Pain, Chronic
Conditions
Keywords
chronic pain, complex regional pain syndrome, virtual reality, home based, mindfulness, pain neuroscience education
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).
Interventions
BEHAVIORALin clinic pain VR reduction exercises
During the in clinic training phase, participants will use commercially available VR during in clinic VR physical therapy exercises, to help reduce their pain and improve functionality. But this group will not take a VR system home until after completing the in clinic training phase.
BEHAVIORALIn clinic VRpain reduction exercises + VR homeworks
During the training phase, participants will use commercially available VR during in clinic physical therapy exercises, and during the training phase, they will also receive a VR system they take home and will begin VR homeworks during the traininng phase, to help reduce their pain and improve functionality.
Sponsors
Mayday Fund
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The participants will not be told there is more than one treatment group, but during the consenting process each participant will be fully informed about the treatment they will personally receive. The statistician will not be told which group received more treatments.
Intervention model description
Participants will be randomly assigned to one of two groups (exploratory). One group will receive VR more often than the other group. Primary Hypothesis. As planned apriori, collapsing across groups, using a within subject repeated measures ANOVA (or non-parametric equivalent), we predict that compared to pre-treatment, our sample of CRPS (chronic pain) patients will report a significant improvement in the amount of CRPS pain (e.g., less pain) and improved (increased) physical ability/functionality after four months of home-based VR therapy homeworks (four months after baseline) and that they would continue to report significant improvements on an ad-hoc one year post-treatment followup. Secondary hypothesis. CRPS patients would show reduced CRPS hypersensitivity to brief thermal (e.g., cold) stimuli. and reduced CRPS-related co-morbid psychological symptoms after 4 months of home-based VR therapy, and on long term improvements on ad-hoc followup measures one year post-treatment.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* adults (18+) * confirmed diagnosis of either CRPS I or CRPS II of one or both upper limbs (as defined by the Budapest Criteria) * average pain score in the affected CRPS limb(s) greater than or equal to 3 out of 10 * on a stable treatment plan for 4 weeks prior to the VR intervention phase * ability to wear a VR head-mounted display * ability to speak and read English * ability to provide informed consent.
Exclusion criteria
* personal history of severe motion sickness * severe systemic disease that is a constant threat to life (ASA class IV+) * prisoners.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Patient Global Impression of Change scale (PGIC), regarding CRPS pain. | Change from baseline to 16 weeks | 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 16 weeks | 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
| Measure | Time frame | Description |
|---|---|---|
| Mindfulness. | Change from baseline to 16 weeks. | 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). |
| The Central Sensitization Inventory (CSI). | Change from baseline to 16 weeks | 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. |
| Pain Catastrophizing Scale. | Change from baseline to 16 weeks. | 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. |
| Quickdash (measure of physical function). | Change from baseline to 16 weeks | 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 16 weeks. | Patients answer 17 questions about their fear of movement by responding strongly disagree, disagree, agree, or strongly agree. |
| The 8-item PROMIS Sleep Disturbance Short Form. | Change from baseline to 16 weeks. | 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. |
| CES-D Center for Epidemiologic Studies Depression Scale (CES-D), NIMH. | Change from baseline to 16 weeks | 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. |
Countries
United States
Outcome results
None listed