Using Immersive Virtual Reality to Treat Complex Regional Pain Syndrome in Adults

Study Overview
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Brief Summary
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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
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Participants will go into simple fun pain distracting virtual reality worlds (no previous video game experience needed). They will also learn some simple 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).

Official Title
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Exploring the Role of Immersive Virtual Reality in Managing Upper-limb Complex Regional Pain Syndrome in Adults

Conditions
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Pain, Chronic

Intervention / Treatment
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* Behavioral: in clinic pain VR reduction exercises
* Behavioral: In clinic VRpain reduction exercises + VR homeworks


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomly assigned to one of two groups. One group will receive VR more often than the other group. Primary Hypothesis. 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 the two weeks of in-clinic Virtual Reality therapy, and improvements will be maintained after an additional four weeks of home-based VR therapy homeworks (at week 6), and again 14 weeks after baseline. Secondary hypothesis. In a Between Groups ANOVA (or non-parametric equivalent), we predict the group that receives more VR (VR in clinic and VR homework during first 2 weeks) will show significant more self-reported improvement in pain and functionality, after the first two weeks of treatment.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Roosevelt in clinic VR<br>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. | Behavioral: in clinic pain VR reduction exercises<br>* During the first two weeks of treatment, participants will use commercially available VR during in clinic VR physical therapy exercises, to help reduce their pain and improve functionality.<br>|
| Experimental: Roosevelt in Clinic VR + VR homeworks<br>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. | Behavioral: In clinic VRpain reduction exercises + VR homeworks<br>* During the first two weeks of treatment, participants will use commercially available VR during in clinic physical therapy exercises, and during homeworks to help reduce their pain and improve functionality.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Patient Global Impression of Change scale (PGIC), regarding CRPS pain. | 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. | Change from baseline to 2 weeks | 
| The Patient Global Impression of Change scale (PGIC), regarding CRPS pain. | 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. | Change from baseline to 6 weeks | 
| The Patient Global Impression of Change scale (PGIC), regarding CRPS pain. | 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. | Change from baseline to 14 weeks | 
| The Patient Global Impression of Change scale (PGIC), regarding functionality/physical abilities | The 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. | Change from baseline to 2 weeks | 
| The Patient Global Impression of Change scale (PGIC), regarding functionality/physical abilities. | 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. | Change from baseline to 6 weeks | 
| The Patient Global Impression of Change scale (PGIC), regarding functionality/physical abilities. | 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. | Change from baseline to 14 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Central Sensitization Inventory (CSI). | 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. | Change from baseline to 2 weeks | 
| The Central Sensitization Inventory (CSI). | 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. | Change from baseline to 6 weeks | 
| The Central Sensitization Inventory (CSI). | 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. | Change from baseline to 14 weeks | 
| CES-D Center for Epidemiologic Studies Depression Scale (CES-D), NIMH. | 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. | Change from baseline to 2 weeks | 
| CES-D Center for Epidemiologic Studies Depression Scale (CES-D), NIMH. | 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. | Change from baseline to 6 weeks | 
| CES-D Center for Epidemiologic Studies Depression Scale (CES-D), NIMH. | 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. | Change from baseline to 14 weeks | 
| Mindfulness. | 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). | Change from baseline to 2 weeks. | 
| Mindfulness. | 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). | Change from baseline to 6 weeks. | 
| Mindfulness. | 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). | Change from baseline to 14 weeks. | 
| Pain Catastrophizing Scale. | 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. | Change from baseline to 2 weeks. | 
| Pain Catastrophizing Scale. | 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. | Change from baseline to 6 weeks. | 
| Pain Catastrophizing Scale. | 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. | Change from baseline to 14 weeks. | 
| The 8-item PROMIS Sleep Disturbance Short Form. | 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. | Change from baseline to 2 weeks. | 
| The 8-item PROMIS Sleep Disturbance Short Form. | 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. | Change from baseline to 6 weeks. | 
| The 8-item PROMIS Sleep Disturbance Short Form. | 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. | Change from baseline to 14 weeks. | 
| Quickdash (measure of physical function). | 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. | Change from baseline to 2 weeks | 
| Quickdash (measure of physical function). | 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. | Change from baseline to 6 weeks | 
| Quickdash (measure of physical function). | 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. | Change from baseline to 14 weeks | 
| Tampa Scale for Kinesiophobia. | Patients answer 17 questions about their fear of movement by responding strongly disagree, disagree, agree, or strongly agree. | Change from baseline to 2 weeks | 
| Tampa Scale for Kinesiophobia. | Patients answer 17 questions about their fear of movement by responding strongly disagree, disagree, agree, or strongly agree. | Change from baseline to 6 weeks | 
| Tampa Scale for Kinesiophobia. | Patients answer 17 questions about their fear of movement by responding strongly disagree, disagree, agree, or strongly agree. | Change from baseline to 14 weeks. | 
| Brief Pain Inventory (BPI) Short form, Pain interference scale. | The BPI pain interference scale is a self-administered questionnaire which includes 7 items where the patient is asked to rate their perceived impact of pain on various functional activities. The final score ranges from 0 to 10 (0=pain does not interfere; 10=pain completely interferes). | Change from baseline to 2 weeks | 
| Brief Pain Inventory (BPI) Short form, Pain interference scale. | The BPI pain interference scale is a self-administered questionnaire which includes 7 items where the patient is asked to rate their perceived impact of pain on various functional activities. The final score ranges from 0 to 10 (0=pain does not interfere; 10=pain completely interferes). | Change from baseline to 6 weeks | 
| Brief Pain Inventory (BPI) Short form, Pain interference scale. | The BPI pain interference scale is a self-administered questionnaire which includes 7 items where the patient is asked to rate their perceived impact of pain on various functional activities. The final score ranges from 0 to 10 (0=pain does not interfere; 10=pain completely interferes). | Change from baseline to 14 weeks |