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Pain, ChronicNCT05888142

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

A study testing in clinic pain VR reduction exercises and In clinic VRpain reduction exercises + VR homeworks in people with Pain, Chronic, run by University of Washington at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Pain, Chronic
What is being tested?
in clinic pain VR reduction exercises and In clinic VRpain reduction exercises + VR homeworks
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
1 siteUnited States
Study dates
16 Sep 2022to 3 Aug 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Washington (only CRPS patients are eligible)

    Seattle, Washington, 98195

Other trials in United States

About this study

Official title: 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.

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).

Conditions
Pain, Chronic
Being tested
in clinic pain VR reduction exercises, In clinic VRpain reduction exercises + VR homeworks
Keywords
chronic pain, complex regional pain syndrome, virtual reality, home based, mindfulness, pain neuroscience education
Medical subject headings
Chronic Pain, Complex Regional Pain Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • in clinic pain VR reduction exercisesBehavioural

    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 homeworksBehavioural

    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.

Study groups in NCT05888142
Study groupRoleWhat they receive
Roosevelt "in clinic VR"Active comparatorDuring 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.
Receives: Behavioral: in clinic pain VR reduction exercises
Roosevelt "in Clinic VR" + "VR homeworks"ExperimentalDuring 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.
Receives: Behavioral: In clinic VRpain reduction exercises + VR homeworks

What is being measured

The primary outcome is the main question the study is designed to answer.

  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."

    Measured: 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."

    Measured: 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."

    Measured: 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."

    Measured: Change from baseline to one year post-treatment

Secondary outcomes (14)

  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".

    Measured: 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".

    Measured: 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.

    Measured: 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.

    Measured: 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).

    Measured: 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).

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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".

    Measured: 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".

    Measured: Change from baseline to one year post-treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2023
  2. Study start16 Sep 2022
  3. Primary completion3 Aug 2024
  4. Study completion3 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05888142
Sponsor's protocol ID
STUDY00015202
Status last verified
Dec 2024
First submitted
21 Apr 2023
Last updated
6 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: we will analyze and publish our results.

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

  • 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.

    PubMed 41438885

Questions about this trial

What is this clinical trial studying?

A study testing in clinic pain VR reduction exercises and In clinic VRpain reduction exercises + VR homeworks in people with Pain, Chronic, run by University of Washington at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Patient Global Impression of Change scale (PGIC), regarding CRPS pain. (time frame: Change from baseline to 16 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05888142, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.

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