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

NCT05961501 | Enrolling By Invitation Phase 2

• 1 other identifier: WMU1/2023
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

cannabidiol; cannabinol

Outcome Measures

Primary Outcomes (2)

• 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.

  Each participant will undergo pressure pain threshold test (PPT) using the Wagner Paintest FPX 25 algometer before and after taking an aqueous solution containing CBD and CBN.

  3 months

• The influence of an aqueous solution containing CBD and CBN on electrical activity and nerve conduction in muscles using EMG ( Electromyography).

  Each participant will undergo EMG ( Electromyography) before and after taking an aqueous solution containing CBD and CBN. EMG measures the electrical activity of the muscle during rest, slight contraction and forceful contraction.

  3 months

Secondary Outcomes (13)

• 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.

  3 months

• 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.

  3 months

• The influence of an aqueous solution containing CBD and CBN on muscle pain assessed using Graded Chronic Pain Scale.

  3 months

• The influence of an aqueous solution containing CBD and CBN on muscle pain assessed using McGill Pain Questionnaire.

  3 months

• The influence of an aqueous solution containing CBD and CBN on muscle pain assessed using Pittsburgh Sleep Quality Index.

  3 months

Study Arms (2)

Study Group

EXPERIMENTAL

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

Drug: An aqueous solution containing CBD and CBN

Control group

PLACEBO COMPARATOR

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

Other: The aqueous solution of placebo

Interventions

An aqueous solution containing CBD and CBN DRUG

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

Study Group

The aqueous solution of placebo OTHER

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

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wroclaw Medical University: lead

Study Sites (1)

Wroclaw Medical University

Wroclaw, 50-425, Poland

Location

MeSH Terms

Conditions

Myalgia; Facial Pain; Tension-Type Headache; Headache

Interventions

Cannabinol

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

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: May 25, 2023
• First Posted: July 27, 2023
• 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

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)