence to support the importance of DNS exercise in improving balance, trunk function, and fall prevention in PWMS. This study provides clinical evidence that DNS may be more effective for PWMS than CS.

Isometric tests to evaluate upper and lower extremity functioning in people with multiple sclerosis: reliability and validity

BackgroundBoth upper and lower extremity motor symptoms are common in people with multiple sclerosis (PwMS) and there is a need to develop objective, reliable, and valid outcome measures. The aim of this study was to evaluate the reliability and external validity of the standard and novel isometric tests in the assessment of neuromuscular functioning in both upper (grip force; GF) and lower (knee extensors; KE) extremities in PwMS. MethodsTwenty-nine relapsing-remitting PwMS (Expanded Disability Status Scale (EDSS)<6) completed isometric and functional tests in upper (grip force) and lower (knee extension) extremity in two separate visits. Isometric testing included maximum force (maxF), maximum rate of force development (maxRFD), and our recently developed novel brief force pulse protocol (BFP). The dependent variables of BFP included rate of force development and relaxation scaling factors (RFD-SF and RFR-SF), which quantifies an individual's ability to scale the rates of force development and relaxation with the magnitude of force pulse produced. PwMS also completed functional tests of upper (9-hole peg (9HPT), finger tapping (FTT)) and lower extremity (25-ft walk test (T25WT), timed up and go (TUG), 5-time sit-to-stand (5StS), and Multiple Sclerosis Spasticity Scale (MSSS-88)). ResultsMost isometric outcome measures had high reliability (ICCs>0.87 and CVs<12%). In GF, both RFD-SF and RFR-SF had significant associations with 9HPT and FTT (r's between 0.49-0.55, p<0.05). In KE, while maxF, maxRFD, and RFD-SF were moderately correlated to some of the functional tests, the strongest correlations were observed for the RFR-SF (T25FW, r=0.71; TUG, r=0.60; 5StS, r=0.47; MSSS-88, r=0.60, and EDSS, r=0.71). Multiple linear regression analysis indicated that RFD-SF is the only predictor for 9HPT and RFR-SF is the only predictor of walking speed among the studied variables. ConclusionsBFP protocol provides highly reliable and relevant outcome measures to evaluate both upper and lower extremity functioning in PwMS. Specifically, the ability to relax muscle forces quickly after a quick force production highly contributes to walking speed in PwMS.

MS Spasticity: Take Control (STC) for ambulatory adults: protocol for a randomized controlled trial

BackgroundSpasticity affects 60–80% of people with multiple sclerosis (MS), impacting activity, participation and quality of life. We developed the group delivered spasticity self-management program, “MS Spasticity: Take Control” (STC), with DVDs for education and lower extremity stretching. STC is based on an international guideline and recommendations from systematic reviews and emphasizes the importance of stretching with specific stretching exercises. Our pilot trial (n = 38) compared STC followed by one month of home stretching practice to unguided use of the National MS Society (NMSS) brochure titled “Stretching for People with MS: An Illustrated Manual,” also followed by one month of home stretching practice. In this pilot trial, STC showed promising effects on the impact of spasticity (MS Spasticity Scale-88) and other self-report and physical performance measures. We will now carry out a fully-powered trial to evaluate the effect of STC compared to a comparably delivered control program on the impact and severity of spasticity in people with MS and self-reported lower extremity spasticity.MethodsTwo hundred-twenty ambulatory adults with MS self-reported spasticity interfering with daily activities will be randomized 1:1 to STC or control, using the same NMSS brochure used in the pilot study, with both programs delivered in groups with trained facilitators. Outcomes are the impact of spasticity with the MS Spasticity Scale-88, the severity of spasticity with the Numeric Rating Scale for Spasticity, other self-report questionnaires, and physical performance walking measures at baseline and one and 6 months after the interventions.DiscussionStretching is the cornerstone of spasticity management. Stretching takes time and energy every day. Unfortunately, beyond the logical expectation that regular stretching should help prevent muscle shortening and contractures in the presence of spasticity, there is very little data on the effects of stretching on spasticity in people with MS or any other condition. Our pilot trial of STC suggested that education and stretching help reduce the impact of spasticity. To definitively determine if this education and instructional program with daily stretching practice is effective, a fully powered trial with a comparable control intervention and facilitators who did not create STC is needed. Here we report the protocol for this trial.Trial registrationNCT03166930 May 25, 2017.

Assessment and Measurement of Spasticity in MS: State of the Evidence.

The purpose of this review is to familiarize the reader with assessments and measurement of spasticity in people with multiple sclerosis (MS). Spasticity affects 60-84% of people with MS, worsening as disability worsens and impacting activity, participation, and quality of life. Spasticity manifests in many ways, including spasms, resistance to passive stretch, pain, and perception of tightness, and can affect muscles throughout the body, making assessment and quantification of spasticity challenging but important. Assessment tools include those quantified by clinicians, instrumentation, and patients. Most tools for measuring spasticity are based on clinician scoring, were developed many years ago, and have undergone minimal recent advances. More recent developments are patient-reported outcome measures for spasticity, including the Numeric Rating Scale for Spasticity (NRS-S) and the disease-specific Multiple Sclerosis Spasticity Scale-88 (MSSS), and, most recently, imaging through elastography. MS-related spasticity is common and often disabling. There are various spasticity measurement tools available, each with advantages and limitations. Newer tools are likely to be developed as our understanding of spasticity in MS grows.

The effect of cycling using active-passive trainers on spasticity, cardiovascular fitness, function and quality of life in people with moderate to severe Multiple Sclerosis (MS); a feasibility study.

BackgroundExercise options for those with moderate to high levels of disability are limited. The aim of the study was to evaluate the feasibility of a progressive, four week lower limb cycling programme using active-passive trainers (APT's) on spasticity, cardiovascular fitness, function and quality of life in people with moderate to severe MS. MethodsParticipants were in-patients in the Physical Disability Rehabilitation Unit, Queen Elizabeth University Hospital, Glasgow, UK and randomised to APT + usual care or usual care only. The APT group received 30 min of APT (2 min passive warm up, 26 min active cycling, 2 min passive cool down), five days per week for 4 weeks. Outcome measures; Oxygen Uptake Efficiency Slope, Modified Ashworth Scale, Multiple Sclerosis Spasticity Scale, Functional Independence Measure, Timed 25 foot walk test and the MSQOL-54, were taken before and after the intervention period. Symmetry, distance cycled and active participation were also recorded for each cycling session. Results24 participants were recruited, 15 to the intervention and 9 to the control group. There was a 100% adherence to the intervention and a significant increase in average speed, power output and distance cycled (p < 0.001 for each) over the four weeks. There were no adverse events and both groups improved in average scores for all outcome measures. ConclusionsAPT cycling was well tolerated, while the cycling parameters improved it was difficult to separate the effects of the therapy programme and APT cycling. A longer duration, fully powered trial in a community setting is merited.

(171) Evaluating the Pain and Discomfort Scale to Assess Spasticity-Related Pain in Cerebral Palsy

Assessing pain among individuals with communicative impairments and developmental disabilities is a clinical challenge. In this preliminary study, we addressed, in part, the issue of the association between chronic pain and spasticity in cerebral palsy (CP). Specifically, we evaluated the measurement performance of a proxy-reported spasticity rating scale (Multiple Sclerosis Spasticity Scale–MSSS) and the feasibility of a range of motion examination procedure (Pain Examination Procedure–PEP) using direct-observation to code behavioral reactivity during the exam (Pain and Discomfort Scale – PADS). Fifteen individuals with CP (mean age=10.9 years, range=6.2-17.2 years; GMFCS=3-5; male=46%) were evaluated pre- (T1) and post- (T2) intrathecal baclofen pump (ITB) surgical implant to treat spasticity. The PEP protocol was successfully completed for all participants in the clinical setting. Cronbach's alpha for the MSSS was 0.96. PADS change scores (T1 to T2) were significantly correlated with MSSS change scores (r=0.80, p=0.006). The strong positive correlation suggests the PADS/PEP protocol may be measuring spasticity-related pain and discomfort, providing initial construct validity evidence between an objective/direct and subjective/indirect assessment method for pain and spasticity in CP. T1 PADS scores were also highly positively correlated with both PADS change and MSSS change scores (r=-0.72, p=0.006; r=-0.85, p=0.002), providing preliminary evidence of the predictive utility of a pre-ITB surgery PADS/PEP protocol. This was not a random sample, therefore the results are specific to the sample and may not hold for the population of individuals living with CP. Given the absence of self-report, we cannot be certain and do not claim to have measured the pain experience of the individuals in the sample. Future work should continue to examine the PADS as a potential pain behavior assessment tool to provide a direct assessment option for the study of pain among individuals with CP and related developmental disabilities. Supported by NICHD Grant No. 73126

Polymorphisms in the CIITA -168A/G (rs3087456) and CIITA +1614G/C (rs4774) may influence severity in multiple sclerosis patients.

We examined the impact of CIITA polymorphisms -168A/G (rs3087456) and +1614G/C (rs4774) on the risk of disability progression, severity and on responses to first-line immunomodulator treatments. Genomic DNA was extracted from blood samples. We used ABI3730xl and GeneMapper v.4.0 software to identify genotype variations. All patients were followed up and clinically reassessed at three-month intervals. Disability progression was measured by the Expanded Disability Status Scale and disease severity by the Multiple Sclerosis Spasticity Scale (MSSS). We included 37 men and 80 women. We found no evidence regarding the influence of the single nucleotide polymorphisms studied in the Expanded Disability Status Scale or therapeutic response of the evaluated drugs. We performed a logistic regression analysis with the MSSS and found that a less severe MS course was associated with wild type CIITA -168AA and CIITA +1614GG, as the chance of the patient progressing to MSSS2 and MSSS3 decreased in 61% and 75% with CIITA -168AA and 66% and 75% with CIITA +1614GG, respectively (p < 0.0001). Although less significant, the CIITA +1614 GC also pointed to a less severe MS course and the chance of the patient progressing to MSSS3 decreased 79% (p = 0.015). We also observed that the CIITA -168GG genotype was more frequent in MSSS2 and MSSS3 and had 40% lower odds ratio to becoming more severe MS. These data suggest that CIITA -168AA, CIITA +1614GG and CIITA +1614 GC polymorphisms may be associated with a better MS clinical course. This knowledge may be useful for a better understanding of MS and its therapeutic management.

Evaluation of the Multiple Sclerosis Spasticity Scale 88: A Short Report.

Background:The Multiple Sclerosis Spasticity Scale 88 (MSSS-88) is designed to capture the patient experience and impact of spasticity, but there is limited evaluation against clinician-rated measures of spasticity.Objective:To evaluate the convergent validity and responsiveness of the MSSS-88.Design:Longitudinal study.Setting:University Laboratory.Subjects:Thirty-four people with multiple sclerosis.Methods:People with multiple sclerosis (MS; n = 34) completed the self-reported 12-item Multiple Sclerosis Walking Scale, Multiple Sclerosis Spasticity Scale, Barthel Index alongside the clinician-rated Ashworth Scale, and a laboratory-based measure of ankle spasticity. Spasticity measure responsiveness was evaluated in 20 participants at two time points, an average of 8.75 ± 3.8 months apart.Results:In people with MS (mean age 55.1 ± 8.1 years; Expanded Disability Scale range 4.5-7.0), spasticity symptom specific subscales of the MSSS-88 (stiffness and spasms) showed strong and significant correlations with the clinician-rated Ashworth Scale (r = 0.52-0.53; P < .01). Responsiveness of the MSSS-88 was comparable to a laboratory-based measure of ankle spasticity.Conclusions:Our findings lend additional support to the convergent validity of this measure.

The 88-item Multiple Sclerosis Spasticity Scale: a Rasch validation of the Italian version and suggestions for refinement of the original scale

In multiple sclerosis (MS), the impact of spasticity on the patient's life is a key issue, and it is fundamental that existing tools measuring the patient's perspective undergo psychometric analysis and refinement to optimize confidence in their use in clinical practice and research. We examined-by Rasch analysis (RA)-the main metric characteristics of the 88-item Multiple Sclerosis Spasticity Scale (MSSS-88) to: (i) further validate its Italian version (MSSS-88-IT), previously validated through classical test theory methods only and (ii) independently verify the measurement properties of the original scale. MSSS-88 data from a convenience sample of 232 subjects with MS underwent RA, mainly examining item fit, reliability indices, test information function, dimensionality, local item independence, and differential item functioning (DIF). Most items fitted the Rasch model, but 13/88 items showed a misfit in infit and/or outfit values. Rasch reliability indices were high (> 0.80). Test information functions in most subscales showed a sharp decrease in measurement precision as the ability level departs from the quite limited central range of maximal information. The unidimensionality of each subscale was confirmed. Thirteen item pairs showed local dependency (residual correlations > 0.30) and three items presented DIF. Reliability, dimensionality and some internal construct validity characteristics of the MSSS-88-IT were confirmed. But, drawbacks of the original MSSS-88 emerged related to some item misfit, redundancy, or malfunctioning. Thus, further large independent studies are recommended, to verify the robustness of previous findings and examine the appropriateness of a few targeted item replacements.

Effect of repetitive transcranial magnetic stimulation on leg spasticity in primary progressive and secondary progressive form of multiple sclerosis

Lower limb spasticity is one of the most common symptoms in multiple sclerosis (MS) patients with an increasing severity as the disease progresses. Previous clinical and experimental results of excitatory repetitive transcranial magnetic stimulation (rTMS) highlighted possible role in reducing of lower limb spasticity in MS patients. The aim of our pilot study was to explore effects of rTMS on leg spasticity in MS patients. Our pilot study included 20 MS patients with secondary progressive (SP) and primary progressive form (PP) of disease with Expanded Disability Status Scale (EDDS) score 4–6.5 and lower limb spasticity, that were referred to Clinic for Rehabilitation Dr Miroslav Zotovic, Belgrade. They were simple randomized in two groups: first group included ten patients with rTMS and second group was placebo group with sham rTMS. For rTMS intervention, we used the intermittent theta burst stimulation over M1 leg area for the worst affected leg. Both group had exercise therapy (ET) session after the rTMS (real/sham) intervention during the three weeks. Primary outcome measure for spasticity was Modified Ashworth Scale (MAS). Secondary outcome measures included clinical assessment of spasticity Multiple Sclerosis Spasticity Scale (MSSS88) and the Timed-25-foot walk. Outcome measures were evaluated before and after three weeks of treatment, and compared within the group and between two groups. There were no statistically differences between the group regarding age, gender, education, form and duration of disease, EDSS. A statistically significant difference was found in the group of patients treated with the rTMS for MAS (W = 2.714; P = 0.007), T25 W (Z = 2.813; P = 0.005) and MSSS88 (Z = 2.803; P = 0.005). In placebo group these changes were not statistically significant. rTMS associated with short period of ET may induce significant reduction of spasticity in SP and PP form of disease.

Effects of whole-body vibration training in patients with multiple sclerosis: A systematic review

IntroductionMultiple sclerosis (MS) is an autoimmune inflammatory disease of the central nervous system. MS is characterised by nerve demyelination that can alter nerve transmission and lead to such symptoms as fatigue, muscle weakness, and impaired motor function. There are 47000 people with MS in Spain. Vibration training can be an effective and complementary alternative to traditional exercise to treat patients with MS. The aim of this study was to analyse the effectiveness of vibration training programmes in patients with MS. DevelopmentWe searched 5 electronic databases (PubMed, SPORTDiscus, SciELO, Lilacs, IBECS, and ISI Web of Knowledge) in August 2015. By using a set of keywords, we found studies linking vibration training and MS and included randomised controlled trials that applied vibration training to patients with MS. Our search yielded 71 studies. Only 9 of them were included after removing duplicate studies and those which were not relevant according to our selection criteria. These studies obtained different outcomes. ConclusionsSome studies found improvements in muscle strength, functional capacity, coordination, resistance, balance, and some areas of 88-Item Multiple Sclerosis Spasticity Scale. However, we identified limitations in some of these studies and there are still few publications on vibration training and MS to ensure training effectiveness.

The cross-cultural adaptation and psychometric validation of the MSSS-88 for use in Italian patients with multiple sclerosis

Purpose: To cross-culturally translate the Multiple Sclerosis Spasticity Scale into Italian and to evaluate its psychometric properties in patients with multiple sclerosis.Methods: The Italian version of Multiple Sclerosis Spasticity Scale was developed in accordance with international standards and subsequently administered to 232 Italian adults with multiple sclerosis. The following psychometric properties were analyzed: internal consistency through Cronbach’s α and item-to-total correlation, dimensionality with factor analysis, and convergent and criterion validity through hypotheses-testing, comparing the Multiple Sclerosis Spasticity Scale with other outcome measures (Fatigue Severity Scale, Multiple Sclerosis Quality of Life, Modified Ashworth Scale, Barthel Index, and Expanded Disability Status Scale) and analyzing related constructs. Finally, we correlated the MSSS-88 subscales with each other.Results: The final Multiple Sclerosis Spasticity Scale version was well-understood by all subjects. The internal consistency was good (Cronbach’s α ≥0.90). Factor analysis revealed that each subscale was unidimensional. Convergent and criterion validity were supported by acceptable correlations with other disease-specific questionnaires, according to the a priori expectations.Conclusions: The final Italian Multiple Sclerosis Spasticity Scale version showed robust psychometric properties. Therefore, it can be recommended as an assessment tool for clinical and research use to evaluate spasticity in Italian patients with multiple sclerosis.Implications for rehabilitationThe Multiple Sclerosis Spasticity Scale was developed to measure patients’ perception of the impact of spasticity on life of subjects with multiple sclerosis.In a sample of Italian subjects with multiple sclerosis, the Multiple Sclerosis Spasticity Scale revealed good internal consistency and convergent and criterion validity.Factor analysis demonstrated that each subscale was unidimensional.Each subscale can be used to assess the impact of spasticity in Italian patients with multiple sclerosis.

Subscales correlations between MSSS-88 and PRISM scales in evaluation of spasticity for patients with multiple sclerosis

Introduction/Objective. Patient-reported outcomes have been recognized as an important way of assessing health and well-being of patients with multiple sclerosis (MS). The aim of the study is to determine the correlation between different subscales of Patient-Reported Impact of Spasticity Measure (PRISM) and Multiple Sclerosis Spasticity Scale (MSSS-88) scales in the estimation of spasticity influence on different domains Methods. The study is a cross-sectional observational study. MSSS-88 and PRISM scales were analyzed in five domains (body-function domain, activity domain, participation domain, personal factors/wellbeing domain, and hypothesis). For statistical interpretation of the correlation we performed the Spearman?s ?-test, concurrent validity, divergent validity, and the linear regression model. Results. We found a significant correlation between subscales of evaluated MSSS-88 and PRISM scales for body domains; the highest correlation was between the need for assistance/positioning (NA/P) and walking (W). Spasticity has the weakest correlation with the need for intervention (NI). The presence of pain has a negative impact and significant positive correlation between pain discomfort and NI. In the domain of body function for males, there was a non-significant correlation between muscle spasms and NI. The same applies for social functioning and social embarrassment domains, as well as for emotional health and psychological agitation for personal factors / wellbeing domain. The differences between genders of MS patients persist in different domains; muscle spasms are strong predictors for NI, and body movement is a strong predictor versus W for NA/P. Conclusion. MSSS-88 and PRISM scales can be considered reliable in measuring different domains of disability for MS patients with spasticity. Because it is shorter, quicker, and simple to use, it is concluded that the PRISM scale can successfully compete with and replace the MSSS-88 scale in certain domains.

Validation of the Serbian Version of Multiple Sclerosis Spasticity Scale 88 (MSSS-88).

ObjectiveMultiple Sclerosis Spasticity Scale (MSSS)-88 has been developed for self-assessment of spasticity symptoms in patients with multiple sclerosis (MS). The objective of this study was to validate MSSS-88 and evaluate the psychometric properties in patients with MS in Serbia.MethodsThe study comprised 65 MS patients with spasticity. MSSS-88 consists of 88 items grouped in eight sections. Internal consistency of the MSSS-88SR subscales was determined using Cronbach’s alpha coefficient. Test/retest reliability with an intra-class correlation coefficient (ICC) for each MSSS-88SR subscale was performed. Clinical validity of MSSS-88SR was determined by correlations with the Numeric Rating Scale (NRS) and the Modified Ashworth Scale (MAS).ResultsThe range of Cronbach’s alpha for all scales and ICC was 0.91–0.96 and 0.84–0.91, respectively. All ICCs were statistically significant (p<0.05). All evaluated subscales of MSSS-88 were significantly correlated with the NRS scale. The highest correlation coefficients were registered between the WL subscale and the EDSS and MAS, while the strongest relationship was observed between the MSS subscale and the NRS.ConclusionThe Serbian translated version of this instrument may be useful as a clinical measure for spasticity and functionality in patients with MS.

Spasticity in multiple sclerosis: Associations with impairments and overall quality of life

Objectives(1)To determine the association between spasticity and quality of life (QOL) in multiple sclerosis (MS).(2)To investigate the associations between spasticity and impairments of function and activity limitations. DesignCross-sectional survey. SettingA convenience sample of people with MS routinely attending an appointment with their local MS service. Participants701 patients with clinically definite MS. Main outcome measuresDemographic details were obtained and patients completed a battery of measures including spasticity (Multiple Sclerosis Spasticity Scale – 88), fatigue (Neurological Fatigue Index – MS), urinary dysfunction (Qualiveen-SF), pain (Neuropathic Pain Scale), mood disorder (Hospital Anxiety and Depression Scale), disability (World Health Organisation Disability Assessment Schedule) and QOL (Leeds Multiple Sclerosis QOL Scale). Results85.7% of patients reported spasticity. Patients with higher levels of spasticity were more likely to be disabled, suffer from depression and anxiety, have higher levels of fatigue and report more pain and bladder problems (p<0.01). Spasticity remained as a significant direct effect upon QOL in a multivariate model adjusted for other impairments, activity limitation and depression. ConclusionsThere is a strong association between spasticity and fatigue, depression, anxiety, pain and bladder problems. The retention of a significant direct relationship with QOL in a multivariate model emphasises its influence upon the everyday lives of people with MS.

Anodal transcranial direct current stimulation of motor cortex does not ameliorate spasticity in multiple sclerosis.

To assess whether anodal transcranial direct current stimulation (tDCS) is effective in modulating lower limb spasticity in MS patients. Previously, anodal tDCS has been shown to improve motor deficits in several neurological diseases and, recently, it has been proposed as effective in decreasing spasticity after stroke. However, the effect of anodal tDCS on spasticity is not examined in MS. We performed a single-centre randomized, double-blind, sham-controlled study to investigate efficacy of anodal vs sham tDCS in 20 relapsing-remitting MS patients. Ten patients received anodal tDCS stimulation to the primary motor cortex of the more affected side, 20 minutes/day for 5 consecutive days. Ten patients received sham tDCS stimulation. Spasticity was assessed by using the modified Ashworth scale (MAS), the self-scoring MSSS-88 (Multiple Sclerosis Spasticity Scale) and Multiple Sclerosis Walking Scale (MSWS-12) at baseline and at the end of protocol stimulation. No side effects were detected during either anodal tDCS or sham. In both groups, there was no significant improvement in MAS, MSSS-88 and MSWS-12 scores. Moreover the comparison between anodal tDCS and sham showed no difference. Five-daily sessions of anodal tDCS to the primary motor cortex does do not improve lower limb spasticity in MS patients.

The Cannabinoid Use in Progressive Inflammatory brain Disease (CUPID) trial: a randomised double-blind placebo-controlled parallel-group multicentre trial and economic evaluation of cannabinoids to slow progression in multiple sclerosis.

The Cannabinoid Use in Progressive Inflammatory brain Disease (CUPID) trial aimed to determine whether or not oral Δ(9)-tetrahydrocannabinol (Δ(9)-THC) slowed the course of progressive multiple sclerosis (MS); evaluate safety of cannabinoid administration; and, improve methods for testing treatments in progressive MS. There were three objectives in the CUPID study: (1) to evaluate whether or not Δ(9)-THC could slow the course of progressive MS; (2) to assess the long-term safety of Δ(9)-THC; and (3) to explore newer ways of conducting clinical trials in progressive MS. The CUPID trial was a randomised, double-blind, placebo-controlled, parallel-group, multicentre trial. Patients were randomised in a 2 : 1 ratio to Δ(9)-THC or placebo. Randomisation was balanced according to Expanded Disability Status Scale (EDSS) score, study site and disease type. Analyses were by intention to treat, following a pre-specified statistical analysis plan. A cranial magnetic resonance imaging (MRI) substudy, Rasch measurement theory (RMT) analyses and an economic evaluation were undertaken. Twenty-seven UK sites. Adults aged 18-65 years with primary or secondary progressive MS, 1-year evidence of disease progression and baseline EDSS 4.0-6.5. Oral Δ(9)-THC (maximum 28 mg/day) or matching placebo. Three and 6 months, and then 6-monthly up to 36 or 42 months. Primary outcomes were time to EDSS progression, and change in Multiple Sclerosis Impact Scale-29 version 2 (MSIS-29v2) 20-point physical subscale (MSIS-29phys) score. Various secondary patient- and clinician-reported outcomes and MRI outcomes were assessed. RMT analyses examined performance of MS-specific rating scales as measurement instruments and tested for a symptomatic or disease-modifying treatment effect. Economic evaluation estimated mean incremental costs and quality-adjusted life-years (QALYs). Effectiveness - recruitment targets were achieved. Of the 498 randomised patients (332 to active and 166 to placebo), 493 (329 active and 164 placebo) were analysed. no significant treatment effect; hazard ratio EDSS score progression (active : placebo) 0.92 [95% confidence interval (CI) 0.68 to 1.23]; and estimated between-group difference in MSIS-29phys score (active-placebo) -0.9 points (95% CI -2.0 to 0.2 points). Secondary clinical and MRI outcomes: no significant treatment effects. Safety - at least one serious adverse event: 35% and 28% of active and placebo patients, respectively. RMT analyses - scale evaluation: MSIS-29 version 2, MS Walking Scale-12 version 2 and MS Spasticity Scale-88 were robust measurement instruments. There was no clear symptomatic or disease-modifying treatment effect. Economic evaluation - estimated mean incremental cost to NHS over usual care, over 3 years £27,443.20 per patient. No between-group difference in QALYs. The CUPID trial failed to demonstrate a significant treatment effect in primary or secondary outcomes. There were no major safety concerns, but unwanted side effects seemed to affect compliance. Participants were more disabled than in previous studies and deteriorated less than expected, possibly reducing our ability to detect treatment effects. RMT analyses supported performance of MS-specific rating scales as measures, enabled group- and individual person-level examination of treatment effects, but did not influence study inferences. The intervention had significant additional costs with no improvement in health outcomes; therefore, it was dominated by usual care and not cost-effective. Future work should focus on determining further factors to predict clinical deterioration, to inform the development of new studies, and modifying treatments in order to minimise side effects and improve study compliance. The absence of disease-modifying treatments in progressive MS warrants further studies of the cannabinoid pathway in potential neuroprotection. Current Controlled Trials ISRCTN62942668. The National Institute for Health Research Health Technology Assessment programme, the Medical Research Council Efficacy and Mechanism Evaluation programme, Multiple Sclerosis Society and Multiple Sclerosis Trust. The report will be published in full in Health Technology Assessment; Vol. 19, No. 12. See the NIHR Journals Library website for further project information.

Linguistic and psychometric validation of the MSSS-88 questionnaire for patients with multiple sclerosis and spasticity in Germany.

BackgroundMultiple sclerosis (MS) is an inflammatory disease where many of the patients suffer from spasticity impacting their quality-of-life. The purpose of this paper was to linguistically validate and psychometrically test the Multiple Sclerosis Spasticity Scale (MSSS-88) in German speaking MS patients.MethodsThe study had two stages: 1) forward/backward translations of the original MSSS-88 scale into German, discussions with MS-experts and cognitive debriefings with MS patients; 2) psychometric evaluation of the German version. Data collection took part in an observational multi-centre study in Germany (MOVE2).ResultsThe German translation of the MSSS-88 scale was discussed with three MS-experts; followed by two cognitive debriefing sessions with 12 MS patients. For psychometric evaluation the MSSS-88 was filled in by 87 MS patients with a mean age of 50.2 ± 10.4 years; 26.4% of them had severe spasticity. Data quality was acceptable. Missing data for items of the MSSS-88 were low (range 0–5.75%). Psychometric testing of the MSSS-88 revealed excellent values for reliability and validity. Significant differences between groups regarding severity, grading, type and self-ratings of MS-spasticity and sleep disturbances were found. Sensitivity to change could be demonstrated for the MSSS-88 in the group of MS patients treated with cannabinoid oromucosal spray vs. non-treated patients. In the treated group significant changes with a moderate effect size were found for ‘muscle spasms’, ‘emotional health’ and ‘pain/discomfort’. No significant changes could be detected in the non-treated group.ConclusionPreliminary evidence from this small study supports reliability, validity, and responsiveness of the German version of the MSSS-88 for measuring the impact of spasticity in MS.