Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04777877 |
| Other study ID # |
2021P000203 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 18, 2021 |
| Est. completion date |
August 31, 2022 |
Study information
| Verified date |
April 2023 |
| Source |
Spaulding Rehabilitation Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The primary objective of this study is to explore the feasibility and acceptability of the
delivery of educational content using a virtual reality headset in the setting of an
outpatient physical therapy (PT) course of care for chronic low back pain. We aim to collect
both qualitative and quantitative data regarding: 1) specifics of device use in the course of
PT care 2) acceptability of both the content and delivery method from the therapist and
subject perspective 3) subject attributes to characterize the study population and explore
possible associations with content responses and 4) changes in pain knowledge from pre to
post intervention. Information learned in this pilot study will assist us in 1) improving the
content and delivery method of a chronic pain education program 2) implementing the program
across the Spaulding rehabilitation network and 3) designing a more rigorous effectiveness
trial.
Description:
Study staff physical therapists will identify potential subjects upon completion of a
standard physical therapy evaluation on patients referred for low back pain. Spaulding
Outpatient sites in Malden, Quincy YMCA and Charlestown will participate.
- Inclusion criteria: 1) pain lasting > 3 months and 2) > 18 years of age
- Exclusion criteria: 1) inability to understand and communicate in English 2) inability
to provide informed consent Individuals who meet the inclusion/exclusion criteria will
receive an information study sheet, the full consent form for reference, and hear a
brief explanation of the study from the treating study staff physical therapist. It will
be emphasized that study participation is completely voluntary and refusal to
participate will in no way impact their care at that clinic site or other MGB facilities
either now or in the future.
SUBJECT ENROLLMENT
Once an eligible subject is identified, the evaluating study staff physical therapist will
briefly introduce the study and provide the study information sheet and full consent form for
review. Interested individuals will be contacted by phone by study staff. Study staff
obtaining consent will discuss the details of the study with the individual using the full
consent form and study information sheet as a guide and will cover all of the required
elements of informed consent, including the purpose of the research, the study procedures,
risks and benefits associated with participation, and answer study-related questions.
Subjects will be advised that their clinical care will not be affected in any way if they
decide to participate or decline participation, and that participation can be discontinued at
any time. The principal investigator's and consenting study staff's contact information will
be provided on the information sheet and consent form, and other study staff will provide
their contact information as appropriate. The study will be explained in detail and the
individual will be given the chance to ask any questions. Informed consent will be obtained
verbally over the phone due to the minimal study risk, low study burden, and the necessity of
limiting in-person contact. Study staff will document verbal consent by electronically
signing a copy of the IRB approved telephone information consent document which will be
electronically stored in a protected Dropbox file that only study staff will have access to.
Paper consent forms will not be stored. A copy will be securely emailed via Outlook to the
treating study staff physical therapist. This copy will be printed and provided to the
subject in-person by the treating study staff physical therapist at the subject's next
scheduled physical therapy visit.
Due to the minimal risk involved, informed consent may be given with less than 12 hours of
notice, or they may be given additional time to consider.
STUDY PROCEDURES
Study staff physical therapists will be informed of enrollment. Once enrolled, subjects will
complete the Keele STarT back questionnaire and a pain knowledge check. The pain education
content will be delivered via the Oculus Go virtual reality (VR) headset at the beginning or
end of the subjects scheduled PT appointments. There will be no added costs for content
delivery and no additional study visits will be required outside of the regularly scheduled
PT visits. Upon completing the pain education series, subjects will complete a feedback
survey and a post-pain knowledge check. Study staff physical therapists will complete a
survey for each enrolled subject.
Additionally, demographic information will be collected from the Epic electronic health
record (EHR) such as: age, gender, educational level, relevant past medical history, results
of relevant images, and pertinent physical therapy evaluation and treatment information that
is standard of care for this patient population. This information will be used to
characterize the study sample and begin to identify important attributes that may have more
relevance regarding the response to the content.
