VirtualNoPain-Project: Combination of Virtual Reality (VR) and Brain-Computer Interface (BCI) in Chronic Pain Management

Not Applicable

Recruiting

Conditions: M79.7
Fibromyalgia

Registration Number: DRKS00032556

Lead Sponsor: eurologische Klinik und Poliklinik, Universitätsklinikum Würzburg

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Female

Target Recruitment: 20

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

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.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
1. Composite score of duration and severity of pain exacerbations compared between pre-treatment phase, treatment phase, and follow-up phase.<br>2. Amount of analgesic intake recorded during each of the pre-treatment, treatment, and follow-up phases.<br>3. Current rating on the numerical rating scale (NRS) before and after each intervention. <br>4. Frequency of use and side effects during the two-week treatment.