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)