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Behavioural Intervention

Virtual Mirror Therapy for Phantom Limb Pain

N/A

Waitlist Available

Led By Conley Carr, MD

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

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

Must have

Presence of unilateral upper extremity amputation with continued intermittent or persistent phantom limb pain symptoms > 1 yr after amputation

Pain must be >=4 of 10 on the VAS at least intermittently (i.e. can have no pain at times but they must at least have 4/10 intensity of pain when pain does occur)

Must not have

Active nausea/vomiting

Uncontrolled vertigo

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 6 - week 52

Awards & highlights

No Placebo-Only Group

Summary

This trial will investigate whether Virtual Mirror therapy can reduce chronic phantom limb pain for amputees. If successful, a larger trial will be conducted.

Who is the study for?

This trial is for individuals with one upper limb amputated who have experienced phantom limb pain of at least moderate intensity (4/10) intermittently or persistently for over a year. It's not suitable for those with uncontrolled mental health conditions, seizure disorders, severe simulator sickness, certain eye conditions, extreme claustrophobia, active nausea/vomiting, vertigo, facial wounds that could interfere with a headset use, or immunodeficiency.

What is being tested?

The study is testing Virtual Mirror Therapy to see if it can help reduce chronic phantom limb pain in people who've had an arm amputated. This pilot study will set the stage for a larger-scale randomized controlled trial including both arm and leg amputees.

What are the potential side effects?

Potential side effects may include discomfort from wearing the virtual reality headset like simulator sickness (similar to motion sickness), eye strain or headache. Since this therapy is non-invasive and does not involve drugs or surgery, serious side effects are unlikely.

Eligibility Criteria

Inclusion Criteria

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

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I have had one arm amputated and still feel pain in the missing part for over a year.

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My pain reaches a level of 4 out of 10 at times.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently experiencing nausea or vomiting.

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I suffer from severe dizziness that I cannot control.

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I have had shingles in my eye.

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I am blind in both eyes.

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My bipolar disorder or schizophrenia is not under control.

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I do not have an uncontrolled immune deficiency.

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I have no facial wounds near my eyes, nose, or cheeks that could affect wearing a headset.

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I have conjunctivitis.

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I have seizures that are not controlled by medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 6 - week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 6 - week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 6 - week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Baseline Numeric Rating Scale of Chronic Phantom Limb Pain

Baseline Pain Disability Questionnaire of Chronic Phantom Limb Pain

Change from Baseline Numeric Rating Scale at Session 2

+7 more

Secondary study objectives

Change in Quality from Baseline Chronic Phantom Limb Pain at Session 2

Change in Quality from Baseline Chronic Phantom Limb Pain at Session 3

Change in Quality from Baseline Chronic Phantom Limb Pain at Session 4

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Unilateral upper extremity amputeesExperimental Treatment1 Intervention

Unilateral upper extremity amputees suffering from chronic phantom limb pain \> 1 yr will be recruited from a hospital based outpatient Physical Medicine and Rehabilitation Amputee Clinic at UAB.

0 / 11Eligibility criteria met