Concentration of Receptors With Affinity for Cannabidiol and Cannabinol and the Effect on Chronic Orofacial Pain of Muscle Origin

NCT06405646 | Enrolling By Invitation

• 1 other identifier: WMU1/2024
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Myalgia; Muscle Pain; Orofacial Pain; Headache, Tension; Headaches Muscular

Keywords

cannabidiol; cannabinol; TRPV1 receptor; CB1 receptor; CB2 receptor

Outcome Measures

Primary Outcomes (2)

• 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

  Each participant will undergo blood test focusing on CB1, CB2, TRPV-1 concentration

  May 5, 2024 - December 31, 2024

• Assessment of the occurrence of chronic orofacial pain of muscular origin assessed using the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) protocol.

  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.

  May 5, 2024 - December 31, 2024

Secondary Outcomes (8)

• 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 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

Study Arms (2)

Study group

Participants with chronic pain in the masticatory muscles

Diagnostic Test: Blood CB1, CB2, TRPV-1 concentration measurement

Control group

Participants without chronic pain in the masticatory muscles

Diagnostic Test: Blood CB1, CB2, TRPV-1 concentration measurement

Interventions

Blood CB1, CB2, TRPV-1 concentration measurement DIAGNOSTIC_TEST

In each of the patients blood CB1, CB2, TRPV-1 concentration will be measure

Control group; Study group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with suspicion of Chronic Orofacial Pain of Muscle Origin referred to the Wroclaw Medical University. Healthy controls.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Wroclaw Medical University: lead

Study Sites (1)

Wroclaw Medical University

Wroclaw, 50-425, Poland

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Myalgia; Facial Pain; Tension-Type Headache

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: May 8, 2024
• Study Start: April 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-03

Locations

PL (1)