Clinical trial NCT05961501: The Effectiveness of CBD and CBN in the Treatment of Facial Pain and Headache of Muscular Origin
Official title: The Evaluation of the Effectiveness of Cannabidiol (CBD) and Cannabinol (CBN) Oral Solutions in the Treatment of Facial Pain and Headache of Muscular Origin
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Myalgia
Muscle Pain
Orofacial Pain
Headache, Tension
Headaches Muscular
Headache
Keywords: cannabidiol
cannabinol
Lead sponsor: Wroclaw Medical University
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

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.

Primary outcomes:
measure: The influence of an aqueous solution containing CBD and CBN on muscle pain assessed using pressure pain threshold test (PPT) using the Wagner Paintest FPX 25 algometer.
timeFrame: 3 months
measure: The influence of an aqueous solution containing CBD and CBN on electrical activity and nerve conduction in muscles using EMG ( Electromyography).
timeFrame: 3 months
Secondary outcomes:
measure: The effectiveness of an aqueous solution containing CBD and CBN reduction on Facial Pain and Headache of Muscular Origin assessed by clinical examination in accordance to Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) protocol.
timeFrame: 3 months
measure: The influence of an aqueous solution containing CBD and CBN on reduction of Facial Pain and Headache of Muscular Origin using Pain Numerical Rating Scale.
timeFrame: 3 months
measure: The influence of an aqueous solution containing CBD and CBN on muscle pain assessed using Graded Chronic Pain Scale.
timeFrame: 3 months
measure: The influence of an aqueous solution containing CBD and CBN on muscle pain assessed using McGill Pain Questionnaire.
timeFrame: 3 months
measure: The influence of an aqueous solution containing CBD and CBN on muscle pain assessed using Pittsburgh Sleep Quality Index.
timeFrame: 3 months
measure: The influence of an aqueous solution containing CBD and CBN on muscle pain assessed using Satisfaction with Life Scale Questionnaire.
timeFrame: 3 months
measure: The influence of an aqueous solution containing CBD and CBN on muscle pain assessed using the Migraine Disability Assessment Test - MIDAS
timeFrame: 3 months
measure: The influence of an aqueous solution containing CBD and CBN on muscle pain assessed by Central Sensitization Inventory
timeFrame: 3 months
measure: The influence of an aqueous solution containing CBD and CBN on muscle pain assessed by Bruxscreen Q questionnaire.
timeFrame: 3 months
measure: The influence of an aqueous solution containing CBD and CBN on muscle pain assessed by Generalized Anxiety Disorder -7
timeFrame: 3 months
measure: The influence of an aqueous solution containing CBD and CBN on muscle pain assessed by Insomnia Severity Index (ISI)
timeFrame: 3 months
measure: The influence of an aqueous solution containing CBD and CBN on muscle pain assessed by Perceived Stress Scale -10
timeFrame: 3 months
measure: The influence of an aqueous solution containing CBD and CBN on muscle pain assessed by Somatic Symptom Scale - 8
timeFrame: 3 months
Other outcomes:
Locations:
city: Wroclaw
country: Poland
facility: Wroclaw Medical University
Study officials:
References: