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Trial registered on ANZCTR


Registration number
ACTRN12617000841370
Ethics application status
Approved
Date submitted
1/06/2017
Date registered
7/06/2017
Date last updated
11/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Clinical trial to evaluate magnetically enhanced ibuprofen delivery in people with knee osteoarthitis
Scientific title
Double-blind, randomized pilot study to evaluate the effect of diamagnetically enhanced transdermal ibuprofen in comparison to placebo on pain and function in individuals with knee osteoarthritis
Secondary ID [1] 292085 0
RC56221
Universal Trial Number (UTN)
U1111-1197-0970
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
osteoarthritis 303526 0
Condition category
Condition code
Musculoskeletal 302938 302938 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The kneeguard patch is a transdermal patch containing ibuprofen 5% (125 mg) in a silicon gel. The patch has a magnetic backing layer made from strontium ferrite crystals encapsulated in a PVC matrix. The patch will be applied 3 times per day for a period of 6 hours. The duration of the trial will be 48 hours. The patch will be applied by the study participant. They will receive reminders from an iPad application when the patch is due to be changed and they will need to indicate in that app when the have re-applied the patch (as a means to monitor adherence).
There will be a minimum washout period of 5 days between test sessions.
Intervention code [1] 298252 0
Treatment: Drugs
Intervention code [2] 298253 0
Treatment: Devices
Comparator / control treatment
The comparator will be a placebo patch containing no ibuprofen and with a non-magnetised backing but otherwise similar in appearance.
Control group
Placebo

Outcomes
Primary outcome [1] 302335 0
VAS rating of pain on movement
Timepoint [1] 302335 0
48 hours
Primary outcome [2] 302336 0
WOMAC pain score
Timepoint [2] 302336 0
48 hours
Primary outcome [3] 302337 0
WOMAC function score
Timepoint [3] 302337 0
48 hours
Secondary outcome [1] 335555 0
VAS resting pain rating
Timepoint [1] 335555 0
48 hours
Secondary outcome [2] 335556 0
Aggregated locomotor function (ALF) test completion time
Timepoint [2] 335556 0
48 hours
Secondary outcome [3] 335557 0
Pressure Pain Threshold asessed using a digital algometer
Timepoint [3] 335557 0
48 hours
Secondary outcome [4] 335605 0
Skin irritation ratings categorized on a 4 point scale according to severity, with 3 indicating skin breakdown (e.g., blistering, raw, breakdown of the skin etc.), 2 indicating minor changes in the skin condition (e.g., dry, flaky, red or rash), 1 indicating symptoms of altered sensation (e.g., itchy, heat, tingling) and 0 indicating no reaction at all.
Timepoint [4] 335605 0
Assessed at 24 hours (by telephone) and 48 hours

Eligibility
Key inclusion criteria
Medically diagnosed painful knee osteoarthritis (Pain rating greater than or equal to 4 of 10) based on ACR guidelines
Minimum age
60 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
history of neurological disorders affecting sensory, motor or cognitive function; recent lower limb injury or surgery; history of other chronic pain disorders; history of Gastric ulcers or renal disease; known or suspected allergy/sensitivity to ibuprofen; known or suspected allergy/sensitivity to adhesive or tape; history of any serious adverse events related to previous NSAID use.

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)
Allocation concealed. Allocation determined by central holder of randomisation schedule.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Analysis of variance.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 16297 0
6845 - Perth

Funding & Sponsors
Funding source category [1] 296616 0
Government body
Name [1] 296616 0
Department of Industry, Innovation and Science
Address [1] 296616 0
Department of Industry, Innovation and Science
GPO Box 2013
Canberra, ACT, 2601
Country [1] 296616 0
Australia
Funding source category [2] 296644 0
Commercial sector/Industry
Name [2] 296644 0
OBJ Ltd
Address [2] 296644 0
284 Oxford St
Leederville
Western Australia 6007
Country [2] 296644 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
GPO Box U1987
Perth, WA 6845
Country
Australia
Secondary sponsor category [1] 295601 0
Individual
Name [1] 295601 0
Prof Tony Wright
Address [1] 295601 0
School of Physiotherapy and Exercise Science
Curtin University
GPO Box U1987
Perth, WA 6845
Country [1] 295601 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297848 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 297848 0
Curtin University
GPO Box U1987
Perth, WA 6845
Ethics committee country [1] 297848 0
Australia
Date submitted for ethics approval [1] 297848 0
09/06/2017
Approval date [1] 297848 0
14/08/2017
Ethics approval number [1] 297848 0
HRE2017-0528

Summary
Brief summary
Osteoarthritis is a long term degenerative disease process that affects the major joints. Osteoarthritis pain and inflammation is often treated using non-steroidal anti-inflammatory drugs (NSAIDs). In some cases these drugs can be applied through the skin to treat the affected joint below. The skin however provides a significant barrier to drug penetration. Various methods can be used to enhance drug penetration through the skin. In this case the method of enhancement will be by using a low level magnetic field (similar to a fridge magnet). The aim of this study is to evaluate changes in pain and function following short term (48 hours) use of ibuprofen (5%), a topical NSAID, administered in a patch with a magnetic backing strip. The magnetic backing is designed to enhance the absorption of ibuprofen. The ibuprofen patch will be compared to a placebo patch containing no drug and no magnetic backing.
The main objective is to determine if the magnetically enhanced ibuprofen patch achieves superior outcomes to placebo in reducing pain and improving function over 48 hours.
The primary hypothesis is that the transdermal ibuprofen magnetic patch will result in significantly lower ratings of pain on movement compared to placebo.
The pilot study will recruit a group of 24 participants with knee osteoarthritis. Each participant will complete 2, 48 hour study periods. At the start of each study period they will have their current pain and function assessed in a University laboratory. Participants will then have a patch containing either ibuprofen or placebo applied to their knee(s). When this testing has been completed they will be given an iPad which they will use to complete further testing over a 48 hour period as they go about their normal activities while wearing the knee patch. The iPad will prompt them to complete a rating of their pain at rest and pain on movement approximately every 2.5 hours and it will remind them to change the patch approximately every five hours. After 48 hours they will return to the research laboratory and complete the other pain and function tests. After an interval of 1 week all participants will return to the laboratory and complete the full 48 hour testing process while wearing the alternative patch (placebo or ibuprofen). Neither the participants nor the researchers will know on which occasion they received the ibuprofen treatment.
It is envisaged that the participants pain levels will be less and their function will be better during the period in which they are wearing the ibuprofen patch. This is a pilot study gathering preliminary data from a relatively small number of participants. The data from the study will be used by the company that has commissioned the research to inform a future large randomised, controlled clinical trial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75254 0
Prof Tony Wright
Address 75254 0
School of Physiotherapy and Exercise Science
Curtin University
GPO Box U1987
Perth, WA 6845
Country 75254 0
Australia
Phone 75254 0
+61 8 9266 3675
Fax 75254 0
Email 75254 0
T.Wright@curtin.edu.au
Contact person for public queries
Name 75255 0
Prof Tony Wright
Address 75255 0
School of Physiotherapy and Exercise Science
Curtin University
GPO Box U1987
Perth, WA 6845
Country 75255 0
Australia
Phone 75255 0
+61 8 9266 3675
Fax 75255 0
Email 75255 0
T.Wright@curtin.edu.au
Contact person for scientific queries
Name 75256 0
Prof Tony Wright
Address 75256 0
School of Physiotherapy and Exercise Science
Curtin University
GPO Box U1987
Perth, WA 6845
Country 75256 0
Australia
Phone 75256 0
+61 8 9266 3675
Fax 75256 0
Email 75256 0
T.Wright@curtin.edu.au

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary