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NCT05467631 Clinical Trial

Topical Phytoterpenes for Plantar Fasciitis

Plantar Fasciitis Clinical Trial

Official title:
Topical Phytoterpene Mixture for Treatment of Plantar Fasciitis in Adults

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05467631
Other study ID # PF-001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 15, 2019
Est. completion date August 3, 2020

Study information
Verified date July 2023
Source Center for Biomedical Research, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Randomized controlled trial of mixture of essential oils containing tea tree oil, rosemary, clove, pepper, in a formulation with skin permeation enhancers including limonene for the treatment of plantar fasciitis in adult men and women. Forty-two patients will be randomized to receive twice daily topical application of the treatment formulation or plain tea tree oil as a control. Analog pain scores will be assessed at the start of treatment and at two weeks. Analysis will be by student's T-test.

Description:

Randomized controlled trial of mixture of essential oils containing tea tree oil, rosemary, clove, pepper, in a formulation with skin permeation enhancers including limonene for the treatment of plantar fasciitis in adult men and women. Forty-two patients will be randomized to receive twice daily topical application of the treatment formulation or plain tea tree oil as a control. Analog pain scores will be assessed at the start of treatment and at two weeks. Analysis will be by student's T-test. Primary outcome measure will be the difference in pain score between baseline score and pain score at 2 weeks.

Recruitment information / eligibility
Status Completed
Enrollment 42
Est. completion date August 3, 2020
Est. primary completion date April 21, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - Plantar fasciitis diagnosed by a medical practitioner and at least 3 months in duration Exclusion Criteria: - Age under 18 years, any history of diabetes, history of foot surgery

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Topical oil application
Topical Comparison

Locations
Country Name City State
United States Center for Biomedical Research,Inc. Boise Idaho

Sponsors (1)
Lead Sponsor Collaborator
Center for Biomedical Research, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Pain Score Between Baseline and 2 Weeks Patients will be asked to rate pain on a 1-10 analog scale at the start of the study and at 2 weeks 2 weeks
See also
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