Chronic PainXR-PAINNCT06296433
Extended Reality-Assisted Therapy for Chronic Pain Management
A study testing VR rehabilitation and VR video application in people with Chronic Pain and Low Back Pain, run by Institut d'Investigacions Biomèdiques August Pi i Sunyer at 1 site in Spain.
Trial summary
The goal of this clinical trial is to test a home-based virtual reality rehabilitation application in patients with chronic low back pain. The main question it aims to answer are: Is a prototype of a novel VR software application effective at reducing pain, improving daily function, improving range of motion, and… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Pain, Low Back Pain
- What is being tested?
- VR rehabilitation and VR video application
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2024to 31 Dec 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18-65 of either sex
- Diagnosis of chronic low back pain of >12 weeks, with or without associated somatic referred leg pain
- Average pain intensity over the previous month ≤7/10 and ≥ 2/10)
Who cannot join
- Spondylolysis, fracture, cauda equina syndrome, active spinal infection
- Acute radiculopathy or compromised nerve root
- Recent spinal surgery (<12 months) or lower limb surgery (<3 months)
- Major depressive symptoms as indicated by the Patient Health Questionnaire-2 depression screen score of 4 or more.
- Current or prior diagnosis of epilepsy, seizure disorder, dementia, migraines, balance disorder, or other neurological diseases that may prevent the use of virtual reality or adverse effects.
- Cardiopulmonary or pulmonary disorder with contraindication to physical exercise
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
IDIBAPS
Barcelona, 08036
Maria V Sanchez-Vives, 93 227 5400 ext. 4302, msanche3@clinic.cat
About this study
Official title: Extended Reality-Assisted Therapy for Chronic Pain Management: Can Immersive Virtual Reality Improve Range of Motion and Disability in Patients With Chronic Low Back Pain?
The goal of this clinical trial is to test a home-based virtual reality rehabilitation application in patients with chronic low back pain. The main question it aims to answer are:
Is a prototype of a novel VR software application effective at reducing pain, improving daily function, improving range of motion, and reducing fear of movement in adult patients with chronic low back pain compared with a passive VR intervention? Participants in the treatment group will use the application daily for 20 minutes for a period of 3 weeks at home and unsupervised. Researchers will compare use of the VR application with a control group that watches 2D video to see if the treatment group have improved pain, disability, range of motion, and fear of movement.
Read the detailed description
This is a two-arm randomized parallel controlled trial designed to test a prototype of a VR software application that the investigators have developed for patients with chronic low back pain. The app contains (1) educational messages delivered by a virtual therapist, (2) gamified exercises in which the patient has to move to reach goals or avoid objects, (3) therapeutic exercises, in which patients perform difficult or feared movements, (4) relaxation/mindfulness. There will be two groups consisting of adult patients of both sexes with persistent low back pain. Patients (n = 100) will be randomly assigned to either an interventional VR treatment (n = 50) or a control treatment (n = 50).
Patients in the VR intervention group will use the VR software application daily for a 20-minute training program. In the virtual reality application, they will be embodied into an avatar through congruent visuotactile and visuomotor stimulation (observed in first person) and will perform gamified movements and exercises for 15-20 minutes. These exercises will increase in difficulty for 3 weeks and will include educational and relaxation components. The control treatment will consist of a passive VR intervention in which the patient watches a TV show on a 2D screen but while wearing the virtual reality headset. They will be able to choose from three popular TV series with short episodes (20 minutes). The investigators will use validated outcome measures to assess changes in pain and function. These will be measured at baseline, after treatment (3 weeks), and at 1 month follow-up for both the treatment group and the control group. Both groups will be advised to continue their normal daily activities and routines, with no restrictions on activity or exercise, in addition to VR treatment.
- Conditions
- Chronic Pain, Low Back Pain
- Being tested
- VR rehabilitation, VR video application
- Keywords
- virtual reality, embodiment, chronic pain, rehabilitation
- Medical subject headings
- Chronic Pain, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR rehabilitationOther
VR software application containing education, exergames, therapeutic exercises and relaxation sections.
VR video applicationOther
VR software application that plays 2D nature videos
| Study group | Role | What they receive |
|---|---|---|
| VR rehabilitation treatment | Experimental | Daily use of VR rehabilitation program independently at home for a period of 3 weeks. Each daily session is 20 minutes. Receives: Other: VR rehabilitation |
| VR control treatment | Placebo comparator | Daily watching 2D video independently at home using VR headset for a period of 20 minutes. Receives: Other: VR video application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Pain Inventory
Allows patients to rate the severity of their pain and the degree to which their pain interferes with common dimensions of feeling and function. Minimum score 0, maximum score 70, higher score = worse outcome.
Measured: Baseline, 4 weeks, 8 weeks
Secondary outcomes (4)
Roland-Morris Disability Questionnaire
The Roland-Morris Disability Questionnaire is a self-reported measure consisting of 24 yes/no questions designed to assess functional disability related to back pain, with higher scores indicating greater disability. Minimum score 0, maximum score 24.
Measured: Baseline, 4 weeks, 8 weeks
Short-Form 12
The Short-Form-12 is a widely used, short-form health survey consisting of 12 questions that assess physical and mental health functioning, providing a concise measure of overall health status. Scores above 50 represent better than average quality of life, below 50 represents worse than average quality of life.
Measured: Baseline, 4 weeks, 8 weeks
Patient Global Impression of Change
The Patient Global Impression of Change is a self-reported assessment used to measure an individual's perceived change in health status or symptoms over time, typically ranging from "very much worse" to "very much improved." Minimum score 1, maximum score 7. Higher score indicated greater improvement in patient's condition (better outcome)
Measured: Baseline, 4 weeks, 8 weeks
Pain Catastrophization Scale
a self-report measure consisting of two subscales, assessing beliefs about how physical activity and work-related activities may exacerbate pain and lead to avoidance behaviors in individuals with low back pain. Minimum score 0, maximum score 52. Higher score indicates worse outcome.
Measured: Baseline, 4 weeks, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start1 Apr 2024
- Primary completion30 Nov 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut d'Investigacions Biomèdiques August Pi i Sunyer
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Maria V. Sanchez-Vives, Institut d'Investigacions Biomèdiques August Pi i Sunyer
- Investigators
- Maria V Sanchez-Vives, Principal investigator, Institut d'Investigacions Biomèdiques August Pi i Sunyer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06296433
- Sponsor's protocol ID
- HCB_2023_1196
- Acronym
- XR-PAIN
- Status last verified
- May 2024
- First submitted
- 29 Feb 2024
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study data will be made available on request from the study authors
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended Reality-Assisted Therapy for Chronic Pain Management: Can Immersive Virtual Reality Improve Range of Motion and Disability in Patients With Chronic Low Back Pain?
- ClinicalTrials.gov ID
- NCT06296433
- Acronym / sponsor ID
- XR-PAIN / HCB_2023_1196
- Conditions
- Chronic Pain, Low Back Pain
- Keywords
- virtual reality, embodiment, chronic pain, rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Institut d'Investigacions Biomèdiques August Pi i SunyerUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 6 Mar 2024 (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.
The goal of this clinical trial is to test a home-based virtual reality rehabilitation application in patients with chronic low back pain. The main question it aims to answer are:
Is a prototype of a novel VR software application effective at reducing pain, improving daily function, improving range of motion, and reducing fear of movement in adult patients with chronic low back pain compared with a passive VR intervention? Participants in the treatment group will use the application daily for 20 minutes for a period of 3 weeks at home and unsupervised. Researchers will compare use of the VR application with a control group that watches 2D video to see if the treatment group have improved pain, disability, range of motion, and fear of movement.
Detailed description
This is a two-arm randomized parallel controlled trial designed to test a prototype of a VR software application that the investigators have developed for patients with chronic low back pain. The app contains (1) educational messages delivered by a virtual therapist, (2) gamified exercises in which the patient has to move to reach goals or avoid objects, (3) therapeutic exercises, in which patients perform difficult or feared movements, (4) relaxation/mindfulness. There will be two groups consisting of adult patients of both sexes with persistent low back pain. Patients (n = 100) will be randomly assigned to either an interventional VR treatment (n = 50) or a control treatment (n = 50).
Patients in the VR intervention group will use the VR software application daily for a 20-minute training program. In the virtual reality application, they will be embodied into an avatar through congruent visuotactile and visuomotor stimulation (observed in first person) and will perform gamified movements and exercises for 15-20 minutes. These exercises will increase in difficulty for 3 weeks and will include educational and relaxation components. The control treatment will consist of a passive VR intervention in which the patient watches a TV show on a 2D screen but while wearing the virtual reality headset. They will be able to choose from three popular TV series with short episodes (20 minutes). The investigators will use validated outcome measures to assess changes in pain and function. These will be measured at baseline, after treatment (3 weeks), and at 1 month follow-up for both the treatment group and the control group. Both groups will be advised to continue their normal daily activities and routines, with no restrictions on activity or exercise, in addition to VR treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR rehabilitation treatment | Experimental | Other: VR rehabilitationDaily use of VR rehabilitation program independently at home for a period of 3 weeks. Each daily session is 20 minutes. |
| VR control treatment | Placebo comparator | Other: VR video applicationDaily watching 2D video independently at home using VR headset for a period of 20 minutes. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 18-65 of either sex
- Diagnosis of chronic low back pain of >12 weeks, with or without associated somatic referred leg pain
- Average pain intensity over the previous month ≤7/10 and ≥ 2/10)
Key exclusion criteria (7 listed)
- Spondylolysis, fracture, cauda equina syndrome, active spinal infection
- Acute radiculopathy or compromised nerve root
- Recent spinal surgery (<12 months) or lower limb surgery (<3 months)
- Major depressive symptoms as indicated by the Patient Health Questionnaire-2 depression screen score of 4 or more.
- Current or prior diagnosis of epilepsy, seizure disorder, dementia, migraines, balance disorder, or other neurological diseases that may prevent the use of virtual reality or adverse effects.
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 |
|---|---|---|
| VR rehabilitationVR software application containing education, exergames, therapeutic exercises and relaxation sections. | Other | VR rehabilitation treatment |
| VR video applicationVR software application that plays 2D nature videos | Other | VR control treatment |
Primary outcome
Brief Pain Inventory
Time frame: Baseline, 4 weeks, 8 weeks
Allows patients to rate the severity of their pain and the degree to which their pain interferes with common dimensions of feeling and function. Minimum score 0, maximum score 70, higher score = worse outcome.
4 secondary outcomes
Roland-Morris Disability Questionnaire
Time frame: Baseline, 4 weeks, 8 weeks
Short-Form 12
Time frame: Baseline, 4 weeks, 8 weeks
Patient Global Impression of Change
Time frame: Baseline, 4 weeks, 8 weeks
Pain Catastrophization Scale
Time frame: Baseline, 4 weeks, 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Individual participant dataSharing planned: Yes. Study data will be made available on request from the study authors
Related trials for Chronic Pain
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SERENITY Study of Chronic Pain Interference in Adults
Chronic Low Back Pain, Spinal Cord Injury
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Different Treatments in Chronic Pain Patients.
Chronic Pain, Nociplastic Pain
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Dual-Task Core Stabilization Training in Chronic Nonspecific Low Back Pain
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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.
Maria V Sanchez-Vives principal investigator
Institut d'Investigacions Biomèdiques August Pi i Sunyer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR rehabilitation and VR video application in people with Chronic Pain and Low Back Pain, run by Institut d'Investigacions Biomèdiques August Pi i Sunyer at 1 site in Spain.
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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 10 May 2024. 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 Spain. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tony Donegan (+34676606825, tonydonegan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Pain Inventory (time frame: Baseline, 4 weeks, 8 weeks). 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 10 May 2024.