JMIR Publications

ABSTRACT

Background:

Osteoarthritis (OA) is a disabling condition that affects more than one-third of people over the age of 65. Currently, 80% of these patients report movement limitations, 20% are unable to perform major activities of daily living, and approximately 11% require personal care. In 2014, the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis recommended as the first step in the pharmacological treatment of knee osteoarthritis, a background therapy of chronic symptomatic slow-acting osteoarthritic drugs such as glucosamine sulfate, chondroitin sulfate, and hyaluronic acid. The latter has been extensively evaluated in clinical trials as intra-articular and oral administration. Recent reviews have shown that studies on oral hyaluronic acid generally measure symptoms using only subjective parameters, such as visual analogue scales or quality of life questionnaires. As a result, objective measures are lacking, and data validity is generally impaired.

Objective:

The main goal of this pilot study with oral hyaluronic acid is to evaluate the feasibility of using objective tools as outcomes to evaluate improvements in knee mobility. We propose ultrasound and range of motion measurements with goniometer that could objectively correlate changes in joint mobility with pain reduction, as assessed by the visual analogue scale. The secondary objective is to collect data to estimate the time and budget for the main double-blind study randomized trial. These data may be quantitative (such as enrollment rate per month, number of screening failures, and new potential outcomes) and qualitative (site logistical issues, patient reluctance to enroll, and interpersonal difficulties for investigators).

Methods:

This open-label pilot and feasibility study is conducted in an orthopedic clinic (Timisoara, Romania). The study includes male and female subjects, aged 50-70 years, who have been diagnosed with symptomatic knee osteoarthritis and have experienced mild joint discomfort for at least 6 months. Eight patients must be enrolled and treated with Syalox® 300 Plus (River Pharma, Italy) for eight weeks. It is a dietary supplement containing high molecular weight hyaluronic acid, which has already been marketed in several European countries. Assessments are made at the baseline and final visits.

Results:

The data must be collected between February 2018 and May 2018. It is expected that the results will be published by 2024.

Conclusions:

The data from this pilot study will be used to assess the feasibility of a future randomized clinical trial in OA. In particular, must be evaluated the planned outcomes (ultrasound and Range of Motion), safety, quantitative and qualitative data to estimate in advance the time and budget required for the future main study. Finally, the pilot study should provide preliminary information on the efficacy of the investigational product. Clinical Trial: ClinicalTrials.gov: NCT03421054; https://clinicaltrials.gov/study/NCT03421054?term=NCT03421054&rank=