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Trial registered on ANZCTR


Registration number
ACTRN12619001299190
Ethics application status
Not required
Date submitted
4/09/2019
Date registered
20/09/2019
Date last updated
3/02/2020
Date data sharing statement initially provided
20/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of Topical creams in reducing knee pain:
a double-blinded randomised study
Scientific title
Effectiveness of Topical creams in reducing knee pain:
a double-blinded randomised study
Secondary ID [1] 299183 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
osteoarthritis 314283 0
Condition category
Condition code
Musculoskeletal 312633 312633 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Compound cream ingredients Ketoprofen 10%, amitriptyline 5%, and gabapentin 5% (Cream C)
4mL measured by an actuated pump twice daily applied to the knee for 4 weeks. Remaining product will be weighed at the end of the 4 weeks to gauge adherence.
Intervention code [1] 315475 0
Treatment: Drugs
Comparator / control treatment
Cream ingredients Ketoprofen 10% only (Cream K )
4mL measured by an actuated pump twice daily applied to the knee for 4 weeks
Control group
Active

Outcomes
Primary outcome [1] 321284 0
Knee pain
VAS Score (with anchors 0-10)
Timepoint [1] 321284 0
4 weeks following twice daily application
Secondary outcome [1] 374533 0
Sleep disturbance VAS
Timepoint [1] 374533 0
4 weeks following twice daily application
Secondary outcome [2] 374534 0
Forgotten knee joint scale
Timepoint [2] 374534 0
4 weeks following twice daily application

Eligibility
Key inclusion criteria
Inclusion:
1. The individual has signed a Patient Informed Consent (PIC) specific to this study, and approved by the Institutional Ethics Review Board.
2. The individual is between 18 and 80 years of age.
3. The individual clinically presents with Grade 2 or higher osteoarthritis of the knee OR has undergone uncomplicated primary TKR in the previous 2 weeks.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion:
1. Persistent opioid medication use > 3 months
2. Is pregnant or planning to become pregnant
3. Surgical invention planned in < 2 months
4. Comorbidities of complex pain disorder or severe mobility compromise (eg. complex regional pain syndrome, severe back pain, gout, multiple sclerosis, muscular mystrophy, Parkinson’s disease, morbidly obese, hemiplegic).
5. Known allergy to egg, or ketoprofen
6. Taking blood thinners eg. warfarin, apixaban, ticagrelor, rivaroxaoba, dabigatran
7. The individual is a prisoner, physically or mentally compromised, is unwilling or unable to comply with scheduled evaluations and/or treatment (eg. Vegan unwilling to use egg-based conduit)

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)
Preparations will be labelled with an ID number and issued to participants
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised random assignment schedule
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
De-identified data will be analysed by a statistician team for the calculation of t-statistics, their related p-values and graphical summaries. Mean, median, standard deviation, minimum and maximum data will be presented for quantitative variables and the appropriate parametric and non-parametric statistical analysis performed based on the distribution of the data.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
14/10/2019
Actual
Date of last participant enrolment
Anticipated
14/10/2019
Actual
Date of last data collection
Anticipated
23/12/2019
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 303724 0
Commercial sector/Industry
Name [1] 303724 0
Spearwood 7Day Pharmacy
Country [1] 303724 0
Australia
Primary sponsor type
Other Collaborative groups
Name
The Joint Studio
Address
1/85 Monash Ave
Nedlands, WA 6009
Country
Australia
Secondary sponsor category [1] 303841 0
None
Name [1] 303841 0
None
Address [1] 303841 0
None
Country [1] 303841 0

Ethics approval
Ethics application status
Not required
Ethics committee name [1] 304249 0
Ramsay Health HREC
Ethics committee address [1] 304249 0
Hollywood Private Hospital
Monash Ave
Nedlands, WA 6009
Ethics committee country [1] 304249 0
Australia
Date submitted for ethics approval [1] 304249 0
17/07/2019
Approval date [1] 304249 0
Ethics approval number [1] 304249 0

Summary
Brief summary
The use of compounded topical pain creams to reduce pain and inflammation has increased dramatically, yet their effectiveness has not been well evaluated. This study compares the efficacy of two topical compound cream in reducing acute postoperative and/or chronic arthritic knee pain.
In this double-blind, randomised study we examine two topical creams; Ketoprofen 10% only verses a compound cream (Ketoprofen 10% plus amitriptyline 5%, gabapentin 5%) applied twice a day. Findings of this study will identify which compound combination is more superior in reducing the knee pain in of 2 clinical populations 1) those experiencing postoperative knee pain; and 2) arthritic knee pain.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96282 0
Prof Riaz Khan
Address 96282 0
The Joint Studio
1/85 Monash Ave
Nedlands WA 6009
Country 96282 0
Australia
Phone 96282 0
+61 8 9386 3933
Fax 96282 0
Email 96282 0
[email protected]
Contact person for public queries
Name 96283 0
Samantha Haebich
Address 96283 0
C/ Research Manager
The Joint Studio
1/85 Monash Ave
Nedlands WA 6009
Country 96283 0
Australia
Phone 96283 0
+61 8 64609781
Fax 96283 0
Email 96283 0
[email protected]
Contact person for scientific queries
Name 96284 0
Riaz Khan
Address 96284 0
The Joint Studio
1/85 Monash Ave
Nedlands WA 6009
Country 96284 0
Australia
Phone 96284 0
+61 8 9386 3933
Fax 96284 0
Email 96284 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
No additional documents have been identified.