Biofreeze and the Effect on Knee Osteoarthritis

NCT04351594 | Completed Phase 2

• 1 other identifier: MUN8051
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Knee osteoarthritis (OA) is a progressive disease that can be accompanied by considerable joint pain and dysfunction. It is a goal in the medical field to find effective treatments for knee OA that are non-interventional, have minor or no negative side effects, and are relatively easy to administer for the patient and health care professionals. Biofreeze, a topical analgesic containing menthol, is an easily accessible gel, with no known serious negative side effects. If the application of Biofreeze can reduce the pain and dysfunction associated with knee OA, it could be an effective treatment for patients. The objective of the study is to assess how 4 weeks of Biofreeze application to a knee affected by OA effects pain and dysfunction associated with the disease.

Conditions

Knee Osteoarthritis

Keywords

Osteoarthritis; Pain management; Menthol; Knee

Outcome Measures

Primary Outcomes (1)

• Efficacy comparison of (Biofreeze) Menthol 4%, Menthol 0% as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), version 3.0

  Endpoint is a non-inferiority statistical comparison. Comparison is based off of analysis of identical questionnaires administered at baseline and at 4 weeks

  4 weeks

Study Arms (2)

Topical analgesia (+Menthol)

EXPERIMENTAL

Biofreeze Topical Gel with active ingredient (Menthol 4%)

Drug: Biofreeze 4 % Topical Gel

Topical analgesia (-Menthol)

PLACEBO COMPARATOR

Biofreeze Topical Gel with no active ingredient (Menthol 0%)

Other: Biofreeze placebo gel

Interventions

Biofreeze 4 % Topical Gel DRUG

Biofreeze gel with active manufactured ingredient (Menthol 4%)

Also known as: Menthol 4% Topical gel

Topical analgesia (+Menthol)

Biofreeze placebo gel OTHER

Biofreeze gel with no active manufactured to have the same look, feel and odour as Biofreeze topical gel.

Also known as: Placebo gel (Menthol 0%)

Topical analgesia (-Menthol)

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women aged 50-80 years
• Body mass index (BMI) less than 40
• Knee osteoarthritis of grade one or more according to Kellgren-Lawrence scale
• Average pain intensity of grade 4 or more on a 10-point visual analogue scale for at least 6 months.
• Meet clinical and radiographic criteria of the American College of Rheumatology (ACR) for knee OA

You may not qualify if:

• Acute arthritis,
• Rheumatologic diseases
• Infective arthritis
• Traumatic arthritis,
• History of knee replacement surgery
• Patients receiving multiple corticosteroid injections (Greater than 2 injections)

Sponsors & Collaborators

• Memorial University of Newfoundland: lead

Study Sites (1)

Memorial University, Faculty of Medicine Department of Surgery

St. John's, Newfoundland and Labrador, A1B3V6, Canada

Location

Related Publications (4)

• Airaksinen OV, Kyrklund N, Latvala K, Kouri JP, Gronblad M, Kolari P. Efficacy of cold gel for soft tissue injuries: a prospective randomized double-blinded trial. Am J Sports Med. 2003 Sep-Oct;31(5):680-4. doi: 10.1177/03635465030310050801.

  PMID: 12975186 BACKGROUND

• Bookman AA, Williams KS, Shainhouse JZ. Effect of a topical diclofenac solution for relieving symptoms of primary osteoarthritis of the knee: a randomized controlled trial. CMAJ. 2004 Aug 17;171(4):333-8. doi: 10.1503/cmaj.1031793.

  PMID: 15313991 BACKGROUND

• Mosavat SH, Masoudi N, Hajimehdipoor H, Emami Meybodi MK, Niktabe Z, Tabarrai M, Ghorat F, Khodadoost M. Efficacy of topical Linum usitatissimum L. (flaxseed) oil in knee osteoarthritis: A double-blind, randomized, placebo-controlled clinical trial. Complement Ther Clin Pract. 2018 May;31:302-307. doi: 10.1016/j.ctcp.2018.03.003. Epub 2018 Mar 14. No abstract available.

  PMID: 29705472 BACKGROUND

• Topp R, Brosky JA Jr, Pieschel D. The effect of either topical menthol or a placebo on functioning and knee pain among patients with knee OA. J Geriatr Phys Ther. 2013 Apr-Jun;36(2):92-9. doi: 10.1519/JPT.0b013e318268dde1.

  PMID: 22976810 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis; Agnosia

Interventions

Gels; Menthol

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Cyclohexane Monoterpenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Monoterpenes; Terpenes; Lipids

Study Officials

• Nick Smith, MD (FRCSC)

  Memorial University Orthopaedic Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Nicholas Smith MD, MSc, FRCSC

Study Record Dates

• First Submitted: April 15, 2020
• First Posted: April 17, 2020
• Study Start: November 1, 2020
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: December 4, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)