Knee OsteoarthritisPhase 3NCT01565070
Osteoarthritis in Older Adults: Recovery of Mobility and Pain With a Topical Analgesic
A Phase 3 study testing Biofreeze in people with Knee Osteoarthritis, run by University of Chile at 1 site in Chile.
Trial summary
Biofreeze® is a topical ointment that has menthol and alcamphor. Its analgesic effect lies in the stimulation of A and C fibers by cold and nociceptive stimulation, respectively, which is produced by menthol, apparently through the newly discovered receptor TRPM8 (Transient Receptor Potential melastatin-8) The aim of… Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Biofreeze
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteChile
- Study dates
- Apr 2012to Dec 2012
- Phase
- Phase 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 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate osteoarthritis of the knee
- Age 60 to 80 years
- Ambulatory
Who cannot join
- Other conditions that affect mobility
- Severe chronic diseases such as cardiac or renal failure
- Cancer
- Presence of gout
- Cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
Biofreeze® is a topical ointment that has menthol and alcamphor. Its analgesic effect lies in the stimulation of A and C fibers by cold and nociceptive stimulation, respectively, which is produced by menthol, apparently through the newly discovered receptor TRPM8 (Transient Receptor Potential melastatin-8) The aim of this study is to investigate if BIOFREEZE ® treatment (Performance Health Inc., Export, PA) improves symptoms associated with moderate knee osteoarthritis, which would decrease the immobility and isolation in older adults.
- Conditions
- Knee Osteoarthritis
- Being tested
- Biofreeze, Placebo
- Keywords
- Osteoarthritis, Pain, Quality of life
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiofreezeDrug
Use of Biofreeze ointment
PlaceboOther
Use of placebo ointment
| Study group | Role | What they receive |
|---|---|---|
| Biofreeze | Active comparator | Not described Receives: Drug: Biofreeze |
| Placebo | Placebo comparator | Use of placebo ointment Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
WOMAC score
WOMAC score corresponds to Western Ontario and McMaster Universities Index of Osteoarthritis
Measured: 60 days
Secondary outcomes (1)
Quality of life measured using SF 36
SF 36 correponds to a health related quality of life score
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2012 (estimated)
- Study startApr 2012
- Primary completionOct 2012 (estimated)
- Study completionDec 2012 (estimated)
Why it stopped: The local authorities did not authorize the use of biofreeze in Chile.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Bunout, University of Chile
- Investigators
- Daniel Bunout, MD, Principal investigator, INTA University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01565070
- Sponsor's protocol ID
- BIOFREEZE OSTEOARTHRITIS
- Other IDs
- HYGIENIC CORPORATION
- Status last verified
- Mar 2012
- First submitted
- 26 Mar 2012
- Last updated
- 10 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zhang J, Enix D, Snyder B, Giggey K, Tepe R. Effects of Biofreeze and chiropractic adjustments on acute low back pain: a pilot study. J Chiropr Med. 2008 Jun;7(2):59-65. doi: 10.1016/j.jcme.2008.02.004.
PubMed 19674721
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteoarthritis in Older Adults: Recovery of Mobility and Pain With a Topical Analgesic
- ClinicalTrials.gov ID
- NCT01565070
- Acronym / sponsor ID
- BIOFREEZE OSTEOARTHRITIS
- Conditions
- Knee Osteoarthritis
- Keywords
- Osteoarthritis, Pain, Quality of life
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The local authorities did not authorize the use of biofreeze in Chile.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 28 Mar 2012 (estimated)
- 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.
Biofreeze® is a topical ointment that has menthol and alcamphor. Its analgesic effect lies in the stimulation of A and C fibers by cold and nociceptive stimulation, respectively, which is produced by menthol, apparently through the newly discovered receptor TRPM8 (Transient Receptor Potential melastatin-8) The aim of this study is to investigate if BIOFREEZE ® treatment (Performance Health Inc., Export, PA) improves symptoms associated with moderate knee osteoarthritis, which would decrease the immobility and isolation in older adults.
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 |
|---|---|---|
| Biofreeze | Active comparator | Drug: Biofreeze |
| Placebo | Placebo comparator | Other: PlaceboUse of placebo ointment |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Moderate osteoarthritis of the knee
- Age 60 to 80 years
- Ambulatory
Key exclusion criteria (5 listed)
- Other conditions that affect mobility
- Severe chronic diseases such as cardiac or renal failure
- Cancer
- Presence of gout
- Cognitive impairment
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 |
|---|---|---|
| BiofreezeUse of Biofreeze ointment | Drug | Biofreeze |
| PlaceboUse of placebo ointment | Other | Placebo |
Primary outcome
WOMAC score
Time frame: 60 days
WOMAC score corresponds to Western Ontario and McMaster Universities Index of Osteoarthritis
1 secondary outcome
Quality of life measured using SF 36
Time frame: 60 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2014.
- Background: PubMed 19674721Zhang J, Enix D, Snyder B, Giggey K, Tepe R. Effects of Biofreeze and chiropractic adjustments on acute low back pain: a pilot study. J Chiropr Med. 2008 Jun;7(2):59-65. doi: 10.1016/j.jcme.2008.02.004.
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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.
Daniel Bunout, MD principal investigator
INTA University of Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Biofreeze in people with Knee Osteoarthritis, run by University of Chile at 1 site in Chile.
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 3 inclusion and 5 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: withdrawn, as of the sponsor's last update on 10 Jul 2014. 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 Chile. 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 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 was withdrawn before enrolling participants, so there are no results.
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?
WOMAC score (time frame: 60 days). 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 NCT01565070, which also lists 1 linked publication.
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 10 Jul 2014.