Cayenne Pepper Cataplasm - Safety Study

NCT03440125 | Completed Phase 1

• 1 other identifier: UP-MunariStudy
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

Low Back Pain; Capsicum; Physical Therapy; Pain

Outcome Measures

Primary Outcomes (3)

• Change in concentration of circulating biomarkers of inflammation, neudroendocrine stress and blood vessel activation

  The blood analysis will include standard analysis of hemogram, C-reactive proteins, creatine-kinase, sedimentation, albumin and cortisol. Enzyme-linked immunosorbent assay (ELISA) will include Tumor necrosis factor-Alpha, Interleukin-6, Leukotriene B4 and P-Selectine. Additionally, microRNA analysis will be performed (gene numbers: 1, 21, 23, 25, 103, 126, 133, 146, 155, 199a, 199b, 191, 206, 451.

  Before the application, 45 minutes after 10th application and 48 hours after 10th application

• Change in systolic and diastolic blood pressure

  Systolic and diastolic blood pressure \[mmHg\], measured at both sides of the body with blood pressure gauge

  Before the application, 45 minutes after 10th application and 48 hours after 10th application

• Heart rate

  Heart rate (bpm), measured with heart rate monitor belt.

  Before the application, 45 minutes after 10th application and 48 hours after 10th application

Secondary Outcomes (7)

• 36-Item Short Form Survey (SF-36)

  Before the application, 45 minutes after 10th application and 48 hours after 10th application

• Change in pain perception

  Before the application, 45 minutes after 10th application and 48 hours after 10th application

• EQ-5D- 5L questionnaire

  Before the application, 45 minutes after 10th application and 48 hours after 10th application

• Oswestry disability index (ODI)

  Before the application, 45 minutes after 10th application and 48 hours after 10th application

• Skin Sensory Function

  Before the application, 45 minutes after 10th application and 48 hours after 10th application

Study Arms (3)

Healthy

EXPERIMENTAL

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

Drug: Cayenne Pepper topical

LBP patients - CPC Group

EXPERIMENTAL

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

Drug: Cayenne Pepper topical

LBP patients - CPC and ES/M Group

EXPERIMENTAL

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.

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

Interventions

Cayenne Pepper topical DRUG

20min topical Cayenne Pepper Cataplasm application containing 5% Cayenne Pepper nd 95% Kaolin mixed with water

Also known as: Cayenne Pepper Cataplasm application

Healthy; LBP patients - CPC Group; LBP patients - CPC and ES/M Group

Electrical stimulation DEVICE

Electrical stimulation 10min 60Hz biphasic rectangular neuromuscular electrical Stimulation (NMES)

Also known as: Neuromuscular Electrical Stimulation (NMES)

LBP patients - CPC and ES/M Group

Massage PROCEDURE

10 minutes of classical massage of low back pain area.

Also known as: Classical massage

LBP patients - CPC and ES/M Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Primorska: lead
• S2P, Science to Practice, Ltd.: collaborator
• Comenius University: collaborator
• Wilhelminenspital Vienna: collaborator
• Ludwig Boltzmann Institute of Electrical Stimulation and Physical Rehabilitation: collaborator

Study Sites (2)

Facultiy of Physical Education and Sports, Comenius University of Bratislava

Bratislava, 81806, Slovakia

Location

Faculty of Health Sciences

Izola, 6310, Slovenia

Location

MeSH Terms

Conditions

Low Back Pain; Pain

Interventions

Electric Stimulation; Massage

Condition Hierarchy (Ancestors)

Back Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Stimulation; Investigative Techniques; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Nejc Šarabon, PhD

  Faculty of Health Sciences, University of Primorska, Slovenia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean of Faculty

Study Record Dates

• First Submitted: February 6, 2018
• First Posted: February 20, 2018
• Study Start: March 15, 2016
• Primary Completion: November 15, 2016
• Study Completion: December 15, 2016
• Last Updated: February 20, 2018

Record last verified: 2018-02

Locations

SL (1)