Pilot, Open and Non-controlled Trial to Assess the Objective Parameters which Correlate Knee Mobility with Pain Reduction in Patients Affected by Knee Osteoarthritis and Treated with Oral Hyaluronic Acid

Andor, Bogdan Corneliu; Cerbu, Simona; Barattini, Dionisio Franco; Dogaru, Dumitru Emanuel; Dulgheru, Ovidiu; Guadagna, Simone; Rosu, Serban

Bogdan Corneliu Andor, Simona Cerbu, Dionisio Franco Barattini, Dumitru Emanuel Dogaru, Ovidiu Dulgheru, Simone Guadagna, Serban Rosu

Pilot, Open and Non-controlled Trial to Assess the Objective Parameters which Correlate Knee Mobility with Pain Reduction in Patients Affected by Knee Osteoarthritis and Treated with Oral Hyaluronic Acid

Abstract:

The study was in preparation for a future randomized clinical trial (RCT) with oral hyaluronic acid (HA) in knee osteoarthritis. Its purpose was to evaluate the feasibility of i) ultrasonography (US) and range of motion (ROM) parameters as objective measurements to correlate the improvement of knee mobility with its pain reduction; ii) the planned recruitment monthly rate to estimate the resources for the main study. In addition, it should give by US, ROM, visual analogue scale (VAS) and KOOS questionnaire, preliminary data on efficacy. This open-label pilot trial was performed in an orthopedic clinic (Timisoara, Romania). Male and female subjects (from 50 to 70 years) diagnosed with symptomatic OA of the knee with i) mild joint discomfort for at least 6 months, ii) Kellgren/Lawrence score 2 by X-ray, iii) pain for at least 15 of the 30 previous days, were included. Exclusion criteria were: inflammatory arthritic condition; oral corticosteroids within 4 weeks; intra-articular injections of HA or corticosteroids within 3 months; anti-inflammatory or chondroprotective drugs within 2 weeks. Following protocol, 8 patients administered for 8 weeks Syalox® 300 Plus (River Pharma, Italy) a product based on HA of high molecular weight. US parameters improved from baseline, even if no statistically significant differences were found. ROM and VAS (at rest, on moving and on pressing) values improved significantly at week 4 and 8 in comparison with baseline. The correlation between objective improvement of knee mobility and subjective pain reduction was documented. The enrolment rate was 8 patients/month. The KOOS subscales scores evidenced statistically significant differences during the study. No adverse event. US and ROM can be used as objective measurements to correlate improvement of knee mobility with pain reduction. The recruitment capability evidenced a realistic estimation of time and budget for the main study. Preliminary data on efficacy using objective measurements (US, ROM) and subjective parameters (VAS, KOOS questionnaire) showed significant improvements and will be used for sample size calculation in the main study.

Keywords:
Pilot trial; feasibility study; knee osteoarthritis; hyaluronic acid; outcome assessment

Issue: 2019, Volume 70, Issue 9

Pages: 3364-3371

Publication date: 2019/10/15

https://doi.org/10.37358/RC.19.9.7551

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This article is published under the Creative Commons Attribution 4.0 International License

Citation Styles

Cite this article as:
ANDOR, B.C., CERBU, S., BARATTINI, D.F., DOGARU, D.E., DULGHERU, O., GUADAGNA, S., ROSU, S., Pilot, Open and Non-controlled Trial to Assess the Objective Parameters which Correlate Knee Mobility with Pain Reduction in Patients Affected by Knee Osteoarthritis and Treated with Oral Hyaluronic Acid, Rev. Chim., 70(9), 2019, 3364-3371.

Vancouver
Andor BC, Cerbu S, Barattini DF, Dogaru DE, Dulgheru O, Guadagna S, Rosu S. Pilot, Open and Non-controlled Trial to Assess the Objective Parameters which Correlate Knee Mobility with Pain Reduction in Patients Affected by Knee Osteoarthritis and Treated with Oral Hyaluronic Acid. Rev. Chim.[internet]. 2019 Sep;70(9):3364-3371. Available from: https://doi.org/10.37358/RC.19.9.7551

APA 6th edition
Andor, B.C., Cerbu, S., Barattini, D.F., Dogaru, D.E., Dulgheru, O., Guadagna, S. & Rosu, S. (2019). Pilot, Open and Non-controlled Trial to Assess the Objective Parameters which Correlate Knee Mobility with Pain Reduction in Patients Affected by Knee Osteoarthritis and Treated with Oral Hyaluronic Acid. Revista de Chimie, 70(9), 3364-3371. https://doi.org/10.37358/RC.19.9.7551

Harvard
Andor, B.C., Cerbu, S., Barattini, D.F., Dogaru, D.E., Dulgheru, O., Guadagna, S., Rosu, S. (2019). 'Pilot, Open and Non-controlled Trial to Assess the Objective Parameters which Correlate Knee Mobility with Pain Reduction in Patients Affected by Knee Osteoarthritis and Treated with Oral Hyaluronic Acid', Revista de Chimie, 70(9), pp. 3364-3371. https://doi.org/10.37358/RC.19.9.7551

IEEE
B.C. Andor, S. Cerbu, D.F. Barattini, D.E. Dogaru, O. Dulgheru, S. Guadagna, S. Rosu, "Pilot, Open and Non-controlled Trial to Assess the Objective Parameters which Correlate Knee Mobility with Pain Reduction in Patients Affected by Knee Osteoarthritis and Treated with Oral Hyaluronic Acid". Revista de Chimie, vol. 70, no. 9, pp. 3364-3371, 2019. [online]. https://doi.org/10.37358/RC.19.9.7551

Text
Bogdan Corneliu Andor, Simona Cerbu, Dionisio Franco Barattini, Dumitru Emanuel Dogaru, Ovidiu Dulgheru, Simone Guadagna, Serban Rosu,
Pilot, Open and Non-controlled Trial to Assess the Objective Parameters which Correlate Knee Mobility with Pain Reduction in Patients Affected by Knee Osteoarthritis and Treated with Oral Hyaluronic Acid,
Revista de Chimie,
Volume 70, Issue 9,
2019,
Pages 3364-3371,
ISSN 2668-8212,
https://doi.org/10.37358/RC.19.9.7551.
(https://revistadechimie.ro/Articles.asp?ID=7551)
Keywords: Pilot trial; feasibility study; knee osteoarthritis; hyaluronic acid; outcome assessment

RIS
TY - JOUR
T1 - Pilot, Open and Non-controlled Trial to Assess the Objective Parameters which Correlate Knee Mobility with Pain Reduction in Patients Affected by Knee Osteoarthritis and Treated with Oral Hyaluronic Acid
A1 - Andor, Bogdan Corneliu
A2 - Cerbu, Simona
A3 - Barattini, Dionisio Franco
A4 - Dogaru, Dumitru Emanuel
A5 - Dulgheru, Ovidiu
A6 - Guadagna, Simone
A7 - Rosu, Serban
JF - Revista de Chimie
JO - Rev. Chim.
PB - Revista de Chimie SRL
SN - 2668-8212
Y1 - 2019
VL - 70
IS - 9
SP - 3364
EP - 3371
UR - https://doi.org/10.37358/RC.19.9.7551
KW - Pilot trial
KW - feasibility study
KW - knee osteoarthritis
KW - hyaluronic acid
KW - outcome assessment
ER -

BibTex
@article{RevCh2019P3364,
author = {Andor Bogdan Corneliu and Cerbu Simona and Barattini Dionisio Franco and Dogaru Dumitru Emanuel and Dulgheru Ovidiu and Guadagna Simone and Rosu Serban},
title = {Pilot, Open and Non-controlled Trial to Assess the Objective Parameters which Correlate Knee Mobility with Pain Reduction in Patients Affected by Knee Osteoarthritis and Treated with Oral Hyaluronic Acid},
journal = {Revista de Chimie},
volume = {70},
number = {9},
pages = {3364-3371},
year = {2019},
issn = {2668-8212},
doi = {https://doi.org/10.37358/RC.19.9.7551},
url = {https://revistadechimie.ro/Articles.asp?ID=7551}
}

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