Using Immersive Virtual Reality to Treat Complex Regional Pain Syndrome in Adults
- Conditions
- Pain, Chronic
- Interventions
- Behavioral: in clinic pain VR reduction exercisesBehavioral: In clinic VRpain reduction exercises + VR homeworks
- Registration Number
- NCT05888142
- Lead Sponsor
- University of Washington
- Brief Summary
This study is designed to test if the use of virtual reality (VR) can improve chronic pain related to CRPS. One way is to use virtual reality. Virtual reality involves looking into a set of goggles and interacting with a computer-simulated world. The use of VR has been shown to be an effective treatment for other pain conditions (Hoffman et al., 2019) and is inexpensive and noninvasive.
- Detailed Description
Participants will "go into" simple fun pain distracting virtual reality worlds (no previous video game experience needed) that encourages physical movement of the injured limb (e.g., their injured hand). They will also learn some simple daily 10 minute stress reduction, mood lifting mindfulness skills in VR and will receive audio instructions to focus their attention on the sights and sounds, and controlled breathing (Flores et al., 2019).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 7
Not provided
- personal history of severe motion sickness
- severe systemic disease that is a constant threat to life (ASA class IV+)
- prisoners.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Roosevelt "in clinic VR" in clinic pain VR reduction exercises Patients in this group will receive VR physical therapy exercises "in clinic" only, during the two week treatment phase of the study (approximately 10 treatment sessions). After the first 2 weeks, all patients will do VR homeworks, including VR exercises and VR mindfulness. Roosevelt "in Clinic VR" + "VR homeworks" In clinic VRpain reduction exercises + VR homeworks Patients in this group will receive VR physical therapy exercises "in clinic", during the two week treatment phase of the study (approximately 10 treatment sessions). They will also take a VR system home and will be encouraged to do VR home works at home, during this first two week period. After the first 2 weeks, all patients will do VR homeworks, including VR exercises and VR mindfulness.
- Primary Outcome Measures
Name Time Method The Patient Global Impression of Change scale (PGIC), regarding CRPS pain. Change from baseline to 1 year post-treatment This self-report measure. reflects a patient's belief about the efficacy of treatment.
Compared with before receiving VR therapy, how would you describe your pain related to CRPS now overall? 7 point scale from - 3 to + 3 (-3 = very much worst, +3 = very much better). This is a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change in CRPS pain as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse."The Patient Global Impression of Change scale (PGIC), regarding functionality/physical abilities. Change from baseline to one year post-treatment This self-report measure reflects a patient's belief about the efficacy of treatment.
Compared with before receiving VR therapy, how would you describe your physical abilities now overall? 7 point scale from - 3 to + 3 (-3 = very much worst, +3 = very much better). This is a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change in physical abilities as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse."
- Secondary Outcome Measures
Name Time Method The Central Sensitization Inventory (CSI). Change from baseline to one year post-treatment The Central Sensitization Inventory (CSI) is a self-report screening instrument designed to measure exaggerated pain sensitivity. 25 questions, patients answer "never, rarely sometimes, often, always".
CES-D Center for Epidemiologic Studies Depression Scale (CES-D), NIMH. Change from baseline to one year post-treatment 20 self-rating questions about how depressed the patient has felt during the past week: rarely, a little of the time, a moderate amount of time, most or all of the time.
Mindfulness. Change from baseline to one year post-treatment Mindfulness. Using a single item graphic rating scale, Patients are asked "how mindful were you during the past week? (on a zero to 10 scale where 0 is not mindful at all, and 10 = completely present in the moment, 100% of the time).
Pain Catastrophizing Scale. Change from baseline to one year post-treatment Pain Catastrophizing Scale. Patients answer 13 questions about thoughts and feelings they have when they are in pain. Not at all, to a slight degree, to a moderate degree, to a great degree, all the time.
The 8-item PROMIS Sleep Disturbance Short Form. Change from baseline to one year post-treatment. The 8-item PROMIS Sleep Disturbance Short Form assesses the sleep quality in the past 7 days, in individuals age 18 and older. Patients rate each question as Very poor, poor, fair, good, very good.
Quickdash (measure of physical function). Change from baseline to one year post-treatment. Patients rate their ability to do a number of activities, 11 questions. QuickDASH uses 11 items to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb.
Tampa Scale for Kinesiophobia. Change from baseline to one year post-treatment. Patients answer 17 questions about their fear of movement by responding "strongly disagree, disagree, agree, or strongly agree".
Trial Locations
- Locations (1)
University of Washington (only CRPS patients are eligible)
🇺🇸Seattle, Washington, United States