Back to resultsTopical Phytoterpenes for Plantar Fasciitis
Primary Purpose
Plantar Fasciitis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Topical oil application
Sponsored by
About this trial
This is an interventional treatment trial for Plantar Fasciitis focused on measuring Heel pain, plantar, fasciitis, foot pain
Eligibility Criteria
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
Sites / Locations
- Center for Biomedical Research,Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Plain Tea Tree Oil Control
Verum
Arm Description
Topical application of 1ml 20% tea tree oil in almond oil base as a carrier twice daily for 2 weeks.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05467631
First Posted
October 26, 2021
Last Updated
July 2, 2023
Sponsor
Center for Biomedical Research, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05467631
Brief Title
Topical Phytoterpenes for Plantar Fasciitis
Official Title
Topical Phytoterpene Mixture for Treatment of Plantar Fasciitis in Adults
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 15, 2019 (Actual)
Primary Completion Date
April 21, 2020 (Actual)
Study Completion Date
August 3, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Center for Biomedical Research, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plantar Fasciitis
Keywords
Heel pain, plantar, fasciitis, foot pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2 groups, plain tea tree oil control and formulated essential oil blend with permeation enhancer as treatment in a randomized trial
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Identical bottles given to participants with serial number, aroma and feel of each treatment group is the same
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Plain Tea Tree Oil Control
Arm Type
Active Comparator
Arm Description
Topical application of 1ml 20% tea tree oil in almond oil base as a carrier twice daily for 2 weeks.
Arm Title
Verum
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Topical oil application
Intervention Description
Topical Comparison
Primary Outcome Measure Information:
Title
Change in Pain Score Between Baseline and 2 Weeks
Description
Patients will be asked to rate pain on a 1-10 analog scale at the start of the study and at 2 weeks
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Briant Burke, MD
Organizational Affiliation
Center for Biomedical Research, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Biomedical Research,Inc.
City
Boise
State/Province
Idaho
ZIP/Postal Code
83706
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Topical Phytoterpenes for Plantar Fasciitis
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