Osteoarthritis in Older Adults: Recovery of Mobility and Pain With a Topical Analgesic
This study is not yet open for participant recruitment.
Verified March 2012 by University of Chile
Sponsor:
University of Chile
Information provided by (Responsible Party):
Daniel Bunout, University of Chile
ClinicalTrials.gov Identifier:
NCT01565070
First received: March 26, 2012
Last updated: March 27, 2012
Last verified: March 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Knee Osteoarthritis |
Drug: Biofreeze Other: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Osteoarthritis in Older Adults: Recovery of Mobility and Pain With a Topical Analgesic |
Resource links provided by NLM:
MedlinePlus related topics:
Osteoarthritis
Drug Information available for:
Menthol
U.S. FDA Resources
Further study details as provided by University of Chile:
Primary Outcome Measures:
- WOMAC score [ Time Frame: 60 days ] [ Designated as safety issue: No ]WOMAC score corresponds to Western Ontario and McMaster Universities Index of Osteoarthritis
Secondary Outcome Measures:
- Quality of life measured using SF 36 [ Time Frame: 60 days ] [ Designated as safety issue: No ]SF 36 correponds to a health related quality of life score
| Estimated Enrollment: | 50 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Biofreeze |
Drug: Biofreeze
Use of Biofreeze ointment
|
|
Placebo Comparator: Placebo
Use of placebo ointment
|
Other: Placebo
Use of placebo ointment
|
Eligibility| Ages Eligible for Study: | 60 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Moderate osteoarthritis of the knee
- Age 60 to 80 years
- Ambulatory
Exclusion Criteria:
- Other conditions that affect mobility
- Severe chronic diseases such as cardiac or renal failure
- Cancer
- Presence of gout
- Cognitive impairment
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01565070
Contacts
| Contact: Natalia Jara, MD | 56 (2) 9781452 | nmjara@gmail.com |
| Contact: Juan Berger, MSc | juanignacioberger@gmail.com |
Locations
| Chile | |
| Institute of Nutrition and Food Technology | Not yet recruiting |
| Santiago, Met, Chile, 7830489 | |
| Contact: Magdalena Araya, MD 56 (2) 9781411 maraya@inta.uchile.cl | |
| Contact: Mauricio Gonzalez, MSc 56 (2) 9781411 mgonzale@inta.uchile.cl | |
| Principal Investigator: Daniel Bunout, MD | |
| Sub-Investigator: Natalia Jara, MD | |
| Sub-Investigator: Juan Berger, MSc | |
Sponsors and Collaborators
University of Chile
Investigators
| Principal Investigator: | Daniel Bunout, MD | INTA University of Chile |
More Information
Publications:
| Responsible Party: | Daniel Bunout, Medical Doctor, University of Chile |
| ClinicalTrials.gov Identifier: | NCT01565070 History of Changes |
| Other Study ID Numbers: | BIOFREEZE OSTEOARTHRITIS, HYGIENIC CORPORATION |
| Study First Received: | March 26, 2012 |
| Last Updated: | March 27, 2012 |
| Health Authority: | Chile: Ministry of Health |
Keywords provided by University of Chile:
|
Osteoarthritis Pain Quality of life |
Additional relevant MeSH terms:
|
Osteoarthritis Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Analgesics Menthol |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Antipruritics Dermatologic Agents |
ClinicalTrials.gov processed this record on June 13, 2013