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
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Plantar
• Plantar Fasciitis

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