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

NCT05888142 | Completed

• 1 other identifier: STUDY00015202
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Chronic

Keywords

chronic pain, complex regional pain syndrome, virtual reality, home based, mindfulness, pain neuroscience education

Outcome Measures

Primary Outcomes (4)

• 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 16 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 1 year post-treatment

• 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 16 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 one year post-treatment

Secondary Outcomes (14)

• The Central Sensitization Inventory (CSI).

  Change from baseline to 16 weeks

• The Central Sensitization Inventory (CSI).

  Change from baseline to one year post-treatment

• CES-D Center for Epidemiologic Studies Depression Scale (CES-D), NIMH.

  Change from baseline to 16 weeks

• CES-D Center for Epidemiologic Studies Depression Scale (CES-D), NIMH.

  Change from baseline to one year post-treatment

• Mindfulness.

  Change from baseline to 16 weeks.

Study Arms (2)

Roosevelt "in clinic VR"

ACTIVE COMPARATOR

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.

Behavioral: in clinic pain VR reduction exercises

Roosevelt "in Clinic VR" + "VR homeworks"

EXPERIMENTAL

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.

Behavioral: In clinic VRpain reduction exercises + VR homeworks

Interventions

in clinic pain VR reduction exercises BEHAVIORAL

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"

In clinic VRpain reduction exercises + VR homeworks BEHAVIORAL

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.

Roosevelt "in Clinic VR" + "VR homeworks"

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• personal history of severe motion sickness
• severe systemic disease that is a constant threat to life (ASA class IV+)
• prisoners.

Sponsors & Collaborators

• University of Washington: lead
• Mayday Fund: collaborator

Study Sites (1)

University of Washington (only CRPS patients are eligible)

Seattle, Washington, 98195, United States

Location

Related Publications (11)

• 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.

  PMID: 33585833 BACKGROUND

• 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.

  PMID: 29740365 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 21856077 BACKGROUND

• 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.

  PMID: 23490634 BACKGROUND

• 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.

  BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 22250775 BACKGROUND

• 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.

  PMID: 15866967 BACKGROUND

• 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.

  PMID: 24234727 BACKGROUND

• Fontenot MR, Curatolo M, Stacey BR, Flor H, Hoffman HG. Sustained symptom reduction in complex regional pain syndrome with a novel home-based virtual reality program: a pilot study. Front Neurol. 2025 Dec 8;16:1622897. doi: 10.3389/fneur.2025.1622897. eCollection 2025.

  PMID: 41438885 DERIVED

MeSH Terms

Conditions

Chronic Pain; Complex Regional Pain Syndromes

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases

Study Officials

• Miles Fontenot, MD, Ph.D

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident: School of Medicine: Anesthesiology & Pain Medicine

Model Details: 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.

Study Record Dates

• First Submitted: April 21, 2023
• First Posted: June 5, 2023
• Study Start: September 16, 2022
• Primary Completion: August 3, 2024
• Study Completion: August 3, 2024
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)