Search

Study Design: Double-blind, randomized, placebo-controlled, parallel-group multicentric phase IIA clinical trial., Objective: To assess the safety and tolerability of oral administration of NFX-88 in subjects with chronic spinal cord injury (SCI) and explore its efficacy in pain control., Setting: A total of 7 spinal cord injury rehabilitation units in Spain., Methods: A total of 61 adult with traumatic complete or incomplete spinal cord injury (C4-T12 level), were randomised 1:1:1:1 to a placebo, NFX88 1.05 g, 2.1 g, 4.2 g/day for up to 12 weeks. The placebo or NFX-88 was administered as add-on therapy to pre-existing pregabalin (150-300 mg per day). Safety and tolerability were evaluated, and the Visual Analogue Scale (VAS) was the primary measure to explore the efficacy of NFX-88 in pain control., Results: No severe treatment-related adverse effects were reported for any of the four study groups. 44 SCI individuals completed the study and were analysed. The data obtained from the VAS analysis and the PainDETECT Questionnaire (PD-Q) suggested that the combination of NFX88 with pregabalin is more effective than pregabalin with placebo at reducing neuropathic pain (NP) in individuals with SCI and that the dose 2.10 g/day causes the most dramatic pain relief., Conclusions: NFX88 treatment was found to be highly safe and well tolerated, with the dose of 2.10 g/day being the most effective at causing pain relief. Thus, the promising efficacy of this first-in-class lipid mediator deserves further consideration in future clinical trials., (© 2024. The Author(s).)

Objective: The Foot and Ankle Ability Measure (FAAM) is an internationally widely used outcome measure of foot and ankle disorders available in several languages. The purpose of this study was to develop and validate a FAAM Spanish-version with 29 items of Activities of Daily Living (ADL) and SPORT subscales in rehabilitation setting., Materials and Methods: A two-stage observational study was conducted. The FAAM was cross-culturally adapted to Spanish through a double-forward translation and a double-backward translation; the psychometric properties were then validated. The participants (n = 147), with various chronic foot and ankle disorders, completed the Spanish version of the Foot and Ankle Ability Measure ADL and SPORT, SF-36, and a pain intensity visual analogue scale (Pain VAS). The full sample was used to determine the factor structure, the internal consistency, and the convergent criterion validity, and a subgroup (n = 46) was used to determine the reliability at 48-72 h., Results: The factor structure of Spanish version of FAAM ADL and SPORT subscales were both one-dimensional, demonstrating high internal consistency (α = 0.97 and α = 0.93, respectively). The reliability values were ICC = 0.90 and ICC = 0.76, respectively. The convergent validity criterion of Spanish version of FAAM with the Pain VAS (r = 0.50) and Physical Function of SF-36 (r = 0.64) were moderately correlated., Conclusions: The Spanish version of FAAM with 29 items are a valid foot and ankle disorder outcome measure with similar psychometric properties to the original version and versions in other languages., (Copyright © 2021 Sociedad Española de Rehabilitación y Medicina Física. Publicado por Elsevier España, S.L.U. All rights reserved.)

Background: Patients often experience pain as a result of a stroke. However, the mechanism of this pain remains uncertain. Our aim was to investigate the relationship between pressure pain thresholds (PPTs) and disability pain in patients with hemiplegic shoulder pain (HSP). Methods : Twenty-six post-stroke patients (age 53.35 ± 13.09 years) and healthy controls (54.35 ± 12.37 years) participated. We investigated spontaneous shoulder pain, disability pain perception through the shoulder pain and disability index (SPADI), and the PPTs over joint C5-C6, upper trapezius, deltoid, epicondyle, second metacarpal, and tibialis anterior, bilaterally., Results: The analysis of variance (ANOVA) showed significant differences in pain between groups ( p < 0.001) and differences in the SPADI ( p < 0.001) between groups but not between sides for PPTs over deltoid (group: p = 0.007; side: p = 0.750), epicondyle (group: p = 0.001; side: p = 0.848), and tibialis anterior (group: p < 0.001; side: p = 0.932). Pain in the affected arm was negatively associated with PPTs over the affected epicondyle ( p = 0.003) and affected tibialis anterior ( p = 0.009). Pain (SPADI) appeared negatively correlated with PPTs over the affected epicondyle ( p = 0.047), and disability (SPADI) was negatively associated with PPTs over the affected tibialis anterior ( p = 0.041)., Conclusions: Post-stroke patients showed a relationship between widespread pressure pain hypersensitivity with lower PPT levels and pain disability perception, suggesting a central sensitization mediated by bilateral and symmetric pain patterns., Competing Interests: The authors declare no conflict of interest.

Background: The Shoulder Pain Disability Index (SPADI) is a recently published but widely used outcome measure., Methods: This study included 136 patients with shoulder disorders. SPADI was first translated and back-translated and then subjected to psychometric validation. Participants completed the Spanish versions of the SPADI, general health (SF-12), the Simple Shoulder Test (SST), Disability of Arm, Shoulder, and Hand (DASH) questionnaires and a pain intensity visual analog scale (VAS)., Results: The factors explained 62.8 % of the variance, with an internal consistency of α = 0.916 and 0.860, respectively. The confirmatory factor analysis showed a Comparative Fit Index of 0.82 and a Normed Fit Index of 0.80. The Root Mean Square Error of Aproximation was 0.12. The x (2) test for the 2-factor model was significant (x (2) = 185.41, df = 62, p < 0.01). The test-retest reliability was high, with an item ranging of the interclass correlation coefficient (ICC) from 0.89 to 0.93. The ICC for the total score was 0.91 (95 % CI 0.88 to 0.94). Measurement error by minimal detectable change (MDC)95 was 12.2 %. In the construct validity analysis, strong positive correlations were observed between Spanish Version of the SPADI and DASH (pain: r = 0.80; p < 0.01; disability: r = 0.76; p < 0.01). Moderate positive correlations were observed between Spanish Version of the SPADI and VAS (pain: r = 0.67; p < 0.01; disability: r = 0.65; p < 0.01). Moderate negative correlations were obtained between Spanish Version of the SPADI and SST-Sp (pain: r = -0.71; p < 0.01; disability: r = -0.75; p < 0.01). However, pain total Spanish Version of the SPADI was only weakly correlated with physical and mental components of SF-12 (both r = 0.40; p < 0.01)., Conclusions: This Spanish version of SPADI demonstrated satisfactory psychometric properties in a patient sample in the hospital setting.

Background: The Simple Shoulder Test (SST-Sp) is a widely used outcome measure., Objective: The purpose of this study was to develop and validate a Spanish-version SST (SST-Sp)., Methods: A two-stage observational study was conducted. The SST was initially cross-culturally adapted to Spanish through double forward and backward translation and then validated for its psychometric characteristics. Participants (n = 66) with several shoulder disorders completed the SST-Sp, DASH, VAS and SF-12. The full sample was employed to determine factor structure, internal consistency and concurrent criterion validity. Reliability was determined in the first 24-48 h in a subsample of 21 patients., Results: The SST-Sp showed three factors that explained the 56.1% of variance, and the internal consistency for each factor was α = 0.738, 0.723 and 0.667, and reliability was ICC = 0.687-0.944. The factor structure was three-dimensional and supported construct validity. Criterion validity determined from the relationship between the SST-Sp and DASH was strong (r = -0.73; p < 0.001) and fair for VAS (r = -0.537; p < 0.001). Relationships between SST-Sp and SF-12 were weak for both physical (r = -0.47; p < 0.001) and mental (r = -0.43; p < 0.001) dimensions., Conclusions: The SST-Sp supports the findings of the original English version as being a valid shoulder outcome measure with similar psychometric properties to the original English version.

Study Design: A case report., Objective: To present two cases of spinal cord infarction (SCI) in carriers of the C677T methylenetetrahydrofolate reductase (MTHFR) polymorphism., Setting: Physical Medicine and Rehabilitation Department, Section for Rehabilitation and Traumatology, Hospital Virgen de las Nieves, Granada, Spain., Methods: Two cases are presented, one with SCI at the C7 level American Spinal Injury Association (ASIA) A and one at the C5 level (ASIA A). One patient presented an acute onset of tetraplegia and the other a centromedular syndrome. In both cases the patients were carriers of the MTHFR polymorphism, which is a unique risk factor., Results: Increased blood levels of homocysteine related to mutation of the MTHFR gene increase the risk of a thrombotic episode, triggering the development of SCI. These two cases increase the limited number reported in the recent literature regarding MTHFR polymorphism carriers suffering from thrombotic SCI., Conclusion: MTHFR mutation can be considered a risk factor for thrombotic SCI, but it is not the sole risk factor. We propose that a consensus regarding the inclusion of anticoagulation treatment after confirmation of the diagnosis in these patients is needed.