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Clinical Trials/NCT05888142
NCT05888142
Completed
N/A

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

University of Washington1 site in 1 country7 target enrollmentSeptember 16, 2022
ConditionsPain, Chronic

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pain, Chronic
Sponsor
University of Washington
Enrollment
7
Locations
1
Primary Endpoint
The Patient Global Impression of Change scale (PGIC), regarding CRPS pain.
Status
Completed
Last Updated
last year

Overview

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.

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).

Registry
clinicaltrials.gov
Start Date
September 16, 2022
End Date
August 3, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Miles Fontenot

Resident: School of Medicine: Anesthesiology & Pain Medicine

University of Washington

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

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

Outcomes

Primary Outcomes

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."

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

  • 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 one year post-treatment)
  • Mindfulness.(Change from baseline to one year post-treatment)
  • Pain Catastrophizing Scale.(Change from baseline to one year post-treatment)
  • The 8-item PROMIS Sleep Disturbance Short Form.(Change from baseline to one year post-treatment.)
  • Quickdash (measure of physical function).(Change from baseline to one year post-treatment.)
  • Tampa Scale for Kinesiophobia.(Change from baseline to one year post-treatment.)

Study Sites (1)

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