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Immersive Virtual Reality and Chronic Back Pain

Primary Purpose

Chronic Back Pain

Status
Completed
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 Back Pain

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 20 to 75 years old
  2. Any Back Pain (including neck pain) that has lasted greater than 3 months due to non-cancer related injury or illness.

Exclusion Criteria:

  1. People with back pain primarily due to rheumatic (e.g. rheumatoid arthritis or fibromyalgia)
  2. people with back pain due to central neurological disorders (e.g. stroke, multiple sclerosis, spinal cord injury)
  3. 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
  4. had a seizure, loss of awareness, or other symptom linked to an epileptic condition
  5. insufficient vision to see IVR programs
  6. insufficient upper extremity coordination to operate IVR controls
  7. insufficient cognitive ability to answer questionnaires or learn to use the IVR
  8. unable to understand and respond to English
  9. Does not own a cell phone or tablet for baseline and follow-up EMA testing.

Sites / Locations

  • Tufts Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

10 Minutes/20 Minutes

20 Minutes/10 Minutes

Arm Description

Subject takes part in 10 minute VR experience first and 20 minute VR experience second

Subject takes part in 20 minute VR experience first and 10 minute VR experience second

Outcomes

Primary Outcome Measures

Pain Numerical Rating Scale
Pain Intensity - Numerical rating scale 0 to 10 with lower score better score
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.
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

Secondary Outcome Measures

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
PROMIS Fatigue
Fatigue on a scale of 0 to 28 with a lower score indicating less frequent experiences of fatigue

Full Information

First Posted
March 10, 2020
Last Updated
August 11, 2023
Sponsor
Tufts University
Collaborators
Tufts Clinical and Translational Science Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04307446
Brief Title
Immersive Virtual Reality and Chronic Back Pain
Official Title
The Feasibility of Immersive Virtual Reality as a Treatment for Chronic Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
July 6, 2022 (Actual)
Study Completion Date
May 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tufts University
Collaborators
Tufts Clinical and Translational Science Institute

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.
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
10 Minutes/20 Minutes
Arm Type
Experimental
Arm Description
Subject takes part in 10 minute VR experience first and 20 minute VR experience second
Arm Title
20 Minutes/10 Minutes
Arm Type
Experimental
Arm Description
Subject takes part in 20 minute VR experience first and 10 minute VR experience second
Intervention Type
Device
Intervention Name(s)
Immersive Virtual Reality
Intervention Description
Immersive Virtual Reality
Primary Outcome Measure Information:
Title
Pain Numerical Rating Scale
Description
Pain Intensity - Numerical rating scale 0 to 10 with lower score better score
Time Frame
Change in Pain Intensity from before to immediately after intervention
Title
Mechanical Pressure Pain Thresholds (MPPTh)
Description
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.
Time Frame
Median Pre and post intervention sensitivity to pressure scores in kilograms
Title
Mechanical Temporal Summation of Pain (MTSP)
Description
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
Time Frame
Change in Sensitivity to pinprick from before to immediately after intervention
Secondary Outcome Measure Information:
Title
PANAS
Description
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
Time Frame
Change in affect form before immediately after intervention
Title
PROMIS Fatigue
Description
Fatigue on a scale of 0 to 28 with a lower score indicating less frequent experiences of fatigue
Time Frame
Change in fatigue from before to immediately after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy Baker, ScD
Organizational Affiliation
Tufts University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Immersive Virtual Reality and Chronic Back Pain

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