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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03440125 |
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Date of registration:
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06/02/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Cayenne Pepper Cataplasm - Safety Study
Munari04 |
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Scientific title:
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Cayenne Pepper Cataplasm Application and Potential Side Effects |
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Date of first enrolment:
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March 15, 2016 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03440125 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Investigator, Outcomes Assessor).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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Slovakia
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Slovenia
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Contacts
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Name:
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Nejc Šarabon, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Faculty of Health Sciences, University of Primorska, Slovenia |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Chronic low back pain (>3 months)
- Body mass index below 35 kg/m?2
Exclusion Criteria:
- pregnancy
- sensibility disorders (e.g. due to neurological disease)
- injuries, open wounds or rash in intervention area
- known hypersensitivity against the applied substances
- HIV, Hepatitis C and other due blood communicable infectious diseases
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Low Back Pain
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Intervention(s)
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Device: Electrical stimulation
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Drug: Cayenne Pepper topical
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Procedure: Massage
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Primary Outcome(s)
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Change in concentration of circulating biomarkers of inflammation, neudroendocrine stress and blood vessel activation
[Time Frame: Before the application, 45 minutes after 10th application and 48 hours after 10th application]
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Change in systolic and diastolic blood pressure
[Time Frame: Before the application, 45 minutes after 10th application and 48 hours after 10th application]
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Heart rate
[Time Frame: Before the application, 45 minutes after 10th application and 48 hours after 10th application]
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Secondary Outcome(s)
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36-Item Short Form Survey (SF-36)
[Time Frame: Before the application, 45 minutes after 10th application and 48 hours after 10th application]
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Oswestry disability index (ODI)
[Time Frame: Before the application, 45 minutes after 10th application and 48 hours after 10th application]
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Change in pain perception
[Time Frame: Before the application, 45 minutes after 10th application and 48 hours after 10th application]
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Skin Temperature
[Time Frame: Before the application, 45 minutes after 10th application and 48 hours after 10th application]
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Flexibility
[Time Frame: Before the application, 45 minutes after 10th application and 48 hours after 10th application]
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EQ-5D- 5L questionnaire
[Time Frame: Before the application, 45 minutes after 10th application and 48 hours after 10th application]
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Skin Sensory Function
[Time Frame: Before the application, 45 minutes after 10th application and 48 hours after 10th application]
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Secondary ID(s)
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UP-MunariStudy
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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