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Low Back PainPhase 1/2Munari04NCT03440125

Cayenne Pepper Cataplasm - Safety Study

A Phase 1/2 study testing Cayenne Pepper topical, Electrical stimulation and Massage in people with Low Back Pain, run by University of Primorska at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Low Back Pain
What is being tested?
Cayenne Pepper topical, Electrical stimulation and Massage
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
2 sitesin 2 countries
Study dates
15 Mar 2016to 15 Dec 2016
Phase
Phase 1/2
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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 locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Slovakia1 site

  • Facultiy of Physical Education and Sports, Comenius University of Bratislava

    Bratislava, 81806

Other trials in Slovakia

Slovenia1 site

  • Faculty of Health Sciences

    Izola, 6310

Other trials in Slovenia

About this study

Official title: Cayenne Pepper Cataplasm Application and Potential Side Effects

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.

Read the 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.

Conditions
Low Back Pain
Being tested
Cayenne Pepper topical, Electrical stimulation, Massage
Keywords
Low Back Pain, Capsicum, Physical Therapy, Pain
Medical subject headings
Low Back Pain, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cayenne Pepper topicalDrug

    Also called Cayenne Pepper Cataplasm application

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

  • Electrical stimulationDevice

    Also called Neuromuscular Electrical Stimulation (NMES)

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

  • MassageProcedure or surgery

    Also called Classical massage

    10 minutes of classical massage of low back pain area.

Study groups in NCT03440125
Study groupRoleWhat they receive
HealthyExperimentalHealthy participants with no low back pain. 20 min application of Cayenne Pepper Cataplasm (Cayenne Pepper topical) on the back will be administered.
Receives: Drug: Cayenne Pepper topical
LBP patients - CPC GroupExperimentalParticipants suffering from low back pain (LBP) receiving 10 times (within 3 weeks) 20min application of Cayenne Pepper Cataplasm (Cayenne Pepper topical).
Receives: Drug: Cayenne Pepper topical
LBP patients - CPC and ES/M GroupExperimentalParticipants 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.
Receives: Drug: Cayenne Pepper topical; Device: Electrical stimulation; Procedure: Massage

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. Change in systolic and diastolic blood pressure

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

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

  3. Heart rate

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

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

Secondary outcomes (7)

  1. 36-Item Short Form Survey (SF-36)

    The Short Form (36) Health Survey (SF-36) is a patient-reported survey of patient health. It consists of eight scaled scores, which are the weighted sums all questions in their respective section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the higher is the disability.

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

  2. Change in pain perception

    Pain perception during rest and movement assessed with visual analogue scale (0-10). 0 represents no pain, and 10 represents severe pain.

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

  3. EQ-5D- 5L questionnaire

    EQ-5D- 5L questionnaire includes following aspects: mobility, care, usual activities, pain/discomfort, anxiety/depression, crosswalk-index, self-feeling of health. Each aspect is evaluated on a 1-5 scale, with following descriptions of levels: having no problems, having slight problems, having moderate problems, having severe problems and being unable to do/having extreme problems. Visual analogue scale is the second part of the questionnaire, asking to mark health status on the day of the interview on a 20 cm vertical scale with end points of 0 and 100. There are notes at the both ends of the scale that the bottom rate (0) corresponds to " the worst health you can imagine", and the highest rate (100) corresponds to "the best health you can imagine".

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

  4. Oswestry disability index (ODI)

    ODI will be used only in LBP arms (Arm 2 and 3). ODI is commonly used by clinicians and researchers to quantify disability for low back pain.

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

  5. Skin Sensory Function

    Skin sensory function will be assessed by 2-point discrimination test (which is carried out using two pins, oriented in medial-lateral direction and pressed perpendicularly to the skin, with the medial pin being 3 cm laterally from the L3 spinal process. The subject is asked to report whether he/she felt one or two pins) and mono filament/light touch sensitivity tests (monofilaments calibrated to 0.025, 0.07, 2, 5, and 10 grams The subject is asked to report when he/she felt touching the skin with a monofilament 3 cm laterally from L3 spinal process). The lightest mono filament and the lowest pin inter-distance are take as final outcome measures.

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

  6. Flexibility

    Assessment of total spine flexibility (forward bend test) and separately for the lumbar part (Schober's test) and thoracic part.

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

  7. Skin Temperature

    Skin temperature [°C] at the site of application (low back) and at the control part of the body (neck), measured with a laser thermometer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2018
  2. Study start15 Mar 2016
  3. Primary completion15 Nov 2016
  4. Study completion15 Dec 2016

Resources

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03440125
Sponsor's protocol ID
UP-MunariStudy
Acronym
Munari04
Status last verified
Feb 2018
First submitted
6 Feb 2018
Last updated
20 Feb 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Cayenne Pepper topical, Electrical stimulation and Massage in people with Low Back Pain, run by University of Primorska at 2 sites in 2 countries.

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 2 inclusion and 5 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 20 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Slovakia, Slovenia. 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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 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). The study lists 3 primary outcomes in all. 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 NCT03440125.

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 20 Feb 2018.

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