Lower Limb Amputation Above Knee (Injury)NCT03338842
Virtual Reality Treatment for Phantom Limb Pain
A study testing Distractor and Lower limb VR in people with Lower Limb Amputation Above Knee (Injury) and Lower Limb Amputation Below Knee (Injury), run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lower Limb Amputation Above Knee (Injury), Lower Limb Amputation Below Knee (Injury), Phantom Limb Pain
- What is being tested?
- Distractor and Lower limb VR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jan 2018to 1 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
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.
Read the detailed description
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.
- Conditions
- Lower Limb Amputation Above Knee (Injury), Lower Limb Amputation Below Knee (Injury), Phantom Limb Pain
- Being tested
- Distractor and Lower limb VR
- Medical subject headings
- Wounds and Injuries, Phantom Limb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distractor and Lower limb VRDevice
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Distractor and Lower limb VR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
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
Measured: Pre and post Phase 1; Pre and post Phase 2; at 1, 4 and 8 weeks
Changes in the 13-item Pain Catastrophizing scale
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
Measured: Pre and post Phase 1; Pre and post Phase 2; at 1, 4 and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2017
- Study start12 Jan 2018
- Primary completion1 Nov 2019
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Lower Limb Amputation Above Knee (Injury)Studies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Moss Rehabilitation Research Institute
- Responsible party
- Sponsor
- Investigators
- Branch Coslett, Principal investigator, hbc@mail.med.upenn.eduLaurel Buxbaum, Principal investigator, Lbuxbaum@einstein.edu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03338842
- Sponsor's protocol ID
- 823287
- Status last verified
- Jun 2020
- First submitted
- 1 Nov 2017
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20827116Dietrich 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.
PubMed 22085692Chan 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.
PubMed 18032777Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.
PubMed 8080219Melzack R. The short-form McGill Pain Questionnaire. Pain. 1987 Aug;30(2):191-197. doi: 10.1016/0304-3959(87)91074-8.
PubMed 3670870Holbrook 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.
PubMed 6869117Ware 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.
PubMed 8628042Zigmond 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.
PubMed 6880820Goller 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.
PubMed 22981809
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Treatment for Phantom Limb Pain
- ClinicalTrials.gov ID
- NCT03338842
- Acronym / sponsor ID
- 823287
- Conditions
- Lower Limb Amputation Above Knee (Injury), Lower Limb Amputation Below Knee (Injury), Phantom Limb Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Moss Rehabilitation Research Institute
- Study start
- 12 Jan 2018 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 9 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Distractor and Lower limb VR | Experimental | Device: Distractor and Lower limb VRThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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:
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Distractor and Lower limb VRIn 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. | Device | Distractor and Lower limb VR |
Primary outcome
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.
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.
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.
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.
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
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Background: PubMed 20827116Weeks SR, Anderson-Barnes VC, Tsao JW. Phantom limb pain: theories and therapies. Neurologist. 2010 Sep;16(5):277-86. doi: 10.1097/NRL.0b013e3181edf128.
- Background: PubMed 22085692Dietrich 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.
- Background: PubMed 18032777Chan 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.
- Background: PubMed 8080219Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.
- Background: PubMed 3670870Melzack R. The short-form McGill Pain Questionnaire. Pain. 1987 Aug;30(2):191-197. doi: 10.1016/0304-3959(87)91074-8.
- Background: PubMed 6869117Holbrook 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.
- Background: PubMed 8628042Ware 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.
- Background: PubMed 6880820Zigmond 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.
- Background: PubMed 22981809Goller 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Branch Coslett principal investigator
hbc@mail.med.upenn.edu
Laurel Buxbaum principal investigator
Lbuxbaum@einstein.edu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Distractor and Lower limb VR in people with Lower Limb Amputation Above Knee (Injury) and Lower Limb Amputation Below Knee (Injury), run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03338842, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2020.