Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04307446 |
| Other study ID # |
STUDY00000192 |
| Secondary ID |
UL1TR002544 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2021 |
| Est. completion date |
May 31, 2023 |
Study information
| Verified date |
August 2023 |
| Source |
Tufts University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
