Clinical trial NCT03440125: Cayenne Pepper Cataplasm - Safety Study
Official title: Cayenne Pepper Cataplasm Application and Potential Side Effects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Low Back Pain
Keywords: Low Back Pain
Capsicum
Physical Therapy
Pain
Lead sponsor: University of Primorska
Sponsor class: OTHER
Collaborators: name: S2P, Science to Practice, Ltd.
name: Comenius University
name: Wilhelminenspital Vienna
name: Ludwig Boltzmann Institute of Electrical Stimulation and Physical Rehabilitation
First posted: 2018-02-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The beneficial analgesic effects of Rubefacenciae (redden skin substances), is known since 1830 as a treatment for pain, cramps, and disorders of the musculoskeletal system. Herbal cataplasms containing rubefacient substances, such as Cayenne pepper, are commonly used as natural medications to treat painful or aching areas in the case of acute or chronic back pain, and rheumatisms. In Vienna and lower Austria, a Cayenne Pepper Cataplasm (CPC) application containing Cayenne pepper and Kaolin powder in mixed proportion, is commonly used to treat musculoskeletal conditions of pain especially of the low back. However, a concern about the safety of such applications was recently raised.

Therefore, the aims of the present study are to evaluate the effects of 10x 20min CP cataplasm application as a single treatment or in combination with electrical stimulation and massage on selected functional and molecular parameters on i) healthy subjects and ii) subjects suffering from low back pain.

Detailed description: Musculoskeletal diseases, such as neck and low back pain, are widespread disorders in many developed countries. Their management is challenging, and it may have mounting socioeconomic burden. Several evidences in the literature demonstrate the efficacy of many therapeutic strategies in the treatment of these conditions, based on pharmacological or surgical interventions. Physical medicine therapies are good alternatives that may have beneficial effects, especially when used as first line of intervention before approaching more expensive pharmacological or invasive medications. The beneficial analgesic effects of Applicatio Epispasticorum of Rubefacenciae (redden skin substances), is known since 1830 as a treatment for pain, cramps, and disorders of the musculoskeletal system. Herbal cataplasms containing rubefacient substances, such as Cayenne pepper (CP), are commonly used as natural medications to treat painful or aching areas in the case of acute or chronic back pain, and rheumatisms. They are also used in pain involving joints caused by osteoarthritis. A galenic preparation composed of rubefacient substances of vegetable origin, which generated vasodilation and increase in blood circulation on the treated areas, was first prescribed in 1909 by Dr. Giuseppe Munari to treat pain of various areas of the locomotive system. He proposed a method based on applications prepared according to his own galenic formula that have become famous all over Italy and Europe. In Vienna and lower Austria, a Munari-like application containing CP and Kaolin powder in mixed proportion, is commonly used to treat musculoskeletal conditions of pain especially of the low back. The research on responses to CPC applications, particularly in combination with other modalities is scarce.

Therefore, the aims of the present study are firstly to evaluate the effects of 10x 20min CP cataplasm application on selected functional and molecular parameters on healthy subjects. Then, the same applications will be used on subjects suffering from low back pain (LBP) - both as a single treatment and in combination with electrical stimulation and massage.

Eligibility criteria: Inclusion Criteria:

* Chronic low back pain (\>3 months)
* Body mass index below 35 kg/mˇ2

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

Primary outcomes:
measure: Change in concentration of circulating biomarkers of inflammation, neudroendocrine stress and blood vessel activation
timeFrame: Before the application, 45 minutes after 10th application and 48 hours after 10th application
measure: Change in systolic and diastolic blood pressure
timeFrame: Before the application, 45 minutes after 10th application and 48 hours after 10th application
measure: Heart rate
timeFrame: Before the application, 45 minutes after 10th application and 48 hours after 10th application
Secondary outcomes:
measure: 36-Item Short Form Survey (SF-36)
timeFrame: Before the application, 45 minutes after 10th application and 48 hours after 10th application
measure: Change in pain perception
timeFrame: Before the application, 45 minutes after 10th application and 48 hours after 10th application
measure: EQ-5D- 5L questionnaire
timeFrame: Before the application, 45 minutes after 10th application and 48 hours after 10th application
measure: Oswestry disability index (ODI)
timeFrame: Before the application, 45 minutes after 10th application and 48 hours after 10th application
measure: Skin Sensory Function
timeFrame: Before the application, 45 minutes after 10th application and 48 hours after 10th application
measure: Flexibility
timeFrame: Before the application, 45 minutes after 10th application and 48 hours after 10th application
measure: Skin Temperature
timeFrame: Before the application, 45 minutes after 10th application and 48 hours after 10th application
Other outcomes:
Locations:
city: Bratislava
country: Slovakia
facility: Facultiy of Physical Education and Sports, Comenius University of Bratislava
city: Izola
country: Slovenia
facility: Faculty of Health Sciences
Study officials:
affiliation: Faculty of Health Sciences, University of Primorska, Slovenia
name: Nejc Šarabon, PhD
role: PRINCIPAL_INVESTIGATOR
References: