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Topical Phytoterpenes for Plantar Fasciitis

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ClinicalTrials.gov Identifier: NCT05467631
Recruitment Status : Completed
First Posted : July 20, 2022
Last Update Posted : July 20, 2022
Sponsor:
Information provided by (Responsible Party):
Center for Biomedical Research, Inc.

Study Description
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Brief Summary:
Randomized controlled trial of mixture of essential oils containing tea tree oil, rosemary, clove, pepper, and CBD 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.

Condition or disease Intervention/treatment Phase
Plantar Fasciitis Other: Topical oil application Not Applicable

Detailed Description:
Randomized controlled trial of mixture of essential oils containing tea tree oil, rosemary, clove, pepper, and CBD 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 2 groups, plain tea tree oil control and formulated essential oil blend with permeation enhancer as treatment in a randomized trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Identical bottles given to participants with serial number, aroma and feel of each treatment group is the same
Primary Purpose: Treatment
Official Title: Topical Phytoterpene Mixture for Treatment of Plantar Fasciitis in Adults
Actual Study Start Date : January 15, 2019
Actual Primary Completion Date : April 21, 2020
Actual Study Completion Date : August 3, 2020
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Plain Tea Tree Oil Control
Topical application of 20% tea tree oil in almond oil base as a carrier twice daily for 2 weeks.
 Other: Topical oil application
Topical Comparison
Experimental: Verum
Therapeutic mixture applied topically twice daily for two weeks
 Other: Topical oil application
Topical Comparison


Outcome Measures
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Primary Outcome Measures :
  1. Change in Pain Score Between Baseline and 2 Weeks [ Time Frame: 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05467631


Locations
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United States, Idaho
Center for Biomedical Research,Inc.
Boise, Idaho, United States, 83706
Sponsors and Collaborators
Center for Biomedical Research, Inc.
Investigators
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Principal Investigator: Briant Burke, MD Center for Biomedical Research, Inc.
More Information
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Responsible Party: Center for Biomedical Research, Inc.
ClinicalTrials.gov Identifier: NCT05467631    
Other Study ID Numbers: PF-001
First Posted: July 20, 2022    Key Record Dates
Last Update Posted: July 20, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Center for Biomedical Research, Inc.:
Heel pain, plantar, fasciitis, foot pain
Additional relevant MeSH terms:
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Fasciitis
Fasciitis, Plantar
Musculoskeletal Diseases
Foot Diseases