Topical Phytoterpenes for Plantar Fasciitis

NCT ID: NCT05467631

Last Updated: 2023-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-15

Study Completion Date

2020-08-03

Brief Summary

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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

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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.

Conditions

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Plantar Fasciitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

2 groups, plain tea tree oil control and formulated essential oil blend with permeation enhancer as treatment in a randomized trial
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Identical bottles given to participants with serial number, aroma and feel of each treatment group is the same

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Topical oil application

Intervention Type OTHER

Topical Comparison

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.

Group Type EXPERIMENTAL

Topical oil application

Intervention Type OTHER

Topical Comparison

Interventions

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Topical oil application

Topical Comparison

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Center for Biomedical Research, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Briant Burke, MD

Role: PRINCIPAL_INVESTIGATOR

Center for Biomedical Research, Inc.

Locations

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Center for Biomedical Research,Inc.

Boise, Idaho, United States

Site Status

Countries

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United States

References

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Burke BE, Baillie JE. Randomized placebo controlled trial of phytoterpenes in DMSO for the treatment of plantar fasciitis. Sci Rep. 2024 Jul 31;14(1):17621. doi: 10.1038/s41598-024-65979-1.

Reference Type DERIVED
PMID: 39085322 (View on PubMed)

Other Identifiers

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PF-001

Identifier Type: -

Identifier Source: org_study_id

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