Virtual Reality Treatment for Phantom Limb Pain

NCT03338842 | Completed

• 1 other identifier: 823287
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lower Limb Amputation Above Knee (Injury); Lower Limb Amputation Below Knee (Injury); Phantom Limb Pain

Outcome Measures

Primary Outcomes (5)

• Changes in the Brief Pain Inventory

  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.

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

• Changes in the McGill Pain Questionnaire

  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.

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

• Changes in the Frenchay Activities Index

  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.

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

• Changes in the12-Item Short Form Health Survey

  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.

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

• Changes in the Hospital Anxiety and Depression Scale

  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

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

Secondary Outcomes (2)

• Changes in the Limb deficiency and Phantom Limb questionnaire.

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

• Changes in the 13-item Pain Catastrophizing scale

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

Study Arms (1)

Distractor and Lower limb VR

EXPERIMENTAL

The training sessions consist of Phase 1 (Distractor VR) in which patients will explore VR environments and Phase 2 (Lower limb VR) in which they will play games using their VR lower-limbs.

Device: Distractor and Lower limb VR

Interventions

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.

Distractor and Lower limb VR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead
• Moss Rehabilitation Research Institute: collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (9)

• Weeks SR, Anderson-Barnes VC, Tsao JW. Phantom limb pain: theories and therapies. Neurologist. 2010 Sep;16(5):277-86. doi: 10.1097/NRL.0b013e3181edf128.

  PMID: 20827116 BACKGROUND

• Dietrich C, Walter-Walsh K, Preissler S, Hofmann GO, Witte OW, Miltner WH, Weiss T. Sensory feedback prosthesis reduces phantom limb pain: proof of a principle. Neurosci Lett. 2012 Jan 24;507(2):97-100. doi: 10.1016/j.neulet.2011.10.068. Epub 2011 Nov 7.

  PMID: 22085692 BACKGROUND

• Chan BL, Witt R, Charrow AP, Magee A, Howard R, Pasquina PF, Heilman KM, Tsao JW. Mirror therapy for phantom limb pain. N Engl J Med. 2007 Nov 22;357(21):2206-7. doi: 10.1056/NEJMc071927. No abstract available.

  PMID: 18032777 BACKGROUND

• Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.

  PMID: 8080219 BACKGROUND

• Melzack R. The short-form McGill Pain Questionnaire. Pain. 1987 Aug;30(2):191-197. doi: 10.1016/0304-3959(87)91074-8.

  PMID: 3670870 BACKGROUND

• Holbrook M, Skilbeck CE. An activities index for use with stroke patients. Age Ageing. 1983 May;12(2):166-70. doi: 10.1093/ageing/12.2.166.

  PMID: 6869117 BACKGROUND

• Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.

  PMID: 8628042 BACKGROUND

• Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.

  PMID: 6880820 BACKGROUND

• Goller AI, Richards K, Novak S, Ward J. Mirror-touch synaesthesia in the phantom limbs of amputees. Cortex. 2013 Jan;49(1):243-51. doi: 10.1016/j.cortex.2011.05.002. Epub 2011 Jun 22.

  PMID: 22981809 BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries; Phantom Limb

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain

Study Officials

• Branch Coslett

  hbc@mail.med.upenn.edu

  PRINCIPAL INVESTIGATOR

• Laurel Buxbaum

  Lbuxbaum@einstein.edu

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 1, 2017
• First Posted: November 9, 2017
• Study Start: January 12, 2018
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: June 16, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)