Knee Osteoarthritis Clinical Trial
Official title:
Effect of a Menthol Gel (Biofreeze) on the Symptoms Associated With Knee Osteoarthritis: a Double-blind Randomized Control Trial.
Knee osteoarthritis (OA) is a progressive disease that can be accompanied by considerable joint pain and dysfunction. It is a goal in the medical field to find effective treatments for knee OA that are non-interventional, have minor or no negative side effects, and are relatively easy to administer for the patient and health care professionals. Biofreeze, a topical analgesic containing menthol, is an easily accessible gel, with no known serious negative side effects. If the application of Biofreeze can reduce the pain and dysfunction associated with knee OA, it could be an effective treatment for patients. The objective of the study is to assess how 4 weeks of Biofreeze application to a knee affected by OA effects pain and dysfunction associated with the disease.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | November 1, 2021 |
Est. primary completion date | November 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years to 80 Years |
Eligibility | Inclusion Criteria: 1. Men and women aged 50-80 years 2. Body mass index (BMI) less than 40 3. Knee osteoarthritis of grade one or more according to Kellgren-Lawrence scale 4. Average pain intensity of grade 4 or more on a 10-point visual analogue scale for at least 6 months. 5. Meet clinical and radiographic criteria of the American College of Rheumatology (ACR) for knee OA Exclusion Criteria: 1. Acute arthritis, 2. Rheumatologic diseases 3. Infective arthritis 4. Traumatic arthritis, 5. History of knee replacement surgery 6. Patients receiving multiple corticosteroid injections (Greater than 2 injections) |
Country | Name | City | State |
---|---|---|---|
Canada | Memorial University, Faculty of Medicine Department of Surgery | St. John's | Newfoundland and Labrador |
Lead Sponsor | Collaborator |
---|---|
Memorial University of Newfoundland |
Canada,
Airaksinen OV, Kyrklund N, Latvala K, Kouri JP, Grönblad M, Kolari P. Efficacy of cold gel for soft tissue injuries: a prospective randomized double-blinded trial. Am J Sports Med. 2003 Sep-Oct;31(5):680-4. — View Citation
Bookman AA, Williams KS, Shainhouse JZ. Effect of a topical diclofenac solution for relieving symptoms of primary osteoarthritis of the knee: a randomized controlled trial. CMAJ. 2004 Aug 17;171(4):333-8. — View Citation
Mosavat SH, Masoudi N, Hajimehdipoor H, Emami Meybodi MK, Niktabe Z, Tabarrai M, Ghorat F, Khodadoost M. Efficacy of topical Linum usitatissimum L. (flaxseed) oil in knee osteoarthritis: A double-blind, randomized, placebo-controlled clinical trial. Complement Ther Clin Pract. 2018 May;31:302-307. doi: 10.1016/j.ctcp.2018.03.003. Epub 2018 Mar 14. — View Citation
Topp R, Brosky JA Jr, Pieschel D. The effect of either topical menthol or a placebo on functioning and knee pain among patients with knee OA. J Geriatr Phys Ther. 2013 Apr-Jun;36(2):92-9. doi: 10.1519/JPT.0b013e318268dde1. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy comparison of (Biofreeze) Menthol 4%, Menthol 0% as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), version 3.0 | Endpoint is a non-inferiority statistical comparison. Comparison is based off of analysis of identical questionnaires administered at baseline and at 4 weeks | 4 weeks |
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