The CanPain SCI clinical practice guidelines for rehabilitation management of neuropathic pain after spinal cord injury: 2021 update.

STUDY DESIGN: Clinical practice guidelines. OBJECTIVES: The objective was to update the 2016 version of the Canadian clinical practice guidelines for the management of neuropathic pain in people with spinal cord injury (SCI). SETTING: The guidelines are relevant for inpatient, outpatient and community SCI rehabilitation settings in Canada. METHODS: The guidelines were updated in accordance with the Appraisal of Guidelines for Research and Evaluation II tool. A Steering Committee and Working Group reviewed the relevant evidence on neuropathic pain management (encompassing screening and diagnosis, treatment and models of care) after SCI. The quality of evidence was scored using Grading of Recommendations Assessment, Development and Evaluation (GRADE). A consensus process was followed to achieve agreement on recommendations and clinical considerations. RESULTS: The working group identified and reviewed 46 additional relevant articles published since the last version of the guidelines. The panel agreed on 3 new screening and diagnosis recommendations and 8 new treatment recommendations. Two key changes to these treatment recommendations included the introduction of general treatment principles and a new treatment recommendation classification system. No new recommendations to model of care were made. CONCLUSIONS: The CanPainSCI recommendations for the management of neuropathic pain after SCI should be used to inform practice.

Health Conditions: Effect on Function, Health-Related Quality of Life, and Life Satisfaction After Traumatic Spinal Cord Injury. A Prospective Observational Registry Cohort Study.

OBJECTIVE: To analyze relations among injury, demographic, and environmental factors on function, health-related quality of life (HRQoL), and life satisfaction in individuals with traumatic spinal cord injury (SCI). DESIGN: Prospective observational registry cohort study. SETTING: Specialized acute and rehabilitation SCI centers. PARTICIPANTS: Participants (N=340) from the Rick Hansen Spinal Cord Injury Registry (RHSCIR) who were prospectively recruited from 2004 to 2014 were included. The model cohort participants were 79.1% men, with a mean age of 41.6±17.3 years. Of the participants, 34.7% were motor/sensory complete (ASIA Impairment Scale [AIS] grade A). INTERVENTIONS: None. MAIN OUTCOME MEASURES: Path analysis was used to determine relations among SCI severity (AIS grade and anatomic level [cervical/thoracolumbar]), age at injury, education, number of health conditions, functional independence (FIM motor score), HRQoL (Medical Outcomes Study 36-Item Short-Form Health Survey [Version 2] Physical Component Score [PCS] and Mental Component Score [MCS]), and life satisfaction (Life Satisfaction-11 [LiSat-11]). Model fit was assessed using recommended published indices. RESULTS: Goodness of fit of the model was supported by all indices, indicating the model results closely matched the RHSCIR data. Higher age, higher severity injuries, cervical injuries, and more health conditions negatively affected FIM motor score, whereas employment had a positive effect. Higher age, less education, more severe injuries (AIS grades A-C), and more health conditions negatively correlated with PCS (worse physical health). More health conditions were negatively correlated with a lower MCS (worse mental health), however were positively associated with reduced function. Being married and having higher function positively affected Lisat-11, but more health conditions had a negative effect. CONCLUSIONS: Complex interactions and enduring effects of health conditions after SCI have a negative effect on function, HRQoL, and life satisfaction. Modeling relations among these types of concepts will inform clinicians how to positively effect outcomes after SCI (eg, development of screening tools and protocols for managing individuals with traumatic SCI who have multiple health conditions).

A Delphi-Based Consensus Statement on the Management of Anticoagulated Patients With Botulinum Toxin for Limb Spasticity.

OBJECTIVE: To create a consensus statement on the considerations for treatment of anticoagulated patients with botulinum toxin A (BoNTA) intramuscular injections for limb spasticity. DESIGN: We used the Delphi method. SETTING: A multiquestion electronic survey. PARTICIPANTS: Canadian physicians (N=39) who use BoNTA injections for spasticity management in their practice. INTERVENTIONS: After the survey was sent, there were e-mail discussions to facilitate an understanding of the issues underlying the responses. Consensus for each question was reached when agreement level was ≥75%. MAIN OUTCOME MEASURES: Not applicable. RESULTS: When injecting BoNTA in anticoagulated patients: (1) BoNTA injections should not be withheld regardless of muscles injected; (2) a 25G or smaller size needle should be used when injecting into the deep leg compartment muscles; (3) international normalized ratio (INR) level should be ≤3.5 when injecting the deep leg compartment muscles; (4) if there are clinical concerns such as history of a fluctuating INR, recent bleeding, excessive or new bruising, then an INR value on the day of injection with point-of-care testing or within the preceding 2-3 days should be taken into consideration when injecting deep compartment muscles; (5) the concern regarding bleeding when using direct oral anticoagulants (DOACs) should be the same as with warfarin (when INR is in the therapeutic range); (6) the dose and scheduling of DOACs should not be altered for the purpose of minimizing the risk of bleeding prior to BoNTA injections. CONCLUSIONS: These consensus statements provide a framework for physicians to consider when injecting BoNTA for spasticity in anticoagulated patients. These consensus statements are not strict guidelines or decision-making steps, but rather an effort to generate common understanding in the absence of evidence in the literature.

Prolonged-release fampridine and walking and balance in MS: randomised controlled MOBILE trial.

BACKGROUND: Mobility impairment is a common disability in MS and negatively impacts patients' lives. OBJECTIVE: Evaluate the effect of prolonged-release (PR) fampridine (extended-release dalfampridine in the United States) on self-assessed walking disability, dynamic/static balance and safety in patients with MS. METHODS: MOBILE was a randomised, double-blind, exploratory, placebo-controlled trial. Patients with progressive/relapsing-remitting MS and Expanded Disability Status Scale score of 4.0-7.0 were treated with PR-fampridine or placebo twice daily for 24 weeks. Efficacy endpoints included change from baseline in the 12-item MS Walking Scale (MSWS-12), Timed Up and Go (TUG) test and Berg Balance Scale (BBS). RESULTS: 132 patients were randomised at 24 sites in six countries. PR-fampridine therapy resulted in greater median improvements from baseline in MSWS-12 score, TUG speed and BBS total score versus placebo over 24 weeks. A higher proportion of patients receiving PR-fampridine versus placebo experienced significant improvements at MSWS-12 improvement thresholds ⩾7 (p = 0.0275), ⩾8 (p = 0.0153) and ⩾9 points (p = 0.0088) and TUG speed thresholds ⩾10% (p = 0.0021) and ⩾15% (p = 0.0262). PR-fampridine was well tolerated. CONCLUSIONS: PR-fampridine therapy resulted in early and sustained improvements in broad measures of walking and balance over six months.

Neuropathic pain post spinal cord injury part 1: systematic review of physical and behavioral treatment.

BACKGROUND: Neuropathic pain has various physiologic and psychosocial aspects. Hence, there is a growing use of adjunct nonpharmacological therapy with traditional pharmacotherapy to reduce neuropathic pain post spinal cord injury (SCI). OBJECTIVE: The purpose of this study was to conduct a systematic review of published research on nonpharmacological treatment of neuropathic pain after SCI. METHODS: MEDLINE, CINAHL, EMBASE, and PsycINFO databases were searched for articles addressing nonpharmacological treatment of pain post SCI. Articles were restricted to the English language. Article selection was conducted by 2 independent reviewers with the following inclusion criteria: the subjects participated in a treatment or intervention for neuropathic pain; at least 50% of the subjects had an SCI; at least 3 subjects had an SCI; and a definable intervention was being studied. Data extracted included study design, study type, subject demographics, inclusion and exclusion criteria, sample size, outcome measures, and study results. Randomized controlled trials (RCTs) were assessed for quality using the Physiotherapy Evidence Database (PEDro) assessment scale. Levels of evidence were assigned to each intervention using a modified Sackett scale. RESULTS: The 16 articles selected for this review fell into 1 of 2 categories of nonpharmacological management of pain after SCI: physical and behavioral treatments. The pooled sample size of all studies included 433 participants. Of the 16 studies included, 7 were level 1, 3 were level 2, and 6 were level 4 studies. CONCLUSIONS: Physical interventions demonstrated the strongest evidence based on quality of studies and numbers of RCTs in the nonpharmacological treatment of post-SCI pain. Of these interventions, transcranial electrical stimulation had the strongest evidence of reducing pain. Despite a growing body of literature, there is still a significant lack of research on the use of nonpharmacological therapies for SCI pain.

Neuropathic pain post spinal cord injury part 2: systematic review of dorsal root entry zone procedure.

BACKGROUND: Pharmacotherapy may not sufficiently reduce neuropathic pain in many individuals post spinal cord injury (SCI). The use of alternative therapies such as surgery may be effective in reducing neuropathic pain in these individuals. However, because of the invasive nature of surgery, it is important to examine the evidence for use of this treatment. OBJECTIVE: The purpose of this study was to conduct a systematic review of published literature on the surgical treatment of neuropathic pain after SCI. METHODS: MEDLINE, CINAHL, EMBASE, and PsycINFO databases were searched for articles in which surgical treatment of pain after SCI was examined. Articles were restricted to the English language. Article selection was conducted by 2 independent reviewers with the following inclusion criteria: the subjects participated in a surgical intervention for neuropathic pain; at least 50% of the subjects had an SCI; at least 3 subjects had an SCI; and a definable intervention involving the dorsal root entry zone (DREZ) procedure was used to reduce pain. Data extracted included study design, study type, subject demographics, inclusion and exclusion criteria, sample size, outcome measures, and study results. Randomized controlled trials (RCTs) were assessed for quality using the Physiotherapy Evidence Database (PEDro) assessment scale. Levels of evidence were assigned to each intervention using a modified Sackett scale. RESULTS: Eleven studies met the inclusion criteria. One study provided level 2 evidence, and the rest provided level 4 evidence. The DREZ procedure was shown to be more effective for segmental pain than for diffuse pain after SCI. Further, individuals with conus medullaris level injury were found to have a higher level of neuropathic pain relief than those with cervical, thoracic, or cauda equina injury. CONCLUSIONS: The studies demonstrated that the DREZ procedure may be effective in reducing segmental pain. Hence, DREZ may be important in treatment of neuropathic pain in individuals resistant to less invasive treatments. Because the studies lacked control conditions and examination of long-term effects, there is a need for larger trials with more stringent conditions.

Head pre-cooling improves symptoms of heat-sensitive multiple sclerosis patients.

BACKGROUND: Damage to the central nervous system by Multiple Sclerosis (MS) leads to multiple symptoms, including weakness, ambulatory dysfunction, visual disturbances and fatigue. Heat can exacerbate the symptoms of MS whereas cooling can provide symptomatic relief. Since the head and neck areas are particularly sensitive to cold and cooling interventions, we investigated the effects of cooling the head and neck for 60 minutes on the symptoms of MS. METHODS: We used a double blinded, placebo controlled, cross-over study design to evaluate the effects of head and neck cooling on six heat-sensitive, stable, ambulatory females with MS (Extended Disability Status Scale 2.5-6.5). To isolate the effects of perceived versus physiological cooling, a sham cooling condition was incorporated, where subjects perceived the sensation of being cooled without any actual physiological cooling. Participants visited the clinic three times for 60 minutes of true, sham, or no cooling using a custom head and neck cooling hood, followed by evaluation of ambulation, visual acuity, and muscle strength. Rectal and skin temperature, heart rate, and thermal sensation were measured throughout cooling and testing. RESULTS: Both the true and sham cooling elicited significant sensations of thermal cooling, but only the true cooling condition decreased core temperature by 0.37 °C (36.97 ± 0.21 to 36.60 ± 0.23 °C). True cooling improved performance in the six minute walk test and the timed up-and-go test but not visual acuity or hand grip strength. CONCLUSIONS: Head and neck cooling may be an effective tool in increasing ambulatory capacity in individuals with MS and heat sensitivity.

A systematic review of pharmacologic treatments of pain after spinal cord injury.

OBJECTIVE: To conduct a systematic review of published research on the pharmacologic treatment of pain after spinal cord injury (SCI). DATA SOURCES: MEDLINE, CINAHL, EMBASE, and PsycINFO databases were searched for articles published 1980 to June 2009 addressing the treatment of pain post SCI. Randomized controlled trials (RCTs) were assessed for methodologic quality using the Physiotherapy Evidence Database (PEDro) assessment scale, whereas non-RCTs were assessed by using the Downs and Black (D&B) evaluation tool. A level of evidence was assigned to each intervention by using a modified Sackett scale. STUDY SELECTION: The review included RCTs and non-RCTs, which included prospective controlled trials, cohort, case series, case-control, pre-post studies, and post studies. Case studies were included only when there were no other studies found. DATA EXTRACTION: Data extracted included the PEDro or D&B score, the type of study, a brief summary of intervention outcomes, the type of pain, the type of pain scale, and the study findings. DATA SYNTHESIS: Articles selected for this particular review evaluated different interventions in the pharmacologic management of pain after SCI. Twenty-eight studies met inclusion criteria; there were 21 randomized controlled trials; of these, 19 had level 1 evidence. Treatments were divided into 5 categories: anticonvulsants, antidepressants, analgesics, cannabinoids, and antispasticity medications. CONCLUSIONS: Most studies did not specify participants' types of pain, making it difficult to identify the type of pain being targeted by the treatment. Anticonvulsant and analgesic drugs had the highest levels of evidence and were the drugs most often studied. Gabapentin and pregabalin had strong evidence (5 level 1 RCTs) for effectiveness in treating post-SCI neuropathic pain as did intravenous analgesics (lidocaine, ketamine, and morphine), but the latter only had short-term benefits. Tricyclic antidepressants only showed benefit for neuropathic pain in depressed persons. Intrathecal baclofen reduced musculoskeletal pain associated with spasticity; however, there was conflicting evidence for the reduction in neuropathic pain. Studies assessing the effectiveness of opioids were limited and revealed only small benefits. Cannabinoids showed conflicting evidence in improving spasticity-related pain. Clonidine and morphine when given together had a significant synergistic neuropathic pain-relieving effect.

Dalteparin vs low-dose unfractionated heparin for prophylaxis against clinically evident venous thromboembolism in acute traumatic spinal cord injury: a retrospective cohort study.

BACKGROUND: When venous thromboembolism (VTE) includes deep-vein thrombosis (DVT) and pulmonary embolism (PE), patients with acute traumatic spinal cord injury (SCI) have the highest incidence of VTE among all hospitalized groups, with PE the third most common cause of death. Although low-molecular-weight heparin (LMWH) outperforms low-dose unfractionated heparin (LDUH) in other patient populations, the evidence in SCI remains less robust. OBJECTIVE: To determine whether the efficacy for LMWH shown in previous SCI surveillance studies (eg, routine Doppler ultrasound) would translate into real-world effectiveness in which only clinically evident VTE is investigated (ie, after symptoms or signs present). METHODS: A retrospective cohort study was conducted of 90 patients receiving LMWH dalteparin (5,000 U daily) or LDUH (5,000 U twice daily) for VTE prophylaxis after acute traumatic SCI. The incidence of radiographically confirmed VTE was primarily analyzed, and secondary outcomes included complications of bleeding and heparin-induced thrombocytopenia. RESULTS: There was no statistically significant association (p = 0.7054) between the incidence of VTE (7.78% overall) and the type of prophylaxis received (LDUH 3/47 vs dalteparin 4/43). There was no significant differences in complications, location of VTE, and incidence of fatal PE. Paraplegia (as opposed to tetraplegia) was the only risk factor identified for VTE. CONCLUSIONS: There continues to be an absence of definitive evidence for dalteparin (or other LMWH) over LDUH as the choice for VTE prophylaxis in patients with SCI. Novel approaches to VTE prophylaxis are urgently required for this population, whose risk of fatal PE has not decreased over the last 25 years.

Placebo theory and its implications for research and clinical practice: a review of the recent literature.

Although placebo effect is a common phenomenon in medicine and research, its mechanisms are not well understood. With the advent of modern medicine, placebo became a symbol for an outdated, morally questionable practice implying deceit and paternalism. However, in recent years, there has been an increasing amount of rigorous research into the mechanisms of placebo response and placebo analgesia with most studies coming from the field of pain medicine. New theories on placebo mechanisms have shown that placebo represents the psychosocial aspect of every treatment and the study of placebo is essentially the study of psychosocial context that surrounds the patient. Therefore, its understanding is essential for researchers and all medical practitioners, particularly those dealing with patients suffering from pain, depression, and motor disorders. In this article, we review the theories on placebo mechanisms and discuss their implications for clinical practice and the design of clinical trials.

Does Specialized Inpatient Rehabilitation Affect Whether or Not People with Traumatic Spinal Cord Injury Return Home?

Return to living at home is an important patient-reported outcome following traumatic spinal cord injury (tSCI). Specialized inpatient rehabilitation assists such patients in maximizing function and independence. Our project aim was to describe those patients receiving specialized rehabilitation after tSCI in Canada, and to determine if such rehabilitation improved the likelihood of returning home. This cohort study utilized data from the Rick Hansen Spinal Cord Injury Registry (RHSCIR) to identify patients with tSCI discharged from 1 of 18 participating acute specialized spine facilities between 2011 and 2015 to either 1 of 13 participating specialized rehabilitation facilities, or to another discharge destination. To determine if specialized rehabilitation affected likelihood of returning home, multiple logistic regressions and propensity score matchings were performed to account for age at injury, gender, neurological severity and level, acute length of stay (LOS), and region of residence. The χ2 test was used to compare rate of return home between matched groups. Of the 1599 patients included, 71% received specialized rehabilitation. Receiving specialized rehabilitation was a significant and strong predictor of return to home after controlling for covariates (adjusted odds ratio = 3.1; 95% confidence interval [CI], 1.6-5.9). The rate of return to home was significantly higher in the matched rehabilitation group than the no rehabilitation group (98% vs. 87%, p = 0.0004). For the matched patients, an extra 11 patients returned home for every 100 patients receiving specialized rehabilitation. However, effect of age on returning home requires further investigation. Improving access to specialized rehabilitation could potentially reduce discharges to nursing homes or other non-home destinations.

Advancing research and clinical care in the management of neuropathic pain after spinal cord injury: Key findings from a Canadian summit.

Background: Optimal management of neuropathic pain (NP) is essential to enhancing health-related quality of life for individuals living with spinal cord injury (SCI). A key strategic priority for the Ontario Neurotrauma Foundation (ONF) and Rick Hansen Institute (RHI) is optimizing NP management after SCI. Aims: A National Canadian Summit, sponsored by ONF and RHI, was held to develop a strategic plan to improve NP management after SCI. Methods: In a one-day meeting held in Toronto, Ontario, a multidisciplinary panel of 18 Canadian stakeholders utilized a consensus workshop methodology to (1) describe the current state of the field, (2) create a long-term vision, and (3) identify steps for moving into action. Results: A review of the current state of the field identified strengths including rigourously developed evidence syntheses and practice landscape documentation. Identified gaps included limited evidence on NP hindering recommendation development in evidence syntheses, absence of a national strategy, care silos with limited cross-continuum connections, limited consumer involvement, and limited practice standard implementation. The panel identified key themes for a long-term vision to improve the management of SCI NP in Canada, including establishing an integrated collaborative network; standardized care and outcome evaluation; education; advocacy; and directing resources to innovative solutions. The panel identified the next step as prioritization of areas that will have the greatest impact in a 5-year time frame. Conclusion: A strategic plan outlining a long-term vision to improve management of NP after SCI in Canada was developed and will inform future activities of the sponsors.

Contexte: La gestion optimale de la douleur neuropathique est essentielle à l'amélioration de la qualité de vie liée à la santé des personnes vivant avec une lésion de la moelle épinière. L'une des priorités stratégiques de la Fondation ontarienne de neurotraumatologie et de l'Institut Rick Hansen est l'optimisation de la prise en charge de la douleur neuropathique après une lésion de la moelle épinière.Buts: Un sommet national canadien parrainé par la Fondation ontarienne de neurotraumatologie et l'Institut Rick Hansen a été tenu afin d'élaborer un plan stratégique pour l'amélioration de la gestion de la douleur neuropathique après une lésion de la moelle épinière.Méthodes: Dans le cadre d'une rencontre d'une journée tenue à Toronto, Ontario, un panel multidisciplinaire composé de 18 parties prenantes canadiennes a eu recours à la méthodologie de l'atelier consensuel pour (1) décrire la situation actuelle dans le domaine, (2) définir une vision à long terme et (3) déterminer les étapes à suivre pour passer à l'action.Résultats: Une revue de la situation actuelle dans le domaine a permis d'en répertorier les forces, parmi lesquelles on compte des synthèses de données probantes élaborées avec rigueur et la documentation des pratiques. Les lacunes suivantes ont été répertoriées: des données probantes limitées en ce qui concerne la formulation de recommandations pour empêcher la douleur neuropathique dans les synthèses de données probantes; l'absence de stratégie nationale; un mode de prestation des soins en silos, où les liens entre les continuums sont limités; une participation du consommateur limitée et une mise en œuvre limitée des normes de pratique. Le panel a répertorié les grands thèmes pour élaborer une vision à long terme afin d'améliorer la prise en charge de la douleur neuropathique occasionnée par une lésion de la moelle épinière au Canada, parmi lesquels on compte: l'établissement d'un réseau de collaboration intégré; la normalisation des soins et l'évaluation des résultats; l'éducation; le plaidoyer; et l'attribution de ressources aux solutions novatrices. Le panel a déterminé que la prochaine étape consisterait à prioriser les domaines qui auront le plus de répercussions au cours des cinq prochaines années.Conclusion: Un plan stratégique définissant une vision à long terme pour améliorer la prise en charge de la douleur neuropathique après une lésion de la moelle épinière a été élaboré. Ce plan servira de base aux prochaines activités des promoteurs.

Prolonged-release fampridine treatment improved subject-reported impact of multiple sclerosis: Item-level analysis of the MSIS-29.

Prolonged-release (PR) fampridine is approved to treat walking impairment in persons with multiple sclerosis (MS); however, treatment benefits may extend beyond walking. MOBILE was a phase 2, 24-week, double-blind, placebo-controlled exploratory study to assess the impact of 10mg PR-fampridine twice daily versus placebo on several subject-assessed measures. This analysis evaluated the physical and psychological health outcomes of subjects with progressing or relapsing MS from individual items of the Multiple Sclerosis Impact Scale (MSIS-29). PR-fampridine treatment (n=68) resulted in greater improvements from baseline in the MSIS-29 physical (PHYS) and psychological (PSYCH) impact subscales, with differences of 89% and 148% in mean score reduction from baseline (n=64) at week 24 versus placebo, respectively. MSIS-29 item analysis showed that a higher percentage of PR-fampridine subjects had mean improvements in 16/20 PHYS and 6/9 PSYCH items versus placebo after 24weeks. Post hoc analysis of the 12-item Multiple Sclerosis Walking Scale (MSWS-12) improver population (≥8-point mean improvement) demonstrated differences in mean reductions from baseline of 97% and 111% in PR-fampridine MSIS-29 PHYS and PSYCH subscales versus the overall placebo group over 24weeks. A higher percentage of MSWS-12 improvers treated with PR-fampridine showed mean improvements in 20/20 PHYS and 8/9 PSYCH items versus placebo at 24weeks. In conclusion, PR-fampridine resulted in physical and psychological benefits versus placebo, sustained over 24weeks.