Knee OsteoarthritisPhase 2/3NCT04351594
Biofreeze and the Effect on Knee Osteoarthritis
A Phase 2/3 study testing Biofreeze 4 % Topical Gel in people with Knee Osteoarthritis, run by Memorial University of Newfoundland at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Biofreeze 4 % Topical Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2020to 1 Jan 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Acute arthritis,
- Rheumatologic diseases
- Infective arthritis
- Traumatic arthritis,
- History of knee replacement surgery
- Patients receiving multiple corticosteroid injections (Greater than 2 injections)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Memorial University, Faculty of Medicine Department of Surgery
St. John's, Newfoundland and Labrador, A1B3V6
About this study
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.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Biofreeze 4 % Topical Gel, Biofreeze placebo gel
- Keywords
- Osteoarthritis, Pain management, Menthol, Knee
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biofreeze 4 % Topical GelDrug
Also called Menthol 4% Topical gel
Biofreeze gel with active manufactured ingredient (Menthol 4%)
Biofreeze placebo gelOther
Also called Placebo gel (Menthol 0%)
Biofreeze gel with no active manufactured to have the same look, feel and odour as Biofreeze topical gel.
| Study group | Role | What they receive |
|---|---|---|
| Topical analgesia (+Menthol) | Experimental | Biofreeze Topical Gel with active ingredient (Menthol 4%) Receives: Drug: Biofreeze 4 % Topical Gel |
| Topical analgesia (-Menthol) | Placebo comparator | Biofreeze Topical Gel with no active ingredient (Menthol 0%) Receives: Other: Biofreeze placebo gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start1 Nov 2020
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial University of Newfoundland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nick Smith, Memorial University of Newfoundland
- Investigators
- Nick Smith, MD (FRCSC), Principal investigator, Memorial University Orthopaedic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04351594
- Sponsor's protocol ID
- MUN8051
- Status last verified
- Nov 2024
- First submitted
- 15 Apr 2020
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Investigators plan to share the study results as a whole but no plans to share individual results.
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.
PubMed 12975186Bookman 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.
PubMed 15313991Mosavat 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.
PubMed 29705472Topp 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.
PubMed 22976810
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Menthol Gel (Biofreeze) on the Symptoms Associated with Knee Osteoarthritis: a Double-blind Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT04351594
- Acronym / sponsor ID
- MUN8051
- Conditions
- Knee Osteoarthritis
- Keywords
- Osteoarthritis, Pain management, Menthol, Knee
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Memorial University of NewfoundlandUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 17 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topical analgesia (+Menthol) | Experimental | Drug: Biofreeze 4 % Topical GelBiofreeze Topical Gel with active ingredient (Menthol 4%) |
| Topical analgesia (-Menthol) | Placebo comparator | Other: Biofreeze placebo gelBiofreeze Topical Gel with no active ingredient (Menthol 0%) |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- Acute arthritis,
- Rheumatologic diseases
- Infective arthritis
- Traumatic arthritis,
- History of knee replacement surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biofreeze 4 % Topical GelAlso: Menthol 4% Topical gelBiofreeze gel with active manufactured ingredient (Menthol 4%) | Drug | Topical analgesia (+Menthol) |
| Biofreeze placebo gelAlso: Placebo gel (Menthol 0%)Biofreeze gel with no active manufactured to have the same look, feel and odour as Biofreeze topical gel. | Other | Topical analgesia (-Menthol) |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Background: PubMed 12975186Airaksinen 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.
- Background: PubMed 15313991Bookman 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.
- Background: PubMed 29705472Mosavat 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.
- Background: PubMed 22976810Topp 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.
- Individual participant dataSharing planned: No. Investigators plan to share the study results as a whole but no plans to share individual results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nick Smith, MD (FRCSC) principal investigator
Memorial University Orthopaedic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Biofreeze 4 % Topical Gel in people with Knee Osteoarthritis, run by Memorial University of Newfoundland at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04351594, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.