Plantar FasciitisNCT05467631
Topical Phytoterpenes for Plantar Fasciitis
A study testing Topical oil application in people with Plantar Fasciitis, run by Center for Biomedical Research, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Plantar Fasciitis
- What is being tested?
- Topical oil application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2019to 3 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Plantar fasciitis diagnosed by a medical practitioner and at least 3 months in duration
Who cannot join
- Age under 18 years, any history of diabetes, history of foot surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Biomedical Research,Inc.
Boise, Idaho, 83706
About this study
Official title: Topical Phytoterpene Mixture for Treatment of Plantar Fasciitis in Adults
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.
Read the 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.
- Conditions
- Plantar Fasciitis
- Being tested
- Topical oil application
- Keywords
- Heel pain, plantar, fasciitis, foot pain
- Medical subject headings
- Fasciitis, Plantar, Fasciitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical oil applicationOther
Topical Comparison
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Topical oil application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start15 Jan 2019
- Primary completion21 Apr 2020
- Study completion3 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Plantar FasciitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Biomedical Research, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Briant Burke, MD, Principal investigator, Center for Biomedical Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05467631
- Sponsor's protocol ID
- PF-001
- Status last verified
- Jul 2023
- First submitted
- 26 Oct 2021
- Last updated
- 6 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39085322
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Phytoterpene Mixture for Treatment of Plantar Fasciitis in Adults
- ClinicalTrials.gov ID
- NCT05467631
- Acronym / sponsor ID
- PF-001
- Conditions
- Plantar Fasciitis
- Keywords
- Heel pain, plantar, fasciitis, foot pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Center for Biomedical Research, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 21 Apr 2020 (actual)
- Study completion
- 3 Aug 2020 (actual)
- First posted
- 20 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 2 groups, plain tea tree oil control and formulated essential oil blend with permeation enhancer as treatment in a randomized trial
| Arm | Type | Receives |
|---|---|---|
| Plain Tea Tree Oil Control | Active comparator | Other: Topical oil applicationTopical application of 1ml 20% tea tree oil in almond oil base as a carrier twice daily for 2 weeks. |
| Verum | Experimental | Other: Topical oil applicationTopical 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Plantar fasciitis diagnosed by a medical practitioner and at least 3 months in duration
Key exclusion criteria (1 listed)
- Age under 18 years, any history of diabetes, history of foot surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical oil applicationTopical Comparison | Other | Plain Tea Tree Oil Control, Verum |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
- Derived from this study: PubMed 39085322Burke 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.
Related trials for Plantar Fasciitis
Not yet recruiting
Efficacy of TECAR Therapy in Plantar Fasciitis
Plantar Fasciitis
Active, not recruiting
Active Release Technique vs. Dynamic Soft Tissue Mobilization for Plantar Pain
Plantar Fascitis
Not yet recruiting
Hip Muscle Strengthening and Calf Myofascial Release in Females With Chronic Plantar Fasciitis
Chronic Planter Fascitis
Recruiting
F-18 Sodium Fluoride PET/CT-Guided Pain Palliation in Chronic Plantar Fasciitis: A Comparative Study of ¹⁷⁷Lutetium-Corticosteroid-Local Anaesthetic Injection vs Corticosteroid-Local Anaesthetic Injection
Plantar Fascitis, Chronic Heel Pain
Not yet recruiting
Radial vs Focused Shockwave Therapy for Plantar Fasciitis
Plantar Fasciitis, Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Briant Burke, MD principal investigator
Center for Biomedical Research, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical oil application in people with Plantar Fasciitis, run by Center for Biomedical Research, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Score Between Baseline and 2 Weeks (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05467631, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2023.