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Behavioral Intervention

Virtual Reality Therapy for Phantom Limb Pain

N/A
Recruiting
Led By Glenn Gaston, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age > 18 years old
Presence of phantom limb pain or negative phantom sensation(s)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights

Study Summary

This trial examines Phantom Limb Pain, which affects 60-68% of amputees. It can lead to anxiety, depression & reduced wellbeing. It affects 3 million Americans & 185,000 new cases each year.

Who is the study for?
This trial is for adults over 18 who have had a major limb amputated and are experiencing phantom limb pain or sensations. It's not suitable for individuals with active mental illness, neurological diseases, cognitive impairments that affect survey participation, those without phantom limb issues, or non-English speakers.Check my eligibility
What is being tested?
The study explores the effectiveness of virtual reality therapy in alleviating phantom limb pain compared to a matched control group. Participants will be randomly assigned to receive either VR therapy or no intervention to assess differences in their experiences of pain.See study design
What are the potential side effects?
Virtual reality therapy is generally considered low-risk; however, some participants may experience dizziness, nausea, eye strain or disorientation during VR sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am older than 18 years.
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I experience pain or odd sensations where my limb used to be.
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I have had a major limb amputated.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 4
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 4 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phantom limb pain levels using Short-form McGill Pain Questionnaire (SF-MPQ)
Secondary outcome measures
Change in Brief Pain Inventory (BPI) interference scale scores
Change in Patient Health Questionnaire-9 (PHQ-9) scores
Change in Short-Form McGill Pain Questionnaire (SF-MPQ) scores
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Virtual Reality (VR) InterventionExperimental Treatment1 Intervention
Individuals undergoing virtual reality therapy intervention
Group II: Matched ControlPlacebo Group1 Intervention
The matched controls will receive standard care without the VR intervention

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Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,244 Previous Clinical Trials
1,004,768 Total Patients Enrolled
Glenn Gaston, MDPrincipal InvestigatorAtrium Health Musculoskeletal Institute

Frequently Asked Questions

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

Is there still room in this clinical research for participants?

"The clinicaltrials.gov portal reveals that the trial, which initially opened on November 1st 2023 and was updated most recently in October 4th 2023 is not currently enrolling candidates. However, 29 other medical trials are recruiting at this moment."

Answered by AI
~9 spots leftby Oct 2024