Life Experiences of Patients With Multiple Sclerosis About Their Spasticity: A Phenomenological Study.

Spasticity is one of the main symptoms that is most common in patients with Multiple Sclerosis and causes increased disability. The aim of this study is to understand the experiences of patients with Multiple Sclerosis about their spasticity from their perspective. This study was conducted as a qualitative study with a Hermeneutic phenomenological framework. The data were evaluated by using VanManen's thematic analysis method. As a result of the data analysis, four main themes were elicited, namely, "the meaning of spasticity for the patient," "the difficulties of living with spasticity," 'coping with spasticity," and "the new me created by spasticity." It was understood that spasticity is a symptom that brings about difficulties in psychological, social, and working life as well as physical difficulties. Nurses should be aware of the psychological symptoms as well as the physical symptoms that patients experience due to spasticity and should create a patient-specific management program.

Electrical stimulation for limb spasticity in children with stroke: A protocol for systematic review.

BACKGROUND: This systematic review protocol will appraise the effectiveness and safety of electrical stimulation (ES) for limb spasticity (LS) in children with stroke. METHODS: Cochrane Library, EMBASE, PUBMED, PsycINFO, Scopus, OpenGrey, CINAHL, ACMD, CNKI, and WANGFANG will be systematically retrieved for randomized controlled trials (RCTs) testing the effectiveness of ES compared with other interventions on LS in children with stroke. Two independent authors will evaluate eligibility using predefined criteria and will perform data extraction and study quality appraisal of eligible trials. Primary outcomes include gait velocity, and limb spasticity status. Limb function, quality of life, pain intensity, and adverse events will be assessed as secondary outcomes. We will perform data analysis using RevMan 5.3 software. RESULTS: This systematic review will summarize the most recent evidence to assess the effectiveness and safety of ES for LS in children with stroke. CONCLUSIONS: The results of this study may help to determine whether ES is effective or not for LS in children with stroke. STUDY REGISTRATION: INPLASY202050115.

Modified PRISM and SCI-SET Spasticity Measures for Persons With Traumatic Spinal Cord Injury: Results of a Rasch Analyses.

OBJECTIVE: To evaluate the psychometric properties of the Spinal Cord Injury Spasticity Evaluation Tool (SCI-SET) and Patient-Reported Impact of Spasticity Measure (PRISM) using Rasch analysis to optimize their validity and efficiency. DESIGN: Rasch analysis of the SCI-SET and PRISM represents a secondary analysis of data collected as part of a collaborative research project of the SCI Model Systems Centers. The overall survey was organized into 4 sections: (1) participant demographics and injury characteristics, (2) participant experiences of spasticity, (3) SCI-SET, and (4) PRISM. Participants were recruited from the community via multiple avenues. Data were collected and managed via an online survey tool using a secure web-based data management application. SETTING: Participating Spinal Cord Injury Model Systems Centers. PARTICIPANTS: Most participants (N=1239) had lived with their injury for more than 2 years and used a wheelchair as their primary mode of mobility. The majority of the sample (58%) sustained cervical injuries. INTERVENTIONS: None. MAIN OUTCOME MEASURES: SCI-SET and PRISM. RESULTS: The SCI-SET demonstrated strong measurement properties with acceptably high reliability and point-measure correlations and no evidence of multidimensionality. However, respondents underused some rating scale categories. Analyses of the PRISM demonstrated 3 distinct subscales relating to the physical, psychological, and social influences of spasticity; respondents underused some rating scale categories. Combining underused rating scale categories for both spasticity instruments resulted in increased reliability and reduced respondent burden compared with the original versions. Both the Modified SCI-SET (person separation reliability=0.93) and Modified PRISM (person separation reliability=0.85, 0.89, 0.83 for physical, psychological, and social subscores, respectively) display strong measurement properties. CONCLUSIONS: Measurement properties of the SCI-SET and PRISM improved from use of Rasch model methods. The SCI-SET required minor revisions, whereas the PRISM required definition of subscores. Both modified spasticity measures demonstrated adequate psychometric properties, and correlations among the modified measures were high, providing evidence of convergent validity. We recommend use of the Modified SCI-SET and Modified PRISM measures in future studies.

Mindfulness Meditation Effects on Poststroke Spasticity: A Feasibility Study.

This study examined the feasibility of an adapted 2-week mindfulness meditation protocol for chronic stroke survivors. In addition, preliminary effects of this adapted intervention on spasticity and quality of life in individuals after stroke were explored. Ten chronic stroke survivors with spasticity listened to 2 weeks of short mindfulness meditation recordings, adapted from Jon Kabat-Zinn's Mindfulness-Based Stress Reduction course, in a pre/post repeated measures design. Measures of spasticity, quality of life, mindfulness, and anxiety, along with qualitative data from participants' daily journals, were assessed. On average, participants reported meditating 12.5 days of the full 15 days (mean 12.5 days, SD 0.94, range 8-15 days). Seven of the 10 participants wrote comments in their journals. In addition, there were no adverse effects due to the intervention. Exploratory preliminary analyses also showed statistically significant improvements in spasticity in both the elbow (P = .032) and wrist (P = .023) after 2 weeks of meditation, along with improvements in quality of life measures for Energy (P = .013), Personality (P = .026), and Work/Productivity (P = .032). This feasibility study suggests that individuals with spasticity following stroke are able to adhere to a 2-week home-based mindfulness meditation program. In addition, preliminary results also suggest that this adapted, short mindfulness meditation program might be a promising approach for individuals with spasticity following stroke. Future research should expand on these preliminary findings with a larger sample size and control group.

Examining the Effects of a Powered Exoskeleton on Quality of Life and Secondary Impairments in People Living With Spinal Cord Injury.

Background: Secondary impairments associated with spinal cord injury (SCI) limit one's independent functionality and negatively impact quality of life (QoL). Objective: The purpose of this study was to explore changes in secondary health conditions that may result from using a powered exoskeleton as well as their potential impact on QoL. Methods: Forty-five participants presenting with SCI ranging from T3-L2 were included in this study. Outcome measures included self-reported assessments of pain, spasticity, bladder/bowel function, Satisfaction with Life Scale (SWLS), and Modified Ashworth Scale (MAS). Results: Participants reported significantly less spasticity at the conclusion of the study, 0.9 ± 1.7, compared to baseline, 1.6 ± 0.9 [t (44) = 2.83, p < .001]. MAS testing revealed that 26.7% of participants presented with decreased spasticity at the conclusion of the trial. Participants reported less pain at the end of the trial, 0.9 ± 1.6, compared to the start, 1.1 ± 1.7 [t (44) = 1.42, p > .05]. No negative changes in bowel and bladder were reported; positive changes were reported by 20% and 9% of participants with respect to bowel and bladder management. There was no statistically significant change in SWLS sum score from baseline, 20.4 ± 8.0, to conclusion of the study, 21.3 ± 7.6 [t (44) = -1.1, p > .05]. Conclusion: Findings suggest using a powered exoskeleton may decrease spasticity in people living with SCI. Although improvements in secondary impairments did not result in a significant improvement in QoL, it is believed that using a powered exoskeleton in one's community will lead to increased community integration facilitating an improvement in QoL.

The experience of spasticity after spinal cord injury: perceived characteristics and impact on daily life.

STUDY DESIGN: Cross-sectional survey. OBJECTIVES: Determine the impact of motor control characteristics attributed to spasticity, such as spasms, stiffness, and clonus on the daily life of people with spinal cord injury (SCI). SETTING: Nationwide, United States. METHODS: Internet-administered questionnaire, the Patient Reported Impact of Spasticity Measure (PRISM) and items describing characteristics of spasticity including stiffness, spasms, clonus, and pain. RESULTS: Of the 145 respondents, 113 (78%) reported a PRISM score of at least 5/164, indicating spasticity had some impact on their daily lives. Stiffness impact was highly correlated (ρ = 0.84; p < 0.01) with the PRISM negative impact on Daily Activities subscale and moderately correlated with the other PRISM subscales (ρ = 0.55-0.63; p < 0.01). Spasm presence had a negligible or low correlation with PRISM negative impact subscales (ρ = 0.29-0.47; p < 0.01). Trunk muscle stiffness and spasms had a low correlation with PRISM Need for Assistance and Daily activities (ρ = 0.42 and ρ = 0.41, p < 0.01, respectively). Anti-spasticity medications were ineffective for 58% of respondents. Pain in the legs was reported by 57% of respondents. CONCLUSIONS: The experience of spasticity is highly individualized, and is often distributed differently across arms, trunk, and legs. Despite the fact that traditional definitions of spasticity focus on reflex responsiveness, the stiffness associated with spasticity appears to be more problematic than spasms or clonus. The self-described characteristics of spasticity and its physiological presentation are complex and related to pain. This varied presentation lends support to the concept that management of spasticity may be best achieved by multimodality strategies.

Initial psychometric validation of the questionnaire on pain caused by spasticity (QPS).

BACKGROUND: The Questionnaire on Pain caused by Spasticity (QPS) is a modular patient- and observer-reported outcome measure of spasticity-related pain (SRP) in children with cerebral palsy (CP). Originally developed for an English-speaking population, we conducted a psychometric validation of a recently developed Chinese language version of the QPS. METHODS: This was a prospective, observational study involving 137 children/adolescents with CP and upper and/or lower limb spasticity and their parents at three sites in China. Six QPS modules were used, three each for upper and lower limb SRP assessment: a patient self-report module; an interviewer-administered module used by site staff based on the cognitive, communicative, and motor abilities of a patient; and a parent/caregiver module administered for all children as an observer-reported outcome to complement the patient-reported outcome. If no assessment by the patient was possible because of age or cognitive impairments, only the parent/caregiver module was completed. Two visits with a 3-week interval provided data to evaluate and establish administrative ease of use, scoring of the QPS (factor analyses, Rasch analyses), reliability (Cronbach's α, intraclass correlation coefficient), validity (correlations with quality of life [PedsQL™], motor impairment [Gross Motor Function Classification System, Gross Motor Function Measure-66, Manual Ability Classification System], and spasticity [Ashworth Scale, Modified Tardieu Scale]). RESULTS: For most children, clinic staff reported no difficulties associated with general QPS use or deciding which module to use. Children (and parents) who reported more demanding activities also reported higher levels of associated SRP (or observed SRP behavior). Activity-related SRP items were combined for a total QPS score. Cronbach's α was low for child self-report, but was acceptable for interviewer-administered and parent reports on SRP. Test-retest reliability was high for all modules. Moderate-strong associations were frequently seen between QPS and quality of life, and were particularly strong in the child self-report group. Relatively weak associations were observed between QPS and motor impairment and spasticity. CONCLUSIONS: This first study was successful in providing initial evidence for the psychometric properties. Clinic staff were able to administer the QPS modules easily, and both children and parents were able to complete the designated QPS appropriately.

Home-based Nintendo Wii training to improve upper-limb function in children ages 7 to 12 with spastic hemiplegic cerebral palsy.

This pilot study compared a Nintendo Wii intervention to single-joint resistance training for the upper limb in children ages 7 to 12 with spastic hemiplegic cerebral palsy (CP). Children were randomized to Wii training (n= 3), or resistance training (n= 3) and trained at home for 6 weeks. Pre, post and 4-week follow-up measures were collected. Outcome measures were the Melbourne Assessment (MA2), and ABILHAND-Kids, and grip strength. Compliance, motivation and feasibility of each intervention was explored using daily logbook responses and questionnaires. Descriptive statistics were used. Three children improved in the MA2, two of which were in the Wii training group. Improvements in the ABILHAND-Kids were minimal for all participants. Grip strength improvements were observed in 3 participants, two of which were in the resistance training group. The Wii training group reported higher compliance and more consistently positive responses to motivation and feasibility questions. Therefore, Wii training may be an effective home-based rehabilitation strategy, and is worth exploring in a larger trial. Implications of Wii training in the context of motivation theory are discussed.

Relationship between neuromuscular and perceived fatigue and locomotor performance in patients with multiple sclerosis.

BACKGROUND: Fatigue is a common problem in patients with multiple sclerosis; however, the impact of neuromuscular and perceived fatigue on locomotor performance is currently unknown in these patients. AIM: The aim of this study was: 1) to determine the relationship between perceived and neuromuscular fatigue and locomotor performance in patients with multiple sclerosis; 2) to determine if neuromuscular and perceived fatigue depend on the severity of the pathology defined by the Expanded disability status scale score (EDSS). DESIGN: Observational study. SETTING: Outpatients from a hospital rehabilitation department. POPULATION: Thirty patients with multiple sclerosis underwent clinical (spasticity, strength, perceived fatigue and locomotor performance) and isokinetic evaluations (peak torque of knee flexor and extensor muscles and neuromuscular fatigue of knee extensor muscles). METHODS: The main outcome measures were perceived and neuromuscular fatigue and locomotor performance. Secondary outcomes were strength of the weakest limb and peak isometric torque of knee flexor and extensor muscles, spasticity, EDSS. RESULTS: There were no significant correlations between perceived or neuromuscular fatigue and locomotor performance. Locomotor performance was correlated with EDSS, spasticity, strength of the weakest limb and peak isometric torque of knee flexor and extensor muscles. Eighty­three percent of the variance of the 6MWT could be explained by EDSS score, strength of the weakest limb (MRCsum), torque produced during the last five contractions of the fatigue protocol and peak isometric torque of knee flexor muscles. Patients with moderate disability (EDSS Score 4-6) had greater levels of neuromuscular fatigue than patients with mild disability (<4). CONCLUSIONS: Although fatigue is a disabling symptom of multiple sclerosis, and neuromuscular fatigue was found to be higher in more disabled patients, locomotor performance was correlated with strength and spasticity but not with fatigue. CLINICAL REHABILITATION IMPACT: Nevertheless, fatigue was related to 6MWT performance since torque produced during the last five contractions of the fatigue protocol was one of the factors which explained performance.

Contralesional Cathodal versus Dual Transcranial Direct Current Stimulation for Decreasing Upper Limb Spasticity in Chronic Stroke Individuals: A Clinical and Neurophysiological Study.

BACKGROUND: Different transcranial direct current stimulation (tDCS) paradigms have been implemented to treat poststroke spasticity, but discordant results have been reported. OBJECTIVE: This study aimed to determine the efficacy and persistence of dual tDCS (anode over affected motor cortex [M1] and cathode over contralateral M1) compared with cathodal tDCS (cathode over contralateral M1) on upper limb (UL) functional, behavioral, and neurophysiological measures in chronic poststroke individuals. SUBJECTS AND METHODS: Ten subjects with UL spasticity (7 men; mean 62 years; 8 ischemic stroke; years from event: 2.3 years) were enrolled in a cross-over, double-blinded study. Cathodal and dual tDCS, both preceded by 1 week of sham stimulation 1 month before real stimulation, were applied with 3 months interval. Stimulating paradigm was 20 minutes for five consecutive days in each block. Evaluations were performed before (T1), after real or sham treatment (T2), and after 1 (T3), 4 (T4), and 8 weeks (T5). Functional, behavioral, and neurophysiological tests were performed at each time. RESULTS: Both tDCS paradigms decreased spasticity, increased strength, and ameliorated behavioral scales. Cathodal tDCS was superior to dual tDCS in reducing UL distal spasticity immediately after treatment (T2: cathodal > dual: P = .023) and provided a higher and longer lasting reduction at proximal districts (T3: cathodal > dual: P = .042; T4: cathodal > dual: P = .028; T5: cathodal > dual: P = .05). These findings are supported by an H-reflex modulation (overall time effect P > .002). CONCLUSIONS: Cathodal tDCS is slightly more effective than dual tDCS in reducing distal UL spasticity in chronic poststroke subjects. A modulation of spinal inhibitory mechanisms, demonstrated by H-reflex modifications, supports this finding.

Effects of tibial nerve neurotomy on posture and gait in stroke patients: A focus on patient-perceived benefits in daily life.

OBJECTIVE: To evaluate the objective and subjective functional effectiveness of tibial nerve neurotomy (TNN) in post-stroke spastic equinovarus foot (SEF). METHODS: In an open study, 23 hemiplegic patients were assessed immediately before TNN and then 5months after TNN. The main outcome measure was the Lower Limb Function Assessment Scale (LL-FAS), which provided an ecologic assessment of impairments in standing and walking (i.e. kinematic abnormalities) and their impacts on activities of daily living. Patients were also assessed for global clinical impression of change, fear of falling, neuromotor impairments, spatiotemporal and video gait parameters and walking capacities. RESULTS: TNN had a very marked effect on the level of spasticity and the range of motion in dorsiflexion (p<10(-3)). These changes resulted in better foot positioning when standing and walking (particularly in stance), which was perceived very favorably by the patients. There was a clear, patient-perceived improvement in activities performed when standing and walking (LL-FAS (p<0.01)), the global clinical impression of change (p<10(-3)) and the fear of falling (p=0.022) that was not revealed by conventional, objective measurements (New Functional Ambulation Classification, Rivermead Mobility Index). CONCLUSION: TNN is an effective treatment for post-stroke SEF; it is associated with a patient-reported improvement in standing and walking abilities during activities of daily living. Further research must now assess the long-term subjective efficacy of TNN.

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

DESIGN: Cross-sectional survey. SETTING: A convenience sample of people with MS routinely attending an appointment with their local MS service. PARTICIPANTS: 701 patients with clinically definite MS. MAIN OUTCOME MEASURES: Demographic 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). RESULTS: 85.7% 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. CONCLUSIONS: There 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.

Effectiveness of neuromuscular taping on painful hemiplegic shoulder: a randomised clinical trial.

PURPOSE: The purpose of this trial was to investigate changes in pain, the range of motion (ROM) and spasticity in people with painful hemiplegic shoulder (PHS) after the application of an upper limb neuromuscular taping (NMT). METHODS: We conducted a randomised clinical trial. The study included 32 people, 31% female (mean ± SD age: 66 ± 9 years), with PHS after stroke with pain at rest and during functional movements. The experimental group received the application of NMT and a standard physical therapy programme (SPTP), whereas the control group received SPTP. The groups received four 45-minute long sessions over four weeks. The VAS, ROM and spasticity were assessed before and after the intervention with follow-up at four weeks. RESULTS: The experimental group had a greater reduction in pain compared to the control group at the end of the intervention, as well as at one month after the intervention (p < 0.001; all the group differences were greater than 4.5 cm, which is greater than the minimal clinically important difference of 2.0 cm). The experimental group had a significantly higher (i.e. better) ROM, by 30.0°, than the control group in shoulder flexion (95% CI: 37.3-22.7) at 4 weeks and by 24.8° (95% CI: 32.1-17.6) at 8 weeks as well as in abduction by 30.6° (95% CI: 37.5-23.7) at 4 weeks and 25.1° (95% CI: 33.8-16.3) at 8 weeks. CONCLUSION: Our study demonstrates that NMT decreases pain and increases the ROM in subjects with shoulder pain after a stroke. Implications for Rehabilitation Painful hemiplegic shoulder is a frequent complication after stroke with negative impacts on functional activities and on quality of life of people, moreover restricts rehabilitation intervention. Neuromuscular taping is a technique introduced by David Blow for the treatment of neuromuscoloskeletal problems. This study shows the reduction of pain and the improvement of range of motion after the application of an upper limb neuromuscular taping. Rehabilitation professionals who are involved in the management of painful hemiplegic shoulder may like to consider the benefits that neuromuscular taping can produce on upper limb.

Assessing Caregiver Burden and Relationship between Caregiver Burden and Basic Activities of Daily Living in Stroke Patients with Spasticity.

Objective: To evaluate caregiver burden of stroke patients with spasticity and to study the relationship between the caregiver burden and the ability to perform basic activities of daily living (bADL) of these patients. Material and Method: The study design was a cross-sectional descriptive research. The demographic data of 52 stroke patients with spasticity and their caregivers at Songklanagarind Hospital in Thailand were recorded. The Zarit Burden Interview (ZBI) in the Thai version measured the caregiver burdens. The modified Barthel Index (BI) evaluated the bADL of the patients. The correlation between the ZBI and modified BI were calculated by The Spearman's rank correlation coefficient (rs) with p<0.05 considered as a significant level. Results: The caregivers were mainly female (80.8%) who felt no burden (57%). The ZBI score did not significantly relate to the modified BI in either the activity or total score. However, the ZBI score was significantly associated to the caring hours per day (median 14 hours/day, rs = 0.37, p = 0.007) and left hemiparesis (p = 0.03). Conclusion: Most caregivers realized that stroke survivors with spasticity were not a burden. There was no relationship between the caregiver burden and the bADL of the patients, but the burden was related to daily caregiving hours and stroke that affected the left side of the body.

The negative impact of spasticity on the health-related quality of life of stroke survivors: a longitudinal cohort study.

BACKGROUND: Spasticity often leads to symptomatic and functional problems that can cause disability for stroke survivors. We studied whether spasticity has a negative impact on health-related quality of life (HRQoL). METHODS: As part of the Greater Cincinnati/Northern Kentucky Stroke Study (NCT00642213), 460 ischemic stroke patients were interviewed during hospitalization and then followed over time. HRQoL was measured by the Physical Component Summary (PCS) and Mental Component Summary (MCS) scores of the Short Form-12 (SF-12), EuroQol-5 dimension (EQ-5D), and Stroke-Specific Quality of Life (SSQOL) instruments, with lower scores indicating worse health. HRQoL differences between stroke survivors with and without spasticity were compared, adjusting for age, race, stroke severity, pre-stroke function, and comorbidities. RESULTS: Of the 460 ischemic stroke patients, 328 had spasticity data available 3 months after their stroke (mean age of 66 years, 49% were female, and 26% were black). Of these patients, 54 (16%) reported having spasticity. Three months following their stroke, patients who reported spasticity had lower mean scores on the PCS (29.6 ± 1.4 vs 37.3 ± 0.6; P < .001), EQ-5D (0.59 ± 0.03 vs 0.71 ± 0.01; P < .001), and SSQOL (3.57 ± 0.08 versus 3.78 ± 0.03; P = .03) compared with patients who did not report spasticity. Lower HRQoL scores were also observed at the 1-year (PCS, EQ-5D, and SSQOL) and 2-year (EQ-5D and SSQOL) interviews in those with spasticity compared with those without spasticity. CONCLUSIONS: Statistically and clinically meaningful differences in HRQoL exist between stroke survivors with and without spasticity.

Validity and reliability of the Serbian version of Patient-Reported Impact of Spasticity Measure in multiple sclerosis.

The Patient-Reported Impact of Spasticity Measure (PRISM) has been developed recently to assess the impact of spasticity on quality of life after spinal cord injury. Although PRISM may also be useful in patients with multiple sclerosis (MS), its psychometric properties in MS have not been established and PRISM is currently available only in English. The aims of this cross-sectional study were to translate PRISM into the Serbian language (PRISMSR) and examine its validity (construct, convergent, divergent) and reliability (internal consistency, test-retest reliability) in 48 patients with spasticity because of MS diagnosed at least 1 year earlier and in remission at least 3 months. PRISMSR was administered twice 3 days apart. The validity of seven PRISMSR subscales was examined against the Modified Ashworth Scale (MAS), the Numerical Rating Scale (NRS) for spasticity, sex, and education. Internal consistency was assessed with Cronbach α and test-retest reliability with intraclass correlation coefficient for agreement (ICC2,1). During the forward-backward translation, only one PRISM item required minor cultural adaption. Almost all PRISMSR scores correlated significantly with MAS and NRS scores (r=0.29-0.51, 0.001≤P≤0.043). They were all significantly higher for MAS≥2 group versus the MAS<2 group (0.003≤P≤0.035) and for the NRS≥7 group versus the NRS<7 group (0.001≤P≤0.042), except for the Social Embarrassment subscale (P=0.083). The PRISMSR scores were not significantly different between sexes (P≥0.104) or those with high school versus college degree (P≥0.139). Both Cronbach α (0.78-0.93) and test-retest ICC2,1 (0.82-0.90) were high. The original PRISM may be translated successfully into other languages. PRISMSR shows adequate validity and reliability for assessing the impact of spasticity on quality of life in patients with MS.

Placebo effects in a multiple sclerosis spasticity enriched clinical trial with the oromucosal cannabinoid spray (THC/CBD): dimension and possible causes.

Regulatory authorities admit clinical studies with an initial enrichment phase to select patients that respond to treatment before randomization (Enriched Design Studies; EDSs). The trial period aims to prevent long-term drug exposure risks in patients with limited chances of improvement while optimizing costs. In EDSs for symptom control therapies providing early improvements and without a wash-out period, it is difficult to show further improvements and thus large therapeutic gains versus placebo. Moreover, in trials with cannabinoids, the therapeutic gains can be further biased in the postenrichment randomized phase because of carryover and other effects. The aims of the present review article are to examine the placebo effects in the enrichment and postenrichment phases of an EDS with Δ(9) -tetrahydrocannabinol and cannabidiol (THC/CBD) oromucosal spray in patients with multiple sclerosis (MS) spasticity and to discuss the possible causes of maintained efficacy after randomization in the placebo-allocated patients. The overall mean therapeutic gain of THC/CBD spray over placebo in resistant MS spasticity after 16 weeks can be estimated as a ~1.27-point improvement on the spasticity 0-10 Numerical Rating Scale (NRS; ~-20.1% of the baseline NRS score). We conclude that careful interpretation of the results of EDSs is required, especially when cannabinoid-based medications are being investigated.

MObility ImproVEment with spasticity in multiple sclerosis in Europe: the MOVE 1 EU study.

AIM: using a protocol similar to that of the MOVE 1 study in Germany, the multicenter, observational MOVE 1 EU study examined the burden of multiple sclerosis (MS)-related spasticity in other EU countries (Belgium, Finland, France, Ireland, Norway, Poland and Portugal). MATERIALS & METHODS: A 12-month retrospective chart documentation was combined with questionnaires for physicians and patients at the time of enrollment. A total of 281 patients from neurology departments and MS units formed the per protocol population. RESULTS: in most patients, MS spasticity frequently restricted daily activities and caused some/moderate problems in EQ-5D subdomains of mobility, usual activities and pain/discomfort. Overall, 48% of physicians and 34% of patients were at least partly dissatisfied with the effectiveness of available pharmacotherapy options for MS spasticity. CONCLUSION: Results of the MOVE 1 Germany and MOVE 1 EU studies are aligned and highlight the need to optimize the therapeutic management of patients with MS spasticity across Europe so as to improve their overall well-being and quality of life.

[Multiple sclerosis, neuromyelitis optica and spasticity: control of specific symptoms and quality of life]. / Multiple Sklerose, Neuromyelitis optica und spastische Bewegungsstörungen: Spezifische Symptomkontrolle und Lebensqualität.

Spastic movement disorders show a high lifetime prevalence among patients suffering from multiple sclerosis and neuromyelitis optica. Due to the high number of factors interacting with the individual manifestations of spasticity, its symptomatic treatment affords continuous and careful balancing of therapeutic measures. A trend observed over the past few years is to base symptomatic treatment of MS on subjective assessments of functional disorders rather than on specific individual pathological signs and symptoms. This has led to a more generous and more patient-oriented perspective. Therefore, a detailed analysis, characterisation and evaluation of the individual clinical course of the disease is not only indispensable, but is actually gaining even more importance in avoiding uncontrolled polypharmacy with correspondingly increased risks for side effects.

Intrathecal baclofen improves psychiatric symptoms in spasticity patients.

Symptoms of psychological distress are relatively common in spasticity patients as a result either of the primary central nervous system insult or as a reaction to the ensuing impairment. Intrathecal baclofen (ITB) is an established treatment for the spasticity with an unknown effect on the psychiatric symptoms. In this study, we evaluate the role of ITB in the amelioration of psychological distress symptoms in 15 patients who were not mentally disabled or psychotic. The patients were assessed with the Symptom Check List 90-Revised before and a mean of 12 months after ITB treatment. A significant improvement was noted at the subscales of positive symptoms total and anxiety. The anxiety subscale improvement was correlated with the ITB dose, but not with the reduction in the spasticity. An interesting trend was also noted in the subscales of general severity index, depression, and obsession-compulsion. The results show an additional beneficial effect of ITB and highlight the need of further clarification of the causative mechanism.