Evaluating the effects on function and pain of two gels applied over the knee in people with mild to moderate osteoarthritis: a 2-week randomised control trial. The KnEe Guard (KEG) trial.

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000345583
• Date of registration: 15/04/2015
• Prospective Registration: Yes
• Primary sponsor: OBJ Limited
• Public title: Evaluating the effects on function and pain of two gels applied over the knee in people with mild to moderate osteoarthritis: a 2-week randomised control trial. The KnEe Guard (KEG) trial.
• Scientific title: A comparison between a new knee guard device and an established non-steroidal anti-inflammatory formulation on function and pain in mild to moderate knee osteoarthritis: A pilot randomised controlled equivalence trial.
• Date of first enrolment: 13/07/2015
• Target sample size: 114
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12615000345583.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Phase 2

Countries of recruitment

Australia

Contacts

• Name: Prof Bill Vicenzino

• Name: Prof Bill Vicenzino

Key inclusion & exclusion criteria

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


Age minimum: 40 Years
Age maximum: 55 Years
Gender: Males

Health Condition(s) or Problem(s) studied

knee osteoarthritis;
knee osteoarthritis

Musculoskeletal - Osteoarthritis

Intervention(s)

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

Primary Outcome(s)

Primary Clinical Endpoint: Knee Injury and Osteoarthritis outcome (KOOS) score.

The KOOS is an instrument to assess a patient’s opinion about their knee and associated problems. It is intended for use with knee injury that can result in post-traumatic osteoarthritis. It consists of 5 subscales; pain, other symptoms, function in daily living, function in sport and knee related quality of life. It has high test retest reliability (ICC >0.75). Normalized scores will be calculated for each subscale and a mean normalized score will be calculated for the overall scale. [Testing will be carried out at baseline and at two weeks after treatment commenced.

The primary end point will be after 2 weeks of knee guard or NSAID use.]

Total time required to complete a battery of functional tests.

1.Timed Balsom agility run.
2. Timed step test
3. Timed shuttle run.
4. Timed Stair Climb (walking up and down two flights of stairs)
The total time required to complete all four tests will be recorded as an aggregated function score. The knee guard device and NSAID will not be worn during the testing.

[Testing will be carried out at baseline and at two weeks after treatment commenced.

The primary end point will be after 2 weeks of knee guard or NSAID use.]

Secondary Outcome(s)

Participants will be provided with a diary to record daily any problems associated with application or wearing of the knee guard device or NSAID. This will be a closed ended question (yes or no) 'Have you had any other problems not outlined above with the application or use of the knee guard device or the NSAID. This will be followed by an open ended instruction to explain or provide further information if 'yes' was selected in the closed ended question.[Daily over the two week period.]

Participants will be provided with a diary to record daily any discomfort with usage of the knee guard and NSAID. This will be a closed ended question (yes or no) 'Have you had any discomfort with the use of the knee guard device or the NSAID. This will be followed by an open ended instruction to explain or provide further information if 'yes' was chosen in the closed ended question.
[Daily over the two week period. ]

Participants will be provided with a diary to record daily any side effects associated with the knee guard device. Examples of possible, but very low likelihood, side effects are: stomach upset, constipation, diarrhoea, headaches, rashes.[Daily over the two week period.

*This will be in addition to the instructions on the information sheet that directs the participant to report at any time directly to the investigators any adverse effects.]

11 point Numerical Rating Scale (NRS) for pain: 0 is no pain and 10 is worst pain imaginable.[Participants will record this daily throughout the two weeks after treatment commenced, including at baseline.

The primary end point will be after 2 weeks of knee guard or NSAID use.]

Participants will be contacted by telephone or email on two occasions in the two week period post testing to inquire about any soreness post testing or any side effects related to the medication or device use. This communication will serve to (a) record any issues (which will be used to validate the daily diary entries), (b) answer any queries regarding the application of treatments or use of diaries, and in doing so (c) remind the participant to complete the diary daily. [Two occasions after baseline testing in the two week period. This will occur once in the first week between days 3 and 6, and once in the second week between days 9 and 12.]

Lower Extremity Functional Scale (LEFS).

The LEFS is a 20 item questionnaire about a person’s ability to perform everyday tasks. It assesses activity limitations associated with a lower limb problem. It has high test retest reliability (ICC 0.94). A normalized score will be calculated.[Testing will be carried out at baseline and at two weeks after treatment commenced.

The primary end point will be after 2 weeks of knee guard or NSAID use.]

Participants will be provided with a diary to record daily any side effects associated with usage of the NSAID. Examples of possible side effects in those who do not have contraindications or precautions to NSAID (note: people who have any contraindications or precautions will be excluded from participation) are: heart attack, stroke, high blood pressure, heart failure from body swelling (fluid retention), kidney problems including kidney failure, bleeding and ulcers in the stomach and intestine, low red blood cells (anemia), life-threatening skin reactions, life-threatening allergic reactions, liver problems including liver failure, asthma attacks in people who have asthma, stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting, dizziness. The screening process prior to inclusion of participant into the study will exclude those who are known to be at risk of these side effects.
[Daily over the two week period.

*This will be in addition to the instructions on the information sheet that directs the participant to report at any time directly to the investigators any adverse effects. It is important that the screening process will exclude anyone at risk of any of these side effects.]

Secondary ID(s)

Nil known

Source(s) of Monetary Support

OBJ Limited

Secondary Sponsor(s)

Bill Vicenzino

Ethics review

Status: Approved
Approval date:
Contact:

University of Queensland Medical Research Ethics Committee