Chronic Back PainNCT04307446
Immersive Virtual Reality and Chronic Back Pain
A study testing Immersive Virtual Reality in people with Chronic Back Pain, run by Tufts University at 1 site in United States.
Trial summary
In the proposed project the investigators will evaluate the feasibility of Immersive Virtual Reality (IVR) and assess the initial effects of IVR on symptoms, affect, and tolerance to cutaneous stimuli. In this single-arm trial, the investigators will recruit 20 adults with CBP. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Chronic Back Pain
- What is being tested?
- Immersive Virtual Reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2021to 31 May 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 20 to 75 years old
- Any Back Pain (including neck pain) that has lasted greater than 3 months due to non-cancer related injury or illness.
Who cannot join
- People with back pain primarily due to rheumatic (e.g. rheumatoid arthritis or fibromyalgia)
- people with back pain due to central neurological disorders (e.g. stroke, multiple sclerosis, spinal cord injury)
- has contagious disorder on the face (such as pink eye) that could be transmitted via the VR head set or has open areas on the face that would come in contact with the headset
- had a seizure, loss of awareness, or other symptom linked to an epileptic condition
- insufficient vision to see IVR programs
- insufficient upper extremity coordination to operate IVR controls
Show all 9Show fewer
- insufficient cognitive ability to answer questionnaires or learn to use the IVR
- unable to understand and respond to English
- Does not own a cell phone or tablet for baseline and follow-up EMA testing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Feasibility of Immersive Virtual Reality as a Treatment for Chronic Back Pain
In the proposed project the investigators will evaluate the feasibility of Immersive Virtual Reality (IVR) and assess the initial effects of IVR on symptoms, affect, and tolerance to cutaneous stimuli. In this single-arm trial, the investigators will recruit 20 adults with CBP. Prior to their IVR experience, subjects will complete multiday baseline assessments using ecological momentary assessment (EMA) methodology to establish typical levels of symptoms and affect. Afterward, in a single experimental session, they will participate in two counterbalanced IVR sessions: one 10-minute and one 20-minute. Immediately after each session the investigators will measure current symptoms and affect using valid and reliable self-report questionnaires, and we will measure changes in tolerance to cutaneous stimuli using quantitative sensory testing. We will measure symptoms and affect for 72 hours after the experimental session using EMA to determine if there is a carryover. At the completion of this study, we will continue to work with stakeholders to develop clinically relevant IVR interventions for people with CBP.
Read the detailed description
Visit 1-Remote: Consent. Random assignment: Subjects will complete informed consent and data collection of baseline information (demographics, medical history, perceptions of pain, and experiences with VR), surveys on pain, Pain interference, fatigue, and affect. The investigators will also help the participant upload the EMA technology onto their personal phone or tablet. Subjects will then be randomly assigned to receive either the 10- minute IVR session first or the 20-minute IVR session first. Visit 1 will take between 45 and 60 minutes.
Multiple Baseline EMA-Remote: Visit 2 will be scheduled 1-2 weeks later. During the time between visits the investigators will use ecological momentary assessment (EMA) technology to collect multiple measures of pain, fatigue and affect. In EMA subjects respond to prompts delivered through their cell phone or tablet ("pings") with documentation of current symptoms. It is a well-recognized method to capture immediate, synchronized experiences in subjects' natural environments. During this data collection period subjects will be "pinged" 3x daily and asked to rate their current levels of pain, fatigue, and affect. Time to complete these responses will be 15 minutes.
Visit 2-In person: pre Survey/Quantitative Sensory Testing (QST); First VR visit; post Survey/QST. The investigators will collect current pain, pain interference, fatigue and affect, and Quantitative Sensory Testing (QST). QST involves cutaneous (skin) psychophysical (semi-subjective) testing to assess sensory and pain perception pathways. QST quantifies the thresholds of detection of stimuli, the perceived intensity, and the temporal summation (changes in perception over multiple applications). These pain testing procedures are widely-accepted, non-invasive, and non-tissue damaging. The investigators will complete two types QST. Mechanical Pressure Pain Thresholds (MPPTh) will be assessed using a digital pressure algometer on the right upper trapezius and right thumb MP joint. Mechanical Temporal Summation of Pain (MTSP) will be assessed using weighted pinprick stimulators. The investigators will apply a train of 10 stimuli at the rate of 1 per second on the middle finger of the right hand, and subjects will rate the painfulness of the first, fifth, and tenth stimulus. All subjects will take part in two VR experiences (10 min and 20 min) for a total of 30-minutes in VR. After each experience subjects will rate their current pain, fatigue, and affect, and the investigators will complete QST. At the end of both sessions the subjects will rate their experiences of immersion using the Igroup Presence Questionaire, engagement using the Use Engagement Scale (UES), and simulation tolerance using the Simulator Sickness Questionnaire (SSQ). The investigators will also ask a series of open-ended questions about the participant's experiences with IVR and participation in the study. These will include questions about their enjoyment, perceptions of pain, and what they liked/did not like about the IVR experience as well as questions about the burden of being in the study. Visit 2 will take 1.5 to 2 hours
Post Visit 2 EMA-Remote: Subjects will complete three more days (72 hours) of 3x a day prompts for pain, fatigue and affect.
Visit 3-In person: pre Survey/Quantitative Sensory Testing (QST); Second VR visit; post Survey/QST
Post Visit 3 EMA-Remote: Subjects will complete 2 more days (48 hours) of 3x a day prompts for pain, fatigue and affect.
- Conditions
- Chronic Back Pain
- Being tested
- Immersive Virtual Reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immersive Virtual RealityDevice
Immersive Virtual Reality
| Study group | Role | What they receive |
|---|---|---|
| 10 Minutes/20 Minutes | Experimental | Subject takes part in 10 minute VR experience first and 20 minute VR experience second Receives: Device: Immersive Virtual Reality |
| 20 Minutes/10 Minutes | Experimental | Subject takes part in 20 minute VR experience first and 10 minute VR experience second Receives: Device: Immersive Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Numerical Rating Scale
Pain Intensity - Numerical rating scale 0 to 10 with lower score better score
Measured: Change in Pain Intensity from before to immediately after intervention
Mechanical Pressure Pain Thresholds (MPPTh)
Sensitivity to pressure will be assessed using a digital pressure algometer on the right upper trapezius and right thumb MP joint. The measures from each site were averaged to obtain an overall mean pressure score for each participant. A lower score indicates a better outcome.
Measured: Median Pre and post intervention sensitivity to pressure scores in kilograms
Mechanical Temporal Summation of Pain (MTSP)
Sensitivity to pinprick was assessed using weighted pinprick stimulators. We applied a train of 10 stimuli at the rate of 1 per second on the middle finger of the right hand, and subjects rated the painfulness of the first and tenth stimulus using a 1 to 100 pain intentsity rating scale. We calculated the difference from the 1st stimuus to the 10th stimulus to calculate the sensitivity. A lower change score is a better outcome
Measured: Change in Sensitivity to pinprick from before to immediately after intervention
Secondary outcomes (2)
PANAS
Two scales one for Positive and one for Negative Affect - Score for each scale 10 to 50 with lower score indicating less of that affect
Measured: Change in affect form before immediately after intervention
PROMIS Fatigue
Fatigue on a scale of 0 to 28 with a lower score indicating less frequent experiences of fatigue
Measured: Change in fatigue from before to immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start1 May 2021
- Primary completion6 Jul 2022
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Back 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nancy Baker, Tufts University
- Investigators
- Nancy Baker, ScD, Principal investigator, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04307446
- Sponsor's protocol ID
- STUDY00000192
- Other IDs
- UL1TR002544
- Status last verified
- Aug 2023
- First submitted
- 10 Mar 2020
- Last updated
- 15 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of Immersive Virtual Reality as a Treatment for Chronic Back Pain
- ClinicalTrials.gov ID
- NCT04307446
- Acronym / sponsor ID
- STUDY00000192
- Conditions
- Chronic Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 6 Jul 2022 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 13 Mar 2020 (actual)
- Results
- Posted 15 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the proposed project the investigators will evaluate the feasibility of Immersive Virtual Reality (IVR) and assess the initial effects of IVR on symptoms, affect, and tolerance to cutaneous stimuli. In this single-arm trial, the investigators will recruit 20 adults with CBP. Prior to their IVR experience, subjects will complete multiday baseline assessments using ecological momentary assessment (EMA) methodology to establish typical levels of symptoms and affect. Afterward, in a single experimental session, they will participate in two counterbalanced IVR sessions: one 10-minute and one 20-minute. Immediately after each session the investigators will measure current symptoms and affect using valid and reliable self-report questionnaires, and we will measure changes in tolerance to cutaneous stimuli using quantitative sensory testing. We will measure symptoms and affect for 72 hours after the experimental session using EMA to determine if there is a carryover. At the completion of this study, we will continue to work with stakeholders to develop clinically relevant IVR interventions for people with CBP.
Detailed description
Visit 1-Remote: Consent. Random assignment: Subjects will complete informed consent and data collection of baseline information (demographics, medical history, perceptions of pain, and experiences with VR), surveys on pain, Pain interference, fatigue, and affect. The investigators will also help the participant upload the EMA technology onto their personal phone or tablet. Subjects will then be randomly assigned to receive either the 10- minute IVR session first or the 20-minute IVR session first. Visit 1 will take between 45 and 60 minutes.
Multiple Baseline EMA-Remote: Visit 2 will be scheduled 1-2 weeks later. During the time between visits the investigators will use ecological momentary assessment (EMA) technology to collect multiple measures of pain, fatigue and affect. In EMA subjects respond to prompts delivered through their cell phone or tablet ("pings") with documentation of current symptoms. It is a well-recognized method to capture immediate, synchronized experiences in subjects' natural environments. During this data collection period subjects will be "pinged" 3x daily and asked to rate their current levels of pain, fatigue, and affect. Time to complete these responses will be 15 minutes.
Visit 2-In person: pre Survey/Quantitative Sensory Testing (QST); First VR visit; post Survey/QST. The investigators will collect current pain, pain interference, fatigue and affect, and Quantitative Sensory Testing (QST). QST involves cutaneous (skin) psychophysical (semi-subjective) testing to assess sensory and pain perception pathways. QST quantifies the thresholds of detection of stimuli, the perceived intensity, and the temporal summation (changes in perception over multiple applications). These pain testing procedures are widely-accepted, non-invasive, and non-tissue damaging. The investigators will complete two types QST. Mechanical Pressure Pain Thresholds (MPPTh) will be assessed using a digital pressure algometer on the right upper trapezius and right thumb MP joint. Mechanical Temporal Summation of Pain (MTSP) will be assessed using weighted pinprick stimulators. The investigators will apply a train of 10 stimuli at the rate of 1 per second on the middle finger of the right hand, and subjects will rate the painfulness of the first, fifth, and tenth stimulus. All subjects will take part in two VR experiences (10 min and 20 min) for a total of 30-minutes in VR. After each experience subjects will rate their current pain, fatigue, and affect, and the investigators will complete QST. At the end of both sessions the subjects will rate their experiences of immersion using the Igroup Presence Questionaire, engagement using the Use Engagement Scale (UES), and simulation tolerance using the Simulator Sickness Questionnaire (SSQ). The investigators will also ask a series of open-ended questions about the participant's experiences with IVR and participation in the study. These will include questions about their enjoyment, perceptions of pain, and what they liked/did not like about the IVR experience as well as questions about the burden of being in the study. Visit 2 will take 1.5 to 2 hours
Post Visit 2 EMA-Remote: Subjects will complete three more days (72 hours) of 3x a day prompts for pain, fatigue and affect.
Visit 3-In person: pre Survey/Quantitative Sensory Testing (QST); Second VR visit; post Survey/QST
Post Visit 3 EMA-Remote: Subjects will complete 2 more days (48 hours) of 3x a day prompts for pain, fatigue and affect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 10 Minutes/20 Minutes | Experimental | Device: Immersive Virtual RealitySubject takes part in 10 minute VR experience first and 20 minute VR experience second |
| 20 Minutes/10 Minutes | Experimental | Device: Immersive Virtual RealitySubject takes part in 20 minute VR experience first and 10 minute VR experience second |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 20 to 75 years old
- Any Back Pain (including neck pain) that has lasted greater than 3 months due to non-cancer related injury or illness.
Key exclusion criteria (9 listed)
- People with back pain primarily due to rheumatic (e.g. rheumatoid arthritis or fibromyalgia)
- people with back pain due to central neurological disorders (e.g. stroke, multiple sclerosis, spinal cord injury)
- has contagious disorder on the face (such as pink eye) that could be transmitted via the VR head set or has open areas on the face that would come in contact with the headset
- had a seizure, loss of awareness, or other symptom linked to an epileptic condition
- insufficient vision to see IVR programs
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 RealityImmersive Virtual Reality | Device | 10 Minutes/20 Minutes, 20 Minutes/10 Minutes |
Primary outcome
Pain Numerical Rating Scale
Time frame: Change in Pain Intensity from before to immediately after intervention
Pain Intensity - Numerical rating scale 0 to 10 with lower score better score
Mechanical Pressure Pain Thresholds (MPPTh)
Time frame: Median Pre and post intervention sensitivity to pressure scores in kilograms
Sensitivity to pressure will be assessed using a digital pressure algometer on the right upper trapezius and right thumb MP joint. The measures from each site were averaged to obtain an overall mean pressure score for each participant. A lower score indicates a better outcome.
Mechanical Temporal Summation of Pain (MTSP)
Time frame: Change in Sensitivity to pinprick from before to immediately after intervention
Sensitivity to pinprick was assessed using weighted pinprick stimulators. We applied a train of 10 stimuli at the rate of 1 per second on the middle finger of the right hand, and subjects rated the painfulness of the first and tenth stimulus using a 1 to 100 pain intentsity rating scale. We calculated the difference from the 1st stimuus to the 10th stimulus to calculate the sensitivity. A lower change score is a better outcome
2 secondary outcomes
PANAS
Time frame: Change in affect form before immediately after intervention
PROMIS Fatigue
Time frame: Change in fatigue from before to immediately after intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Nancy Baker, ScD principal investigator
Tufts University
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 Chronic Back Pain, run by Tufts 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 2 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: finished, as of the sponsor's last update on 15 Aug 2023. 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?
Yes. Results are posted in the registry (first posted 15 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pain Numerical Rating Scale (time frame: Change in Pain Intensity from before to immediately after intervention). The study lists 3 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 15 Aug 2023.