Phantom Limb PainNCT05194800

Virtual Mirror Therapy for Relief of Chronic Phantom Limb Pain

A study testing Virtual Mirror Therapy in people with Phantom Limb Pain, run by University of Alabama at Birmingham.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Trial summary

The purpose of this project is to further investigate the use of Virtual Mirror therapy for alleviating symptoms of chronic phantom limb pain. This initial pilot study will inform a fully powered randomized control trial which will include both upper and lower extremity amputees Read more about this study

Who is it for?: Ages 18 to 89 years
Conditions the study is for: Phantom Limb Pain
What is being tested?: Virtual Mirror Therapy
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: No sites listed yet
Study dates: May 2024to May 2026
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 to 89 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

Who cannot join

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.

About this study

Read the detailed 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

Conditions: Phantom Limb Pain
Being tested: Virtual Mirror Therapy
Keywords: Virtual Mirror Therapy, Chronic Phantom Limb Pain
Medical subject headings: Phantom Limb

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Virtual Mirror TherapyOther
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.

Study groups in NCT05194800
Study group	Role	What they receive
Unilateral upper extremity amputees	Experimental	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. Receives: Other: Virtual Mirror Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Baseline Numeric Rating Scale of Chronic Phantom Limb Pain
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.
Measured: Baseline (Week 0)
Change from Baseline Numeric Rating Scale at Session1
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).
Measured: Week 1 - Week 52
Change from Baseline Numeric Rating Scale at Session 2
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).
Measured: Week 2 - Week 52
Change from Baseline Numeric Rating Scale at Session 3
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).
Measured: Week 3 - Week 52
Change from Baseline Numeric Rating Scale at Session 4
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).
Measured: Week 4 - Week 52
Change from Baseline Numeric Rating Scale at Session 5
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).
Measured: Week 5 - Week 52
Change from Baseline Numeric Rating Scale at Session 6
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).
Measured: Week 6 - Week 52
Baseline Pain Disability Questionnaire of Chronic Phantom Limb Pain
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).
Measured: Baseline (Week 0)
Change from Baseline Pain Disability Questionnaire at Week 6
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).
Measured: 6 weeks after final session (Session 6)
Change from Baseline Pain Disability Questionnaire at Week 12
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).
Measured: 12 weeks after final session (Session 6)

Secondary outcomes (7)

Change in Quality from Baseline Chronic Phantom Limb Pain at Session1
Free-text section where participants can further describe any changes regarding their pain (change in quality etc).
Measured: Week 1 - Week 52
Change in Quality from Baseline Chronic Phantom Limb Pain at Session 2
Free-text section where participants can further describe any changes regarding their pain (change in quality etc).
Measured: Week 2 - Week 52
Change in Quality from Baseline Chronic Phantom Limb Pain at Session 3
Free-text section where participants can further describe any changes regarding their pain (change in quality etc).
Measured: Week 3 - Week 52
Change in Quality from Baseline Chronic Phantom Limb Pain at Session 4
Free-text section where participants can further describe any changes regarding their pain (change in quality etc).
Measured: Week 4 - Week 52
Change in Quality from Baseline Chronic Phantom Limb Pain at Session 5
Free-text section where participants can further describe any changes regarding their pain (change in quality etc).
Measured: Week 5 - Week 52
Change in Quality from Baseline Chronic Phantom Limb Pain at Session 6
Free-text section where participants can further describe any changes regarding their pain (change in quality etc).
Measured: Week 6 - Week 52
Impressions of change from Baseline Chronic Phantom Limb Pain at Session 6
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.
Measured: Week 6 - Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2024May 2026

First posted18 Jan 2022
Study startMay 2024 (estimated)
Primary completionMay 2025 (estimated)
Study completionMay 2026 (estimated)

Why it stopped: Tech software issues. Unable to complete development

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Phantom Limb PainStudies of the same condition, open and under way.
More trials run by University of Alabama at BirminghamThe 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
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05194800
Sponsor's protocol ID: IRB-300007560
Status last verified: May 2024
First submitted: 6 Dec 2021
Last updated: 9 May 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
Early Postoperative Pain Following a Limb Amputation
Amputation, Surgical, Pain Management
Not yet recruitingPhase 4
Role of Perineural Catheter in Pain Control and Opioid Consumption After Major Amputation of Lower Limb
Lower Limb Surgery, Pain
Active, not recruitingPhase 1
Psilocybin-assisted Therapy for Phantom Limb Pain
Phantom Limb Pain
Recruiting
Home-based Rehabilitation Intervention for Phantom Limb Pain in Veterans With Lower Limb Amputations
Phantom Limb Pain
RecruitingObservational study
Prospective Study of Sensation and Satisfaction in Cancer and Transgender Mastectomy Patients
Sensation Disorders, Sensation, Phantom

All Phantom Limb Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Virtual Mirror Therapy for Relief of Chronic Phantom Limb Pain
ClinicalTrials.gov ID: NCT05194800
Acronym / sponsor ID: IRB-300007560
Conditions: Phantom Limb Pain
Keywords: Virtual Mirror Therapy, Chronic Phantom Limb Pain
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Tech software issues. Unable to complete development
Enrolment: 0 participants (actual)
Lead sponsor: University of Alabama at BirminghamUniversity, hospital or other
Study start: May 2024 (estimated)
Primary completion: May 2025 (estimated)
Study completion: May 2026 (estimated)
First posted: 18 Jan 2022 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Unilateral upper extremity amputees	Experimental	Other: Virtual Mirror TherapyUnilateral 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.

Who may qualify

Ages: 18 to 89 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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).

Key exclusion criteria (1 listed)

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.

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
Virtual Mirror TherapySubjects 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.	Other	Unilateral upper extremity amputees

Primary outcome

Baseline Numeric Rating Scale of Chronic Phantom Limb Pain
Time frame: Baseline (Week 0)
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.
Change from Baseline Numeric Rating Scale at Session1
Time frame: Week 1 - Week 52
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).
Change from Baseline Numeric Rating Scale at Session 2
Time frame: Week 2 - Week 52
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).
Change from Baseline Numeric Rating Scale at Session 3
Time frame: Week 3 - Week 52
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).
Change from Baseline Numeric Rating Scale at Session 4
Time frame: Week 4 - Week 52
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).
Change from Baseline Numeric Rating Scale at Session 5
Time frame: Week 5 - Week 52
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).
Change from Baseline Numeric Rating Scale at Session 6
Time frame: Week 6 - Week 52
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).
Baseline Pain Disability Questionnaire of Chronic Phantom Limb Pain
Time frame: Baseline (Week 0)
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).
Change from Baseline Pain Disability Questionnaire at Week 6
Time frame: 6 weeks after final session (Session 6)
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).
Change from Baseline Pain Disability Questionnaire at Week 12
Time frame: 12 weeks after final session (Session 6)
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).

7 secondary outcomes

Change in Quality from Baseline Chronic Phantom Limb Pain at Session1
Time frame: Week 1 - Week 52
Change in Quality from Baseline Chronic Phantom Limb Pain at Session 2
Time frame: Week 2 - Week 52
Change in Quality from Baseline Chronic Phantom Limb Pain at Session 3
Time frame: Week 3 - Week 52
Change in Quality from Baseline Chronic Phantom Limb Pain at Session 4
Time frame: Week 4 - Week 52
Change in Quality from Baseline Chronic Phantom Limb Pain at Session 5
Time frame: Week 5 - Week 52
Change in Quality from Baseline Chronic Phantom Limb Pain at Session 6
Time frame: Week 6 - Week 52
Impressions of change from Baseline Chronic Phantom Limb Pain at Session 6
Time frame: Week 6 - Week 52

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
Individual participant dataSharing planned: No

Related trials for Phantom Limb Pain

RecruitingObservational study
Early Postoperative Pain Following a Limb Amputation
Amputation, Surgical, Pain Management
Not yet recruitingPhase 4
Role of Perineural Catheter in Pain Control and Opioid Consumption After Major Amputation of Lower Limb
Lower Limb Surgery, Pain
Active, not recruitingPhase 1
Psilocybin-assisted Therapy for Phantom Limb Pain
Phantom Limb Pain
Recruiting
Home-based Rehabilitation Intervention for Phantom Limb Pain in Veterans With Lower Limb Amputations
Phantom Limb Pain
RecruitingObservational study
Prospective Study of Sensation and Satisfaction in Cancer and Transgender Mastectomy Patients
Sensation Disorders, Sensation, Phantom

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.

Conley Carr, MD principal investigator

The University of Alabama at Birmingham

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Mirror Therapy in people with Phantom Limb Pain, run by University of Alabama at Birmingham.

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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.

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 was withdrawn before enrolling participants, so there are no results.

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?

Baseline Numeric Rating Scale of Chronic Phantom Limb Pain (time frame: Baseline (Week 0)). The study lists 10 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 NCT05194800.

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 9 May 2024; AzTrials last refreshed its copy on 7 Nov 2026.