Topical Phytoterpenes for Plantar Fasciitis

Study Overview
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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.

Official Title
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Topical Phytoterpene Mixture for Treatment of Plantar Fasciitis in Adults

Conditions
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Plantar Fasciitis

Intervention / Treatment
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* Other: Topical oil application


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Plain Tea Tree Oil Control<br>Topical application of 1ml 20% tea tree oil in almond oil base as a carrier twice daily for 2 weeks. | Other: Topical oil application<br>* Topical Comparison<br>|
| Experimental: Verum<br>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<br>* Topical Comparison<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heel pain, plantar, fasciitis, foot pain