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

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University of Washington

Status

Completed

Conditions

Pain, Chronic

Treatments

Behavioral: in clinic pain VR reduction exercises
Behavioral: In clinic VRpain reduction exercises + VR homeworks

Study type

Interventional

Funder types

Other

Identifiers

NCT05888142
STUDY00015202

Details and patient eligibility

About

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.

Full 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).

Enrollment

7 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

7 participants in 2 patient groups

Roosevelt "in clinic VR"
Active Comparator group
Description:
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.
Treatment:
Behavioral: in clinic pain VR reduction exercises
Roosevelt "in Clinic VR" + "VR homeworks"
Experimental group
Description:
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.
Treatment:
Behavioral: In clinic VRpain reduction exercises + VR homeworks

Trial contacts and locations

1

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Central trial contact

Hunter Hoffman, Ph.D.; Miles Fontenot, MD, Ph.D

Data sourced from clinicaltrials.gov

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