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Immersive Virtual Reality and Central Sensitization in People With Chronic Pain

Primary Purpose

Chronic Pain

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Immersive Virtual Reality
Sponsored by
Tufts University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring Immersive Virtual Reality

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 25-65
  2. CLBP lasting for more than 6 months as the primary complaint
  3. Typical pain ratings ≥ 4/10 on a visual analogue scale
  4. Currently prescribed oral opioid therapy and under consideration for dose reduction by the prescribing clinician.
  5. able to speak and understand English

Exclusion Criteria:

  1. Evidence of delirium, dementia, psychosis, or other cognitive impairment preventing completion of study procedures
  2. current (i.e., active) substance use disorder (SUD).
  3. history of myocardial infarction or other serious cardiovascular condition.
  4. current peripheral neuropathy.
  5. current pregnancy, or intention to become pregnant during the study.
  6. current intrathecal pump
  7. history of seizures
  8. history severe motion sickness

Sites / Locations

  • Brigham and Women's HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All participants

Arm Description

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.

Outcomes

Primary Outcome Measures

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
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
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.
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.
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
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
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"
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"

Secondary Outcome Measures

Simulator Sickness Questionnaire
Scale examining symptoms related to user experience in IVR. 16 symptoms. Scale of none, slight, moderate, severe
IGroup Presence Questionnaire
User immersion measured with 14 questions related to immersion in IVR experience. Scale of 1-7.

Full Information

First Posted
October 23, 2020
Last Updated
December 1, 2022
Sponsor
Tufts University
Collaborators
Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04609787
Brief Title
Immersive Virtual Reality and Central Sensitization in People With Chronic Pain
Official Title
The Effect of Immersive Virtual Reality on Central Sensitization in People With Chronic Pain: A Proof of Concept Pilot
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 5, 2021 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tufts University
Collaborators
Brigham and Women's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Immersive Virtual Reality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Pre-IVR MPPTh and MTSP with post IVR levels will be compared.
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
All participants
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Immersive Virtual Reality
Intervention Description
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.
Primary Outcome Measure Information:
Title
Quantitative sensory testing (QST): Mechanical Pressure Pain Thresholds (MPPTh)
Description
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
Time Frame
Completed immediately prior to IVR intervention: Approximately 5 minutes
Title
Quantitative sensory testing (QST): Mechanical Pressure Pain Thresholds (MPPTh)
Description
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
Time Frame
Completed immediately after IVR intervention: Approximately 5 minutes
Title
Quantitative sensory testing (QST): Mechanical Temporal Summation of Pain (MTSP)
Description
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.
Time Frame
Completed immediately prior to IVR intervention: Approximately 5 minutes
Title
Quantitative sensory testing (QST): Mechanical Temporal Summation of Pain (MTSP)
Description
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.
Time Frame
Completed immediately after IVR intervention: Approximately 5 minutes
Title
PANAS
Description
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
Time Frame
Completed immediately prior to IVR intervention
Title
PANAS
Description
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
Time Frame
Completed immediately after IVR intervention
Title
Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2)
Description
Scale examining quality of pain with 22 possible pain related symptoms - Score for each scale 0 - 10; 0 as "none", 10 as "worst possible"
Time Frame
Completed immediately prior to IVR intervention
Title
Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2)
Description
Scale examining quality of pain with 22 possible pain related symptoms - Score for each scale 0 - 10; 0 as "none", 10 as "worst possible"
Time Frame
Completed immediately after IVR intervention
Secondary Outcome Measure Information:
Title
Simulator Sickness Questionnaire
Description
Scale examining symptoms related to user experience in IVR. 16 symptoms. Scale of none, slight, moderate, severe
Time Frame
Completed immediately after IVR experience
Title
IGroup Presence Questionnaire
Description
User immersion measured with 14 questions related to immersion in IVR experience. Scale of 1-7.
Time Frame
Completed immediately after IVR experience

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nancy A Baker
Phone
617 627-5562
Email
Nancy.Baker@Tufts.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Augusta H Polhemus
Phone
412 328-8622
Email
augusta.polhemus@tufts.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy A Baker
Organizational Affiliation
Tufts University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Chestnut Hill
State/Province
Massachusetts
ZIP/Postal Code
02467
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marise Cornelius
Phone
617-732-9463
Email
mcornelius@bwh.harvard.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Immersive Virtual Reality and Central Sensitization in People With Chronic Pain

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