Overview

Biofreeze and the Effect on Knee Osteoarthritis

Status:
Recruiting
Trial end date:
2021-11-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Memorial University of Newfoundland
Treatments:
Menthol
Criteria
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)