Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Recruiting NCT05644054

Cannabinoids Effect on Central and Peripheral Pain Modulation in Fibromyalgia

Conditions: Fibromyalgia, Primary

Sex: Female
Ages: 20 Years – 60 Years
Phase: NA
Enrollment: 40
Sponsor: Tel Aviv Medical Center

Location: Israel

Summary

Fibromyalgia is a syndrome characterized by widespread chronic pain involving all musculoskeletal systems, accompanied by chronic sleep disorders, fatigue, memory problems, and more. Despite the advancement in the understanding of pain mechanisms thanks to various innovations in neuroscience and pain medicine, the syndrome's treatments are not satisfying, even in the presence of optimal multidisciplinary therapy, and many patients continue to suffer from chronic pain and associated symptoms.Although the pathophysiology of Fibromyalgia is not fully understood, there is evidence supporting the involvement of several mechanisms, including central sensitization, descending pain modulation pathway deficiency, and autonomic dysfunction, confirmed by physiological and functional imaging studies.Following the above reasons, there is great importance in understanding the effect of new treatments on pain mechanisms in Fibromyalgia syndrome. In the past few years, more and more research is providing evidence for cannabis analgesia in chronic pain syndromes, with an emphasis on Tetrahydrocannabinol (THC). However, only a little research has examined its efficacy in random double-blind experiments. Thus, testing the effect of THC in experimental clinical pain models could give a hint to our understanding of the pain regulation system in Fibromyalgia.The current research will study the effects of the cannabinoid THC component on pain regulation in Fibromyalgia in a double-blind controlled design. For that matter, the investigators will perform different peripheral physiological tests and functional magnetic resonance imaging. Additionally, the investigators aim to disclose the neural mechanisms underlying pain-autonomic interactions in Fibromyalgia patients.

Eligibility Criteria

Inclusion Criteria:Diagnosed with fibromyalgia for over 3 months according to American college of rheumatologyDo not respond well to analgesic medications and or have severe side effectsMedium to high level of pain (over 40 on visual analogue scale scale)Does not have other pain-related syndromesNot treated regularly with cannabis.Is ready to stop taking central nervous system medications 3 days prior to the experiment.Exclusion Criteria:alleviated levels of anxiety (above 52 in STAI)Psychiatric medications due to psychiatric diagnoses (depression, bi-polar syndrome, etc.).Cardiovascular problemsNeurological diseases (other than migraine).Pregnancy or breastfeedingAlcoholism or substance abuseCancerBlood pressure problemsPatients that used cannabis in the past monthIllegibility to MRI

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05644054). StuddyBuddy aggregates publicly available trial information.