The Effectiveness of CBD and CBN in the Treatment of Facial Pain and Headache of Muscular Origin

NCT ID: NCT05961501

Last Updated: 2025-07-16

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2026-02-28

Brief Summary

The aim of the study is to evaluate the effectiveness of an aqueous solution containing CBD and CBN in the management of Facial Pain and Headache of Muscular Origin. A randomized (block randomization), double-blind, two-arm controlled trial will involve 42 adult patients diagnosed with Facial Pain and Headache of Muscular Origin which is lasting more than 3 months on the basis of clinical examination. Qualified study participants will be randomly assigned to two groups. The studied group will receive tan aqueous solution containing CBD and CBN, to drink at home in the dose determined by the attending physician, while the control group will receive an aqueous solution of placebo, to drink at home in the dose determined by the attending physician during this time. Each subject will be tested on the qualification day (D0), on 20 days after D0 (D20), and then 40 (D40) and 60 (D60) days after the qualification day using electromyography (EMG), pressure pain threshold test (PPT), clinical examination and surveys.

Detailed Description

Background: Orofacial pain is a common occurrence. According to available scientific research, it occurs in up to 16 to 25% of the human population. In its chronic form, orofacial pain can lead to reduced sleep quality, reduced life satisfaction, and psychoemotional disorders, including depressive disorders. A popular tendency among patients suffering from chronic orofacial pain is the abuse of non-steroidal anti-inflammatory drugs, which in most cases show low, short-term and disproportionate to side effects effectiveness. There are scientific reports suggesting that substances such as cannabidiol (CBD) and cannabinol (CBN) may be effective in the treatment of chronic nociceptive and neuropathic pain. However, studies on the effectiveness of these substances in alleviating muscular orofacial pain are clearly lacking

Aim: The aim of the study is to evaluate the effectiveness of an aqueous solution containing CBD and CBN in the management of Facial Pain and Headache of Muscular Origin

Material and methods: A randomized (block randomization), double-blind, two-arm controlled trial will involve 42 adult patients diagnosed with Facial Pain and Headache of Muscular Origin which is lasting more than 3 months on the basis of clinical examination. Criteria for exclusion from the study will include: patients under 18 years of age, patients who are allergic to any ingredient of the preparation, pregnant or breast-feeding women, patients taking preparations that contain similar ingredients and/or have similar effects, obese patients, patients with active cancer, patients with severe systemic diseases, including genetic and neurological diseases, patients with severe mental illnesses, patients who are taking or in the last 12 months have taken antidepressants and/or myorelaxants and/or other drugs that affect neuromuscular activity, patients addicted to alcohol or drugs.

Qualified study participants will be randomly assigned to two groups. The studied group will receive an aqueous solution containing CBD and CBN, to drink at home in the dose determined by the attending physician, while the control group will receive an aqueous solution of placebo, to drink at home in the dose determined by the attending physician during this time. Each subject will be tested on the day of qualification (day 0), after 20 (day 20), and then 40 (day 40) and 60(day 60) days after the qualification day using the following methods:

• EMG (Electromyography) (day 0, day 20, day 40, day 60)
• Pressure pain threshold test (PPT) using the Wagner Paintest FPX 25 algometer (day 0, day 20, day 40, day 60)
• Clinical examination according to diagnostic criteria for temporomandibular disorders - DC / TMD International Examination Form (day 0, day 20, day 40, day 60)
• Surveys: Graded Chronic Pain Scale oraz McGill Pain Questionnaire (day 0, day 20, day 40, day 60), Satisfaction with Life Scale (day 0, day 20, day 40, day 60), Pittsburgh Sleep Quality Index (day 0, day 20, day 40, day 60), The Migraine Disability Assessment Test -MIDAS (day 0, day 20, day 40, day 60), Central Sensitisation Inventory (CSI) (day 0, day 20, day 40, day 60), Bruxscreen Q (day 0, day 20, day 40, day 60), Generalised Anxiety Disorder Assessment (day 0, day 20, day 40, day 60), Insomnia Severity Index (day 0, day 20, day 40, day 60), The Perceived Stress Scale (day 0, day 20, day 40, day 60), Somatic Symptom Scale - 8 (day 0, day 20, day 40, day 60)

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Study Group

Participants with facial pain and headache of muscular origin which last for more than 3 months. Each of the participants in this group will receive the aqueous solution of CBD and CBN to drink in home every day for 60 days in a specific dose determined by the attending physician

Group Type: EXPERIMENTAL

An aqueous solution containing CBD and CBN

Intervention Type: DRUG

An aqueous solution containing CBD and CBN, to drink at home in the dose determined by the attending physician

Control group

Participants with facial pain and headache of muscular origin which last for more than 3 months. Each of the participants in this group will receive the placebo to drink in home every day for 60 days in a specific dose determined by the attending physician

Group Type: PLACEBO_COMPARATOR

The aqueous solution of placebo

Intervention Type: OTHER

An aqueous solution of placebo, to drink at home in the dose determined by the attending physician

Interventions

An aqueous solution containing CBD and CBN

An aqueous solution containing CBD and CBN, to drink at home in the dose determined by the attending physician

Intervention Type: DRUG

The aqueous solution of placebo

An aqueous solution of placebo, to drink at home in the dose determined by the attending physician

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• facial pain and headache of muscular origin for more than 3 months

Exclusion Criteria

• patients under 18 years of age,
• patients who are allergic to any ingredient of the preparation,
• pregnant or breast-feeding women,
• patients taking preparations that contain similar ingredients and/or have similar effects,
• obese patients,
• patients with active cancer,
• patients with severe systemic diseases, including genetic and neurological diseases,
• patients with severe mental illnesses,
• patients who are taking or in the last 12 months have taken antidepressants and/or myorelaxants and/or other drugs that affect neuromuscular activity,
• patients addicted to alcohol or drugs.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wroclaw Medical University

OTHER

Sponsor Role: lead

Responsible Party

Joanna Smardz

Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Wroclaw Medical University

Wroclaw, , Poland

Countries

Poland

Other Identifiers

WMU1/2023

Identifier Type: -

Identifier Source: org_study_id