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OpenTrials
Completed

NCT Number: NCT03338842

Virtual Reality Treatment for Phantom Limb Pain

Patients with limb amputations experience the sensation of the missing extremity, which is sometimes coupled with a persistent and debilitating pain in the missing limb, a condition known as phantom limb pain (PLP). This study will test the use of virtual reality (VR) training as a possible treatment of PLP.

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Key information

Conditions

Lower Limb Amputation Above Knee (Injury) Lower Limb Amputation Below Knee (Injury) Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Phantom Limb Phantom Limb Pain Postoperative Complications Signs and Symptoms Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

Approximately 90% of patients with limb amputations experience the persistent sensation of the missing extremity, a phenomenon known as phantom limb (PL). Most patients with PL also experience a persistent and debilitating pain in the missing limb, a condition known as phantom limb pain (PLP).PLP is often attributed to a disruption of the primary sensory-motor representation, generating "noise" in the representation of the missing extremity, manifesting as pain. If loss of sensory feedback causes degradation of the these cortices, interventions that provide visual feedback about the missing extremity might fine-tune the primary sensory-motor cortices, thereby reducing pain. Within this framework, the present study explores the use of virtual reality (VR) training as a possible treatment of PLP. Twenty-five subjects with lower-limb amputation and chronic PLP will undergo a Virtual Reality (VR) treatment (17 one-hour sessions) consisting in two phases: a Distraction VR phase (5-7 sessions) in which they will explore VR environments using a joystick and a Lower-Limb VR treatment phase (10-12 sessions) in which they will participate in a variety of games and activities using their VR lower-limbs. A comprehensive battery for the assessment of the characteristics, intensity and the daily-life implication of PLP will be presented before and after the treatment and in three follow up testing sessions (1,4, 8 weeks). Furthermore, pain intensity will be assessed before and after each VR session. A dramatic reduction of PLP is expected after the VR treatment and that these beneficial effects remain stable in time.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects will have undergone amputation of one leg (either above or below the knee) at least 4 months before the enrollment in the study;
  • Will have chronic pain in the phantom limb:

Exclusion criteria

  • History of stroke or traumatic brain injury;
  • Major active psychiatric illness that may interfere with required study procedures or treatments as determined by the PI on the study, who is a behavioral neurologist;
  • Subjects with major medical illness that would be expected to interfere with their ability to complete the study will be excluded.
  • Subjects with implanted electronic devices.

Treatment and study plan

Distractor and Lower limb VR

Device

In the first phase (A), subjects will receive the Distraction VR treatment during 5, 6, or 7 one-hour-long sessions occurring twice weekly. After the A phase, the remaining sessions (B phase) will consist of Lower-Limb VR treatment. This number includes a mean of 6 (range 5-7) phase A sessions and mean of 11 (range 10-12) phase B sessions.

Primary outcomes

  1. Changes in the Brief Pain Inventory

    Time frame: Pre and post Phase 1; Pre and post Phase 2; at 1, 4 and 8 weeks

    The Brief Pain Inventory is a questionnaire which provide a description of the type and location of pain (question 1-2),the pain severity (question 3-6 pain rating scales with 0-10 range - with 10 indicating severe pain), of the current treatment for pain (question 7-8) and the pain interference in daily life (question 9- range from 0 to 10 with a maximum score of 10 indicating severe interference). A decrease (i.e. reduction in the scores) in pain severity and in the pain interference in daily activity is expected as consequence of the virtual reality training.

  2. Changes in the McGill Pain Questionnaire

    Time frame: Pre and post Phase 1; Pre and post Phase 2; at 1, 4 and 8 weeks

    The McGill Pain Questionnaire is a questionnaire which provide a description of the type of pain using series of adjectives on of the pain severity, using a visual analogue scale (range of 0-100 range - with 100 indicating severe pain). A decrease in pain severity (decrease in the score in the visual analogue scale) is expected as consequence of the virtual reality training.

  3. Changes in the Frenchay Activities Index

    Time frame: Pre and post Phase 1; Pre and post Phase 2; at 1, 4 and 8 weeks

    The the Frenchay Activities Index is a 15 items questionnaire, which investigate how often people perform certain daily activity (e.g. preparing meals), using a scale from 0 to 3, with a score of 3 indicating that the activity is performed frequently. An increase in the Frenchay Activities Index is expected as consequence of the virtual reality training.

  4. Changes in the12-Item Short Form Health Survey

    Time frame: Pre and post Phase 1; Pre and post Phase 2; at 1, 4 and 8 weeks

    The12-Item Short Form Health Survey is a questionnaire which investigate the quality of emotional and physical heath of individuals. An improvement in the quality of the individuals' health is expected as consequence of the training.

  5. Changes in the Hospital Anxiety and Depression Scale

    Time frame: Pre and post Phase 1; Pre and post Phase 2; at 1, 4 and 8 weeks

    The Hospital Anxiety and Depression Scale measures depression is a 14 questions scale, which measure the level of depression and anxiety (maximum score of 21 indicating abnormal performance). A decrease in the score in this scale is expected as consequence of the virtual reality training

Secondary outcomes

  1. Changes in the Limb deficiency and Phantom Limb questionnaire.

    Time frame: Pre and post Phase 1; Pre and post Phase 2; at 1, 4 and 8 weeks

    The Limb Deficiency and Phantom Limb questionnaire investigate qualitatively the phantom limb sensations.A reduction in the reported phantom limb sensation is expected as consequence of the virtual reality training

  2. Changes in the 13-item Pain Catastrophizing scale

    Time frame: Pre and post Phase 1; Pre and post Phase 2; at 1, 4 and 8 weeks

    The 13-item Pain Catastrophizing scale assesses the level of negative thoughts and feeling associated with pain using a scale from 0-4 (score of 4 indicating highest frequency; maximum overall score 52). A reduction of the overall score is expected after the virtual reality training

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Moss Rehabilitation Research Institute

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 9, 2017
Registry last updated
Jun 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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