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Biofreeze and the Effect on Knee Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04351594
Recruitment Status : Recruiting
First Posted : April 17, 2020
Last Update Posted : February 24, 2021
Information provided by (Responsible Party):
Nick Smith, Memorial University of Newfoundland

Brief 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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Drug: Biofreeze 4 % Topical Gel Other: Biofreeze placebo gel Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of a Menthol Gel (Biofreeze) on the Symptoms Associated With Knee Osteoarthritis: a Double-blind Randomized Control Trial.
Actual Study Start Date : November 1, 2020
Estimated Primary Completion Date : November 1, 2021
Estimated Study Completion Date : November 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Topical analgesia (+Menthol)
Biofreeze Topical Gel with active ingredient (Menthol 4%)
Drug: Biofreeze 4 % Topical Gel
Biofreeze gel with active manufactured ingredient (Menthol 4%)
Other Name: Menthol 4% Topical gel

Placebo Comparator: Topical analgesia (-Menthol)
Biofreeze Topical Gel with no active ingredient (Menthol 0%)
Other: Biofreeze placebo gel
Biofreeze gel with no active manufactured to have the same look, feel and odour as Biofreeze topical gel.
Other Name: Placebo gel (Menthol 0%)

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04351594

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Contact: Nick Smith, MD (FRCSC) 709-746-6512
Contact: Justin Murphy, MD, MSc 709-765-2161

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Canada, Newfoundland and Labrador
Memorial University, Faculty of Medicine Department of Surgery Recruiting
St. John's, Newfoundland and Labrador, Canada, A1B3V6
Contact: Nick Smith, MD (FRCSC)    (709)746-6512   
Contact: Justin Murphy, MD, MSc    (709)765-2161   
Sponsors and Collaborators
Memorial University of Newfoundland
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Principal Investigator: Nick Smith, MD (FRCSC) Memorial University Orthopaedic Surgery
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Responsible Party: Nick Smith, Dr. Nicholas Smith MD, MSc, FRCSC, Memorial University of Newfoundland Identifier: NCT04351594    
Other Study ID Numbers: MUN8051
First Posted: April 17, 2020    Key Record Dates
Last Update Posted: February 24, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Investigators plan to share the study results as a whole but no plans to share individual results.

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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
Keywords provided by Nick Smith, Memorial University of Newfoundland:
Pain management
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Dermatologic Agents