Cayenne Pepper Cataplasm - Safety Study (Munari04)

University of Primorska

Status and phase: Completed; Phase 2; Phase 1

Conditions: Low Back Pain

Treatments: Procedure: Massage; Device: Electrical stimulation; Drug: Cayenne Pepper topical

Study type: Interventional

Funder types: Other

Identifiers

NCT03440125

UP-MunariStudy

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 3 patient groups

Healthy

Experimental group

Description:

Healthy participants with no low back pain. 20 min application of Cayenne Pepper Cataplasm (Cayenne Pepper topical) on the back will be administered.

Treatment:

Drug: Cayenne Pepper topical

LBP patients - CPC Group

Experimental group

Description:

Participants suffering from low back pain (LBP) receiving 10 times (within 3 weeks) 20min application of Cayenne Pepper Cataplasm (Cayenne Pepper topical).

Treatment:

Drug: Cayenne Pepper topical

LBP patients - CPC and ES/M Group

Experimental group

Description:

Participants suffering from low back pain (LBP) receiving 10 times (within 3 weeks) 20min application of Cayenne Pepper Cataplasm (Cayenne Pepper topical), and half of the subject also receiving 10 min electrical Stimulation and 10 min massage Treatment on the back.

Treatment:

Drug: Cayenne Pepper topical

Procedure: Massage

Device: Electrical stimulation