None listed
Conditions
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.
Interventions
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.
Sponsors
The Joint Studio
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
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.
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)
Outcome results
None listed