Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT03503760
Eligibility Criteria:
Inclusion Criteria:
* patients with an established fibromyalgia diagnosis of at least three months according to American College of Rheumatology 2010 modified criteria and no responsive to their current therapy.
* patients were not responsive to amitryptiline, selective serotonin reuptake inhibitor (SSRI) or duloxetine and pregabalin (with a pain reduction below 50% compared to pre-therapy or intolerant to these drugs)
* patients with a pain level measured with Visual Analogue Scale for Pain (VAS) \> 50/100.
* patients that had been taking other drugs or food supplements for the treatment of fibromyalgia for at least 6 months.
Exclusion Criteria:
* patients that completed either physiotherapy or acupuncture or behavioral treatment in the last 6 months
* patients that were affected by other painful syndromes or potentially painful syndromes other than fibromyalgia.
* pregnant women
* pace-maker carriers
* oncologic patients
* tuberculotic patients.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT03503760
Study Brief:
Protocol Section:
NCT03503760