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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] 285411 0
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 289385 0
Condition category
Condition code
Musculoskeletal 289715 289715 0 0
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] 287338 0
Treatment: Drugs
Intervention code [2] 291554 0
Treatment: Devices
Intervention code [3] 291555 0
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] 293254 0
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] 293254 0
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] 293255 0
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] 293255 0
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] 310681 0
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] 310681 0
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] 310682 0
11 point Numerical Rating Scale (NRS) for pain: 0 is no pain and 10 is worst pain imaginable.
Timepoint [2] 310682 0
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] 310694 0
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] 310694 0
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] 313920 0
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] 313920 0
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.
Secondary outcome [5] 313921 0
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] 313921 0
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] 313922 0
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] 313922 0
Daily over the two week period.
Secondary outcome [7] 313923 0
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] 313923 0
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?
No
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] 290018 0
Commercial sector/Industry
Name [1] 290018 0
OBJ Limited
Country [1] 290018 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
OBJ Limited
Address
284 Oxford St Leederville WA 6007 Australia
Country
Australia
Secondary sponsor category [1] 288714 0
Individual
Name [1] 288714 0
Bill Vicenzino
Address [1] 288714 0
Faculty of Health Sciences: School of Health and Rehabilitation Sciences: Division of Physiotherapy, University of Queensland, St Lucia, Qld 4072
Country [1] 288714 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291725 0
University of Queensland Medical Research Ethics Committee
Ethics committee address [1] 291725 0
Ethics committee country [1] 291725 0
Australia
Date submitted for ethics approval [1] 291725 0
11/11/2014
Approval date [1] 291725 0
02/02/2015
Ethics approval number [1] 291725 0
2014001527

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40690 0
Prof Bill Vicenzino
Address 40690 0
Room 822, Level 8
Therapies Building 84a
School of Health and Rehab Sciences
The University of Queensland
St Lucia
Brisbane Qld 4072
Country 40690 0
Australia
Phone 40690 0
+61 7 3365 2781
Fax 40690 0
Email 40690 0
[email protected]
Contact person for public queries
Name 40691 0
Bill Vicenzino
Address 40691 0
Room 822, Level 8
Therapies Building 84a
School of Health and Rehab Sciences
The University of Queensland
St Lucia
Brisbane Qld 4072
Country 40691 0
Australia
Phone 40691 0
+61 7 3365 2781
Fax 40691 0
Email 40691 0
[email protected]
Contact person for scientific queries
Name 40692 0
Bill Vicenzino
Address 40692 0
Room 822, Level 8
Therapies Building 84a
School of Health and Rehab Sciences
The University of Queensland
St Lucia
Brisbane Qld 4072
Country 40692 0
Australia
Phone 40692 0
+61 7 3365 2781
Fax 40692 0
Email 40692 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbaseA 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.2019https://dx.doi.org/10.1371/journal.pone.0211999
N.B. These documents automatically identified may not have been verified by the study sponsor.