Clinical trial NCT05888142: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Chronic
Keywords: chronic pain, complex regional pain syndrome, virtual reality, home based, mindfulness, pain neuroscience education
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Mayday Fund
First posted: 2023-06-05
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: The Patient Global Impression of Change scale (PGIC), regarding CRPS pain.
timeFrame: Change from baseline to 16 weeks
measure: The Patient Global Impression of Change scale (PGIC), regarding CRPS pain.
timeFrame: Change from baseline to 1 year post-treatment
measure: The Patient Global Impression of Change scale (PGIC), regarding functionality/physical abilities.
timeFrame: Change from baseline to 16 weeks
measure: The Patient Global Impression of Change scale (PGIC), regarding functionality/physical abilities.
timeFrame: Change from baseline to one year post-treatment
Secondary outcomes:
measure: The Central Sensitization Inventory (CSI).
timeFrame: Change from baseline to 16 weeks
measure: The Central Sensitization Inventory (CSI).
timeFrame: Change from baseline to one year post-treatment
measure: CES-D Center for Epidemiologic Studies Depression Scale (CES-D), NIMH.
timeFrame: Change from baseline to 16 weeks
measure: CES-D Center for Epidemiologic Studies Depression Scale (CES-D), NIMH.
timeFrame: Change from baseline to one year post-treatment
measure: Mindfulness.
timeFrame: Change from baseline to 16 weeks.
measure: Mindfulness.
timeFrame: Change from baseline to one year post-treatment
measure: Pain Catastrophizing Scale.
timeFrame: Change from baseline to 16 weeks.
measure: Pain Catastrophizing Scale.
timeFrame: Change from baseline to one year post-treatment
measure: The 8-item PROMIS Sleep Disturbance Short Form.
timeFrame: Change from baseline to 16 weeks.
measure: The 8-item PROMIS Sleep Disturbance Short Form.
timeFrame: Change from baseline to one year post-treatment.
measure: Quickdash (measure of physical function).
timeFrame: Change from baseline to 16 weeks
measure: Quickdash (measure of physical function).
timeFrame: Change from baseline to one year post-treatment.
measure: Tampa Scale for Kinesiophobia.
timeFrame: Change from baseline to 16 weeks.
measure: Tampa Scale for Kinesiophobia.
timeFrame: Change from baseline to one year post-treatment.
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington (only CRPS patients are eligible)
state: Washington
Study officials:
affiliation: University of Washington
name: Miles Fontenot, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
citation: 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.
citation: Sullivan, M. J. L., Bishop, S. C., and Pivik, J. (1995). The Pain Catastrophizing Scale: Development and validation. Psychol Assess. 7: 524-532.
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.
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.
citation: 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.