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

Primary Purpose

Knee Osteoarthritis

Status

Withdrawn

Phase

Phase 3

Locations

Chile

Study Type

Interventional

Intervention

Biofreeze

Placebo

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Osteoarthritis, Pain, Quality of life

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Institute of Nutrition and Food Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Biofreeze

Placebo

Arm Description

Use of placebo ointment

Outcomes

Primary Outcome Measures

WOMAC score

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

Secondary Outcome Measures

Quality of life measured using SF 36

SF 36 correponds to a health related quality of life score

Full Information

NCT ID

NCT01565070

First Posted

March 26, 2012

Last Updated

July 9, 2014

Sponsor

University of Chile

1. Study Identification

Unique Protocol Identification Number

NCT01565070

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2012

Overall Recruitment Status

Withdrawn

Why Stopped

The local authorities did not authorize the use of biofreeze in Chile.

Study Start Date

April 2012 (undefined)

Primary Completion Date

October 2012 (Anticipated)

Study Completion Date

December 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Chile

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Knee Osteoarthritis

Keywords

Osteoarthritis, Pain, Quality of life

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Biofreeze

Arm Type

Active Comparator

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Use of placebo ointment

Intervention Type

Drug

Intervention Name(s)

Biofreeze

Intervention Description

Use of Biofreeze ointment

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Use of placebo ointment

Primary Outcome Measure Information:

Title

WOMAC score

Description

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

Time Frame

60 days

Secondary Outcome Measure Information:

Title

Quality of life measured using SF 36

Description

SF 36 correponds to a health related quality of life score

Time Frame

60 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daniel Bunout, MD

Organizational Affiliation

INTA University of Chile

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institute of Nutrition and Food Technology

City

Santiago

State/Province

Met

ZIP/Postal Code

7830489

Country

Chile

12. IPD Sharing Statement

Citations:

PubMed Identifier

19674721

Citation

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.

Results Reference

background

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

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