Cannabinoids Effect on Central and Peripheral Pain Modulation in Fibromyalgia

• Status: Recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tel Aviv Medical Center

Criteria

Inclusion Criteria:

1. Diagnosed with fibromyalgia for over 3 months according to American college of rheumatology

2. Do not respond well to analgesic medications and or have severe side effects

3. Medium to high level of pain (over 40 on visual analogue scale scale)

4. Does not have other pain-related syndromes

5. Not treated regularly with cannabis.

6. Is ready to stop taking central nervous system medications 3 days prior to the experiment.

Exclusion Criteria:

1. alleviated levels of anxiety (above 52 in STAI)

2. Psychiatric medications due to psychiatric diagnoses (depression, bi-polar syndrome, etc.).

3. Cardiovascular problems

4. Neurological diseases (other than migraine).

5. Pregnancy or breastfeeding

6. Alcoholism or substance abuse

7. Cancer

8. Blood pressure problems

9. Patients that used cannabis in the past month

10. Illegibility to MRI