Effect and usability of anti-inflammatory drug plasters for knee osteoarthritis: A crossover, double-blind, repeated measures, randomized controlled trial.
Journal
Journal of orthopaedic science : official journal of the Japanese Orthopaedic Association
ISSN: 1436-2023
Titre abrégé: J Orthop Sci
Pays: Japan
ID NLM: 9604934
Informations de publication
Date de publication:
May 2021
May 2021
Historique:
received:
29
11
2019
revised:
27
02
2020
accepted:
14
04
2020
pubmed:
11
8
2020
medline:
30
9
2021
entrez:
11
8
2020
Statut:
ppublish
Résumé
The use of plasters is a well-accepted treatment with high adherence. However, the characteristics such as its cool feeling or extensibility favored by elderly have a possibility to contribute to clinical utility. The purpose is to examine the effect of anti-inflammatory drug plasters for knee osteoarthritis and the clinical preference of the patients for using plasters. We conducted a crossover, double-blind, randomized controlled trial (RCT) recruited 168 patients with knee osteoarthritis. We included a "run-in-period" to evaluate the patients' preference among A (first-generation; methyl salicylate), B (second-generation; indomethacin), and N (base substrate for B) before the crossover sequence of two treatment periods with A and B plasters; four arms (N-A-B, A-A-B, N-B-A, and B-B-A) were made to compare the assessment of A, B, and N plasters. We used two measures: The Japanese Knee Osteoarthritis Measure (JKOM), for clinical functions, and the usability questionnaire to evaluate the clinical value of plasters. At baseline, there were no significant differences in characteristics. The subjects in groups A and B showed improved overall JKOM scores at the end of each intervention. Comparison of the change of the mean difference showed that A and B were statistically significant improvement over N (-2.40, (95%CI = -3.58 to -1.21), -2.52, (-3.65 to -1.40)) but no significant difference between A and B - 0.13, (-1.14 to 0.89)). In network analysis for usability, twelve items were independent of JKOM's network structure and consisted of two domains. The analysis of usability showed that N and B were preferred over A significantly. Both the first- and second-generation plasters were statistically superior to the base only, but no significant difference between two generations. The patient is surely aware of the effect of the drug itself, but the two feelings are important in the preference.
Sections du résumé
BACKGROUND
BACKGROUND
The use of plasters is a well-accepted treatment with high adherence. However, the characteristics such as its cool feeling or extensibility favored by elderly have a possibility to contribute to clinical utility. The purpose is to examine the effect of anti-inflammatory drug plasters for knee osteoarthritis and the clinical preference of the patients for using plasters. We conducted a crossover, double-blind, randomized controlled trial (RCT) recruited 168 patients with knee osteoarthritis.
METHODS
METHODS
We included a "run-in-period" to evaluate the patients' preference among A (first-generation; methyl salicylate), B (second-generation; indomethacin), and N (base substrate for B) before the crossover sequence of two treatment periods with A and B plasters; four arms (N-A-B, A-A-B, N-B-A, and B-B-A) were made to compare the assessment of A, B, and N plasters. We used two measures: The Japanese Knee Osteoarthritis Measure (JKOM), for clinical functions, and the usability questionnaire to evaluate the clinical value of plasters.
RESULTS
RESULTS
At baseline, there were no significant differences in characteristics. The subjects in groups A and B showed improved overall JKOM scores at the end of each intervention. Comparison of the change of the mean difference showed that A and B were statistically significant improvement over N (-2.40, (95%CI = -3.58 to -1.21), -2.52, (-3.65 to -1.40)) but no significant difference between A and B - 0.13, (-1.14 to 0.89)). In network analysis for usability, twelve items were independent of JKOM's network structure and consisted of two domains. The analysis of usability showed that N and B were preferred over A significantly.
CONCLUSION
CONCLUSIONS
Both the first- and second-generation plasters were statistically superior to the base only, but no significant difference between two generations. The patient is surely aware of the effect of the drug itself, but the two feelings are important in the preference.
Identifiants
pubmed: 32773325
pii: S0949-2658(20)30134-2
doi: 10.1016/j.jos.2020.04.014
pii:
doi:
Substances chimiques
Anti-Inflammatory Agents
0
Anti-Inflammatory Agents, Non-Steroidal
0
Pharmaceutical Preparations
0
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
421-429Informations de copyright
Copyright © 2020 The Authors. Published by Elsevier B.V. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of Competing Interest All authors declare that they have no competing interests. (Please see COI Disclosure Form).