Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2025-12-24 @ 4:01 PM
NCT ID:
NCT05939466
Brief 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.
Detailed 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:
NCT05939466
Study Brief:
Protocol Section:
NCT05939466