M79.7
Conditions
Interventions
Group 1: Patients with fibromyalgia syndrome undergo a two-week VR-BCI program (five treatment days per week), combining virtual reality and neurofeedback training.
Sponsors
Neurologische Klinik und Poliklinik, Universitätsklinikum Würzburg
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients with fibromyalgia syndrome (FMS) according to classification criteria of the "American College of Rheumatology" (ACR criteria 2010). For inclusion in the VR-BCI program: mean pain severity of =4 on the NRS in the two-week pre-treatment period.
Exclusion criteria
Exclusion criteria: Severe comorbidities (e.g., cancer, severe heart failure, severe hepatic or renal dysfunction, dementia or other disease with severe cognitive impairment), pregnancy, and other health limitations such as inadequately corrected hearing and vision that would prevent participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The mean values of pain intensity on the numerical rating scale (NRS) over a period of 14 days, collected once daily via pain diary, will be compared between the 1. two-week pre-treatment phase, 2. two-week treatment phase, 3. two-week follow-up phase. A minimum 30% reduction in mean pain intensity between the pre-treatment phase and either the therapy phase or the follow-up phase will be considered a positive outcome. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Composite score of duration and severity of pain exacerbations compared between pre-treatment phase, treatment phase, and follow-up phase. 2. Amount of analgesic intake recorded during each of the pre-treatment, treatment, and follow-up phases. 3. Current rating on the numerical rating scale (NRS) before and after each intervention. 4. Frequency of use and side effects during the two-week treatment. | — |
Countries
Germany
Contacts
Public ContactClaudia Sommer
Neurologische Klinik und Poliklinik, Universitätsklinikum Würzburg
Outcome results
None listed