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Trial registered on ANZCTR

Registration number

ACTRN12615000345583

Ethics application status

Approved

Date submitted

27/03/2015

Date registered

15/04/2015

Date last updated

17/02/2016

Type of registration

Prospectively registered

Titles & IDs

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.

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1162-3893

Trial acronym

The KEG trial

Linked study record

Health condition

Health condition(s) or problem(s) studied:

knee osteoarthritis

Condition category

Condition code

Musculoskeletal

Osteoarthritis

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

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.

Intervention code [1]

Treatment: Drugs

Intervention code [2]

Treatment: Devices

Intervention code [3]

Rehabilitation

Comparator / control treatment

The non steroidal anti inflammatory (NSAID) gel provides relief from ostoarthritic pain. Participants assigned to the NSAID group will be supplied with NSAID medication (diclofenac sodium topical gel) 1% and advised to self-administer it to the affected knee in compliance with the published dosage requirements on a daily basis over the two week trial period. The dosage requires the patient to apply 4g of gel to the affected area 4 times daily (must not exceed 16g per day to this joint and not to be used on other joints or regions).

Adherence to using the NSAiD gel will be measured by diary and research assistant communication during the two weeks, as well as by an exit questionnaire.

Control group

Active

Outcomes

Primary outcome [1]

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.

Timepoint [1]

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.

Primary outcome [2]

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.

Timepoint [2]

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 [1]

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.

Timepoint [1]

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 [2]

11 point Numerical Rating Scale (NRS) for pain: 0 is no pain and 10 is worst pain imaginable.

Timepoint [2]

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.

Secondary outcome [3]

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.

Timepoint [3]

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.

Secondary outcome [4]

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.

Timepoint [4]

Secondary outcome [5]

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.

Timepoint [5]

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 outcome [6]

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.

Timepoint [6]

Daily over the two week period.

Secondary outcome [7]

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.

Timepoint [7]

Daily over the two week period.

Eligibility

Key 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.

Minimum age

40 Years

Maximum age

55 Years

Sex

Males

Can healthy volunteers participate?

Key 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

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Participants will be recruited through an advertising campaign from the general community, sporting clubs and Masters sports groups in the Brisbane metropolitan area. Following initial contact from volunteers, a preliminary telephone interview will determine the participant’s general suitability for the study and arrange an appropriate time for testing. Screening questionnaires will be exchanged by email. Participants will undergo screening to determine their suitability for inclusion in the study. This will include completing the Fitness Australia Adult Pre-Exercise Screening tool. Participants who meet the inclusion criteria, have no exclusion criteria and are classified as low risk on the Pre-Exercise Screening Tool will be asked to provide written informed consent. Allocation will be concealed (opaque sealed envelopes) and generated by a computerised randomisation schedule developed by an off-site independent central trial unit (Queensland Clinical Trial Centre)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

computer generated randomisation schedule

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Phase 2

Type of endpoint/s

Efficacy

Statistical methods / analysis

A sample size of 114 participants will be required to determine a 7% equivalence rate on the KOOS with a 11% SD assuming 90% power and 95% confidence interval. A 10% drop out rate has been included within this sample size.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

21/04/2015

Actual

13/07/2015

Date of last participant enrolment

Anticipated

11/12/2015

Actual

4/12/2015

Date of last data collection

Anticipated

Actual

Sample size

Target

114

Accrual to date

Final

114

Recruitment in Australia

Recruitment state(s)

QLD

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

OBJ Limited

Address [1]

284 Oxford St Leederville WA 6007 Australia

Country [1]

Australia

Primary sponsor type

Commercial sector/Industry

Name

OBJ Limited

Address

284 Oxford St Leederville WA 6007 Australia

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Bill Vicenzino

Address [1]

Faculty of Health Sciences: School of Health and Rehabilitation Sciences: Division of Physiotherapy, University of Queensland, St Lucia, Qld 4072

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Queensland Medical Research Ethics Committee

Ethics committee address [1]

Brisbane, St Lucia QLD 4072

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

11/11/2014

Approval date [1]

02/02/2015

Ethics approval number [1]

2014001527

Summary

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).

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Bill Vicenzino

Address

Room 822, Level 8
Therapies Building 84a
School of Health and Rehab Sciences
The University of Queensland
St Lucia
Brisbane Qld 4072

Country

Australia

Phone

+61 7 3365 2781

Fax

b.vicenzino@uq.edu.au

Contact person for public queries

Name

Bill Vicenzino

Address

Room 822, Level 8
Therapies Building 84a
School of Health and Rehab Sciences
The University of Queensland
St Lucia
Brisbane Qld 4072

Country

Australia

Phone

+61 7 3365 2781

Fax

b.vicenzino@uq.edu.au

Contact person for scientific queries

Name

Bill Vicenzino

Address

Room 822, Level 8
Therapies Building 84a
School of Health and Rehab Sciences
The University of Queensland
St Lucia
Brisbane Qld 4072

Country

Australia

Phone

+61 7 3365 2781

Fax

b.vicenzino@uq.edu.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	A randomised pilot equivalence trial to evaluate diamagnetically enhanced transdermal delivery of key ground substance components in comparison to an established transdermal non-steroidal anti-inflammatory formulation in males with prior knee injury.	2019	https://dx.doi.org/10.1371/journal.pone.0211999

N.B. These documents automatically identified may not have been verified by the study sponsor.

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