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OpenTrials
Completed

NCT Number: NCT05888142

Using Immersive Virtual Reality to Treat 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.

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Key information

Conditions

Pain, Chronic Autonomic Nervous System Diseases Chronic Pain Complex Regional Pain Syndromes Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Washington (only CRPS patients are eligible)

Seattle, Washington, 98195, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. The Patient Global Impression of Change scale (PGIC), regarding CRPS pain.

    Time frame: Change from baseline to 16 weeks

    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."

  2. The Patient Global Impression of Change scale (PGIC), regarding CRPS pain.

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

    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."

  3. The Patient Global Impression of Change scale (PGIC), regarding functionality/physical abilities.

    Time frame: Change from baseline to 16 weeks

    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."

  4. The Patient Global Impression of Change scale (PGIC), regarding functionality/physical abilities.

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

    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."

Secondary outcomes

  1. The Central Sensitization Inventory (CSI).

    Time frame: Change from baseline to 16 weeks

    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".

  2. The Central Sensitization Inventory (CSI).

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

    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".

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

    Time frame: Change from baseline to 16 weeks

    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.

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

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

    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.

  5. Mindfulness.

    Time frame: Change from baseline to 16 weeks.

    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).

  6. Mindfulness.

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

    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).

  7. Pain Catastrophizing Scale.

    Time frame: Change from baseline to 16 weeks.

    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.

  8. Pain Catastrophizing Scale.

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

    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.

  9. The 8-item PROMIS Sleep Disturbance Short Form.

    Time frame: Change from baseline to 16 weeks.

    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.

  10. The 8-item PROMIS Sleep Disturbance Short Form.

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

    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.

  11. Quickdash (measure of physical function).

    Time frame: Change from baseline to 16 weeks

    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.

  12. Quickdash (measure of physical function).

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

    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.

  13. Tampa Scale for Kinesiophobia.

    Time frame: Change from baseline to 16 weeks.

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

  14. Tampa Scale for Kinesiophobia.

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

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

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • Mayday Fund

Registry information

Official study title

Exploring the Role of Immersive Virtual Reality in Managing Upper-limb Complex Regional Pain Syndrome in Adults

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 5, 2023
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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