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Osteoarthritis clinical trials

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NCT ID: NCT03173989 Completed - Osteoarthritis Hand Clinical Trials

Strategies for Patients With Osteoarthritis, by Using Assistive Technology and Exercises.

Start date: August 2, 2014
Phase: N/A
Study type: Interventional

Introduction: Osteoarthritis is a disabling disease that can affect 6% to 12% of the adult population and more than a third of people over 65 years of age. Considering osteoarthritis of hands, existing research about the therapeutic treatment advocates actions such as (1) joint protection, (2) assistive technology and (3) exercises, however, doubts persist as to their effects. Objective: To verify the functional and analgesic effect of joint protection and energy conservation techniques, assistive technology (orthotics and adaptations) and exercises in the treatment of patients with osteoarthritis of the hands. Method: An epidemiological study in which a total sample of patients with knee osteoarthritis will receive joint protection and energy conservation guidelines. Subsequently, the sample will be divided into two groups, group 1 with radiological signs that suggest osteoarthritis of the hands and 2 with patients with radiological signs and symptoms of osteoarthritis of the hands, who present greater functional limitations in the daily life, being eligible for treatment of Rehabilitation, in which will be used orthosis aiming at the relief of pain, stabilization of the affected joints and the prevention of grievance of deformities and orientations of exercises to maintain muscle strength. Participants will be followed up for two years, evaluated with the Disabilities of the Arm, Shoulder and Hand questionnaire (DASH), Stanford Health Assessment Questionnaire (HAQ), palmar grip strength measured with Jamar dynamometer, key pinch strength, three point pinch strength and pulp pinch strength measured with B & L Pinch-gauge dynamometer. The groups will be divided between 1 and 2, the group 1 will be composed of patients who will only perform the orientations informed in the theoretical and practical classes, while the group 2, besides the orientations will receive orthoses with models such as volar hand rest splints, short thumb stabilization splints, and volar finger splints with nocturnal support, aiming at the relief of the pain, stabilization of the affected joints and the prevention of the appearance / aggravation of deformities. Exercise guidelines for maintenance of muscle strength for thumb and fingers will be performed on patients who present significant improvement of pain.

NCT ID: NCT03172780 Completed - Clinical trials for Osteoarthritis, Knee

A Bioequivalence Study Using Clinical Endpoint for Diclofenac Sodium Gel 1% in Osteoarthritis Knee"

Start date: May 24, 2017
Phase: Phase 3
Study type: Interventional

This randomized, double-blind, three-arm, placebo controlled, bioequivalence study with clinical endpoint has been designed to establish clinical equivalence and safety of Mylan's diclofenac gel in the symptomatic treatment of osteoarthritis of knee compared to Voltaren® gel and to establish superiority in efficacy of both compared to a placebo (vehicle) gel. Male or non-pregnant female aged ≥ 35 years with a clinical diagnosis of osteoarthritis of the knee according to the American College of Rheumatology (ACR) criteria Total study duration for the clinical part will be around 56 days that includes screening period of 28 days and treatment period of 4 weeks.

NCT ID: NCT03167502 Completed - Osteoarthritis Clinical Trials

Performance in Walking in Osteoarthritis Patients

EX-ART
Start date: September 19, 2017
Phase: N/A
Study type: Interventional

Few data exist to date on the effect of eccentric muscle building in knee osteoarthritis. No studies have compared the effect of eccentric versus concentric reinforcement in knee osteoarthritis. Our study aims to show the effectiveness of an eccentric reinforcement. This is a randomized, interventional trial.

NCT ID: NCT03164122 Completed - Osteoarthritis Clinical Trials

EVALUATION OF AN INNOVATIVE TREATMENT FOR RADIOCARPAL OSTEOARTHRITIS USING INTRA-ARTICULAR INJECTION OF A MIXTURE OF AUTOLOGOUS MICROFAT AND AUTOLOGOUS PLATELET-RICH PLASMA

AMIPREP
Start date: May 22, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

Recently, the emergence of biotherapies has allowed the use of intra-articular injections of autologous plasma rich platelet (PRP). Their use is widespread since 2010 and is based on the demonstration that platelets-enriched plasma, by virtue of its growth factors concentration, stimulates in vitro and in vivo cartilage regeneration in preclinical models. Recent literature highlights that these autologous products are very well tolerated by humans. PRP, as an intra-articular injection therapy, seems to be an autologous biological medicine, innovative for cartilage injury reparation and showing good primary results for this indication. Adipose tissue contains stromal-vascular fraction (SVF), in which are located a large proportion of mesenchymal multipotent stem cells (Adipose-derived stem cells, ADSCs) able to differentiate into several cellular lines in vitro and in vivo, including cartilage cells. The association of microfat and PRP is interesting in order to potentiate trophic and regenerative effects on damaged cartilage site. The combination of these two products, respectively rich in autologous multipotent stem cells and growth factors, aims to create an optimal environment for cartilage cells regeneration. Furthermore, microfat semi solid phase is playing the role of a nutritive support matrix which contains and limits the diffusion and resorption of PRP liquid while allowing progressive growth factors release on the injection site. The hypothesis of this project is that standardized injection of an innovative treatment (microfat and autologous PRP) should allow delay the use of invasive surgical therapy in the treatment of wrist osteoarthritis. This minimally invasive treatment could provide a curative second line treatment in case of medical treatment failure.

NCT ID: NCT03164070 Completed - Osteoarthritis Clinical Trials

Study of the Laboratory-based Evaluation of the Degrees of Activity of Osteoarthritis

Start date: July 1, 2016
Phase:
Study type: Observational

This study evaluates laboratory-based method to estimate the degrees of activity of medium and large joint osteoarthritis.

NCT ID: NCT03161093 Completed - Clinical trials for Osteoarthritis, Knee

A Study to Determine the Safety and the Efficacy of Fasinumab Compared to Placebo and Naproxen for Treatment of Adults With Pain From Osteoarthritis of the Knee or Hip

FACT OA1
Start date: August 17, 2017
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to evaluate the efficacy of fasinumab compared with placebo, when administered for up to 16 weeks in patients with pain due to osteoarthritis (OA) of the knee or hip. The secondary objectives of the study are: 1. To evaluate the efficacy of fasinumab compared with naproxen, when administered for up to 16 weeks in patients with pain due to OA of the knee or hip 2. To evaluate the efficacy of fasinumab compared with placebo, when administered for up to 44 weeks in patients with pain due to OA of the knee or hip 3. To assess the safety and tolerability of fasinumab compared with naproxen, when administered for up to 16 weeks in patients with pain due to OA of the knee or hip 4. To assess the safety and tolerability of fasinumab compared with naproxen, when administered for up to 52 weeks in patients with pain due to OA of the knee or hip 5. To assess the safety and tolerability of fasinumab compared with naproxen, when administered for up to 104 weeks in patients with pain due to OA of the knee or hip 6. To evaluate the pharmacokinetic (PK) profile of fasinumab administered to patients with pain due to OA of the knee or hip for up to 52 weeks 7. To evaluate the PK profile of fasimumab administered to patients with pain due to OA of the knee or hip for up to 104 weeks 8. To evaluate the immunogenicity of fasinumab administered to patients with pain due to OA of the knee or hip for up to 52 weeks 9. To evaluate the immunogenicity of fasinumab administered to patients with pain due to OA of the knee or hip for up to 104 weeks 10. To evaluate the efficacy of fasinumab compared with naproxen, when administered for up to 44 weeks in patients with pain due to OA of the knee or hip

NCT ID: NCT03160781 Completed - Knee Osteoarthritis Clinical Trials

Intraosseous PRP for Knee Osteoarthritis: Pilot Study

Start date: January 28, 2014
Phase: Phase 2
Study type: Interventional

The aim of this study was to assess a novel approach to treating severe knee osteoarthritis by targeting synovialmembrane, superficial articular cartilage, synovial fluid, and subchondral bone by combining intra-articular injections and intraosseous infiltrations of platelet rich plasma.This study explored a new strategy consisting of intraosseous infiltrations of platelet rich plasma into the subchondral bone in combination with the conventional intra-articular injection in order to tackle several knee joint tissues simultaneously.

NCT ID: NCT03160287 Completed - Osteoarthritis Clinical Trials

Mobile Motivational Physical Activity Targeted Intervention

MobMPATI
Start date: June 1, 2017
Phase: N/A
Study type: Interventional

More than 50% of older persons with osteoarthritis (OA) experience disrupted sleep and insomnia symptoms of difficulty falling asleep, awakening during the night, and awakening too early and being unable to fall back to sleep. Because OA pain has been implicated in sleep problems and because physical exercise interventions have been found to improve pain and sleep quality, staying physically active during the daytime is likely advantageous in terms of improving sleep. Physical exercise interventions with a duration between 10 and 16 weeks have been shown to improve quality of sleep in older adults with self-reported disrupted sleep. Unfortunately, recent reports show that older adults with OA are mainly sedentary and few meet national guidelines for recommended amounts of daily physical activity. A self-management intervention that integrates use of mobile technology to prompt older adults to be physically active, provides ongoing monitoring of the amount of their physical activity and includes self-efficacy enhancements is a novel non-pharmacological intervention both for prevention and treatment of sleep deficiency in persons with OA. The proposed study will involve delivery of automatic physical activity-focused text messages, a novel sleep self-management diary (SleepTight) and motivational interviewing in participants with OA of the hip or knee (most commonly affected joints). The purpose of this Project is to pilot test a new self-management program: MobMPATI, a multidimensional, tailored intervention for sleep deficiency in for older adults with OA. The specific aims are to: 1. Test the acceptability of MobMPATI for older adults with OA and poor sleep quality as a manifestation of sleep deficiency. 2. Test the feasibility of implementing MobMPATI for older adults with OA, as well as collecting electronic data from the sample. 3. Explore pre/posttest changes in self-efficacy, motivation and sleep deficiency measures [total sleep time (TST) and sleep efficiency (SE)] with the MobMPATI intervention. This study will provide feasibility/acceptability and preliminary data necessary for a larger clinical trial of MobMPATI intervention to encourage physical activity and reduce sedentary behavior in older adults with OA as a way of reducing sleep deficiency. Preliminary testing of the intervention will indicate what measures are more sensitive in promoting self-efficacy and motivation so that a smaller number of outcomes could be monitored to reduce participant burden. This study is the first step in this innovative program of research. The knowledge gained will provide data on the benefit of a potentially cost-effective intervention that could be implemented on a large scale to improve health of older adults with OA.

NCT ID: NCT03155737 Completed - Knee Osteoarthritis Clinical Trials

Self-administered Acupressure for Knee Osteoarthritis: A Pilot Randomized Controlled Trial

Start date: June 1, 2017
Phase: N/A
Study type: Interventional

Objectives: To test the feasibility of the study design and clinical effects of self-administered acupressure on relieving knee osteoarthritis (OA) pain. Hypothesis: self-administered acupressure would have a superior beneficial effect compared to health education control group in terms of pain relief in patients with knee osteoarthritis across the 6-week study period. Design and subjects: A pilot randomized controlled trial. 36 subjects with knee OA will be recruited; 18 per group. All eligible subjects will be randomized to either self-administered acupressure or health education control group in 1:1 ratio. Interventions: Subjects in the self-acupressure group will attend two 1.5 hours training sessions to learn self-acupressure and will practice self-acupressure every morning and night for 6 weeks; subjects in the education control group will receive two 1.5 hours training sessions to learn the health information related to knee OA. Main outcome measures: The primary outcome measure is the numerical rating scale for knee pain. Other measures include Western Ontario and McMaster University Osteoarthritis Index, knees' range of motion (ROM), and SF-6D. Acceptability of the self-acupressure training course will also be evaluated. Data Analysis: Differences in the questionnaire scores and ROM will be examined using a mixed-effects model. Both completer and intention-to-treat analyses will be conducted. Effect sizes will be computed by dividing the difference in means by the pooled standard deviation.

NCT ID: NCT03152578 Completed - Pain Clinical Trials

Topical Use of 20% Beta Caryophyllene Alone And In Combination With 0.025% Capsaicin for Pain Caused by Osteoarthritis Of The Knee

Start date: July 1, 2017
Phase: Phase 2
Study type: Interventional

This study consists of a randomized, double-blind, placebo-controlled crossover trial with open label extension evaluating a topical natural health cream containing ß-caryophyllene alone and in combination with 0.025% capsicum oleoresin against placebo. At the end of the randomized controlled phase of the trial all participants will be given open-label combination cream to be administered over the subsequent 3 weeks. Primary Endpoint: Evaluation of improvement in pain interference as measured by the BPI in individuals who are experiencing pain due to osteoarthritis of the knee. Secondary Endpoints: Secondary endpoints are: Confirmation of safety of the topical cream when used daily over 10 weeks. Further evaluation will include overall patient satisfaction with the products tested.