scholarly journals 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

2019 ◽  
Vol 70 (9) ◽  
pp. 3364-3371
Author(s):  
Bogdan Corneliu Andor ◽  
Simona Cerbu ◽  
Dionisio Franco Barattini ◽  
Dumitru Emanuel Dogaru ◽  
Ovidiu Dulgheru ◽  
...  
Keyword(s):  
Hyaluronic Acid ◽  
Knee Osteoarthritis ◽  
Preliminary Data ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Sample Size Calculation ◽  
Pain Reduction ◽  
Main Study ◽  
Open Label ◽  
Objective Measurements

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.

Pilot, open non-controlled trial to assess the feasibility of implementing objective parameters as primary endpoints in a clinical trial with patients affected by knee osteoarthritis. (Preprint)

2019 ◽  
Author(s):  
Bogdan Corneliu Andor ◽  
Dionisio Franco Barattini ◽  
Dumitru Emanuel Dogaru ◽  
Simone Guadagna ◽  
Serban Rosu
Keyword(s):  
Chondroitin Sulphate ◽  
Controlled Trial ◽  
Subjective Evaluation ◽  
Pilot Trial ◽  
Final Visit ◽  
Life Questionnaire ◽  
Quality Of Data ◽  
Open Label ◽  
Objective Measurements

BACKGROUND Osteoarthritis (OA) is one of the top five most disabling conditions and it affects more than one third of persons over 65 years of age. Currently 80% of persons affected by OA already report having some movement limitation, 20% of people are not be able to perform major activities of daily living, and about 11% of the total affected population need of personal care. On 2014 the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) suggested as first step of pharmacological treatment for knee OA a background therapy with chronic symptomatic slow-acting drugs for osteoarthritis (SYSADOAs), such as glucosamine sulphate, chondroitin sulphate and hyaluronic acid (HA). In studies with oral HA, symptoms of OA are often measured using subjective parameters such as the visual analog scale (VAS) or the quality of life questionnaire (QoL) and objective measurements as ultrasonography (US) or range of motion (ROM) are employed in very few trials. This affects the quality of data in the literature. OBJECTIVE The primary objective of this work is to assess the feasibility of implementing US and ROM as objective measurements to correlate the improvement of knee mobility with pain reduction, evaluated using a subjective scale (VAS) in patients assuming a nutraceutical containing HA. The secondary objective is to evaluate the enrollment rate in one month to verify the feasibility for time and budget of the planned future main study. The explorative objective of the trial is to obtain preliminary data on efficacy of the tested product. METHODS This open-label pilot trial is performed in an orthopedic clinic (Timisoara, Romania). Male and female subjects (from 50 to 70 years) diagnosed with symptomatic OA of the knee with mild joint discomfort for at least 6 months are included. Following protocol, 8 patients are administered for 8 weeks Syalox® 300 Plus (River Pharma, Italy), a product based on HA of high molecular weight. Baseline and final visit assessments include orthopedic assessment, US, Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire, VAS and ROM of knee. RESULTS Data collection occurred between February 2018 and June 2018. All results are expected to be available by the end of 2018. CONCLUSIONS This pilot trial will be the first study to analyze the potential correlation between subjective evaluation (VAS, KOOS questionnaire) and objective measurements (US, ROM and actigraphy). The data from this study will assess the feasibility of the planned monthly recruitment rate and the necessary time and budget, and should provide preliminary information on efficacy of the tested product. CLINICALTRIAL ClinicalTrials.gov (NCT number: NCT03421054).

scholarly journals One-year follow-up of efficacy and cost of repeated doses versus single larger dose of intra-articular hyaluronic acid for knee osteoarthritis

2020 ◽  
Vol 28 (1) ◽  
pp. 230949901989502 ◽  
Author(s):  
Vijaya Kumar L Suppan ◽  
Mei Mei Tew ◽  
Bor Chern Wong ◽  
Huan Keat Chan ◽  
Yu Wei Chew ◽  
...  
Keyword(s):  
Hyaluronic Acid ◽  
Single Dose ◽  
Knee Osteoarthritis ◽  
Controlled Trial ◽  
Open Label ◽  
Economic Implications ◽  
Total Treatment ◽  
Repeated Doses ◽  
The Mean

Purpose: A recent 3-month randomized, open-label controlled trial found that the intra-articular hyaluronic acid injection (GO-ON®) given as a single dose of 5 mL is as effective and safe as three repeated doses of 2.5 mL in patients with knee osteoarthritis. However, the information on the long-term efficacy and economic implications of the single-dose regimen is still limited. Hence, this follow-up study was designed to compare the effectiveness and costs of the two regimens 12 months following the treatment. Methods: All the 127 patients, who received either three repeated doses ( n = 64) or a single dose ( n = 63) of GO-ON in the previous trial, were followed up in month 12 following the treatment. The effectiveness of both the regimens was assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and the mean WOMAC scores were compared with those recorded at the baseline and in month 3. Additionally, the total treatment costs of the two regimens, taking account of both direct and indirect costs, were computed and compared. Results: A total of 125 patients (98.4%) completed the assessment. Despite the reduction of the overall mean WOMAC score from 39.24 to 19.93 ( p < 0.001) in the first 3 months following the treatment with GO-ON, no further changes were observed up to month 12 ( p > 0.95). In the meantime, the two regimens did not differ in the mean WOMAC scores ( p = 0.749) and in the subscale scores for pain ( p = 0.970), stiffness ( p = 0.526), and physical functioning ( p = 0.667) in month 12. The cost for single-dose injection was found to be approximately 30% lower compared to the repeated doses. Conclusion: These findings indicate that the single larger dose of GO-ON is as effective as the repeated doses over 12 months, and yet the total treatment cost is lowered.

scholarly journals Randomized controlled trial of convalescent plasma therapy against standard therapy in patients with severe COVID-19 disease

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Manaf AlQahtani ◽  
Abdulkarim Abdulrahman ◽  
Abdulrahman Almadani ◽  
Salman Yousif Alali ◽  
Alaa Mahmood Al Zamrooni ◽  
...  
Keyword(s):  
Standard Therapy ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Severe Disease ◽  
Pilot Trial ◽  
Standard Of Care ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Open Label ◽  
Plasma Therapy

AbstractConvalescent plasma (CP) therapy in COVID-19 disease may improve clinical outcome in severe disease. This pilot study was undertaken to inform feasibility and safety of further definitive studies. This was a prospective, interventional and randomized open label pilot trial in patients with severe COVID-19. Twenty COVID-19 patients received two 200 ml transfusions of convalescent patient CP over 24-h compared with 20 who received standard of care. The primary outcome was the requirement for ventilation (non-invasive or mechanical ventilation). The secondary outcomes were biochemical parameters and mortality at 28 days. The CP group were a higher risk group with higher ferritin levels (p < 0.05) though respiratory indices did not differ. The primary outcome measure was required in 6 controls and 4 patients on CP (risk ratio 0.67, 95% CI 0.22–2.0, p = 0.72); mean time on ventilation (NIV or MV) did not differ. There were no differences in secondary measures at the end of the study. Two patients died in the control and one patient in the CP arm. There were no significant differences in the primary or secondary outcome measures between CP and standard therapy, although a larger definitive study is needed for confirmation. However, the study did show that CP therapy appears to be safe in hospitalized COVID-19 patients with hypoxia.Clinical trials registration NCT04356534: 22/04/2020.

scholarly journals A Guided Internet-Based Problem-Solving Intervention Delivered Through Smartphones for Secondary School Pupils During the COVID-19 Pandemic in India: Protocol for a Pilot Randomized Controlled Trial

10.2196/30339 ◽  
2021 ◽  
Vol 10 (10) ◽  
pp. e30339
Author(s):  
Pattie P Gonsalves ◽  
Rhea Sharma ◽  
Eleanor Hodgson ◽  
Bhargav Bhat ◽  
Abhijeet Jambhale ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Secondary School ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Sample Size Calculation ◽  
Health Intervention ◽  
Mental Health Intervention ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

Background “POD Adventures” is a gamified mental health intervention delivered via a smartphone app and supported by counsellors for a target population of secondary school students in India. This paper describes the protocol for a pilot randomized controlled trial of a remotely delivered version of the intervention in the context of COVID-19 restrictions. Objective Our objectives are to assess the feasibility of research procedures and intervention delivery and to generate preliminary estimates of the effectiveness of the intervention to inform the sample size calculation of a full-scale trial. Methods We will conduct a parallel, 2-arm, individually randomized pilot controlled trial in 11 secondary schools in Goa, India. This pilot trial aims to recruit 70 participants with a felt need for psychological support. Participants will receive either the POD Adventures intervention delivered over 4 weeks or usual care comprising information about local mental health services and national helplines. Outcomes will be assessed at two timepoints: baseline and 6 weeks post randomization. Results The first participant was enrolled on January 28, 2021, and 6-week assessment completed on April 4, 2021. Owing to a second wave of the COVID-19 pandemic in India, schools in Goa were closed on April 22, 2021. Trial participants are currently receiving the intervention or completing follow-up assessments. Conclusions This pilot trial will help understand the feasibility of implementing and evaluating a remotely delivered digital mental health intervention in a low-resource setting. Our findings will be used to design future trials that can address difficulties of accessing psychosocial support in-person and support wider efforts to scale up evidence-based mental health interventions for young people. Trial Registration ClinicalTrials.gov NCT04672486; https://clinicaltrials.gov/ct2/show/NCT04672486 International Registered Report Identifier (IRRID) DERR1-10.2196/30339

scholarly journals A Randomized Controlled Single-Blind Study Demonstrating Superiority of Amniotic Suspension Allograft Injection Over Hyaluronic Acid and Saline Control for Modification of Knee Osteoarthritis Symptoms

2019 ◽  
Vol 32 (11) ◽  
pp. 1143-1154 ◽  
Author(s):  
Jack Farr ◽  
Andreas H. Gomoll ◽  
Adam B. Yanke ◽  
Eric J. Strauss ◽  
Katie C. Mowry ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Hyaluronic Acid ◽  
Knee Osteoarthritis ◽  
Controlled Trial ◽  
Saline Control ◽  
Knee Oa ◽  
Randomized Controlled ◽  
Symptomatic Knee ◽  
Multicenter Randomized Controlled Trial ◽  
Patient Reported

AbstractPlacental-derived tissues are a known source of anti-inflammatory and immune modulating factors. Published pilot data on amniotic suspension allograft (ASA) for the treatment of osteoarthritis (OA) demonstrated safety and trends for improved pain and function. A multicenter randomized controlled trial was designed to evaluate the efficacy of symptom modulation with ASA compared with saline and hyaluronic acid (HA) in subjects with knee OA. A total of 200 subjects were randomized 1:1:1 to ASA, HA, or saline, with subjects blinded to their allocation. Changes from baseline of patient-reported outcomes (PROs)—EQ-5D-5L, Knee Osteoarthritis Outcome Score (KOOS), visual analog scale (VAS), Tegner, and Single Assessment Numerical Evaluation (SANE)—were compared between groups. Patients reporting unacceptable pain at 3 months were considered treatment failures and withdrawn from the study. Statistical analysis was completed by comparing changes in PROs from baseline to 3 and 6 months for all groups. Comparison of demographics between treatment groups showed no significant differences between groups. Patients reporting unacceptable pain at 3 months in each group were ASA (13.2%), HA (68.8%), and saline (75%). Patients receiving ASA demonstrated significantly greater improvements from baseline for overall pain (VAS), KOOS pain, and KOOS-activities of daily living scores compared with those in the HA group (3 months) and both groups (6 months). ASA patients had significantly greater improvements in KOOS symptom scores compared with HA and saline at 3 and 6 months, respectively. OMERACT-OARSI responder rates for ASA, HA, and saline groups were 69.1, 39.1, and 42.6%, respectively (p = 0.0007). Subjects receiving ASA treatment showed greater improvements in PROs and fewer patients reported unacceptable pain compared with HA and saline. The evidence presented in this Level I Randomized Controlled Trial suggests that ASA injection is an effective treatment for the nonoperative management of symptomatic knee OA.

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