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:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2025-12-24 @ 10:40 PM
NCT ID:
NCT02753335
Eligibility Criteria:
Inclusion criteria:
* Patients 18 - 70 years old. For patients who only participate in the clinical RCT (without fMRI) no upper age limit.
* CRPS affecting one single upper or lower limb diagnosed by the IASP (2012) Budapest research criteria (Harden et al., 2010).
* Triggering trauma or the onset of pain \>3 months ago.
* If possible drugs that can influence the fMRI scans should be avoided. Documentation if used.
Exclusion criteria
* Drug abuse.
* Malignant/progressive, systemic or neurodegenerative disease.
* Other severe pain conditions.
* Severe clinical anxiety or depression, symptoms of fatigue or ME of a disabling level.
For patients who participate in the MRI related analyses:
* Metallic implants incompatible with the MR technology or medical condition not recommended for fMRI.
* Pregnancy.
* Phobia for MRI examination.
* Diseases that can cause structural changes and interfere with the interpretation of the MRI-scans (like severe diabetes mellitus, heart disease, ischemic stroke and vascular conditions).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02753335
Study Brief:
Protocol Section:
NCT02753335