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临床试验/NCT03440125
NCT03440125已完成1 期

Cayenne Pepper Cataplasm Application and Potential Side Effects

University of Primorska2 个研究点 分布在 2 个国家目标入组 30 人开始时间: 2016年3月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
30
试验地点
2
主要终点
Change in concentration of circulating biomarkers of inflammation, neudroendocrine stress and blood vessel activation

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Cayenne Pepper topical (Drug)

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).

干预措施: Cayenne Pepper topical (Drug)

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.

干预措施: Cayenne Pepper topical (Drug)

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.

干预措施: Electrical stimulation (Device)

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.

干预措施: Massage (Procedure)

结局指标

主要结局

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

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

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.

Change in systolic and diastolic blood pressure

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

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

Heart rate

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

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

次要结局

  • 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)
  • Flexibility(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)
  • Skin Temperature(Before the application, 45 minutes after 10th application and 48 hours after 10th application)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nejc Sarabon

Dean of Faculty

University of Primorska

研究点 (2)

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