Studies
| Study First Submitted Date | 2021-12-06 |
| Study First Posted Date | 2022-01-18 |
| Last Update Posted Date | 2023-05-11 |
| Start Month Year | May 2024 |
| Primary Completion Month Year | May 2025 |
| Verification Month Year | May 2023 |
| Verification Date | 2023-05-31 |
| Last Update Posted Date | 2023-05-11 |
Detailed Descriptions
| Sequence: | 20594147 |
| Description | Ten unilateral upper extremity amputees suffering from chronic phantom limb pain > 1 yr will be recruited from a hospital based outpatient Physical Medicine and Rehabilitation Amputee Clinic. There will be no control group and all 10 subjects will be offered the use of a Virtual Reality headset therapy game (developed in Unreal Engine using Oculus Quest 2 SDK). Fiducial markers will be placed on the residual limb for tracking via front facing cameras on the Oculus Quest 2 and the sound limb movements will be duplicated (flipped for chirality) and mapped onto the residual limb to provide the appearance of their residual limb. The software will direct the subjects through a series of guided movements, stretches, and visualization exercises which last a total of 15 minutes. Afterwards the subjects will be given 5 minutes of unstructured time in the program to perform any of exercises or movements they desire in order to attempt to relieve their phantom limb pain. Subjects will aim for 1 session per week for a total of 6 weeks. Subjects will rate their phantom limb pain symptoms on the Numeric Rating Scale (NRS) prior to and after each session. Prior to the first session as well as at 6 weeks and 12 weeks subjects will rate their phantom limb pain symptoms on the Pain Disability |
Facilities
| Sequence: | 198770553 |
| Name | The University of Alabama at Birmingahm |
| City | Birmingham |
| State | Alabama |
| Zip | 35294 |
| Country | United States |
Conditions
| Sequence: | 51843559 |
| Name | Phantom Limb Pain |
| Downcase Name | phantom limb pain |
Id Information
| Sequence: | 39896798 |
| Id Source | org_study_id |
| Id Value | IRB-300007560 |
Countries
| Sequence: | 42295109 |
| Name | United States |
| Removed | False |
Design Groups
| Sequence: | 55269246 |
| Group Type | Experimental |
| Title | Unilateral upper extremity amputees |
| Description | Unilateral upper extremity amputees suffering from chronic phantom limb pain > 1 yr will be recruited from a hospital based outpatient Physical Medicine and Rehabilitation Amputee Clinic at UAB. |
Interventions
| Sequence: | 52164292 |
| Intervention Type | Other |
| Name | Virtual Mirror Therapy |
| Description | Subjects will be offered the use of a Virtual Reality headset therapy game. Fiducial markers will be placed on the residual limb for tracking via front facing cameras on the Oculus Quest 2 and the sound limb movements will be duplicated (flipped for chirality) and mapped onto the residual limb to provide the appearance of their residual limb. The software will direct the subjects through a series of guided movements, stretches, and visualization exercises which last a total of 15 minutes. Afterwards the subjects will be given 5 minutes of unstructured time in the program to perform any of exercises or movements they desire in order to attempt to relieve their phantom limb pain. |
Keywords
| Sequence: | 79335316 | Sequence: | 79335317 |
| Name | Virtual Mirror Therapy | Name | Chronic Phantom Limb Pain |
| Downcase Name | virtual mirror therapy | Downcase Name | chronic phantom limb pain |
Design Outcomes
| Sequence: | 176317068 | Sequence: | 176317055 | Sequence: | 176317056 | Sequence: | 176317057 | Sequence: | 176317058 | Sequence: | 176317059 | Sequence: | 176317060 | Sequence: | 176317061 | Sequence: | 176317062 | Sequence: | 176317063 | Sequence: | 176317064 | Sequence: | 176317065 | Sequence: | 176317066 | Sequence: | 176317067 | Sequence: | 176317069 | Sequence: | 176317070 | Sequence: | 176317071 |
| Outcome Type | secondary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
| Measure | Change in Quality from Baseline Chronic Phantom Limb Pain at Session 4 | Measure | Baseline Numeric Rating Scale of Chronic Phantom Limb Pain | Measure | Change from Baseline Numeric Rating Scale at Session1 | Measure | Change from Baseline Numeric Rating Scale at Session 2 | Measure | Change from Baseline Numeric Rating Scale at Session 3 | Measure | Change from Baseline Numeric Rating Scale at Session 4 | Measure | Change from Baseline Numeric Rating Scale at Session 5 | Measure | Change from Baseline Numeric Rating Scale at Session 6 | Measure | Baseline Pain Disability Questionnaire of Chronic Phantom Limb Pain | Measure | Change from Baseline Pain Disability Questionnaire at Week 6 | Measure | Change from Baseline Pain Disability Questionnaire at Week 12 | Measure | Change in Quality from Baseline Chronic Phantom Limb Pain at Session1 | Measure | Change in Quality from Baseline Chronic Phantom Limb Pain at Session 2 | Measure | Change in Quality from Baseline Chronic Phantom Limb Pain at Session 3 | Measure | Change in Quality from Baseline Chronic Phantom Limb Pain at Session 5 | Measure | Change in Quality from Baseline Chronic Phantom Limb Pain at Session 6 | Measure | Impressions of change from Baseline Chronic Phantom Limb Pain at Session 6 |
| Time Frame | Week 4 – Week 52 | Time Frame | Baseline (Week 0) | Time Frame | Week 1 – Week 52 | Time Frame | Week 2 – Week 52 | Time Frame | Week 3 – Week 52 | Time Frame | Week 4 – Week 52 | Time Frame | Week 5 – Week 52 | Time Frame | Week 6 – Week 52 | Time Frame | Baseline (Week 0) | Time Frame | 6 weeks after final session (Session 6) | Time Frame | 12 weeks after final session (Session 6) | Time Frame | Week 1 – Week 52 | Time Frame | Week 2 – Week 52 | Time Frame | Week 3 – Week 52 | Time Frame | Week 5 – Week 52 | Time Frame | Week 6 – Week 52 | Time Frame | Week 6 – Week 52 |
| Description | Free-text section where participants can further describe any changes regarding their pain (change in quality etc). | Description | Subjects will rate their phantom limb pain symptoms on the Numeric Rating Scale (NRS) at Baseline to use as comparison to each study session. If pain is intermittent or constant will be noted and if episodic/intermittent a frequency for how often the pain occurs will be obtained as well. | Description | Subjects will rate their phantom limb pain symptoms on the Numeric Rating Scale (NRS) prior to and after each session. If pain is intermittent or constant will be noted and if episodic/intermittent a frequency for how often the pain occurs will be obtained as well as if the pain is improved, unchanged, or worsened compared to baseline (prior to study). | Description | Subjects will rate their phantom limb pain symptoms on the Numeric Rating Scale (NRS) prior to and after each session. If pain is intermittent or constant will be noted and if episodic/intermittent a frequency for how often the pain occurs will be obtained as well as if the pain is improved, unchanged, or worsened compared to baseline (prior to study). | Description | Subjects will rate their phantom limb pain symptoms on the Numeric Rating Scale (NRS) prior to and after each session. If pain is intermittent or constant will be noted and if episodic/intermittent a frequency for how often the pain occurs will be obtained as well as if the pain is improved, unchanged, or worsened compared to baseline (prior to study). | Description | Subjects will rate their phantom limb pain symptoms on the Numeric Rating Scale (NRS) prior to and after each session. If pain is intermittent or constant will be noted and if episodic/intermittent a frequency for how often the pain occurs will be obtained as well as if the pain is improved, unchanged, or worsened compared to baseline (prior to study). | Description | Subjects will rate their phantom limb pain symptoms on the Numeric Rating Scale (NRS) prior to and after each session. If pain is intermittent or constant will be noted and if episodic/intermittent a frequency for how often the pain occurs will be obtained as well as if the pain is improved, unchanged, or worsened compared to baseline (prior to study). | Description | Subjects will rate their phantom limb pain symptoms on the Numeric Rating Scale (NRS) prior to and after each session. If pain is intermittent or constant will be noted and if episodic/intermittent a frequency for how often the pain occurs will be obtained as well as if the pain is improved, unchanged, or worsened compared to baseline (prior to study). | Description | Prior to the first session as well as at 6 weeks and 12 weeks subjects will rate their phantom limb pain symptoms on the Pain Disability Questionnaire (PDQ). | Description | Prior to the first session as well as at 6 weeks and 12 weeks subjects will rate their phantom limb pain symptoms on the Pain Disability Questionnaire (PDQ). | Description | Prior to the first session as well as at 6 weeks and 12 weeks subjects will rate their phantom limb pain symptoms on the Pain Disability Questionnaire (PDQ). | Description | Free-text section where participants can further describe any changes regarding their pain (change in quality etc). | Description | Free-text section where participants can further describe any changes regarding their pain (change in quality etc). | Description | Free-text section where participants can further describe any changes regarding their pain (change in quality etc). | Description | Free-text section where participants can further describe any changes regarding their pain (change in quality etc). | Description | Free-text section where participants can further describe any changes regarding their pain (change in quality etc). | Description | At the end of 6 sessions of Virtual Mirror Therapy subjects will be given the opportunity to submit opinions/comments regarding their impressions of the sessions. |
Browse Conditions
| Sequence: | 192165309 | Sequence: | 192165301 | Sequence: | 192165302 | Sequence: | 192165303 | Sequence: | 192165304 | Sequence: | 192165305 | Sequence: | 192165306 | Sequence: | 192165307 | Sequence: | 192165308 |
| Mesh Term | Pain | Mesh Term | Phantom Limb | Mesh Term | Perceptual Disorders | Mesh Term | Neurobehavioral Manifestations | Mesh Term | Neurologic Manifestations | Mesh Term | Nervous System Diseases | Mesh Term | Pain, Postoperative | Mesh Term | Postoperative Complications | Mesh Term | Pathologic Processes |
| Downcase Mesh Term | pain | Downcase Mesh Term | phantom limb | Downcase Mesh Term | perceptual disorders | Downcase Mesh Term | neurobehavioral manifestations | Downcase Mesh Term | neurologic manifestations | Downcase Mesh Term | nervous system diseases | Downcase Mesh Term | pain, postoperative | Downcase Mesh Term | postoperative complications | Downcase Mesh Term | pathologic processes |
| Mesh Type | mesh-ancestor | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
| Sequence: | 48015919 |
| Agency Class | OTHER |
| Lead Or Collaborator | lead |
| Name | University of Alabama at Birmingham |
Overall Officials
| Sequence: | 29094276 |
| Role | Principal Investigator |
| Name | Conley Carr, MD |
| Affiliation | The University of Alabama at Birmingham |
Central Contacts
| Sequence: | 11941590 |
| Contact Type | primary |
| Name | Conley Carr, MD |
| Phone | (205) 934-2747 |
| cjcarr@uabmc.edu | |
| Role | Contact |
Design Group Interventions
| Sequence: | 67754939 |
| Design Group Id | 55269246 |
| Intervention Id | 52164292 |
Eligibilities
| Sequence: | 30573692 |
| Gender | All |
| Minimum Age | 18 Years |
| Maximum Age | 89 Years |
| Healthy Volunteers | No |
| Criteria | Inclusion Criteria: Presence of unilateral upper extremity amputation with continued intermittent or persistent phantom limb pain symptoms > 1 yr after amputation, pain must be >=4 of 10 on the VAS at least intermittently (i.e. can have no pain at times but they must at least have 4/10 intensity of pain when pain does occur). Exclusion Criteria: Uncontrolled bipolar/schizophrenia, active psychosis, uncontrolled seizure disorder, history of severe simulator sickness, active nausea/vomiting, uncontrolled vertigo, bilateral blindness, any facial wounds around the cheeks nose or eyes that may interfere with headset, conjunctivitis, zoster ophthalmicus, immunodeficiency (uncontrolled HIV, immuno-suppressive medications, chemotherapy, etc), severe claustrophobia. |
| Adult | True |
| Child | False |
| Older Adult | True |
Calculated Values
| Sequence: | 254292697 |
| Number Of Facilities | 1 |
| Registered In Calendar Year | 2021 |
| Were Results Reported | False |
| Has Us Facility | True |
| Has Single Facility | True |
| Minimum Age Num | 18 |
| Maximum Age Num | 89 |
| Minimum Age Unit | Years |
| Maximum Age Unit | Years |
| Number Of Primary Outcomes To Measure | 10 |
| Number Of Secondary Outcomes To Measure | 7 |
Designs
| Sequence: | 30321903 |
| Allocation | N/A |
| Intervention Model | Single Group Assignment |
| Observational Model | |
| Primary Purpose | Treatment |
| Time Perspective | |
| Masking | None (Open Label) |
Responsible Parties
| Sequence: | 28700622 |
| Responsible Party Type | Principal Investigator |
| Name | Conley Carr |
| Title | Assistant Professor |
| Affiliation | University of Alabama at Birmingham |