NCT01565070

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2012

Shorter than P25 for phase_3 knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 28, 2012

Completed
4 days until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

July 10, 2014

Status Verified

March 1, 2012

Enrollment Period

6 months

First QC Date

March 26, 2012

Last Update Submit

July 9, 2014

Conditions

Knee Osteoarthritis

Keywords

OsteoarthritisPainQuality of life

Outcome Measures

Primary Outcomes (1)

  • WOMAC score

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

    60 days

Secondary Outcomes (1)

  • Quality of life measured using SF 36

    60 days

Study Arms (2)

Biofreeze

ACTIVE COMPARATOR
Drug: Biofreeze

Placebo

PLACEBO COMPARATOR

Use of placebo ointment

Other: Placebo

Interventions

BiofreezeDRUG

Use of Biofreeze ointment

Biofreeze
PlaceboOTHER

Use of placebo ointment

Placebo

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Moderate osteoarthritis of the knee
  • Age 60 to 80 years
  • Ambulatory

You may not qualify if:

  • Other conditions that affect mobility
  • Severe chronic diseases such as cardiac or renal failure
  • Cancer
  • Presence of gout
  • Cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Nutrition and Food Technology

Santiago, Met, 7830489, Chile

Location

Related Publications (1)

  • 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.

    PMID: 19674721BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritisPain

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Daniel Bunout, MD

    INTA University of Chile

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

March 26, 2012

First Posted

March 28, 2012

Study Start

April 1, 2012

Primary Completion

October 1, 2012

Study Completion

December 1, 2012

Last Updated

July 10, 2014

Record last verified: 2012-03

Locations

CL(1)