ClinicalTrials.gg
CompletedNCT05888142Updated Dec 6, 2024

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

An interventional study of in clinic pain VR reduction exercises and In clinic VRpain reduction exercises + VR homeworks in Pain, Chronic, sponsored by University of Washington. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-12-06.

Sponsored by University of Washington · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Sep 2022, registered Apr 2023).

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Phase
Not applicable
Study type
Interventional
Enrollment
7
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 39 studies in Chronic Pain by University of Washington — 3 open to participants now, 6 under way, none of them phase 3. Chronic Pain · University of Washington.

Enrollment
36th of 37
7 · median 153
Started
2022
the only one that year
No phase
30 of 39
3 open now
Registered
32nd of 39
by date

Among the 39 studies in Chronic Pain by University of Washington, this one is the 36th largest by enrollment of the 37 interventional ones that give a count, is the only one that started in 2022, is one of 30 with no phase, and was the 32nd registered.

Chronic Pain

3,227 studies on the registry are indexed under Chronic Pain; 728 are open to participants now.

Browse Chronic Pain studies →

Open to participants now

3 of the 39 studies in Chronic Pain by University of Washington are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 3 open studies →

Where they have run

Who these studies take

Of the 486 Chronic Pain studies recruiting now, 239 (49%) set no upper age limit and 173 (36%) stop at 75 or younger; 43 take children under 18; 64 take healthy volunteers.

This study: 18 Years to 85 Years · all sexes · no healthy volunteers.

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02

Study 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.

Read the 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).

03

Conditions studied

  • Pain, Chronic

Keywords

  • chronic pain, complex regional pain syndrome, virtual reality, home based, mindfulness, pain neuroscience education
04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

Exclusion Criteria:

  • personal history of severe motion sickness
  • severe systemic disease that is a constant threat to life ( IV+)
  • prisoners.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
7 participants (actual)

Study arms

  • Active comparator
    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.

    Behavioral: in clinic pain VR reduction exercises

  • Experimental
    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.

    Behavioral: In clinic VRpain reduction exercises + VR homeworks

Interventions

  • Behavioralin 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.

  • BehavioralIn 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.

06

What researchers measure

Primary outcomes

  1. 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."

    Time frame: Change from baseline to 16 weeks

  2. 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."

    Time frame: Change from baseline to 1 year post-treatment

  3. 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."

    Time frame: Change from baseline to 16 weeks

  4. 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."

    Time frame: Change from baseline to one year post-treatment

Secondary outcomes

  1. 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".

    Time frame: Change from baseline to 16 weeks

  2. 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".

    Time frame: Change from baseline to one year post-treatment

  3. 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.

    Time frame: Change from baseline to 16 weeks

  4. 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.

    Time frame: Change from baseline to one year post-treatment

  5. 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).

    Time frame: Change from baseline to 16 weeks.

  6. 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).

    Time frame: Change from baseline to one year post-treatment

  7. 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.

    Time frame: Change from baseline to 16 weeks.

  8. 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.

    Time frame: Change from baseline to one year post-treatment

  9. 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.

    Time frame: Change from baseline to 16 weeks.

  10. 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.

    Time frame: Change from baseline to one year post-treatment.

  11. 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.

    Time frame: Change from baseline to 16 weeks

  12. 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.

    Time frame: Change from baseline to one year post-treatment.

  13. Tampa Scale for Kinesiophobia.

    Patients answer 17 questions about their fear of movement by responding "strongly disagree, disagree, agree, or strongly agree".

    Time frame: Change from baseline to 16 weeks.

  14. Tampa Scale for Kinesiophobia.

    Patients answer 17 questions about their fear of movement by responding "strongly disagree, disagree, agree, or strongly agree".

    Time frame: Change from baseline to one year post-treatment.

07

Study locations

1 site
  • University of Washington (only CRPS patients are eligible)
    Seattle, Washington 98195, United States
08

References and documents

Publications

  • 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. PubMed 33585833 ↗
  • 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. PubMed 29740365 ↗
  • 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. PubMed 21856077 ↗
  • 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. PubMed 23490634 ↗
  • 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. PubMed 22250775 ↗
  • 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. PubMed 15866967 ↗
  • 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. PubMed 24234727 ↗

Individual participant data

Plan to share: No — we will analyze and publish our results.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2022 to primary completion in Aug 2024, 22 months.

Of 1,295 non-industry interventional studies with no phase under Chronic Pain, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 39. This study's 22 months is close to that.

Counting every sponsor, half of 1,378 studies reached it within 20 months; a quarter within 9 and three quarters within 38.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 21, 2023
First posted
Jun 5, 2023
StartActual
Sep 16, 2022
Primary completionActual
Aug 3, 2024
CompletionActual
Aug 3, 2024
Last update
Dec 6, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05888142
Collaborators
Mayday Fund
Responsible party
Miles Fontenot (Resident: School of Medicine: Anesthesiology & Pain Medicine, University of Washington) — Principal investigator
First posted
Jun 5, 2023
Start date
Sep 16, 2022
Primary completion
Aug 3, 2024
Completion
Aug 3, 2024
Last update
Dec 6, 2024

Study contacts

Miles Fontenot, MD, Ph.D
principal investigator · University of Washington

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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