Efficacy and safety of combination therapy with aceclofenac and pregabalin, compared with aceclofenac monotherapy for chronic pain in patients with osteoarthritis of the knee joints


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Abstract

Background. In 30% of patients with osteoarthritis of the knee joints, neuroplastic changes occur due to central sensitization, which is the rationale for the appointment of complex therapy, including centrally acting drugs, for more effective pain control. Objective. To evaluate the efficacy and safety of combination therapy with NSAIDs and anticonvulsant (pregabalin) in comparison with NSAID monotherapy in patients with osteoarthritis of the knee joints and signs of central sensitization. Methods. The study included 60 women with osteoarthritis of the knee joints (OAK) with signs of nocyplastic pain, the presence of which was assessed using the DN4 questionnaire (> 4 points). All patients were randomized into two groups of 30 people each: group I received combination therapy with aceclofenac and pregabalin, group II - monotherapy with aceclofenac. The observation period was 42 days. All patients underwent a clinical and neurological examination, the overall WOMAC index was determined, the intensity of pain at rest was assessed using a visual analogue scale (VAS), the presence of nocyplastic pain (DN4 and Pain DETECT questionnaires), a study of the emotional-affective sphere (HADS questionnaire) and quality of life ( EQ-5D questionnaire). Results. The intensity of pain at rest according to VAS in patients of group I significantly decreased after 14 days and even more after 42 days (64.0 [50.0; 72.0] vs 49.0 [33.0; 55.0] vs 33.5 [22.0; 49.0] p=0.006). In group II, the intensity of pain at rest also decreased after 14 days (63.0 [41.0; 72.0] vs 48.0 [35.0; 58.0] p<0.001), however, subsequently, from visits 2 to 3 it did not change significantly (48.0 [35.0; 58.0] vs 44.0 [35.0; 60.0]) (p=0.57). Against the background of the therapy in patients of the 1st group receiving combined treatment, on day 42, the DN4, Pain DETECT and the intensity of pain according to the MAS at rest, as well as the severity of anxiety, significantly decreased compared with the 2nd group. Quality of life indicators (EQ-5D questionnaire) and the general WOMAC index did not differ significantly over time. Conclusion. Combination therapy of chronic pain syndrome with signs of nocyplastic pain with pregabalin and aceclofenac in patients with knee osteoarthritis has been shown to be effective in terms of pain intensity, the presence of neuropathic descriptors and the severity of anxiety compared with aceclofenac alone.

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About the authors

E. S Filatova

V.A. Nasonova Research Institute of Rheumatology

Email: es-filatova@mail.ru

L. I Alekseeva

V.A. Nasonova Research Institute of Rheumatology

E. A Taskina

V.A. Nasonova Research Institute of Rheumatology

N. G Kashevarova

V.A. Nasonova Research Institute of Rheumatology

E. P Sharapova

V.A. Nasonova Research Institute of Rheumatology

A. M Lila

V.A. Nasonova Research Institute of Rheumatology; Russian Medical Academy of Continuing Prefessional Education

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