None listed
Conditions
Brief summary
Osteoarthritis (OA) is a common problem for many people, with pain and reduced function the main symptoms. As there is no cure and with many treatment interventions still under investigation, current management strategies are focused at reducing pain and improving joint function. These treatment options include medication, surgery, joint replacement, exercise etc. Studies have shown that a history of injury/trauma to a joint increases the risk of developing OA as you age. It has been reported that there is a greater than 5 fold increased risk of developing knee OA in those with a history of knee injury. Those with significant prior knee injury are therefore a key group to target for preventative interventions and are worthy of investigation and development. OA is characterised by wear and tear of the cartilage between the joint surfaces. Clinical trials have reported that the medications “chondroitin sulphate” and “glucosamine sulphate”, when taken orally have some beneficial effects on pain and function although results have been variable. Chondroitin and glucosamine therefore appear to offer potential benefits as a means of limiting the development of OA and have been supported by the recommendations of international guidelines. As issues regarding the effectiveness of these medications taken orally have arisen, alternative methods are being investigated. This study will assess the effectiveness of a newly developed knee guard device and its diamagnetic technology in people with knee injury/ previous knee surgery, who are at increased risk of developing osteoarthritis. Therefore this study endeavours to determine the effectiveness of the knee guard and investigate if the improvement in physical function with the knee guard device is equivalent to the improvement produced by an established non-steroidal anti-inflammatory (NSAID) formulation. AIMS OF STUDY: This study aims to determine if daily use of a knee guard device will improve physical function in individuals who engage in regular exercise but have knee discomfort related to previous knee injury/surgery. The knee guard product is a knee support intended to help users maintain a healthy knee joint and enhance their recovery from injury. It uses diamagnetic force to deliver therapeutic ingredients through the skin and into the body more effectively than creams or oral supplements. Another aim is to determine if the improvement in physical function with the knee guard device is equivalent to the improvement produced by a well-known non-steroidal anti-inflammatory formulation (NSAID gel).
Interventions
The knee guard device is a self-application and wearable device intended to help users maintain a healthy knee joint and enhancing their recovery from injury. Participants assigned to the knee guard device group will be provided with a two week supply of the knee guard device and instructed by a trial physiotherapist on self-administration and wearing for a period of at least 4 hours (and a maximum of 8 hours) each day. The knee guard device consists of a delivery mechanism (diamegnetic repulsio
The knee guard device is a self-application and wearable device intended to help users maintain a healthy knee joint and enhancing their recovery from injury. Participants assigned to the knee guard device group will be provided with a two week supply of the knee guard device and instructed by a trial physiotherapist on self-administration and wearing for a period of at least 4 hours (and a maximum of 8 hours) each day. The knee guard device consists of a delivery mechanism (diamegnetic repulsion technology) in the form of a knee guard, which wraps around the knee (proximal tibia) and holds pods of a specific formulation. The pods are changed daily. The knee guard device uses diamagnetic force to deliver therapeutic ingredients through the skin and into the body more effectively than topical creams or oral supplements. Due to the large molecular weight of the formulation components it is difficult for them to penetrate the outer layers of the skin. Using a specific formulation and patented diamagnetic repulsion technology, the knee guard device offers enhanced bioavailability of the active molecules in the tissue surrounding the knee joint. The maximum magnetic field produced by the knee guard device is only 2.25% of the accepted USA and EU magnetic field exposure standards. The formulation in the pods contains 10mg Glucosamine, 2.5mg Chondroitin Sulphate, 2.5mg Hyaluronic Acid and 40mg Menthol in a gel formulation. Based in in vitro studies 8.8% of the glucosamine dose, 1.2% of the chondroitin dose and 0.32% of the hyaluronic acid dose is delivered through the skin. It is a specifically developed formulation which has received Therapeutic Goods Administration (TGA) approval. Adherence to wearing the knee guard device will be measured by diary and research assistant communication during the two weeks, as well as by an exit questionnaire.
Sponsors
OBJ Limited
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
Male
Age
40 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
Inclusion Criteria: 1. Males aged 40-55 2. Good general health 3. Currently participating in regular physical activity (>2 hrs per week) 4. (a) Prior history of knee injury requiring arthroscopic surgery, and/or, (b) Prolonged history of recurrent knee pain (>2 / 10 on pain numerical rating scale), and/or (c) A diagnosis of mild to moderate knee osteoarthritis.
Exclusion criteria
Exclusion Criteria: 1. patellofemoral joint dysfunction 2. ligamentous deficiency 3. history of cardiac disease 4. history of high blood pressure 5. history of asthma 6. history of diabetes
Outcome results
None listed