- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04351594
Biofreeze and the Effect on Knee Osteoarthritis
February 22, 2021 updated by: Nick Smith, Memorial University of Newfoundland
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Knee osteoarthritis (OA) is a disease which results in deterioration with articular cartilage and bone tissue of the knee joint (Felson et al., 2000).
The disease is prevalent in the elderly and as it progresses, can cause serious joint pain and a lot of knee dysfunction (National Collaborating Centre for Chronic Conditions, 2008).
In addition to surgical intervention, there are currently a multitude of non-surgical interventional treatments which have been used to help patients deal with the pain and dysfunction associated with OA.
This includes exercise, weight loss, orthotics, topical and oral medications, therapeutic modalities and even more (Dadabo, Fram, and Jayabalan, 2019).
While the aforementioned treatments all have advantages, there are some disadvantages including but not limited to; negative side effects of oral medications, exercise intolerance secondary to pain as well as risk of injury, difficulty in maintaining a healthy diet, cost associated with receiving therapeutic modalities, all of which could make the treatments impractical for some or all patients.
It is a goal for health researchers, to discover a treatment which can significantly reduce pain and dysfunction associated with knee OA while also limiting the negative side effects or difficulties associated with using the treatment.
There are a few studies which have looked at the effect of topical treatments on symptoms associated with knee OA.
One study performed a double-blind, randomized, placebo-controlled clinical trial using linseed oil (Mosavat et al., 2018).
This study found that the administration of linseed oil significantly reduced pain and other symptoms associated with knee OA compared to the control.
Another study used a topical non-steroidal anti-inflammatory drug (NSAID) to treat knee OA pain (Bookman, Williams, and Shainhouse, 2004).This study also found that the treatment helped with pain, the drug was accompanied with some local skin irritation and minimal systemic side effects (Bookman et al.,2004).
Biofreeze, a topical analgesic containing menthol, is a relatively cost-efficient item with no known adverse side effects.
If the administration of Biofreeze to a knee affected with OA relieves pain and symptoms associated with OA, it could be a safe and effective treatment for knee OA patients to use.
The primary objective in this study is to assess the affects of a menthol based topical agent on osteoarthritis of the knee.
Outcome measures are based on scores obtained from the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
The WOMAC questionnaire is a patient-administered questionnaire that contains 24 questions, targeting areas of pain, stiffness and physical function, and can be completed in less than 5 minutes.
The questionnaire will be given to the patients at the beginning and at the end of the 4 week study to compare differences.
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Nick Smith, MD (FRCSC)
- Phone Number: 709-746-6512
- Email: nicksmith@munmed.ca
Study Contact Backup
- Name: Justin Murphy, MD, MSc
- Phone Number: 709-765-2161
- Email: jrmurphy@mun.ca
Study Locations
-
-
Newfoundland and Labrador
-
St. John's, Newfoundland and Labrador, Canada, A1B3V6
- Recruiting
- Memorial University, Faculty of Medicine Department of Surgery
-
Contact:
- Nick Smith, MD (FRCSC)
- Phone Number: (709)746-6512
- Email: nicksmith@munmed.ca
-
Contact:
- Justin Murphy, MD, MSc
- Phone Number: (709)765-2161
- Email: jrmurphy@mun.ca
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Men and women aged 50-80 years
- Body mass index (BMI) less than 40
- Knee osteoarthritis of grade one or more according to Kellgren-Lawrence scale
- Average pain intensity of grade 4 or more on a 10-point visual analogue scale for at least 6 months.
- Meet clinical and radiographic criteria of the American College of Rheumatology (ACR) for knee OA
Exclusion Criteria:
- Acute arthritis,
- Rheumatologic diseases
- Infective arthritis
- Traumatic arthritis,
- History of knee replacement surgery
- Patients receiving multiple corticosteroid injections (Greater than 2 injections)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Topical analgesia (+Menthol)
Biofreeze Topical Gel with active ingredient (Menthol 4%)
|
Biofreeze gel with active manufactured ingredient (Menthol 4%)
Other Names:
|
Placebo Comparator: Topical analgesia (-Menthol)
Biofreeze Topical Gel with no active ingredient (Menthol 0%)
|
Biofreeze gel with no active manufactured to have the same look, feel and odour as Biofreeze topical gel.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy comparison of (Biofreeze) Menthol 4%, Menthol 0% as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), version 3.0
Time Frame: 4 weeks
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Nick Smith, MD (FRCSC), Memorial University Orthopaedic Surgery
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Airaksinen OV, Kyrklund N, Latvala K, Kouri JP, Gronblad 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. doi: 10.1177/03635465030310050801.
- 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. doi: 10.1503/cmaj.1031793.
- 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. No abstract available.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2020
Primary Completion (Anticipated)
November 1, 2021
Study Completion (Anticipated)
November 1, 2021
Study Registration Dates
First Submitted
April 15, 2020
First Submitted That Met QC Criteria
April 15, 2020
First Posted (Actual)
April 17, 2020
Study Record Updates
Last Update Posted (Actual)
February 24, 2021
Last Update Submitted That Met QC Criteria
February 22, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MUN8051
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
Investigators plan to share the study results as a whole but no plans to share individual results.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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