Knee OsteoarthritisPhase 4NCT03888807
Biofreeze® vs. a Placebo on Knee Osteoarthritis Walking Gait Characteristics and Pain
A Phase 4 study testing Biofreeze in people with Knee Osteoarthritis, run by Sport and Spine Rehab Clinical Research Foundation at 1 site in United States.
Trial summary
The purpose of this study is to determine the effect of Biofreeze® versus a placebo on walking gait characteristics and pain during walking in individuals with bilateral knee osteoarthritis (OA). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Biofreeze
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2018to 31 Jul 2024
- Phase
- Phase 4
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- must have been diagnosed with bilateral knee osteoarthritis (OA) and be able to perform all study procedures
Who cannot join
- less than 40 years of age, pregnancy, cancer, rheumatoid arthritis, a total or partial knee replacement, and/or a corticosteroid injection within the past 4 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Biofreeze® vs. a Placebo on Knee Osteoarthritis Walking Gait Characteristics and Pain
The purpose of this study is to determine the effect of Biofreeze® versus a placebo on walking gait characteristics and pain during walking in individuals with bilateral knee osteoarthritis (OA).
Read the detailed description
A convenience sample of 20 participants, >40 years with previously diagnosed bilateral KOA were recruited. Participants must have been diagnosed with bilateral knee OA and be able to perform all study procedures. All participants reported in comfortable clothing and sneakers. After explanation of the study and consent, participants completed the demographics questionnaire, Numeric Pain Rating Scale (NPRS), Western Ontario and McMaster Universities Arthritis Index (WOMAC), and knee function survey. Participants then completed a 3mph 3-minute walking baseline assessment. Following the assessment, participants rated their pain and were randomly assigned to receive a blinded topical of either Biofreeze® or a Placebo. The dose of both gels was 5 mL per knee. The participant then waited 15 minutes, rated their pain, and repeated the 3-minute walking assessment and rated their pain once more. There was a minimum of a 24-72-hour washout period after which time the participants repeated the same protocol using the other topical.
- Conditions
- Knee Osteoarthritis
- Being tested
- Biofreeze, Placebo
- Keywords
- Knee Osteoarthritis, Topical Analgesic
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiofreezeDrug
Biofreeze is a topical analgesic that uses the cooling effect of menthol, a natural pain reliever, to soothe minor muscle and joint pain. The product will be applied immediately after walking. The participant will wait 15 minutes prior to walking again.
PlaceboDrug
The placebo is the Biofreeze product with all active ingredients removed. The product will be applied immediately after walking. The participant will wait 15 minutes prior to walking again.
| Study group | Role | What they receive |
|---|---|---|
| Biofreeze | Experimental | The Biofreeze® gel will contain 3.5% menthol while the placebo will be the same formula with menthol removed and a menthol fragrance added so it is non-distinguishable from the real Biofreeze® gel. The dose of both gels will be 5 mL per knee, which is consistent with previous studies who reported a treatment effect for topical gels containing menthol (1 mL of gel for every 200 cm2 of surface area). The treatment will be applied by the investigator using a gloved hand and syringe containing 5mL of gel. The gel will be applied to the anterior and posterior knee from superior patella to the quadriceps insertion over a period of 5 seconds. The participant will wait 15 minutes, rate the pain in their knees. Receives: Drug: Biofreeze |
| Placebo | Sham comparator | The Biofreeze® gel will contain 3.5% menthol while the placebo will be the same formula with menthol removed and a menthol fragrance added so it is non-distinguishable from the real Biofreeze® gel. The dose of both gels will be 5 mL per knee, which is consistent with previous studies who reported a treatment effect for topical gels containing menthol (1 mL of gel for every 200 cm2 of surface area). The treatment will be applied by the investigator using a gloved hand and syringe containing 5mL of gel. The gel will be applied to the anterior and posterior knee from superior patella to the quadriceps insertion over a period of 5 seconds. The participant will wait 15 minutes, rate the pain in their knees Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Numeric Pain Rating Scale
Pain will be measures on a scale of 0 to 10, 0 being no pain at all and 10 representing the worst imaginable pain.
Measured: Pain will be measured at baseline, immediately following the 3 minute walk, 15 minutes after topical application, and after the second 3 minute walk for both topical applications
Change in Knee Flexion
Knee Flexion Range of Motion will be measured using the Woodway Walker View Treadmill which utilizes a 3D camera and will be measured during the last 30 seconds of the 3 minute walk.
Measured: Knee Flexion Range of Motion will be measured for both topical applications at initial walk and post-topical walk. The session will last a total of 30 minutes.
Change inHip Flexion
Hip Flexion Range of Motion will be measured using the Woodway Walker View Treadmill which utilizes a 3D camera and will be measured during the last 30 seconds of the 3 minute walk.
Measured: Knee Flexion Range of Motion will be measured for both topical applications at initial walk and post-topical walk. The session will last a total of 30 minutes
Change in Step Length
Step Length will be measured using the Woodway Walker View Treadmill which utilizes load cells within the treadmill belt and will be measured during the last 30 seconds of the 3 minute walk.
Measured: Knee Flexion Range of Motion will be measured for both topical applications at initial walk and post-topical walk. The session will last a total of 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2019
- Study start1 Mar 2018
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Why it stopped: Decided not go move forward with this population as recruitment was difficult
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will be randomly assigned 1 of 2 topicals, Gel A or Gel B. Upon completion of study procedures they will return for a second testing session and receive the other topical.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sport and Spine Rehab Clinical Research Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03888807
- Sponsor's protocol ID
- BFvP KneeOA Walking
- Status last verified
- Jul 2024
- First submitted
- 2 Jul 2018
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Biofreeze® vs. a Placebo on Knee Osteoarthritis Walking Gait Characteristics and Pain
- ClinicalTrials.gov ID
- NCT03888807
- Acronym / sponsor ID
- BFvP KneeOA Walking
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee Osteoarthritis, Topical Analgesic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Decided not go move forward with this population as recruitment was difficult
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Sport and Spine Rehab Clinical Research FoundationUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 25 Mar 2019 (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.
The purpose of this study is to determine the effect of Biofreeze® versus a placebo on walking gait characteristics and pain during walking in individuals with bilateral knee osteoarthritis (OA).
Detailed description
A convenience sample of 20 participants, >40 years with previously diagnosed bilateral KOA were recruited. Participants must have been diagnosed with bilateral knee OA and be able to perform all study procedures. All participants reported in comfortable clothing and sneakers. After explanation of the study and consent, participants completed the demographics questionnaire, Numeric Pain Rating Scale (NPRS), Western Ontario and McMaster Universities Arthritis Index (WOMAC), and knee function survey. Participants then completed a 3mph 3-minute walking baseline assessment. Following the assessment, participants rated their pain and were randomly assigned to receive a blinded topical of either Biofreeze® or a Placebo. The dose of both gels was 5 mL per knee. The participant then waited 15 minutes, rated their pain, and repeated the 3-minute walking assessment and rated their pain once more. There was a minimum of a 24-72-hour washout period after which time the participants repeated the same protocol using the other topical.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned 1 of 2 topicals, Gel A or Gel B. Upon completion of study procedures they will return for a second testing session and receive the other topical.
| Arm | Type | Receives |
|---|---|---|
| Biofreeze | Experimental | Drug: BiofreezeThe Biofreeze® gel will contain 3.5% menthol while the placebo will be the same formula with menthol removed and a menthol fragrance added so it is non-distinguishable from the real Biofreeze® gel. The dose of both gels will be 5 mL per knee, which is consistent with previous studies who reported a treatment effect for topical gels containing menthol (1 mL of gel for every 200 cm2 of surface area). The treatment will be applied by the investigator using a gloved hand and syringe containing 5mL of gel. The gel will be applied to the anterior and posterior knee from superior patella to the quadriceps insertion over a period of 5 seconds. The participant will wait 15 minutes, rate the pain in their knees. |
| Placebo | Sham comparator | Drug: PlaceboThe Biofreeze® gel will contain 3.5% menthol while the placebo will be the same formula with menthol removed and a menthol fragrance added so it is non-distinguishable from the real Biofreeze® gel. The dose of both gels will be 5 mL per knee, which is consistent with previous studies who reported a treatment effect for topical gels containing menthol (1 mL of gel for every 200 cm2 of surface area). The treatment will be applied by the investigator using a gloved hand and syringe containing 5mL of gel. The gel will be applied to the anterior and posterior knee from superior patella to the quadriceps insertion over a period of 5 seconds. The participant will wait 15 minutes, rate the pain in their knees |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- must have been diagnosed with bilateral knee osteoarthritis (OA) and be able to perform all study procedures
Key exclusion criteria (1 listed)
- less than 40 years of age, pregnancy, cancer, rheumatoid arthritis, a total or partial knee replacement, and/or a corticosteroid injection within the past 4 weeks
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 |
|---|---|---|
| BiofreezeBiofreeze is a topical analgesic that uses the cooling effect of menthol, a natural pain reliever, to soothe minor muscle and joint pain. The product will be applied immediately after walking. The participant will wait 15 minutes prior to walking again. | Drug | Biofreeze |
| PlaceboThe placebo is the Biofreeze product with all active ingredients removed. The product will be applied immediately after walking. The participant will wait 15 minutes prior to walking again. | Drug | Placebo |
Primary outcome
Change in Numeric Pain Rating Scale
Time frame: Pain will be measured at baseline, immediately following the 3 minute walk, 15 minutes after topical application, and after the second 3 minute walk for both topical applications
Pain will be measures on a scale of 0 to 10, 0 being no pain at all and 10 representing the worst imaginable pain.
Change in Knee Flexion
Time frame: Knee Flexion Range of Motion will be measured for both topical applications at initial walk and post-topical walk. The session will last a total of 30 minutes.
Knee Flexion Range of Motion will be measured using the Woodway Walker View Treadmill which utilizes a 3D camera and will be measured during the last 30 seconds of the 3 minute walk.
Change inHip Flexion
Time frame: Knee Flexion Range of Motion will be measured for both topical applications at initial walk and post-topical walk. The session will last a total of 30 minutes
Hip Flexion Range of Motion will be measured using the Woodway Walker View Treadmill which utilizes a 3D camera and will be measured during the last 30 seconds of the 3 minute walk.
Change in Step Length
Time frame: Knee Flexion Range of Motion will be measured for both topical applications at initial walk and post-topical walk. The session will last a total of 30 minutes
Step Length will be measured using the Woodway Walker View Treadmill which utilizes load cells within the treadmill belt and will be measured during the last 30 seconds of the 3 minute walk.
Results and safety
The study was stopped early (reason given: Decided not go move forward with this population as recruitment was difficult). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Biofreeze in people with Knee Osteoarthritis, run by Sport and Spine Rehab Clinical Research Foundation at 1 site in United States.
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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 2 Aug 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 United States. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early (reason given: Decided not go move forward with this population as recruitment was difficult). Results are not available in the source record.
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?
Change in Numeric Pain Rating Scale (time frame: Pain will be measured at baseline, immediately following the 3 minute walk, 15 minutes after topical application, and after the second 3 minute walk for both topical applications). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Aug 2024.