Topical Phytoterpenes for Plantar Fasciitis

NCT05467631 | Completed DMC

• 1 other identifier: PF-001
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Plantar Fasciitis

Keywords

Heel pain; plantar; fasciitis; foot pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Plain Tea Tree Oil Control

ACTIVE COMPARATOR

Topical application of 1ml 20% tea tree oil in almond oil base as a carrier twice daily for 2 weeks.

Other: Topical oil application

Verum

EXPERIMENTAL

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

Interventions

Topical oil application OTHER

Topical Comparison

Plain Tea Tree Oil Control; Verum

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Plantar fasciitis diagnosed by a medical practitioner and at least 3 months in duration

You may not qualify if:

• Age under 18 years, any history of diabetes, history of foot surgery

Sponsors & Collaborators

• Center for Biomedical Research, Inc.: lead

Study Sites (1)

Center for Biomedical Research,Inc.

Boise, Idaho, 83706, United States

Location

Related Publications (1)

• 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.

  PMID: 39085322 DERIVED

MeSH Terms

Conditions

Fasciitis, Plantar; Fasciitis

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Foot Diseases

Study Officials

• Briant Burke, MD

  Center for Biomedical Research, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Identical bottles given to participants with serial number, aroma and feel of each treatment group is the same
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 2 groups, plain tea tree oil control and formulated essential oil blend with permeation enhancer as treatment in a randomized trial

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: July 20, 2022
• Study Start: January 15, 2019
• Primary Completion: April 21, 2020
• Study Completion: August 3, 2020
• Last Updated: July 6, 2023

Record last verified: 2023-07

Locations

US (1)