Using Immersive Virtual Reality to Treat Complex Regional Pain Syndrome in Adults
NCT ID: NCT05888142
Last Updated: 2024-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
7 participants
INTERVENTIONAL
2022-09-16
2024-08-03
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Roosevelt "in clinic VR"
During the "in clinic" training phase of the study, patients in this group will receive VR physical therapy exercises "in clinic" only (no homeworks during training). After the training phase, all patients will do VR homeworks, including VR exercises and VR mindfulness.
in 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.
Roosevelt "in Clinic VR" + "VR homeworks"
During the training phase, patients in this group will receive VR physical therapy exercises "in clinic". In addition, during the training phase, they will also take a VR system home and will be encouraged to do VR homeworks at home. After the training phase, all patients will do VR homeworks, including VR exercises and VR mindfulness.
In 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.
Interventions
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in 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.
In 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* severe systemic disease that is a constant threat to life (ASA class IV+)
* prisoners.
18 Years
85 Years
ALL
No
Sponsors
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Mayday Fund
OTHER
University of Washington
OTHER
Responsible Party
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Miles Fontenot
Resident: School of Medicine: Anesthesiology & Pain Medicine
Principal Investigators
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Miles Fontenot, MD, Ph.D
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Locations
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University of Washington (only CRPS patients are eligible)
Seattle, Washington, United States
Countries
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References
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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.
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.
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.
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.
Sullivan, M. J. L., Bishop, S. C., and Pivik, J. (1995). The Pain Catastrophizing Scale: Development and validation. Psychol Assess. 7: 524-532.
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.
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.
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.
Other Identifiers
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STUDY00015202
Identifier Type: -
Identifier Source: org_study_id