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CompletadoNCT06077227Registro de ClinicalTrials.gov

Immersive Healing: The Therapeutic Potential of Virtual Reality

Phantom Limb Pain (PLP)

LO ESENCIAL

De qué trata este estudio

El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.

Tipo de estudio
De intervención
Fase
No aplica
Rango de edad
18 años - No especificado
Sexo admitido
Todos los sexos
Voluntarios sanos
No aceptados
Participantes
80 Real

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

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.

Leer la descripción completa

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.

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

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
Entiende la evaluación inicial

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación
Sin asignación al azar
Enmascaramiento
Sin enmascaramiento
Virtual Reality (VR) Intervention

Individuals undergoing virtual reality therapy intervention

Device: virtual reality therapy

Matched Control

The matched controls will receive standard care without the VR intervention

Other: matched control group

virtual reality therapy DEVICE

6 2 times weekly sessions of 30-minute VR therapy in the office with pre- and post-intervention surveys

matched control group OTHER

taking the same surveys as the VR intervention group on a weekly basis for 6 weeks

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Phantom limb pain levels using Short-form McGill Pain Questionnaire (SF-MPQ)

Plazo: Baseline

Short-form McGill Pain Questionnaire - The maximum score an individual can reach on the MPQ is 78. According to the questionnaire, a person with a score of 0 effectively does not experience pain. A person with a high score, nearer to the highest score of 78, more than likely deals with chronic pain daily.

Phantom limb pain levels using Short-form McGill Pain Questionnaire (SF-MPQ)

Plazo: Week 1

Short-form McGill Pain Questionnaire - The maximum score an individual can reach on the MPQ is 78. According to the questionnaire, a person with a score of 0 effectively does not experience pain. A person with a high score, nearer to the highest score of 78, more than likely deals with chronic pain daily.

Phantom limb pain levels using Short-form McGill Pain Questionnaire (SF-MPQ)

Plazo: Week 2

Short-form McGill Pain Questionnaire - The maximum score an individual can reach on the MPQ is 78. According to the questionnaire, a person with a score of 0 effectively does not experience pain. A person with a high score, nearer to the highest score of 78, more than likely deals with chronic pain daily.

Phantom limb pain levels using Short-form McGill Pain Questionnaire (SF-MPQ)

Plazo: Week 3

Short-form McGill Pain Questionnaire - The maximum score an individual can reach on the MPQ is 78. According to the questionnaire, a person with a score of 0 effectively does not experience pain. A person with a high score, nearer to the highest score of 78, more than likely deals with chronic pain daily.

Phantom limb pain levels using Short-form McGill Pain Questionnaire (SF-MPQ)

Plazo: Week 6

Short-form McGill Pain Questionnaire - The maximum score an individual can reach on the MPQ is 78. According to the questionnaire, a person with a score of 0 effectively does not experience pain. A person with a high score, nearer to the highest score of 78, more than likely deals with chronic pain daily.

Medidas secundarias

Change in Brief Pain Inventory (BPI) scores

Plazo: Hour 24

Worst Pain Score: 1 - 4 = Mild Pain. Worst Pain Score: 5 - 6 = Moderate Pain. Worst Pain Score: 7 - 10 = Severe Pain - Scores range from 0 to 10 with higher scores indicating greater pain interference.

Change in Short-Form McGill Pain Questionnaire (SF-MPQ) scores

Plazo: Week 6

A short form of the McGill Pain Questionnaire (SF-MPQ) has been developed. The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe.

Consists of 22 different descriptors of pain and each item is rated based on a 0-10 scale with 0 equal to no pain and 10 equal to the worst pain ever during the past week. The total score is calculated by summing 22 individual scores.

Phantom Limb Experience Survey score

Plazo: Baseline

it is qualitative and there is no good or bad, this is just to define the population and better characterize phantom limb experience - assesses presence, onset, location, character, intensity, triggers, and treatment of phantom limb sensations and phantom limb pain. Includes questions on phantom limb posture, movement, size changes, and telescoping.

Change in Virtual Reality (VR) Therapy Survey scores

Plazo: Week 6

There are several questions within this survey to assess attitude towards VR, which activities are favored and then the effect VR had on them. There is a mix of qualitative questions and quantitative. Quantitative questions are on Likert Scale 1-5. An interval change of +1 on Likert scale would be "good" for question on posture, control over limb. For how long the therapy effect lasts after session is over, it will vary from hours to days to weeks (which is why all descriptors are in there). Even if it lasted 1 hour this would be considered "good".

System Usability Scale

Plazo: Week 6

Assesses subjective usability and satisfaction with the VR system - A perfect score of 100% signifies flawless usability and an exceptional user experience. The average SUS score is 68, and scores up to 70% are generally considered good; a good sus score indicates a decent level of usability.

Simulator Sickness Questionnaire

Plazo: Week 6

negligible (\< 5), minimal (5 - 10), significant (10 - 15), and concerning (15 - 20) symptoms. A simulator resulting in total scores above 20 is considered "bad"

Change in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) scores

Plazo: Week 6

Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions.EQ-5D-5L index scores range from -0.59 to 1, where 1 is the best possible health state

El registro no indica resultados publicados.

Revisa las tablas completas y sus limitaciones en el registro oficial.

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Centros de investigación (1)

El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.

1 centros

OrthoCarolina Hand CenterCharlotte, North Carolina, United StatesEstado desconocido

Equipo y fechas

Patrocinador principal
Wake Forest University Health Sciences
Inicio del estudio
21 dic 2023 Real
Finalización primaria
4 sept 2026 Real
Finalización del estudio
4 sept 2026 Real
Primera publicación
11 oct 2023 Real
Última actualización
9 nov 2026 Real

Contactos oficiales del estudio

No hay un contacto central indicado. Revisa los centros y el registro oficial.

Título oficial del estudio

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

EL PRÓXIMO PASO, CON APOYO HUMANO

Consulta a Wellness Clinical Research

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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.

Consultado: 12 nov 2026 · Última actualización del registro: 9 nov 2026