Rev. Soc. Esp. Dolor. 2020; 27(2): 78-88 / DOI: 10.20986/resed.2020.3775/2019
Marcos Edgar Fernández-Cuadros, Olga Susana Pérez-Moro, María Jesús Albaladejo-Florin, Sandra Álava
ABSTRACT
Purpose: The objective of the present study is to verify for the first time in the literature the symptomatic and modifying disease effect of ozone (O2-O3) through clinical (pain, function and stiffness), biochemical (C-reactive protein [CRP], erythrocyte sedimentation rate [ESR], uric acid) and radiological improvement (minimum medial and lateral joint space) in a series of patients with osteoarthritis of the knee.
Methods: A prospective quasi-experimental beforeand-after study was performed in 115 patients with knee osteoarthritis Kellgren-Lawrence grade 2 or more. The ozone protocol consisted of 4 sessions (one session / week) of an intra-articular injection of 20 ml of a medical mixture of Oxygen-Ozone (95-5ºC) at a concentration of 20 μg / ml. Outcome variables included clinical (pain, stiffness, and function), biochemical (CRP, ESR, uric acid), and radiological variables (minimal femorotibial joint space).
Results: Mean age of the patients was 64.81 ± 11.22 years. Female patients accounted for 75.6 % (n = 87), with a female / male ratio of 3 : 1. Biochemical-variables: CRP decreased from 0.42 ± 0.54 mg/dL to 0.31 ± 0.33 mg/dL (p = 0.0142). ESR decreased from 14.52 ± 10.14 mm/h to 13.08 ± 8.78 mm/h (p= 0.0014). Serum uric acid decreased from 5.12 ± 1.22 mg/dL to 5.05 ± 1.24 (p = 0.1307).
Clinical variables: Ozone (O2-O3) significantly improved pain, stiffness and function clinical variables (p = 0.0000). Pain measured by VAS was 7.11 ± 1.11 points and decreased significantly to 3.56 ± 1.56 points (p = 0.0000). Before the intervention, WOMAC-pain subscale was 14.3 ± 22.29 points and decreased to 7.13 ± 33.13 points (p = 0.0000), WOMAC-stiffness subscale was 2.73 ± 1.39 points and decreased to 1.16 ± 1.13 points (p = 0.0000), WOMAC-function subscale was 41.66 ± 8, 1 points and improved to 25.29 ± 9.72 points (p = 0.0000).
Radiological variables: In 53 patients analyzed radiologically (according to standardized protocol) at one year of follow-up after ozone treatment, the internal compartment increased significantly from 4.12 ± 1.41 mm to 4.4 ± 1.35 mm (p = 0.0008) and the external compartment increased from 6 ± 1.37 to 6.16 ± 1.4 mm (p = 0.0753).
Conclusions: Intra articular ozone has demonstrated a symptomatic and disease modifying effect in patients with osteoarthritis of the knee, improving pain, function and stiffness; decreasing markers of inflammation (CRP, ESR and uric acid), and increasing the minimal joint space of the medial and lateral component evidenced radiologically. In this study it has been shown that ozone modulates inflammation, decreases pain and stiffness, improves function and has an anabolic effect in patients with osteoarthritis of the knee. No adverse effect has been observed after intra articular infiltrations of ozone.
RESUMEN
Objetivo: El objetivo del presente estudio es verificar por primera vez en la literatura el efecto sintomático y modificador de enfermedad del ozono (O2-O3) mediante la mejoría clínica (dolor, función y rigidez), bioquímica (proteína C-reactiva [PCR], velocidad de sedimentación globular [VSG], ácido úrico) y radiológica (mínimo espacio articular medial y lateral) en una serie de pacientes con artrosis de rodilla.
Material y métodos: Se realizó un estudio cuasiexperimental prospectivo tipo antes y después a 115 pacientes con artrosis de rodilla con Kellgren-Lawrence grado 2 o más. El protocolo de ozono consistió en 4 sesiones (una sesión/semana) de una infiltración intrarticular de 20 ml de una mezcla médica de oxígeno-ozono (95-5 %) a una concentración de 20 μg/ml. Las variables de resultado incluyeron variables clínicas (dolor, rigidez y función), bioquímicas (PCR, VSG, ácido úrico) y radiológicas (mínimo espacio articular femorotibial).
Resultados: La edad media de los pacientes fue de 64.81 ± 11.22 años. Los pacientes femeninos representaron el 75.6 % (n = 87), con una relación mujer/hombre de 3:1.
Variables bioquímicas: la PCR disminuyó de 0.42 ± 0.54 mg/dl a 0.31 ± 0.33 mg/dl (p = 0.0142). La VSG disminuyó sus valores desde 14.52 ± 10.14 mm/h hasta 13.08 ± 8.78 mm/h (p = 0,0014). El ácido úrico en suero disminuyó su valor de 5.12 ± 1.22 mg/dl a 5.05 ± 1.24 (p = 0.1307).
Variables clínicas: el ozono (O2-O3) mejoró significativamente las variables clínicas dolor, rigidez y función (p = 0.0000). El dolor medido por EVA fue de 7.11 ± 1.11 puntos y disminuyó significativamente a 3.56 ± 1.56 puntos (p = 0.0000). Antes de la intervención, la subescala WOMAC-dolor fue de 14.3 ± 2.29 puntos y disminuyó a 7.13 ± 3.13 puntos (p = 0.0000), la subescala WOMAC-rigidez fue de 2.73 ± 1.39 puntos y disminuyó a 1.16 ± 1.13 puntos (p = 0.0000), la subescala WOMAC-función fue de 41.66 ± 8.1 puntos y mejoró a 25.29 ± 9.72 puntos (p = 0.0000).
Variables radiológicas: en 53 pacientes analizados radiológicamente (según protocolo estandarizado) al año de seguimiento después del tratamiento con ozono, el compartimento interno aumento significativamente de 4.12 ± 1.41 mm a 4.4 ± 1.35 mm (p = 0.0008) y el compartimento externo aumentó de 6 ± 1.37 a 6.16 ± 1.4 mm (p = 0.0753).
Conclusiones: El ozono intrarticular ha demostrado efecto sintomático y modificador de la enfermedad en los pacientes con artrosis de rodilla, mejorando el dolor, la función y la rigidez; disminuyendo los marcadores de inflamación (PCR, VSG y ácido úrico), y aumentando el mínimo espacio articular del componente medial y lateral evidenciado radiológicamente. En este estudio se ha evidenciado que el ozono modula la inflamación, disminuye el dolor y la rigidez, mejora la función y tiene efecto anabólico en los pacientes con artrosis de rodilla. No se ha observado ningún efecto adverso tras las infiltraciones intrarticulares de ozono.
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