The Influence of the Concentration of Receptors With Affinity for Cannabidol and Cannabinol on the Risk of Occurrence and Severity of Chronic Orofacial Pain of Muscle Origin
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Relationship between the concentration of receptors with affinity for Cannabidol and Cannabinol and the risk of occurrence and severity of chronic orofacial pain of muscle origin
研究概览
简要总结
The main aim of the presented project will be to examine the concentration of selected receptors (CB1, CB2, TRPV-1) showing affinity for binding to cannabidol (CBD) and cannabinol (CBN) in blood samples collected from people with chronic pain in the masticatory muscles and from people without this pain. Moreover, study participants will be examined by a qualified doctor, according to the validated and standardized international DC/TMD protocol (Diagnostic Criteria for Temporomandibular Disorders) and the criteria included in ICOP-1 (International Classification of Orofacial Pain, 1st edition). The nature and duration of pain, psychoemotional state and central sensitization (the phenomenon of increased reactivity of the nervous system to stimuli) will be determined using validated questionnaires. The obtained results will be subjected to statistical analysis in order to check the relationships between the examined parameters.
详细描述
Background: Orofacial pain is a common phenomenon in adult patients in Poland. According to available scientific research, it occurs in over half of the population, i.e. 55.9% In its chronic form, orofacial pain may lead to reduced sleep quality, reduced life satisfaction and psychoemotional disorders, including depressive disorders. A popular trend among patients suffering from chronic orofacial pain is the abuse of non-steroidal anti-inflammatory drugs, which in most cases demonstrate low, short-term effectiveness and disproportionate to the side effects. There are scientific reports suggesting that substances such as cannabidol (CBD) and cannabinol (CBN) may be effective in the treatment of chronic nociceptive and neuropathic pain, but there is a clear lack of research on the importance of the concentration of receptors on which they can potentially affect exogenous cannabinoids in the risk of occurrence and development of chronic pain. Of the many receptors to which cannabinoids have affinity, the present study selected those that are involved in neurotransmission related to pain, in particular orofacial pain. The concentrations of CB1, CB2, TRPV-1 receptors will be examined, below is a brief description of each of them to explain their selection.
CB1 and CB2 receptors are G protein-coupled metabotropic receptors and belong to the 7-transmembrane receptor family. CB1 has been detected in central nervous system synapses and sensory neurons. The effect of high CB1 expression in areas closely related to the regulation of pain sensation is the relief of migraine and neuropathic pain. However, CB2 receptors can be found in T and B lymphocytes, spleen, pancreas and tonsils. They work to modulate the release of cytokines and the migration of immune cells in a way that appears to reduce inflammation and some types of pain.
The TRPV-1 receptor is the so-called transient potential 1 vanilloid receptor. They occur primarily at the peripheral endings of nerve fibers, where, as a result of the stimuli that stimulate them, they may participate in the development and conduction of pain. The receptor mediates peripheral pain sensation, able to lower the activation threshold and delay the response of nociceptors. Secondary analgesia following ligand-dependent activation is used in the treatment of some difficult-to-control types of pain, e.g. neuropathic pain. TRPV1 can be activated by endogenous substances, e.g. anandamide, or exogenous substances, e.g. cannabinoids contained in cannabis. It is also worth adding that CBD has the property of blocking FAAH (the enzyme fatty acid amide hydrolase), protecting anandamide against degradation, which means that CBD is also an agonist towards TRPV-1 and protects the natural agonist against degradation by FAAH.
Aim: The aim of this study is to answer how the concentration of the above receptors may influence the occurrence of chronic pain in the masticatory muscles in the study population.
It should be mentioned that CB1, CB2 and TRPV-1 receptors have not yet been included in this research perspective and there are no publications or scientific reports on this subject.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age over 18, under 80
- •the presence of chronic pain in the muscles of the masticatory system, which lasts for more than 3 months in accordance with the international criteria included in ICOP-1.
排除标准
- •people under 18 years of age
- •pregnant or breastfeeding women,
- •obese people,
- •people with active cancer,
- •people with severe systemic diseases, including genetic and neurological diseases,
- •people with severe mental illnesses and taking psychoactive substances, people who are taking or have taken antidepressants and/or myorelaxants and/or other drugs that affect neuromuscular activity in the last 12 months
- •people addicted to alcohol, drugs and other psychoactive substances
- •condition after craniofacial injuries
研究组 & 干预措施
Study group
Participants with chronic pain in the masticatory muscles
干预措施: Blood CB1, CB2, TRPV-1 concentration measurement (Diagnostic Test)
Control group
Participants without chronic pain in the masticatory muscles
干预措施: Blood CB1, CB2, TRPV-1 concentration measurement (Diagnostic Test)
结局指标
主要结局
Relationship between the concentration of receptors with affinity for Cannabidol and Cannabinol and the risk of occurrence and severity of chronic orofacial pain of muscle origin
时间窗: May 5, 2024 - December 31, 2024
Each participant will undergo blood test focusing on CB1, CB2, TRPV-1 concentration
Assessment of the occurrence of chronic orofacial pain of muscular origin assessed using the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) protocol.
时间窗: May 5, 2024 - December 31, 2024
Each patient will undergo DC/TMD protocol-based clinical examination using DC/TMD examination form assessing incidence of pain of masticatory muscles and surrounding structures.
次要结局
- Assessment of the occurrence of chronic orofacial pain of muscular origin assessed using the Gradual Chronic Pain Scale.(May 5, 2024 - December 31, 2024)
- Assessment of the occurrence of chronic orofacial pain of muscular origin assessed using the McGill Pain Questionnaire.(May 5, 2024 - December 31, 2024)
- Assessment of the occurrence of chronic orofacial pain of muscular origin assessed using the Central Sensitizatin Inventory(May 5, 2024 - December 31, 2024)
- Assessment of the occurrence of chronic orofacial pain of muscular origin assessed using the Migraine Disability Assessment Test (MIDAS)(May 5, 2024 - December 31, 2024)
- Assessment of the occurrence of chronic orofacial pain of muscular origin assessed using the Perceived Stress Scale -10(May 5, 2024 - December 31, 2024)
- Assessment of the occurrence of chronic orofacial pain of muscular origin assessed using the Generalized Anxiety Disorder -7(May 5, 2024 - December 31, 2024)
- Assessment of the occurrence of chronic orofacial pain of muscular origin assessed using the Somatic Symptom Scale - 8(May 5, 2024 - December 31, 2024)
- Assessment of the occurrence of chronic orofacial pain of muscular origin assessed using the Pain Catastrophizing Scale(May 5, 2024 - December 31, 2024)
研究者
Joanna Smardz
Investigator
Wroclaw Medical University
