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

NCT ID: NCT01565070

Last Updated: 2014-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2012-12-31

Brief Summary

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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

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Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Biofreeze

Group Type ACTIVE_COMPARATOR

Biofreeze

Intervention Type DRUG

Use of Biofreeze ointment

Placebo

Use of placebo ointment

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Use of placebo ointment

Interventions

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Biofreeze

Use of Biofreeze ointment

Intervention Type DRUG

Placebo

Use of placebo ointment

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Chile

OTHER

Sponsor Role lead

Responsible Party

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Daniel Bunout

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daniel Bunout, MD

Role: PRINCIPAL_INVESTIGATOR

INTA University of Chile

Locations

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Institute of Nutrition and Food Technology

Santiago, Met, Chile

Site Status

Countries

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Chile

References

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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.

Reference Type BACKGROUND
PMID: 19674721 (View on PubMed)

Other Identifiers

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HYGIENIC CORPORATION

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

BIOFREEZE OSTEOARTHRITIS

Identifier Type: -

Identifier Source: org_study_id

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