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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pain, Chronic
• Intervention / Treatment: Behavioral: in clinic pain VR reduction exercises; Behavioral: In clinic VRpain reduction exercises + VR homeworks

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).

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Miles Fontenot, MD, Ph.D; Phone Number: 631-503-1624; Email: mfon@uw.edu
• Study Contact Backup: Name: Hunter Hoffman, Ph.D.; Phone Number: 206-601-5090; Email: hunthoff9@gmail.com

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98195
      • Recruiting
      • University of Washington (only CRPS patients are eligible)
      • Contact: Hunter Hoffman; Phone Number: 206-601-5090; Email: hunthoff9@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Roosevelt "in clinic VR"; 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; 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.
Experimental: Roosevelt "in Clinic VR" + "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.	Behavioral: In clinic VRpain reduction exercises + VR homeworks; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: Mayday Fund
• Investigators: Principal Investigator: Miles Fontenot, MD, Ph.D, University of Washington

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Sullivan, M. J. L., Bishop, S. C., and Pivik, J. (1995). The Pain Catastrophizing Scale: Development and validation. Psychol Assess. 7: 524-532.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2022
• Primary Completion (Estimated): August 29, 2024
• Study Completion (Estimated): August 29, 2024

Study Registration Dates

• First Submitted: April 21, 2023
• First Submitted That Met QC Criteria: May 23, 2023
• First Posted (Actual): June 5, 2023

Study Record Updates

• Last Update Posted (Actual): June 5, 2023
• Last Update Submitted That Met QC Criteria: May 23, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Autonomic Nervous System Diseases; Chronic Pain; Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy
• Other Study ID Numbers: STUDY00015202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: we will analyze and publish our results.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No