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Medical Cannabis for Treating Pain Related to Fibromyalgia — Bedrocan®-LD  

Fibromyalgia Clinical Trial

Official title:
Is Low Dosage of Medical Cannabis Effective for Treating Pain Related to Fibromyalgia?

Clinical Trial Summary

The goal of this interventional study is to learn about the effect of Medicinal Cannabis (Bedrocan®) on Fibromyalgia patients with pain resistant to conventional therapy. The main question the trial aims to answer are: - Is Bedrocan® effective for treating fibromyalgia-related pain in patients resistant to conventional therapy? - Can a low dosage of medical cannabis taken as a decoction reduce fibromyalgic pain? All patients were trained on how to make the decoction: therapy was started with 100 mg/day (1 folder) and increased to 200 mg/day (2 folders) in non-responders.

Clinical Trial Description

The study took place in the pain therapy unit of San Carlo Hospital (Potenza, Italy) between March 2021 and September 2021. Over this period, 44 subjects visited the pain unit and underwent specialist evaluation. Fibromyalgia syndrome was confirmed using the Widespread Pain Index (WPI) and Symptom Severity (SS) scale criteria, resulting in the recruitment of 34 subjects. Two participants discontinued therapy due to side effects, while 2 other patients were excluded for not initiating treatment within the required timeframe. Therefore, the final number of recruited fibromyalgic subjects for the study was 30. Among these subjects, those who provided informed written consent for starting the trial with medical cannabis were prescribed Bedrocan® once a month, with a total of 30 prescriptions per month for a duration of 6 months. All patients were instructed on how to prepare the decoction; the therapy was started with 100 mg/day (1 chart) and increased to 200 mg/day (2 charts) in non-responsive subjects. The Numerical Rating Scale (NRS) and SF-12 Short Form health questionnaire were used to evaluate pain intensity and the quality of life at the beginning of the study and 6th-month follow-up. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05939466
Study type Interventional
Source Universita degli Studi della Basilicata
Contact
Status Completed
Phase Phase 4
Start date March 1, 2021
Completion date September 30, 2021
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