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Virtual Reality Therapy for Complex Regional Pain Syndrome

N/A

Recruiting

Led By Miles Fontenot, MD, Ph.D

Research Sponsored by University of Washington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ability to wear a VR head-mounted display

Average pain score in the affected CRPS limb(s) greater than or equal to 3 out of 10

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline to 14 weeks

Awards & highlights

Study Summary

This trial tests if VR can help reduce chronic pain due to CRPS. It's noninvasive and cost-effective, with potential to help people with this condition. #virtualreality #CRPS #chronicpain

Who is the study for?

This trial is for adults over 18 with a confirmed diagnosis of CRPS I or II in one or both upper limbs, experiencing pain scores of 3 out of 10 or higher. Participants must have been on a stable treatment plan for at least four weeks and be able to use VR equipment and communicate in English. It's not suitable for those with severe motion sickness, life-threatening systemic diseases, or prisoners.Check my eligibility

What is being tested?

The study examines whether immersive VR can alleviate chronic pain from CRPS. Participants will either do VR exercises in the clinic only, or they'll also get 'VR homework' to do outside the clinic. The effectiveness of these two approaches will be compared.See study design

What are the potential side effects?

While VR is noninvasive and generally safe, some side effects may include temporary discomfort like headaches, eye strain, dizziness, or nausea—especially if prone to motion sickness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can wear a VR headset.

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My average pain score in the affected limb is 3 or more out of 10.

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I have been diagnosed with CRPS in my arm(s) according to the Budapest Criteria.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to 14 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline to 14 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to 14 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

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

Secondary outcome measures

Brief Pain Inventory (BPI) Short form, Pain interference scale.

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

Mindfulness.

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Roosevelt "in Clinic VR" + "VR homeworks"Experimental Treatment1 Intervention

Patients in this group will receive VR physical therapy exercises "in clinic", during the two week treatment phase of the study (approximately 10 treatment sessions). They will also take a VR system home and will be encouraged to do VR home works at home, during this first two week period. After the first 2 weeks, all patients will do VR homeworks, including VR exercises and VR mindfulness.

Group II: Roosevelt "in clinic VR"Active Control1 Intervention

Patients in this group will receive VR physical therapy exercises "in clinic" only, during the two week treatment phase of the study (approximately 10 treatment sessions). After the first 2 weeks, all patients will do VR homeworks, including VR exercises and VR mindfulness.

0 / 3Eligibility criteria met

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Who is running the clinical trial?

University of WashingtonLead Sponsor

1,741 Previous Clinical Trials

1,847,754 Total Patients Enrolled

40 Trials studying Chronic Pain

17,365 Patients Enrolled for Chronic Pain

Mayday FundOTHER

12 Previous Clinical Trials

1,318 Total Patients Enrolled

1 Trials studying Chronic Pain

76 Patients Enrolled for Chronic Pain

Miles Fontenot, MD, Ph.DPrincipal InvestigatorUniversity of Washington

Media Library

Virtual Reality Clinical Trial Eligibility Overview. Trial Name: NCT05888142 — N/A

Chronic Pain Research Study Groups: Roosevelt "in clinic VR", Roosevelt "in Clinic VR" + "VR homeworks"

Chronic Pain Clinical Trial 2023: Virtual Reality Highlights & Side Effects. Trial Name: NCT05888142 — N/A

Virtual Reality 2023 Treatment Timeline for Medical Study. Trial Name: NCT05888142 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial include participants of advanced age?

"The requirements for this medical trial state that participants should be between 18 and 85 years old. Additionally, there are 41 available trials for minors and 391 studies open to people aged 65 or above."

Answered by AI

Are participants actively being sought for this research endeavor?

"This clinical trial, initiated on September 16th 2022 and recently updated on May 23rd 2023, is actively seeking participants."

Answered by AI

To whom does this research opportunity extend?

"This clinical trial is seeking 12 patients that are afflicted with chronic pain, and who have reached the age of consent but not exceeded 85 years old."

Answered by AI

What is the scope of participant enrollment for this research program?

"Affirmative, as per the info found on clinicaltrials.gov, this research project is presently seeking volunteers. It was initially advertised on September 16th 2022 and has been revised recently - May 23rd 2023 being the latest update. In total, 12 participants will be accepted across a single site."

Answered by AI

What is the desired outcome of this research endeavor?

"The primary outcome of this clinical trial, evaluated over a 14-week period from baseline, is the Patient Global Impression of Change scale (PGIC) regarding physical abilities. Secondary outcomes include: Center for Epidemiologic Studies Depression Scale (CES-D), a 20 self-rating questionnaire on depression intensity; Mindfulness using a single item graphic rating scale inquiring about presence in the moment; and Pain Catastrophizing Scale with 13 questions gauging thoughts when in pain."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Miles Fontenot 2022. "Using Immersive Virtual Reality to Treat Complex Regional Pain Syndrome in Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05888142.

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