Single-arm open-label study of Durolane (NASHA nonanimal hyaluronic acid) for the treatment of osteoarthritis of the thumb

Eloisa Velasco,1 Mª Victoria Ribera,2 Joan Pi3 1Department of Orthopedic Surgery, Hospital de Sant Joan Despí Moisés Broggi, Barcelona, Spain; 2Department of Anesthesiology, Vall d’Hebron University Hospital, Barcelona, Spain; 3Department of Orthopedics and Traumatology, Parc Taulí University Hospital, Sabadell, Barcelona, Spain Introduction: Osteoarthritis of the trapeziometacarpal (TMC) joint of the thumb – also known as rhizarthrosis – is painful and has a significant impact on quality of life. Intra-articular injection of hyaluronic acid may potentially meet the need for effective, minimally invasive intervention in patients not responding adequately to initial treatment. We aimed to confirm the safety and effectiveness of viscosupplementation with Durolane (NASHA nonanimal hyaluronic acid) in rhizarthrosis.Patients and methods: This was a prospective, single-arm, multicenter, open-label study with a 6-month follow-up period. Eligible patients had Eaton–Littler grade II–III rhizarthrosis in one TMC joint with pain and visual analog scale (VAS) pain score ≥4 (scale: 0–10). A single injection of NASHA was administered to the affected TMC joint. The primary effectiveness variable was change from baseline in VAS pain score.Results: Thirty-five patients (mean age 60.8 years; 85.7% female) received NASHA and completed the study. The least-squares mean change from baseline in VAS pain score over 6 months was –2.00, a reduction of 27.8% (p<0.001). The reduction in pain exceeded 25% as early as month 1 (26.5%), and gradual improvement was observed throughout the 6-month follow-up period. Secondary effectiveness parameters included QuickDASH (shortened version of Disabilities of the Arm, Shoulder, and Hand [DASH]), Kapandji thumb opposition test, radial abduction, metacarpophalangeal (MCP) joint flexion, and pinch (clamp) strength. Most of these measurements showed statistically significant improvements from baseline over 6 months. Five adverse events (injection site reactions) were reported in four patients (11.4%), and there were no serious or allergic reactions.Conclusion: This study suggests that viscosupplementation using NASHA is effective and well tolerated in treating the symptoms of rhizarthrosis. Keywords: Durolane, hyaluronic acid, osteoarthritis, pain, rhizarthrosis, viscosupplementatio

Prevalence of central and peripheral neuropathic pain in patients attending pain clinics in Spain: factors related to intensity of pain and quality of life

Inmaculada Failde,1,2 María Dueñas,2,3 Maria Victoria Ribera,4 Rafael Gálvez,5 Juan A Mico,2,6,7 Alejandro Salazar,2,3 Helena de Sola,1,2 Concepción Pérez8 1Department of Biomedicine, Biotechnology and Public Health, Faculty of Medicine, University of Cádiz, Cádiz, Spain; 2Institute of Research and Innovation in Biomedical Sciences of the Province of Cadiz, Spain; 3Department of Statistics and Operational Research, Faculty of Sciences, University of Cádiz, Cádiz, Spain; 4Pain Clinic, Hospital Vall d’Hebrón, Barcelona, Spain; 5Pain Clinic, Hospital Virgen de las Nieves, Granada, Spain; 6Department of Neuroscience, Pharmacology and Psychiatry, Faculty of Medicine, University of Cádiz, Cádiz, Spain; 7CIBER of Mental Health, CIBERSAM, Instituto de Salud Carlos III, Madrid, Spain; 8Pain Unit, Hospital de la Princesa, Madrid, Spain Background: The objective of the study was to estimate the prevalence of pure central neuropathic pain (CNP) and peripheral neuropathic pain (PNP) among patients attending pain clinics in Spain. The study also aimed to analyze factors associated with pain intensity and quality of life (QoL). Methods: A cross-sectional study was performed including 53 patients with pure CNP and 281 with pure PNP attending in 104 pain clinics in Spain. The revised grading system proposed in 2008 to determine a definite, probable or possible diagnosis of NP was used. Pain features, psychological variables and QoL were assessed. Descriptive, bivariate and multivariate analyses were performed. Results: The prevalence of pure CNP and PNP amongst neuropathic pain patients was 2.4% (95% CI: 1.7;3.1) and 12.9% (95% CI: 1.5;14.3), respectively. Comorbid anxiety, depression or sleep disorders were high in both groups, but higher in CNP patients (51.1%, 71.4%, respectively). Pain intensity in PNP patients was associated with the presence of depression and sleep disturbances. However, in CNP patients, it was related with pain in the lower limbs. The impairment of QoL was greater in CNP patients than in PNP patients; pain location, presence of depression and sleep disturbance were the factors that most negatively affected QoL. Among PNP patients, women and those with higher pain intensity had worse QoL. Conclusion: Pain intensity and QoL are affected by different factors in patients suffering from CNP or PNP. Identifying these factors could serve to guide therapeutic strategies and improve the QoL of patients. Keywords: central neuropathic pain, peripheral neuropathic pain, pain intensity, quality of lif