Topical Phytoterpenes for Plantar Fasciitis

Not Applicable

Completed

• Conditions: Plantar Fasciitis
• Interventions: Other: Topical oil application

• Registration Number: NCT05467631
• Lead Sponsor: Center for Biomedical Research, Inc.

Brief 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.

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 Timeline

• Study Start: 2019-01-15
• Primary Completion: 2020-04-21
• Study Completion: 2020-08-03
• Study First Submitted: 2021-10-26
• Study First Submitted QC: 2022-07-18
• Study First Posted: 2022-07-20
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-02
• Last Update Posted: 2023-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Verum	Topical oil application	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.
Plain Tea Tree Oil Control	Topical oil application	Topical application of 1ml 20% tea tree oil in almond oil base as a carrier twice daily for 2 weeks.

Primary Outcome Measures

Name	Time	Method
Change in Pain Score Between Baseline and 2 Weeks	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

Trial Locations

Locations (1)

Center for Biomedical Research,Inc.; 🇺🇸 Boise, Idaho, United States