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:

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

History of Changes

Tracking Information

First Received Date ^ICMJE

March 26, 2012

Last Updated Date

March 27, 2012

Start Date ^ICMJE

April 2012

Estimated Primary Completion Date

October 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

WOMAC score [ Time Frame: 60 days ] [ Designated as safety issue: No ]

WOMAC score corresponds to Western Ontario and McMaster Universities Index of Osteoarthritis

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01565070 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Osteoarthritis in Older Adults: Recovery of Mobility and Pain With a Topical Analgesic

Official Title ^ICMJE

Osteoarthritis in Older Adults: Recovery of Mobility and Pain With a Topical Analgesic

Brief 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 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Knee Osteoarthritis

Intervention ^ICMJE

Drug: Biofreeze
Use of Biofreeze ointment
Other: Placebo
Use of placebo ointment

Study Arm (s)

Active Comparator: Biofreeze
Intervention: Drug: Biofreeze
Placebo Comparator: Placebo
Use of placebo ointment

Intervention: Other: Placebo

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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2012

Estimated Primary Completion Date

October 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

60 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Natalia Jara, MD	56 (2) 9781452	nmjara@gmail.com
Contact: Juan Berger, MSc		juanignacioberger@gmail.com

Location Countries ^ICMJE

Chile

Administrative Information

NCT Number ^ICMJE

NCT01565070

Other Study ID Numbers ^ICMJE

BIOFREEZE OSTEOARTHRITIS, HYGIENIC CORPORATION

Has Data Monitoring Committee

Yes

Responsible Party

Daniel Bunout, University of Chile

Study Sponsor ^ICMJE

University of Chile

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Daniel Bunout, MD

INTA University of Chile

Information Provided By

University of Chile

Verification Date

March 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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