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

Primary Purpose

Pain, Chronic

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
in clinic pain VR reduction exercises
In clinic VRpain reduction exercises + VR homeworks
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Chronic

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Washington (only CRPS patients are eligible)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Roosevelt "in clinic VR"

Roosevelt "in Clinic VR" + "VR homeworks"

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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."
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."
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."
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."
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."
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."

Secondary Outcome Measures

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".
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".
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".
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.
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.
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.
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).
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).
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
Tampa Scale for Kinesiophobia.
Patients answer 17 questions about their fear of movement by responding "strongly disagree, disagree, agree, or strongly agree".
Tampa Scale for Kinesiophobia.
Patients answer 17 questions about their fear of movement by responding "strongly disagree, disagree, agree, or strongly agree".
Tampa Scale for Kinesiophobia.
Patients answer 17 questions about their fear of movement by responding "strongly disagree, disagree, agree, or strongly agree".
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).
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).
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).

Full Information

First Posted
April 21, 2023
Last Updated
May 23, 2023
Sponsor
University of Washington
Collaborators
Mayday Fund
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1. Study Identification

Unique Protocol Identification Number
NCT05888142
Brief Title
Using Immersive Virtual Reality to Treat Complex Regional Pain Syndrome in Adults
Official Title
Exploring the Role of Immersive Virtual Reality in Managing Upper-limb Complex Regional Pain Syndrome in Adults
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 16, 2022 (Actual)
Primary Completion Date
August 29, 2024 (Anticipated)
Study Completion Date
August 29, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
Mayday Fund

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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). 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Roosevelt "in clinic VR"
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Roosevelt "in Clinic VR" + "VR homeworks"
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
in clinic pain VR reduction exercises
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
In clinic VRpain reduction exercises + VR homeworks
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Patient Global Impression of Change scale (PGIC), regarding CRPS pain.
Description
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."
Time Frame
Change from baseline to 2 weeks
Title
The Patient Global Impression of Change scale (PGIC), regarding CRPS pain.
Description
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."
Time Frame
Change from baseline to 6 weeks
Title
The Patient Global Impression of Change scale (PGIC), regarding CRPS pain.
Description
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."
Time Frame
Change from baseline to 14 weeks
Title
The Patient Global Impression of Change scale (PGIC), regarding functionality/physical abilities
Description
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."
Time Frame
Change from baseline to 2 weeks
Title
The Patient Global Impression of Change scale (PGIC), regarding functionality/physical abilities.
Description
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."
Time Frame
Change from baseline to 6 weeks
Title
The Patient Global Impression of Change scale (PGIC), regarding functionality/physical abilities.
Description
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."
Time Frame
Change from baseline to 14 weeks
Secondary Outcome Measure Information:
Title
The Central Sensitization Inventory (CSI).
Description
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".
Time Frame
Change from baseline to 2 weeks
Title
The Central Sensitization Inventory (CSI).
Description
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".
Time Frame
Change from baseline to 6 weeks
Title
The Central Sensitization Inventory (CSI).
Description
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".
Time Frame
Change from baseline to 14 weeks
Title
CES-D Center for Epidemiologic Studies Depression Scale (CES-D), NIMH.
Description
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.
Time Frame
Change from baseline to 2 weeks
Title
CES-D Center for Epidemiologic Studies Depression Scale (CES-D), NIMH.
Description
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.
Time Frame
Change from baseline to 6 weeks
Title
CES-D Center for Epidemiologic Studies Depression Scale (CES-D), NIMH.
Description
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.
Time Frame
Change from baseline to 14 weeks
Title
Mindfulness.
Description
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).
Time Frame
Change from baseline to 2 weeks.
Title
Mindfulness.
Description
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).
Time Frame
Change from baseline to 6 weeks.
Title
Mindfulness.
Description
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).
Time Frame
Change from baseline to 14 weeks.
Title
Pain Catastrophizing Scale.
Description
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.
Time Frame
Change from baseline to 2 weeks.
Title
Pain Catastrophizing Scale.
Description
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.
Time Frame
Change from baseline to 6 weeks.
Title
Pain Catastrophizing Scale.
Description
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.
Time Frame
Change from baseline to 14 weeks.
Title
The 8-item PROMIS Sleep Disturbance Short Form.
Description
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.
Time Frame
Change from baseline to 2 weeks.
Title
The 8-item PROMIS Sleep Disturbance Short Form.
Description
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.
Time Frame
Change from baseline to 6 weeks.
Title
The 8-item PROMIS Sleep Disturbance Short Form.
Description
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.
Time Frame
Change from baseline to 14 weeks.
Title
Quickdash (measure of physical function).
Description
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.
Time Frame
Change from baseline to 2 weeks
Title
Quickdash (measure of physical function).
Description
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.
Time Frame
Change from baseline to 6 weeks
Title
Quickdash (measure of physical function).
Description
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.
Time Frame
Change from baseline to 14 weeks
Title
Tampa Scale for Kinesiophobia.
Description
Patients answer 17 questions about their fear of movement by responding "strongly disagree, disagree, agree, or strongly agree".
Time Frame
Change from baseline to 2 weeks
Title
Tampa Scale for Kinesiophobia.
Description
Patients answer 17 questions about their fear of movement by responding "strongly disagree, disagree, agree, or strongly agree".
Time Frame
Change from baseline to 6 weeks
Title
Tampa Scale for Kinesiophobia.
Description
Patients answer 17 questions about their fear of movement by responding "strongly disagree, disagree, agree, or strongly agree".
Time Frame
Change from baseline to 14 weeks.
Title
Brief Pain Inventory (BPI) Short form, Pain interference scale.
Description
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).
Time Frame
Change from baseline to 2 weeks
Title
Brief Pain Inventory (BPI) Short form, Pain interference scale.
Description
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).
Time Frame
Change from baseline to 6 weeks
Title
Brief Pain Inventory (BPI) Short form, Pain interference scale.
Description
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).
Time Frame
Change from baseline to 14 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Miles Fontenot, MD, Ph.D
Phone
631-503-1624
Email
mfon@uw.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Hunter Hoffman, Ph.D.
Phone
206-601-5090
Email
hunthoff9@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miles Fontenot, MD, Ph.D
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington (only CRPS patients are eligible)
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hunter Hoffman
Phone
206-601-5090
Email
hunthoff9@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
we will analyze and publish our results.
Citations:
PubMed Identifier
33585833
Citation
Hoffman HG, Patterson DR, Rodriguez RA, Pena R, Beck W, Meyer WJ. Virtual Reality Analgesia for Children With Large Severe Burn Wounds During Burn Wound Debridement. Front Virtual Real. 2020 Dec;1:602299. doi: 10.3389/frvir.2020.602299. Epub 2020 Dec 10.
Results Reference
background
PubMed Identifier
29740365
Citation
Flores A, Linehan MM, Todd SR, Hoffman HG. The Use of Virtual Reality to Facilitate Mindfulness Skills Training in Dialectical Behavioral Therapy for Spinal Cord Injury: A Case Study. Front Psychol. 2018 Apr 23;9:531. doi: 10.3389/fpsyg.2018.00531. eCollection 2018.
Results Reference
background
Citation
Ferguson L, Scheman J, Patient global impression of change scores within the context of a chronic pain rehabilitation program, The Journal of Pain, Volume 10, 2009, S73. ISSN 1526-5900, https://doi.org/10.1016/j.jpain.2009.01.258.
Results Reference
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PubMed Identifier
21856077
Citation
Ferreira-Valente MA, Pais-Ribeiro JL, Jensen MP. Validity of four pain intensity rating scales. Pain. 2011 Oct;152(10):2399-2404. doi: 10.1016/j.pain.2011.07.005.
Results Reference
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PubMed Identifier
23490634
Citation
Neblett R, Cohen H, Choi Y, Hartzell MM, Williams M, Mayer TG, Gatchel RJ. The Central Sensitization Inventory (CSI): establishing clinically significant values for identifying central sensitivity syndromes in an outpatient chronic pain sample. J Pain. 2013 May;14(5):438-45. doi: 10.1016/j.jpain.2012.11.012. Epub 2013 Mar 13.
Results Reference
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Radloff, L. S. (1977). The CES-D scale: A self report depression scale for research in the general population. Applied Psychological Measurements, 1, 385-401.
Results Reference
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Citation
Sullivan, M. J. L., Bishop, S. C., and Pivik, J. (1995). The Pain Catastrophizing Scale: Development and validation. Psychol Assess. 7: 524-532.
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Citation
Yu L, Buysse DJ, Germain A, Moul DE, Stover A, Dodds NE, Johnston KL, Pilkonis PA. Development of short forms from the PROMIS sleep disturbance and Sleep-Related Impairment item banks. Behav Sleep Med. 2011 Dec 28;10(1):6-24. doi: 10.1080/15402002.2012.636266.
Results Reference
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PubMed Identifier
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Citation
Beaton DE, Wright JG, Katz JN; Upper Extremity Collaborative Group. Development of the QuickDASH: comparison of three item-reduction approaches. J Bone Joint Surg Am. 2005 May;87(5):1038-46. doi: 10.2106/JBJS.D.02060.
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Vlaeyen JW, Kole-Snijders AM, Rotteveel AM, Ruesink R, Heuts PH. The role of fear of movement/(re)injury in pain disability. J Occup Rehabil. 1995 Dec;5(4):235-52. doi: 10.1007/BF02109988.
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Using Immersive Virtual Reality to Treat Complex Regional Pain Syndrome in Adults

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