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

Sponsor
Wroclaw Medical University
Study ID
NCT05961501
Phase
PHASE2/PHASE3
Status
Enrolling By Invitation

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

First listed
Jul 27, 2023
Start date
Apr 1, 2025
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
42 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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
  • Placebo Comparator: 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

Primary Outcome 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. [ Time Frame: 3 months ]

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