NeuropathyNCT03203772
Immersive Virtual Reality for Neuropathic Pain
A study testing Immersive Virtual Reality in people with Neuropathy and Phantom Limb Pain, run by Loma Linda University at 1 site in United States.
Trial summary
Investigating how neuropathic limb pain, including phantom limb pain or complex regional pain syndrome, is affected by virtual reality. While several studies have looked into virtual reality for treating this type of pain, few have used the latest immersive virtual reality hardware combined with motion control for an… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Neuropathy, Phantom Limb Pain, Complex Regional Pain Syndromes
- What is being tested?
- Immersive Virtual Reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2016to 31 Dec 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of complex regional pain syndrome or phantom limb pain in an upper or lower limb
Who cannot join
- Cognitive impairment leading to inability to make own medical decisions
- Complete inability to utilize leg or arm muscles that are needed for motion controller tracking
- History of seizures within the last year
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University Health, East Campus Outpatient Rehabilitation Center
Loma Linda, California, 92354
About this study
Official title: Management of Pain in Limb Neuropathic Conditions Through Immersive Virtual Reality
Investigating how neuropathic limb pain, including phantom limb pain or complex regional pain syndrome, is affected by virtual reality. While several studies have looked into virtual reality for treating this type of pain, few have used the latest immersive virtual reality hardware combined with motion control for an engaging virtual mirror therapy experience. The investigators are interested in studying the use of virtual reality as an alternative treatment option for these conditions.
- Being tested
- Immersive Virtual Reality
- Medical subject headings
- Phantom Limb, Complex Regional Pain Syndromes, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immersive Virtual RealityOther
Participants will engage in virtual visualization therapy in an immersive virtual reality environment
| Study group | Role | What they receive |
|---|---|---|
| Limb neuropathic conditions | Experimental | Includes phantom limb pain, complex regional pain syndrome Receives: Other: Immersive Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Virtual Reality Environment Use Questionnaire
Using a questionnaire, feedback over participant self-reported tolerance of the virtual reality environment, participant likelihood of recommending this therapy to others with similar conditions, reported sense of presence in presented scenario(s), comfort of virtual reality devices, impact on self-reported functional ability outside of clinic, and overall impression of virtual reality therapy will be recorded.
Measured: Immediately following final virtual reality session
Pain Relief with Virtual Reality Therapy: Wong-Baker Scale
Change in Wong-Baker Faces pain scale will be measured. This will be done by obtaining pain scale scores immediately prior to therapy session, immediately following therapy, and several weeks post last therapy session.
Measured: Change from initial scores prior to virtual reality exposure to immediately prior to and following virtual reality sessions, and up to 8 weeks following last sessions
Pain Relief with Virtual Reality Therapy: Visual Analog Scale
Change in Visual Analog Pain Scale will be measured. This will be done by obtaining pain scale scores immediately prior to therapy session, immediately following therapy, and several weeks post last therapy session.
Measured: Change from initial scores prior to virtual reality exposure to immediately prior to and following virtual reality sessions, and up to 8 weeks following last sessions
Pain Relief with Virtual Reality Therapy: Short-Form McGill Pain Scale
Change in Short-Form McGill Pain Questionnaire will be measured. This will be done by obtaining pain scale scores immediately prior to therapy session, immediately following therapy, and several weeks post last therapy session.
Measured: Change from initial scores prior to virtual reality exposure to immediately prior to and following virtual reality sessions, and up to 8 weeks following last sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2017
- Study start14 Aug 2016
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuropathyStudies of the same condition, open and under way.
- 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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian Chau, MD, Principal investigator, Loma Linda Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03203772
- Sponsor's protocol ID
- 5150437
- Status last verified
- May 2021
- First submitted
- 5 Jun 2017
- Last updated
- 14 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Pain in Limb Neuropathic Conditions Through Immersive Virtual Reality
- ClinicalTrials.gov ID
- NCT03203772
- Acronym / sponsor ID
- 5150437
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 14 Aug 2016 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 29 Jun 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.
Investigating how neuropathic limb pain, including phantom limb pain or complex regional pain syndrome, is affected by virtual reality. While several studies have looked into virtual reality for treating this type of pain, few have used the latest immersive virtual reality hardware combined with motion control for an engaging virtual mirror therapy experience. The investigators are interested in studying the use of virtual reality as an alternative treatment option for these conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Limb neuropathic conditions | Experimental | Other: Immersive Virtual RealityIncludes phantom limb pain, complex regional pain syndrome |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of complex regional pain syndrome or phantom limb pain in an upper or lower limb
Key exclusion criteria (3 listed)
- Cognitive impairment leading to inability to make own medical decisions
- Complete inability to utilize leg or arm muscles that are needed for motion controller tracking
- History of seizures within the last year
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 |
|---|---|---|
| Immersive Virtual RealityParticipants will engage in virtual visualization therapy in an immersive virtual reality environment | Other | Limb neuropathic conditions |
Primary outcome
Feasibility of Virtual Reality Environment Use Questionnaire
Time frame: Immediately following final virtual reality session
Using a questionnaire, feedback over participant self-reported tolerance of the virtual reality environment, participant likelihood of recommending this therapy to others with similar conditions, reported sense of presence in presented scenario(s), comfort of virtual reality devices, impact on self-reported functional ability outside of clinic, and overall impression of virtual reality therapy will be recorded.
Pain Relief with Virtual Reality Therapy: Wong-Baker Scale
Time frame: Change from initial scores prior to virtual reality exposure to immediately prior to and following virtual reality sessions, and up to 8 weeks following last sessions
Change in Wong-Baker Faces pain scale will be measured. This will be done by obtaining pain scale scores immediately prior to therapy session, immediately following therapy, and several weeks post last therapy session.
Pain Relief with Virtual Reality Therapy: Visual Analog Scale
Time frame: Change from initial scores prior to virtual reality exposure to immediately prior to and following virtual reality sessions, and up to 8 weeks following last sessions
Change in Visual Analog Pain Scale will be measured. This will be done by obtaining pain scale scores immediately prior to therapy session, immediately following therapy, and several weeks post last therapy session.
Pain Relief with Virtual Reality Therapy: Short-Form McGill Pain Scale
Time frame: Change from initial scores prior to virtual reality exposure to immediately prior to and following virtual reality sessions, and up to 8 weeks following last sessions
Change in Short-Form McGill Pain Questionnaire will be measured. This will be done by obtaining pain scale scores immediately prior to therapy session, immediately following therapy, and several weeks post last therapy session.
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 14 May 2021.
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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.
Brian Chau, MD principal investigator
Loma Linda Univeristy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immersive Virtual Reality in people with Neuropathy and Phantom Limb Pain, run by Loma Linda University 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 1 inclusion and 3 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 14 May 2021. 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?
Feasibility of Virtual Reality Environment Use Questionnaire (time frame: Immediately following final virtual reality session). The study lists 4 primary outcomes in all. 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 14 May 2021.