Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06405646
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-08
First Post:
2024-05-03
Brief Title:
Concentration of Receptors With Affinity for Cannabidiol and Cannabinol and the Effect on Chronic Orofacial Pain of Muscle Origin
Sponsor:
Wroclaw Medical University
Organization:
Wroclaw Medical University
Study Overview
Official Title:
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
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 DCTMD 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
Detailed Description:
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 ie 559 Więckiewicz et al 2020
In its chronic form orofacial pain may lead to reduced sleep quality reduced life satisfaction and psychoemotional disorders including depressive disorders Wieckiewicz et al 2022 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 Grossman et al 2021 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 eg neuropathic pain TRPV1 can be activated by endogenous substances eg anandamide or exogenous substances eg 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
Material and methods
The study included a study group of 51 people suffering from chronic pain in the masticatory muscles and a control group of 51 healthy people without pain in the masticatory muscles Patients will be seen at the Clinic of the University Dental Center in Wrocław The patient will be qualified based on the standardized and validated international DCTMD protocol Diagnostic Criteria for Temporomandibular Disorders and the criteria included in ICOP-1 International Classification of Orofacial Pain 1st edition The patients examination will be performed by a qualified dentist
Criteria for inclusion in the study group will be
age over 18
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
Exclusion criteria
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 andor myorelaxants andor other drugs that affect neuromuscular activity in the last 12 months
people addicted to alcohol drugs and other psychoactive substances
condition after craniofacial injuries
The control group will include people without chronic pain in the masticatory muscles The exclusion criteria remain the same as for the study group
As mentioned above each study participant will initially undergo an extraoral and intraoral examination based on the validated international DCTMD Diagnostic Criteria for Temporomandibular Disorders protocol The examinations will be performed by trained dentists
Patients from both groups will be asked to complete the following validated questionnaires
regarding pain - Graded Chronic Pain Scale and McGill Pain Questionnaire
regarding headache - The Migraine Disability Assessment Test MIDAS
regarding the scale of perceived stress - Perceived Stress Scale - 10 PSS-10
regarding generalized anxiety disorder - Generalized Anxiety Disorder - 7 GAD-7
regarding the scale of somatic symptoms - The Somatic Symptom Scale -8 SSS8
The last stage includes collecting a venous blood sample from patients in the study and control groups and determining the concentration of CB1 CB2 and TRPV-1 receptors The receptors will be determined using specialized ELISA kits
The collected data will then be subjected to statistical analysis in order to verify the research hypothesis and capture statistically significant relationships
In its chronic form orofacial pain may lead to reduced sleep quality reduced life satisfaction and psychoemotional disorders including depressive disorders Wieckiewicz et al 2022 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 Grossman et al 2021 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 eg neuropathic pain TRPV1 can be activated by endogenous substances eg anandamide or exogenous substances eg 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
Material and methods
The study included a study group of 51 people suffering from chronic pain in the masticatory muscles and a control group of 51 healthy people without pain in the masticatory muscles Patients will be seen at the Clinic of the University Dental Center in Wrocław The patient will be qualified based on the standardized and validated international DCTMD protocol Diagnostic Criteria for Temporomandibular Disorders and the criteria included in ICOP-1 International Classification of Orofacial Pain 1st edition The patients examination will be performed by a qualified dentist
Criteria for inclusion in the study group will be
age over 18
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
Exclusion criteria
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 andor myorelaxants andor other drugs that affect neuromuscular activity in the last 12 months
people addicted to alcohol drugs and other psychoactive substances
condition after craniofacial injuries
The control group will include people without chronic pain in the masticatory muscles The exclusion criteria remain the same as for the study group
As mentioned above each study participant will initially undergo an extraoral and intraoral examination based on the validated international DCTMD Diagnostic Criteria for Temporomandibular Disorders protocol The examinations will be performed by trained dentists
Patients from both groups will be asked to complete the following validated questionnaires
regarding pain - Graded Chronic Pain Scale and McGill Pain Questionnaire
regarding headache - The Migraine Disability Assessment Test MIDAS
regarding the scale of perceived stress - Perceived Stress Scale - 10 PSS-10
regarding generalized anxiety disorder - Generalized Anxiety Disorder - 7 GAD-7
regarding the scale of somatic symptoms - The Somatic Symptom Scale -8 SSS8
The last stage includes collecting a venous blood sample from patients in the study and control groups and determining the concentration of CB1 CB2 and TRPV-1 receptors The receptors will be determined using specialized ELISA kits
The collected data will then be subjected to statistical analysis in order to verify the research hypothesis and capture statistically significant relationships
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None