Low Back PainNCT05285462
Feasibility of Virtual Reality Delivery of Pain Neuroscience Education
A study testing VR Pain Education in people with Low Back Pain, run by University of Utah at 1 site in United States.
Trial summary
Randomized Clinical Trail (RCT) for patients already planned to attend physical therapy for chronic low back pain. Patients will be randomized to receive Physical Therapy (PT) as usual or PT plus pain education delivered via virtual-reality headset. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- VR Pain Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2022to 9 Sep 2022
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- i. Age 18-75 at time of first physical therapy session ii. Primary reason for physical therapy is low back pain iii. History of low back pain >/= 12 weeks
Who cannot join
- i. Age >75y/o or <18 y/o ii. Red flag condition that prohibits participation in physical therapy:
- Systemic metabolic disorder
- Neurological or muscular degenerative disorder (including Epilepsy)
- Systemic infection
- Cardiopulmonary or pulmonary disorder with contraindication to physical exercise iii. Recent spinal surgery (<12 months) iv. Specific spinal pathologies, such as severe stenosis or spondylolisthesis or fracture v. Acute radiculopathy or compromised nerve root vi. Currently known to be pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Randomized Clinical Trail (RCT) for patients already planned to attend physical therapy for chronic low back pain. Patients will be randomized to receive Physical Therapy (PT) as usual or PT plus pain education delivered via virtual-reality headset.
Read the detailed description
There is an increasing emphasis in physical therapy and healthcare in general on enhancing patients' ability to self-manage spinal pain as a strategy to reduce disability for impacted individuals and escalating healthcare costs. This change in emphasis requires a paradigm shift on the part of practitioners and patients alike in how they conceptualize and respond to pain. PNE is a promising education strategy that has been shown to influence patient-reported outcomes in those with chronic pain and has been shown to influence the provider's beliefs about pain. However, the delivery of this education has proven difficult for providers in terms of comfortability and time-efficiency. A standardized delivery a PNE by experts in the field could prove efficient and effective.
STUDY DESIGN The investigators' overall goal is to determine the feasibility of VR-delivered pain neuroscience education (PNE). Secondarily, the investigators would like to see if these interventions are best targeted to specific individuals. To accomplish these goals, the investigators will conduct a randomized clinical trial, randomly assigning participants to receive virtual reality (VR) education in addition to usual care or usual care with no additional education.
- Conditions
- Low Back Pain
- Being tested
- VR Pain Education, Usual Care Physical Therapy
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR Pain EducationBehavioural
pain education delivered via VR headset, up to 12 sessions
Usual Care Physical TherapyBehavioural
Normal course of PT without influence by study team on frequency or duration
| Study group | Role | What they receive |
|---|---|---|
| Usual Care PT | Active comparator | Patients will attend normal course of PT without influence from study team. Receives: Behavioral: Usual Care Physical Therapy |
| Usual Care PT + VR Pain Education | Experimental | Patients will attend normal course of PT without influence of duration or frequency of care. Patients will also receive up to 12 session of pain education delivered via VR headset Receives: Behavioral: VR Pain Education; Behavioral: Usual Care Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Recruitment
Count of all potentially eligible subjects (count kept by office coordinators of patients offered the study); count of those determined eligible by research team; count of those that choose to consent. Reasons for no contact or choosing not to enroll will be collected when able.
Measured: 6 weeks
Adherence
Number of visits completed, number of VR modules completed.
Measured: 6 weeks
Acceptability Measures
Patient satisfaction and acceptability of VR-delivered PNE.
Measured: 6 weeks
Secondary outcomes (10)
Oswestry Disability Index (ODI
Patient-completed questionnaire which gives a subjective percentage score of level of function (disability) in activities of daily living in those rehabilitating from low back pain. The ODI shows good internal consistency (α=0.85). Discrimination of all the items is high to perfect (1.08-2.01).
Measured: 6 weeks
Numeric Pain Rating Scale (NPRS)
ranges from 0 (no pain) to 10 (worst imaginable pain) as a measure of pain intensity. The NPRS has excellent test retest reliability for LBP (0.61) and neck pain (0.76).
Measured: 6 weeks
Pain Self-Efficacy Questionnaire (PSEQ):
quantifies an individual's confidence in performing activities despite pain. The PSEQ contains 10 items ranked from 0 ("not at all confident") to 7 ("completely confident"). The PSEQ has high validity when compared with measures of coping (r=0.48) and pain beliefs (r=0.74) and excellent test-retest reliability (0.73).
Measured: 6 weeks
Pain Catastrophizing Scale (PCS)
is used to quantify the catastrophic thoughts regarding pain. Scores range from 0 to 52, with higher scores indicating higher levels of pain catastrophizing. The PCS was found to be highly reliable (chronbach alpha=0.75 to 0.86) and have good criterion-related, concurrent, and discriminant validity.
Measured: 6 weeks
Global Rating of Change (GROC
is used to gain the patient's perceived progress of their condition since the beginning of physical therapy. The GROC ranges from +7 (a very great deal better to 0 (about the same) to) -7(a great deal worse). The GROC is a valid measure of measuring a patient's perceived change in quality of life.
Measured: 6 weeks
Neurophysiology of Pain Questionnaire (NPQ)
is used to gain information regarding the how the patient conceptualizes the origins of his/her pain. This this tool to has acceptable internal consistency and test-retest reliability.
Measured: 6 weeks
Fear Avoidance Beliefs Questionnaire (FABQ)
is used to assess fear and avoidance beliefs related to physical activity (FABQ-PA) and work activity (FABQ-W).
Measured: 6 weeks
Brief Resiliency Scale (BRS):
a measure of a person's ability to bounce back or recover from stress.
Measured: 6 weeks
Back Beliefs Questionnaire (BBQ):
measure patient's attitudes and beliefs towards recovery and return-to-work; and expectations regarding the negative circumstances that could be created as a result of low back pain (LBP)
Measured: 6 weeks
Working Alliance Inventory (WAI):
measure of the therapeutic alliance that assesses three key aspects of the therapeutic alliance: (a) agreement on the tasks of therapy, (b) agreement on the goals of therapy and (c) development of an affective bond. We will be using the short-form version. (Hatcher 2006)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start9 Mar 2022
- Primary completion9 Sep 2022
- Study completion9 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Belmont University, Benchmark Physical Therapy
- Responsible party
- Principal investigator, Elizabeth Lane, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05285462
- Sponsor's protocol ID
- IRB_00145358
- Status last verified
- Feb 2023
- First submitted
- 8 Mar 2022
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Virtual Reality Delivery of Pain Neuroscience Education
- ClinicalTrials.gov ID
- NCT05285462
- Acronym / sponsor ID
- IRB_00145358
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Belmont University, Benchmark Physical Therapy
- Study start
- 9 Mar 2022 (actual)
- Primary completion
- 9 Sep 2022 (actual)
- Study completion
- 9 Sep 2022 (actual)
- First posted
- 17 Mar 2022 (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.
Randomized Clinical Trail (RCT) for patients already planned to attend physical therapy for chronic low back pain. Patients will be randomized to receive Physical Therapy (PT) as usual or PT plus pain education delivered via virtual-reality headset.
Detailed description
There is an increasing emphasis in physical therapy and healthcare in general on enhancing patients' ability to self-manage spinal pain as a strategy to reduce disability for impacted individuals and escalating healthcare costs. This change in emphasis requires a paradigm shift on the part of practitioners and patients alike in how they conceptualize and respond to pain. PNE is a promising education strategy that has been shown to influence patient-reported outcomes in those with chronic pain and has been shown to influence the provider's beliefs about pain. However, the delivery of this education has proven difficult for providers in terms of comfortability and time-efficiency. A standardized delivery a PNE by experts in the field could prove efficient and effective.
STUDY DESIGN The investigators' overall goal is to determine the feasibility of VR-delivered pain neuroscience education (PNE). Secondarily, the investigators would like to see if these interventions are best targeted to specific individuals. To accomplish these goals, the investigators will conduct a randomized clinical trial, randomly assigning participants to receive virtual reality (VR) education in addition to usual care or usual care with no additional education.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care PT | Active comparator | Behavioral: Usual Care Physical TherapyPatients will attend normal course of PT without influence from study team. |
| Usual Care PT + VR Pain Education | Experimental | Behavioral: VR Pain Education, Behavioral: Usual Care Physical TherapyPatients will attend normal course of PT without influence of duration or frequency of care. Patients will also receive up to 12 session of pain education delivered via VR headset |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- i. Age 18-75 at time of first physical therapy session ii. Primary reason for physical therapy is low back pain iii. History of low back pain >/= 12 weeks
Key exclusion criteria (5 listed)
- i. Age >75y/o or <18 y/o ii. Red flag condition that prohibits participation in physical therapy:
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 |
|---|---|---|
| VR Pain Educationpain education delivered via VR headset, up to 12 sessions | Behavioural | Usual Care PT + VR Pain Education |
| Usual Care Physical TherapyNormal course of PT without influence by study team on frequency or duration | Behavioural | Usual Care PT, Usual Care PT + VR Pain Education |
Primary outcome
Rate of Recruitment
Time frame: 6 weeks
Count of all potentially eligible subjects (count kept by office coordinators of patients offered the study); count of those determined eligible by research team; count of those that choose to consent. Reasons for no contact or choosing not to enroll will be collected when able.
Adherence
Time frame: 6 weeks
Number of visits completed, number of VR modules completed.
Acceptability Measures
Time frame: 6 weeks
Patient satisfaction and acceptability of VR-delivered PNE.
10 secondary outcomes
Oswestry Disability Index (ODI
Time frame: 6 weeks
Numeric Pain Rating Scale (NPRS)
Time frame: 6 weeks
Pain Self-Efficacy Questionnaire (PSEQ):
Time frame: 6 weeks
Pain Catastrophizing Scale (PCS)
Time frame: 6 weeks
Global Rating of Change (GROC
Time frame: 6 weeks
Neurophysiology of Pain Questionnaire (NPQ)
Time frame: 6 weeks
Fear Avoidance Beliefs Questionnaire (FABQ)
Time frame: 6 weeks
Brief Resiliency Scale (BRS):
Time frame: 6 weeks
Back Beliefs Questionnaire (BBQ):
Time frame: 6 weeks
Working Alliance Inventory (WAI):
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR Pain Education in people with Low Back Pain, run by University of Utah 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 1 inclusion and 5 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: finished, as of the sponsor's last update on 2 Feb 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of Recruitment (time frame: 6 weeks). The study lists 3 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 2 Feb 2023.