Self-reported Spasticity Research Articles

Spasticity Experience in Adults with Multiple Sclerosis: An Integrated Conceptual Model

Research Objectives To develop a conceptual model of spasticity in MS that integrates the experience of persons with MS (pwMS) and clinicians, in accordance with Food and Drug Administration guidance on patient-focused drug development. Design Targeted literature review of published articles (2014–2019) and input from three spasticity clinical experts (MC, FB, EFF) followed by one-time interviews with a separate group of three clinicians experienced in spasticity treatment/research and semi-structured interviews with pwMS. Patient interview data were collected until concept saturation (no new information provided on successive interviews). Iterative feedback from the three clinical experts and GW spasticity research team guided further refinements. Setting Phone interviews. Participants Three clinical experts; 3 clinicians experienced in spasticity treatment/research; 20 patients with MS ≥12 months and spasticity ≥6 months. Interventions Not applicable. Main Outcome Measures Key concepts of MS spasticity included objective manifestations; subjective patient experiences; triggers; moderators; physical, functional, emotional, and social impacts; and long-term consequences. Results Of 282 abstracts reviewed, 23 full-text articles were used to develop the draft model. The interviewed pwMS were on average 47.3 years old and had self-reported spasticity for an average 12.3 years. Spasms, pain, and stiffness were spasticity descriptors most frequently endorsed by both pwMS and the literature. Some pwMS had difficulty distinguishing spasticity from other MS symptoms (e.g., muscle weakness, tremor, numbness). Some triggers (e.g., skin lesions, constipation, stress), emotional impacts (e.g., embarrassment, frustration), and long-term consequences of spasticity (e.g., loss of employment or driving ability) were reported by pwMS but not in the recent literature. Conclusions MS Spasticity is complex, multidimensional, and heterogeneous. Clinicians and pwMS may use different descriptors. This integrated conceptual model may enhance future research and management of spasticity in pwMS. Author(s) Disclosures Francois Bethoux has a financial relationship with Adamas Pharmaceuticals, Biogen, Genentech, Greenwich Biosciences, Helius Medical, MedRhythms, Osmotica Pharmaceuticals, Qr8, and Springer Publishing. Michelle Cameron has a financial relationship with Adamas Pharmaceuticals, Greenwich Biosciences, and Helius Medical. William R. Lenderking has a financial relationship with Evidera. Erica Zaiser and Katelyn N. Cutts have a financial relationship with Evidera. Joshua R. Steinerman, Joanne Wagner, and Edelle Field-Fote have a financial relationship with Greeenwich Biosciences. To develop a conceptual model of spasticity in MS that integrates the experience of persons with MS (pwMS) and clinicians, in accordance with Food and Drug Administration guidance on patient-focused drug development. Targeted literature review of published articles (2014–2019) and input from three spasticity clinical experts (MC, FB, EFF) followed by one-time interviews with a separate group of three clinicians experienced in spasticity treatment/research and semi-structured interviews with pwMS. Patient interview data were collected until concept saturation (no new information provided on successive interviews). Iterative feedback from the three clinical experts and GW spasticity research team guided further refinements. Phone interviews. Three clinical experts; 3 clinicians experienced in spasticity treatment/research; 20 patients with MS ≥12 months and spasticity ≥6 months. Not applicable. Key concepts of MS spasticity included objective manifestations; subjective patient experiences; triggers; moderators; physical, functional, emotional, and social impacts; and long-term consequences. Of 282 abstracts reviewed, 23 full-text articles were used to develop the draft model. The interviewed pwMS were on average 47.3 years old and had self-reported spasticity for an average 12.3 years. Spasms, pain, and stiffness were spasticity descriptors most frequently endorsed by both pwMS and the literature. Some pwMS had difficulty distinguishing spasticity from other MS symptoms (e.g., muscle weakness, tremor, numbness). Some triggers (e.g., skin lesions, constipation, stress), emotional impacts (e.g., embarrassment, frustration), and long-term consequences of spasticity (e.g., loss of employment or driving ability) were reported by pwMS but not in the recent literature. MS Spasticity is complex, multidimensional, and heterogeneous. Clinicians and pwMS may use different descriptors. This integrated conceptual model may enhance future research and management of spasticity in pwMS.

A cross-sectional survey of cannabis use by people with MS in Oregon and Southwest Washington

Background: Evidence supports that cannabinoids reduce self-reported spasticity and neuropathic pain in people with MS (PwMS), and legal access to cannabis for medical and recreational use continues to rise. However, there are limited data regarding patterns of cannabis use and perceived benefits of cannabis among PwMS in the US. This study describes the prevalence of cannabis use, routes of administration, perceived benefit of cannabis for MS, and characteristics associated with cannabis use and perception of benefit among a population of PwMS living in two states where cannabis is legal for both medical and recreational use.Methods: A survey about treatments used by PwMS, focusing on complementary and alternative medicine (CAM), was sent to PwMS living in Oregon and Southwest Washington. This survey included questions about current and past cannabis use, route of cannabis administration, and perceived benefits, as well as personal demographics.Results: Of the 1188 returned surveys, 1000 had at least 75% complete survey responses and also completed the questions about current and past cannabis use. Thirty percent (n=303) of respondents reported currently using cannabis, 21% (n=210) used in the past but not currently, and 49% (n=487) had never used cannabis. Among current users, rates of use by smoking, vaping, topicals, tinctures and oils, or edibles were similar (35-46%), and most (59%) reported using multiple routes of administration. Most (64-78%, varying by route) current and past users reported cannabis being very or somewhat beneficial for their MS.The odds of current cannabis use were higher in PwMS who: 1) were younger (OR 2.24 [95% CI 1.39-3.61] for those age 18-40 compared with age >60]; 2) had lower household income (OR 3.94 [95% CI 2.55-6.09] with annual income <$25k compared with those with >$100k); 3) had secondary progressive MS (OR 1.77 [95% CI 1.07-2.92]); and 4) had more than minimal MS disability (OR 2.05 [95% CI 1.03-4.10] for those using a walker compared to those with none/minimal disability). The odds of perceiving cannabis as beneficial for MS were higher in: 1) younger individuals (OR 5.61 [95% CI 2.62-11.98] for those age 18-40 compared with age >60); 2) those with lower household income (OR 3.35 [95% CI 1.65-6.80] with annual income <$25k compared with those with >$100k), 3) those not currently using disease modifying therapies (OR 2.32 [95% CI 1.30-4.13]), and 4) those with the greatest disability (OR 17.96; [95% CI 2.00-161.22]).Conclusion: In this survey, 30% of PwMS reported currently using cannabis for their MS, mostly by multiple routes of administration, and most of these people report this being helpful for their MS. People who were younger, had lower household income, had progressive disease, and had more than minimal disability were more likely to use cannabis and report it was beneficial for their MS. People who were not using disease modifying therapies were also more likely to report benefit from cannabis use.

Pain Prevalence, Severity and Interference in Ambulatory People with Multiple Sclerosis and Self-Reported Spasticity (2925)

Pain Prevalence, Severity and Interference in Ambulatory People with Multiple Sclerosis and Self-Reported Spasticity (2925)

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.

Medical cannabis: What practitioners need to know.

The South African (SA) Constitutional Court recently decriminalised the private cultivation, possession and use of cannabis by adults. Cannabis contains varying amounts of the cannabinoids delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD), depending on various cultivation factors. No commercial plant-derived cannabis products are currently registered by the SA Health Products Regulatory Authority (SAHPRA) for medical use. Such products are therefore unregulated, but are freely available in SA, and may be of inadequate quality and unverified composition, and not guaranteed to be safe or effective. SAHPRA has to date approved only one synthetic medical cannabis product, dronabinol. Evidence supporting benefit from medical cannabis exists for two drug-resistant childhood forms of epilepsy, Dravet syndrome and Lennox-Gastaut syndrome. Adjuvant therapy with medical cannabis can reduce seizure frequency for Lennox-Gastaut syndrome and Dravet syndrome by 18.8% and 22.8%, respectively, and may be beneficial for other rare forms of epilepsy. There is moderate evidence for chemotherapy-induced nausea and vomiting with the synthetic cannabinoids. Multiple sclerosis-associated spasticity showed a small clinical improvement in self-reported spasticity when a purified form of THC/CBD was added to existing therapy. Currently, low-level or no convincing evidence exists for the use of medical cannabis for chronic pain, sleep and weight disorders, and neuropsychiatric disorders. Cannabis is associated with a greater risk of adverse effects than active and placebo controls, and may be involved in clinically significant drug-drug interactions. The evolving regulatory and legal landscape on the use of medical cannabis will guide prescription and recreational use in the coming years.

Cannabis Use in People with Multiple Sclerosis and Self-Reported Spasticity (P5.2-100)

Cannabis Use in People with Multiple Sclerosis and Self-Reported Spasticity (P5.2-100)

A longitudinal study of self-reported spasticity among individuals with chronic spinal cord injury.

A longitudinal study. To describe the prevalence and stability of self-reported spasticity severity in adults with chronic spinal cord injury (SCI) over a 3-year timeframe and examine predictors of severity and change in spasticity severity. The data were collected by mail at a medical university in the Southeastern United States. A total of 1790 adults with chronic SCI responded to two self-report assessments, one between 2007 and 2009 (baseline) and another between 2011 and 2014 (follow-up). Average spasticity severity was measured on a numeric rating scale from 0 (no spasticity) to 10 (spasticity as bad as you can imagine). Frequency of prescription medication use for spasticity in the past year was also reported (never, sometimes/weekly, daily). About 82.5% of participants had spasticity at baseline and 86.5% at follow-up. There was a significant change in spasticity severity (0.9 ± 2.3; p < 0.001), corresponding to a 31% increase in mean severity. Overall, the frequency of medication use did not significantly change. At baseline, 55.6% of participants reported using medications for spasticity in the past year; 54.9% reported use at follow-up. Variables significantly associated with spasticity severity included race/ethnicity, age, and spasticity medication use. Spasticity is highly prevalent after SCI. Though severity is mild on average, a statistically significant increase was observed over a relatively short natural timeframe. The changes observed in spasticity severity categories (mild, moderate, severe) highlight the need to monitor spasticity in individuals with chronic SCI.

A group-delivered self-management program reduces spasticity in people with multiple sclerosis: A randomized, controlled pilot trial.

BackgroundSpasticity affects more than 80% of people with multiple sclerosis (MS), affecting activity, participation, and quality of life. Based on an international guideline, an MS spasticity group education and stretching program, MS Spasticity: Take Control (STC), has been developed.ObjectiveThe objective of this paper is to determine whether STC with home stretching is associated with greater changes in spasticity than usual care (UC), consisting of an illustrated stretching booklet and home stretching but without group instruction or support, in people with MS.MethodsAmbulatory MS patients with self-reported spasticity interfering with daily activities were randomized to STC or UC. Individuals completed questionnaires regarding MS, spasticity, walking, fatigue and mood, and physical measures of spasticity and walking.ResultsThirty-eight of 40 participants completed both assessments. Mean total score and scores on two subscales of the MS Spasticity Scale-88 improved more with STC than with UC (p < 0.03). There was no significant change in the Modified Ashworth Scale in either group. Mean scores on the Modified Fatigue Impact Scale, the Beck Depression Inventory-II, and the physical component of the Multiple Sclerosis Impact Scale-29 showed statistically and clinically significant improvements in the STC group only.ConclusionsParticipation in STC improved self-reported impact of spasticity more than UC and provided encouraging improvements in other measures.

Tolerance and effectiveness of a new dynamic hand-wrist orthosis in chronic stroke patients

To evaluate tolerance of a new dynamic hand-wrist orthosis and effectiveness on the prevention of progressive wrist contracture and spasticity after stroke. Chronic stroke patients (N = 6) with upper limb spasticity, who had not been able to endure a static orthosis, were provided with a custom-made dynamic orthosis. Tolerance of the orthosis was evaluated by the daily wearing time, and self-reported pain and spasticity. Effectiveness was measured by contracture of wrist and finger flexor muscles, upper limb spasticity and use of spasticity treatment. Outcome measures were collected at time of fitting of the dynamic orthosis (baseline) and after three and six months. Five patients could endure the dynamic orthosis without discomfort for 6 hours daily during the 6-month period. Self-reported spasticity and pain decreased significantly (p < 0.05) compared to wearing the static orthosis. In comparison to baseline, the maximum passive wrist extension increased significantly from -29° to -12° (p < 0.05). Although, no significant change in spasticity was measured, the use of Botulinum Toxin injections decreased for two patients. The majority of the included chronic stroke patients tolerated the new dynamic orthosis for at least 6 hours daily and the use significantly reduced wrist contractures in a 6-month period.

Assessment of blinding to treatment allocation in studies of a cannabis-based medicine (Sativex®) in people with multiple sclerosis: a new approach

BackgroundMaintenance of the blind-to-treatment allocation is one of the most important means of avoiding bias in randomised controlled clinical trials. Commonly used methodologies to determine whether patients have become unblinded to treatment allocation are imperfect. This may be of particular concern in studies where outcomes are patient-reported, and with products which have a characteristic adverse event profile. We report the results of an evidence-based statistical approach to exploring the possible impact of unblinding to a cannabis-based medicine (Sativex®) in people with muscle spasticity due to multiple sclerosis.MethodsAll 666 patients included in three Phase III placebo-controlled studies were included in this analysis. The relationship between factors that might permit patients to identify their treatment allocation and the effect of treatment on the self-reported primary outcome measure was investigated using a general linear model where the dependent variable was the change from baseline in patient self-reported spasticity severity, and the various possible explanatory factors were regarded as fixed factors in the model.ResultsThere was no significant relationship between the effect of Sativex® on spasticity and the prior use of cannabis or the incidence of ‘typical’ adverse events. Nor was there any significant relationship between the prior use of cannabis and the incidence of ‘typical’ adverse events, nor between prior use of cannabis and dose of Sativex®.ConclusionsThere is no evidence to suggest that there was widespread unblinding to treatment allocation in these three studies. If any patients did become unblinded, then there is no evidence that this led to bias in the assessment of the treatment difference between Sativex® and Placebo for efficacy, adverse events or study drug dosing. This methodology may be suitable for assessment of the integrity of the blind in other randomized clinical trials

Comparison of the effects of body-weight-supported treadmill training and tilt-table standing on spasticity in individuals with chronic spinal cord injury

ObjectiveDetermine the effects of body-weight-supported treadmill training (BWSTT) and tilt-table standing (TTS) on clinically assessed and self-reported spasticity, motor neuron excitability, and related constructs in individuals with chronic spinal cord injury (SCI).DesignRandom cross-over.MethodsSeven individuals with chronic SCI and spasticity performed thrice-weekly BWSTT for 4 weeks and thrice-weekly TTS for 4 weeks, separated by a 4-week wash-out. Clinical (Modified Ashworth Scale, Spinal Cord Assessment Tool for Spinal reflexes) and self-report (Spinal Cord Injury Spasticity Evaluation Tool, Penn Spasm Frequency Scale) assessments of spasticity, quality of life (Quality of Life Index Spinal Cord Injury Version – III), functional mobility (FIM Motor Subscale), plus soleus H-reflex were measured at baseline, after the first training session and within 2 days of completing each training condition.ResultsIn comparison with TTS, a single session of BWSTT had greater beneficial effects for muscle tone (effect size (ES) = 0.69), flexor spasms (ES = 0.57), and the H/M ratio (ES = 0.50). Similarly, flexor spasms (ES = 0.79), clonus (ES = 0.66), and self-reported mobility (ES = 1.27) tended to benefit more from 4 weeks of BWSTT than of TTS. Participation in BWSTT also appeared to be favorable for quality of life (ES = 0.50). In contrast, extensor spasms were reduced to a greater degree with TTS (ES = 0.68 for single session; ES = 1.32 after 4 weeks).ConclusionWhile both BWSTT and TTS may provide specific benefits with respect to spasticity characteristics, data from this pilot study suggest that BWSTT may result in a broader range of positive outcomes.

Spasticity after traumatic spinal cord injury: Nature, severity, and location

Objective: To assess spasticity in a prevalence population of persons with traumatic spinal cord injury (SCI), and determine the degree of correspondence between self-reported spasticity and investigator-elicited spasticity using the modified Ashworth scale. Design: Survey of a near total (88%) prevalence population. Setting: Outpatient clinic of a university hospital. Patients: A total of 354 individuals with SCI. Main Outcome Measures: The survey includes self-reported symptoms, neurologic examination (American Spinal Injury Association [ASia]classification), physical therapy examination, range of motion (ROM), and complications. Results: Presence of problematic spasticity was significantly correlated with cervical incomplete (ASIA B-D) injury. Reports of beneficial effects of spasticity were significantly less common in women. Self-reported problematic spasticity was significantly correlated with extensor spasticity. Spasticity was elicitable by movement provocation in 60% of the patients reporting spasticity. Significant correlations were found between elicitable spasticity and limited ROM. Conclusion: Flexion, extension, and abduction movements performed with the patient placed in a standardized supine test position are suitable both for test of ROM and degree of spasticity. Spasticity was not elicitable by movement provocation on physical examination in 40% of the patients who reported spasticity, thus indicating that the patient's self-report is an important complement to the clinical assessment. A significant association between spasticity and contractures (reduced ROM) was seen.