Chronic PainNCT04609787
Immersive Virtual Reality and Central Sensitization in People With Chronic Pain
A study testing Immersive Virtual Reality in people with Chronic Pain, run by Tufts University at 1 site in United States.
Trial summary
Patients with chronic low back pain from Dr. Robert Edwards' study at the Brigham \& Women's Pain Institute that examines sensory and pain perceptions in patients with chronic pain who use opioids will complete quantitative sensory testing (QST) and current pain levels will be obtained. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Chronic 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
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2021to 1 May 2023
- 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 25-65
- CLBP lasting for more than 6 months as the primary complaint
- Typical pain ratings ≥ 4/10 on a visual analogue scale
- Currently prescribed oral opioid therapy and under consideration for dose reduction by the prescribing clinician.
- able to speak and understand English
Who cannot join
- Evidence of delirium, dementia, psychosis, or other cognitive impairment preventing completion of study procedures
- current (i.e., active) substance use disorder (SUD).
- history of myocardial infarction or other serious cardiovascular condition.
- current peripheral neuropathy.
- current pregnancy, or intention to become pregnant during the study.
- current intrathecal pump
- history of seizures
- history severe motion sickness
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Chestnut Hill, Massachusetts, 02467
About this study
Official title: The Effect of Immersive Virtual Reality on Central Sensitization in People With Chronic Pain: A Proof of Concept Pilot
Patients with chronic low back pain from Dr. Robert Edwards' study at the Brigham \& Women's Pain Institute that examines sensory and pain perceptions in patients with chronic pain who use opioids will complete quantitative sensory testing (QST) and current pain levels will be obtained. Subsequently, 20-minutes of Immersive Virtual Reality (IVR) will be completed and then QST testing will be completed again post-IVR.
Read the detailed description
We will partner with Dr. Robert Edwards at the Brigham \& Women's Pain Institute. Dr. Edward's is an expert in testing central sensitization using quantitative sensory testing (QST).12 QST involves cutaneous (skin) psychophysical (semi-subjective) testing to assess sensory and pain perception pathways.13 QST identifies the intensity of stimuli (touch) is needed to feel something (threshold of detection) and how perception of stimuli changes if it is repeated many times (temporal summation).14 In people with central sensitization, even light intensity of stimulation is perceived as pain and similar intensity stimuli becomes more painful with multiple applications. We hypothesize that people with chronic pain will demonstrate clinically important reductions in the threshold of detection and temporal summation after IVR, which will demonstrate that IVR can affect central sensitization.
We will complete two types of QST testing: Mechanical Pressure Pain Thresholds (MPPTh) to test for threshold of detection, and Mechanical Temporal Summation of Pain (MTSP) to test for temporal summation. In MPPTh we will measure the amount of pressure needed at the shoulder and thumb (body sites that routinely do not have pain in people with low back pain) to elicit a pain report from participants. In MTSP we will apply a train of 10 stimuli (light pinprick) at the rate of 1 per second on the middle finger and have participants rate the painfulness of the first, fifth, and tenth stimulus.
During the study, we will recruit 20 patients with chronic low back pain from Dr. Edwards' study examining sensory and pain perceptions in patients with chronic pain who use opioids. We will complete QST testing and obtain current pain levels. We will complete 20-minutes of IVR, and then complete QST testing again. We will compare pre-IVR MPPTh and MTSP with post IVR levels. We anticipate short term, clinically important decreases in QST levels providing initial confirmation that IVR can positively change central sensitization.
- Conditions
- Chronic Pain
- Being tested
- Immersive Virtual Reality
- Keywords
- Immersive Virtual Reality
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immersive Virtual RealityDevice
Participants are placed in three-dimensional, life-sized computer-generated environments via a computer headset shows potential as a treatment for chronic pain and central sensitization.
| Study group | Role | What they receive |
|---|---|---|
| All participants | Experimental | Quantitative sensory testing will be completed and current pain levels obtained. 20-minutes of immersive virtual reality will be completed, and then complete quantitative sensory testing again. We will compare pre-IVR quantitative sensory testing with post IVR levels. Receives: Device: Immersive Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative sensory testing (QST): Mechanical Pressure Pain Thresholds (MPPTh)
Test for threshold of detection: Measure the amount of pressure needed at the shoulder and thumb (body sites that routinely do not have pain in people with low back pain) to elicit a pain report from participants
Measured: Completed immediately prior to IVR intervention: Approximately 5 minutes
Quantitative sensory testing (QST): Mechanical Pressure Pain Thresholds (MPPTh)
Test for threshold of detection: Measure the amount of pressure needed at the shoulder and thumb (body sites that routinely do not have pain in people with low back pain) to elicit a pain report from participants
Measured: Completed immediately after IVR intervention: Approximately 5 minutes
Quantitative sensory testing (QST): Mechanical Temporal Summation of Pain (MTSP)
Test for temporal summation: Apply a train of 10 stimuli (light pinprick) at the rate of 1 per second on the middle finger and have participants rate the painfulness of the first, fifth, and tenth stimulus.
Measured: Completed immediately prior to IVR intervention: Approximately 5 minutes
Quantitative sensory testing (QST): Mechanical Temporal Summation of Pain (MTSP)
Test for temporal summation: Apply a train of 10 stimuli (light pinprick) at the rate of 1 per second on the middle finger and have participants rate the painfulness of the first, fifth, and tenth stimulus.
Measured: Completed immediately after IVR intervention: Approximately 5 minutes
PANAS
Two scales one for Positive and one for Negative Affect - Score for each scale 10 to 50 with a lower score indicating less of that affect
Measured: Completed immediately prior to IVR intervention
PANAS
Two scales one for Positive and one for Negative Affect - Score for each scale 10 to 50 with a lower score indicating less of that affect
Measured: Completed immediately after IVR intervention
Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2)
Scale examining quality of pain with 22 possible pain related symptoms - Score for each scale 0 - 10; 0 as "none", 10 as "worst possible"
Measured: Completed immediately prior to IVR intervention
Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2)
Scale examining quality of pain with 22 possible pain related symptoms - Score for each scale 0 - 10; 0 as "none", 10 as "worst possible"
Measured: Completed immediately after IVR intervention
Secondary outcomes (2)
Simulator Sickness Questionnaire
Scale examining symptoms related to user experience in IVR. 16 symptoms. Scale of none, slight, moderate, severe
Measured: Completed immediately after IVR experience
IGroup Presence Questionnaire
User immersion measured with 14 questions related to immersion in IVR experience. Scale of 1-7.
Measured: Completed immediately after IVR experience
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start5 Jan 2021
- Primary completion1 May 2023
- Study completion1 May 2023
Why it stopped: COVID prevented acquistion of participants and study funding ended
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
- Not applicable
- Intervention model
- Single group
- Model description
- Pre-IVR MPPTh and MTSP with post IVR levels will be compared.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Responsible party
- Principal investigator, Nancy Baker, Tufts University
- Investigators
- Nancy A Baker, Principal investigator, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04609787
- Sponsor's protocol ID
- 2016P000725
- Status last verified
- Nov 2023
- First submitted
- 23 Oct 2020
- Last updated
- 28 Nov 2023
- Results posted
- No
- 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 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Immersive Virtual Reality on Central Sensitization in People With Chronic Pain: A Proof of Concept Pilot
- ClinicalTrials.gov ID
- NCT04609787
- Acronym / sponsor ID
- 2016P000725
- Conditions
- Chronic Pain
- Keywords
- Immersive Virtual Reality
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID prevented acquistion of participants and study funding ended
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Study start
- 5 Jan 2021 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 30 Oct 2020 (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.
Patients with chronic low back pain from Dr. Robert Edwards' study at the Brigham \& Women's Pain Institute that examines sensory and pain perceptions in patients with chronic pain who use opioids will complete quantitative sensory testing (QST) and current pain levels will be obtained. Subsequently, 20-minutes of Immersive Virtual Reality (IVR) will be completed and then QST testing will be completed again post-IVR.
Detailed description
We will partner with Dr. Robert Edwards at the Brigham \& Women's Pain Institute. Dr. Edward's is an expert in testing central sensitization using quantitative sensory testing (QST).12 QST involves cutaneous (skin) psychophysical (semi-subjective) testing to assess sensory and pain perception pathways.13 QST identifies the intensity of stimuli (touch) is needed to feel something (threshold of detection) and how perception of stimuli changes if it is repeated many times (temporal summation).14 In people with central sensitization, even light intensity of stimulation is perceived as pain and similar intensity stimuli becomes more painful with multiple applications. We hypothesize that people with chronic pain will demonstrate clinically important reductions in the threshold of detection and temporal summation after IVR, which will demonstrate that IVR can affect central sensitization.
We will complete two types of QST testing: Mechanical Pressure Pain Thresholds (MPPTh) to test for threshold of detection, and Mechanical Temporal Summation of Pain (MTSP) to test for temporal summation. In MPPTh we will measure the amount of pressure needed at the shoulder and thumb (body sites that routinely do not have pain in people with low back pain) to elicit a pain report from participants. In MTSP we will apply a train of 10 stimuli (light pinprick) at the rate of 1 per second on the middle finger and have participants rate the painfulness of the first, fifth, and tenth stimulus.
During the study, we will recruit 20 patients with chronic low back pain from Dr. Edwards' study examining sensory and pain perceptions in patients with chronic pain who use opioids. We will complete QST testing and obtain current pain levels. We will complete 20-minutes of IVR, and then complete QST testing again. We will compare pre-IVR MPPTh and MTSP with post IVR levels. We anticipate short term, clinically important decreases in QST levels providing initial confirmation that IVR can positively change central sensitization.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pre-IVR MPPTh and MTSP with post IVR levels will be compared.
| Arm | Type | Receives |
|---|---|---|
| All participants | Experimental | Device: Immersive Virtual RealityQuantitative sensory testing will be completed and current pain levels obtained. 20-minutes of immersive virtual reality will be completed, and then complete quantitative sensory testing again. We will compare pre-IVR quantitative sensory testing with post IVR levels. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 25-65
- CLBP lasting for more than 6 months as the primary complaint
- Typical pain ratings ≥ 4/10 on a visual analogue scale
- Currently prescribed oral opioid therapy and under consideration for dose reduction by the prescribing clinician.
- able to speak and understand English
Key exclusion criteria (8 listed)
- Evidence of delirium, dementia, psychosis, or other cognitive impairment preventing completion of study procedures
- current (i.e., active) substance use disorder (SUD).
- history of myocardial infarction or other serious cardiovascular condition.
- current peripheral neuropathy.
- current pregnancy, or intention to become pregnant during the study.
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 are placed in three-dimensional, life-sized computer-generated environments via a computer headset shows potential as a treatment for chronic pain and central sensitization. | Device | All participants |
Primary outcome
Quantitative sensory testing (QST): Mechanical Pressure Pain Thresholds (MPPTh)
Time frame: Completed immediately prior to IVR intervention: Approximately 5 minutes
Test for threshold of detection: Measure the amount of pressure needed at the shoulder and thumb (body sites that routinely do not have pain in people with low back pain) to elicit a pain report from participants
Quantitative sensory testing (QST): Mechanical Pressure Pain Thresholds (MPPTh)
Time frame: Completed immediately after IVR intervention: Approximately 5 minutes
Test for threshold of detection: Measure the amount of pressure needed at the shoulder and thumb (body sites that routinely do not have pain in people with low back pain) to elicit a pain report from participants
Quantitative sensory testing (QST): Mechanical Temporal Summation of Pain (MTSP)
Time frame: Completed immediately prior to IVR intervention: Approximately 5 minutes
Test for temporal summation: Apply a train of 10 stimuli (light pinprick) at the rate of 1 per second on the middle finger and have participants rate the painfulness of the first, fifth, and tenth stimulus.
Quantitative sensory testing (QST): Mechanical Temporal Summation of Pain (MTSP)
Time frame: Completed immediately after IVR intervention: Approximately 5 minutes
Test for temporal summation: Apply a train of 10 stimuli (light pinprick) at the rate of 1 per second on the middle finger and have participants rate the painfulness of the first, fifth, and tenth stimulus.
PANAS
Time frame: Completed immediately prior to IVR intervention
Two scales one for Positive and one for Negative Affect - Score for each scale 10 to 50 with a lower score indicating less of that affect
PANAS
Time frame: Completed immediately after IVR intervention
Two scales one for Positive and one for Negative Affect - Score for each scale 10 to 50 with a lower score indicating less of that affect
Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2)
Time frame: Completed immediately prior to IVR intervention
Scale examining quality of pain with 22 possible pain related symptoms - Score for each scale 0 - 10; 0 as "none", 10 as "worst possible"
Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2)
Time frame: Completed immediately after IVR intervention
Scale examining quality of pain with 22 possible pain related symptoms - Score for each scale 0 - 10; 0 as "none", 10 as "worst possible"
2 secondary outcomes
Simulator Sickness Questionnaire
Time frame: Completed immediately after IVR experience
IGroup Presence Questionnaire
Time frame: Completed immediately after IVR experience
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 28 Nov 2023.
- 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 A Baker 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 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 5 inclusion and 8 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 28 Nov 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?
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?
Quantitative sensory testing (QST): Mechanical Pressure Pain Thresholds (MPPTh) (time frame: Completed immediately prior to IVR intervention: Approximately 5 minutes). The study lists 8 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 28 Nov 2023.