Topical Phytoterpenes for Plantar Fasciitis

Topical Phytoterpene Mixture for Treatment of Plantar Fasciitis in Adults

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.

Study Overview

• Status: Completed
• Conditions: Plantar Fasciitis
• Intervention / Treatment: Other: Topical oil application

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Idaho
    • Boise, Idaho, United States, 83706
      • Center for Biomedical Research,Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Plain Tea Tree Oil Control; Topical application of 1ml 20% tea tree oil in almond oil base as a carrier twice daily for 2 weeks.	Other: Topical oil application; Topical Comparison
Experimental: Verum; Topical application twice daily of 1ml mixture for 2 weeks of essential oils containing tea tree oil, rosemary, clove, pepper, in a formulation with skin permeation enhancers including limonene.	Other: Topical oil application; Topical Comparison

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Center for Biomedical Research, Inc.
• Investigators: Principal Investigator: Briant Burke, MD, Center for Biomedical Research, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2019
• Primary Completion (Actual): April 21, 2020
• Study Completion (Actual): August 3, 2020

Study Registration Dates

• First Submitted: October 26, 2021
• First Submitted That Met QC Criteria: July 18, 2022
• First Posted (Actual): July 20, 2022

Study Record Updates

• Last Update Posted (Actual): July 6, 2023
• Last Update Submitted That Met QC Criteria: July 2, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Heel pain; foot pain; fasciitis; plantar
• Additional Relevant MeSH Terms: Foot Diseases; Musculoskeletal Diseases; Fasciitis; Fasciitis, Plantar
• Other Study ID Numbers: PF-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No