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Recruiting NCT06077227

Immersive Healing: The Therapeutic Potential of Virtual Reality

No phase Interventional Phantom Limb Pain (PLP)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: virtual reality therapy, matched control group.
Who it may be relevant to
Registry conditions: Phantom Limb Pain (PLP). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Immersive Healing: The Therapeutic Potential of Virtual Reality in Phantom Limb Experience

Overview

Phantom limb pain (PLP) is a significant and pervasive issue among upper limb amputees, severely impacting their quality of life. The literature delineating prevalence of upper versus lower limb amputations is limited, but the prevalence of total amputations in the United States is estimated to reach 3 million individuals by 2050, with approximately 185,000 new cases annually. PLP affects 60-68% of these patients, leading to heightened levels of anxiety, depression, and reduced overall well-being.

Detailed description

Although studies exploring the efficacy of VR therapy for PLP have reported positive outcomes, several limitations, such as small sample sizes, lack of randomization, and inconsistent treatment protocols, have impeded widespread adoption of these innovative approaches. Additionally, the literature does not sufficiently delineate which aspects of the phantom limb experience may be addressed with VR therapy. To overcome these limitations and optimize treatment efficacy, it is crucial to gain a comprehensive understanding of the phantom limb experience, including both somatosensory and kinesthesia-related symptoms. Additionally, this study will address these limitations by employing a larger sample size, rigorous methodology, and a standardized treatment protocol.

Interventions

  • Device virtual reality therapy
    6 2 times weekly sessions of 30-minute VR therapy in the office with pre- and post-intervention surveys
  • Other matched control group
    taking the same surveys as the VR intervention group on a weekly basis for 6 weeks

Primary outcome measures

  • Phantom limb pain levels using Short-form McGill Pain Questionnaire (SF-MPQ) [Time frame: Baseline]
  • Phantom limb pain levels using Short-form McGill Pain Questionnaire (SF-MPQ) [Time frame: Week 1]
  • Phantom limb pain levels using Short-form McGill Pain Questionnaire (SF-MPQ) [Time frame: Week 2]
  • Phantom limb pain levels using Short-form McGill Pain Questionnaire (SF-MPQ) [Time frame: Week 3]
  • Phantom limb pain levels using Short-form McGill Pain Questionnaire (SF-MPQ) [Time frame: Week 6]
Secondary outcome measures (7)
  • Change in Brief Pain Inventory (BPI) scores [Time frame: Hour 24]
  • Change in Short-Form McGill Pain Questionnaire (SF-MPQ) scores [Time frame: Week 6]
  • Phantom Limb Experience Survey score [Time frame: Baseline]
  • Change in Virtual Reality (VR) Therapy Survey scores [Time frame: Week 6]
  • System Usability Scale [Time frame: Week 6]
  • Simulator Sickness Questionnaire [Time frame: Week 6]
  • Change in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) scores [Time frame: Week 6]

Eligibility criteria

Inclusion criteria

  • History of major limb amputation
  • Age > 18 years old
  • Presence of phantom limb pain or negative phantom sensation(s)

Exclusion criteria

  • Active mental illness, neurological disease, or cognitive impairment that would interfere with survey completion
  • Those without phantom limb pain or negative phantom limb sensations
  • Non-English speaking

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • OrthoCarolina Hand Center — Charlotte

Identifiers

NCT: NCT06077227 · IRB00100006

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗