Randomised, double-blind, placebo-controlled, parallel-group, multicentric, phase IIA clinical trial for evaluating the safety, tolerability, and therapeutic efficacy of daily oral administration of NFX88 to treat neuropathic pain in individuals with spinal cord injury.

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.

Association between Physiological and Subjective Aspects of Pain and Disability in Post-Stroke Patients with Shoulder Pain: A Cross-Sectional Study.

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.

Shoulder pain and disability index: cross cultural validation and evaluation of psychometric properties of the Spanish version.

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.