Phantom Limb Syndrome With PainNCT03934528
The Impact of a Virtual Reality Environment on Phantom Limb Pain
A study testing Virtual environment activity in people with Phantom Limb Syndrome With Pain, run by University of Manchester at 1 site in United Kingdom.
Trial summary
Phantom limb pain occurs in the majority of people who lose a limb. It significantly affects quality of life and is hard to manage. Recent evidence suggests that mirror therapy and similar techniques that create a visual representation of the missing limb under the control of the patient may reduce phantom limb pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Phantom Limb Syndrome With Pain
- What is being tested?
- Virtual environment activity
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2019to 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years of age.
- Unilateral upper limb amputee (transradial and transhumeral).
- Amputation occurred at least 6 months ago.
- Stump has fully healed and has no ulcerations present.
Who cannot join
- Amputation of digit(s) only.
- The presence of a wound, ulcer or broken skin on the residual limb.
- The presence of a psychiatric disorder.
- Have pre-existing binocular vision abnormalities.
- A history of seizures or epilepsy.
- A pacemaker or other implanted medical device that could be affected by magnets or components that emit radio waves.
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- Lacking the capacity to understand the instructions on how to use the virtual reality equipment.
- Lacking the capacity to consent.
- Unable to comply with the requirements of the study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Manchester University NHS Foundation Trust
Manchester, M13 9WL
About this study
Official title: The Impact of Simulated Arm Movement Within a Virtual Reality Environment on Phantom Limb Pain in Upper Limb Amputees: A Pilot Study
Phantom limb pain occurs in the majority of people who lose a limb. It significantly affects quality of life and is hard to manage. Recent evidence suggests that mirror therapy and similar techniques that create a visual representation of the missing limb under the control of the patient may reduce phantom limb pain.
The investigators previously explored the use of a virtual reality environment for this purpose with people with upper limb loss but found that using it within the clinical setting limited its potential efficacy. Phantom limb pain is highly variable and assessing the effects of the activity during a hospital appointment when the phantom pain may not be present, or may not be problematic, made it difficult to judge the effects adequately.
This study involves training the patient in the clinic to use a portable, self-contained virtual reality system which they will then use at home, unsupervised, for 2 months. The aim is to discover whether phantom limb pain intensity decreases by performing an activity in a virtual reality environment in which a visual representation of the missing limb is controlled by the patient. Participants will be directed to use the system every day, and whenever their phantom limb pain is present and problematic.
- Conditions
- Phantom Limb Syndrome With Pain
- Being tested
- Virtual environment activity
- Keywords
- Phantom Limb Pain, Virtual Reality, Virtual Environment
- 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 environment activityDevice
Patients undertake an activity using simulated arm movement within a virtual reality environment every day for two months
| Study group | Role | What they receive |
|---|---|---|
| Pilot Study | Experimental | Not described Receives: Device: Virtual environment activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in intensity of phantom limb pain using a numerical rating scale: 0=no pain present to 10=worst imaginable pain.
Measured: 2 months
Secondary outcomes (2)
Change from baseline of number of phantom limb pain episodes per month.
Measured: 2 months
Change from baseline of average duration of phantom limb pain episodes.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2019
- Study startJun 2019 (estimated)
- Primary completionSep 2019 (estimated)
- Study completionNov 2019 (estimated)
Why it stopped: Unable to proceed during lockdown; post-lockdown vendor no longer supports the hardware on which the study was developed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phantom Limb Syndrome With PainStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe 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)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen Pettifer, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03934528
- Sponsor's protocol ID
- IRAS:259344
- Status last verified
- Apr 2025
- First submitted
- 23 Apr 2019
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Simulated Arm Movement Within a Virtual Reality Environment on Phantom Limb Pain in Upper Limb Amputees: A Pilot Study
- ClinicalTrials.gov ID
- NCT03934528
- Acronym / sponsor ID
- IRAS:259344
- Conditions
- Phantom Limb Syndrome With Pain
- Keywords
- Phantom Limb Pain, Virtual Reality, Virtual Environment
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to proceed during lockdown; post-lockdown vendor no longer supports the hardware on which the study was developed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Study start
- Jun 2019 (estimated)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 2 May 2019 (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.
Phantom limb pain occurs in the majority of people who lose a limb. It significantly affects quality of life and is hard to manage. Recent evidence suggests that mirror therapy and similar techniques that create a visual representation of the missing limb under the control of the patient may reduce phantom limb pain.
The investigators previously explored the use of a virtual reality environment for this purpose with people with upper limb loss but found that using it within the clinical setting limited its potential efficacy. Phantom limb pain is highly variable and assessing the effects of the activity during a hospital appointment when the phantom pain may not be present, or may not be problematic, made it difficult to judge the effects adequately.
This study involves training the patient in the clinic to use a portable, self-contained virtual reality system which they will then use at home, unsupervised, for 2 months. The aim is to discover whether phantom limb pain intensity decreases by performing an activity in a virtual reality environment in which a visual representation of the missing limb is controlled by the patient. Participants will be directed to use the system every day, and whenever their phantom limb pain is present and problematic.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pilot Study | Experimental | Device: Virtual environment activity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Over 18 years of age.
- Unilateral upper limb amputee (transradial and transhumeral).
- Amputation occurred at least 6 months ago.
- Stump has fully healed and has no ulcerations present.
Key exclusion criteria (9 listed)
- Amputation of digit(s) only.
- The presence of a wound, ulcer or broken skin on the residual limb.
- The presence of a psychiatric disorder.
- Have pre-existing binocular vision abnormalities.
- A history of seizures or epilepsy.
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 environment activityPatients undertake an activity using simulated arm movement within a virtual reality environment every day for two months | Device | Pilot Study |
Primary outcome
Change from baseline in intensity of phantom limb pain using a numerical rating scale: 0=no pain present to 10=worst imaginable pain.
Time frame: 2 months
2 secondary outcomes
Change from baseline of number of phantom limb pain episodes per month.
Time frame: 2 months
Change from baseline of average duration of phantom limb pain episodes.
Time frame: 2 months
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 30 Apr 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual environment activity in people with Phantom Limb Syndrome With Pain, run by University of Manchester at 1 site in United Kingdom.
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 4 inclusion and 9 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 30 Apr 2025. 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 Kingdom. 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 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?
Change from baseline in intensity of phantom limb pain using a numerical rating scale: 0=no pain present to 10=worst imaginable pain. (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Apr 2025.