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Feasibility of Virtual Reality Delivery of Pain Neuroscience Education

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VR Pain Education
Usual Care Physical Therapy
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

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

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Belmont University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Usual Care PT

Usual Care PT + VR Pain Education

Arm Description

Patients will attend normal course of PT without influence from study team.

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

Outcomes

Primary Outcome Measures

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.
Adherence
Number of visits completed, number of VR modules completed.
Acceptability Measures
Patient satisfaction and acceptability of VR-delivered PNE.

Secondary Outcome Measures

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).
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).
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).
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.
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.
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.
Fear Avoidance Beliefs Questionnaire (FABQ)
is used to assess fear and avoidance beliefs related to physical activity (FABQ-PA) and work activity (FABQ-W).
Brief Resiliency Scale (BRS):
a measure of a person's ability to bounce back or recover from stress.
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)
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)

Full Information

First Posted
March 8, 2022
Last Updated
February 1, 2023
Sponsor
University of Utah
Collaborators
Belmont University, Benchmark Physical Therapy
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1. Study Identification

Unique Protocol Identification Number
NCT05285462
Brief Title
Feasibility of Virtual Reality Delivery of Pain Neuroscience Education
Official Title
Feasibility of Virtual Reality Delivery of Pain Neuroscience Education
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
March 9, 2022 (Actual)
Primary Completion Date
September 9, 2022 (Actual)
Study Completion Date
September 9, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
Collaborators
Belmont University, Benchmark Physical Therapy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Usual Care PT
Arm Type
Active Comparator
Arm Description
Patients will attend normal course of PT without influence from study team.
Arm Title
Usual Care PT + VR Pain Education
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
VR Pain Education
Intervention Description
pain education delivered via VR headset, up to 12 sessions
Intervention Type
Behavioral
Intervention Name(s)
Usual Care Physical Therapy
Intervention Description
Normal course of PT without influence by study team on frequency or duration
Primary Outcome Measure Information:
Title
Rate of Recruitment
Description
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.
Time Frame
6 weeks
Title
Adherence
Description
Number of visits completed, number of VR modules completed.
Time Frame
6 weeks
Title
Acceptability Measures
Description
Patient satisfaction and acceptability of VR-delivered PNE.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Oswestry Disability Index (ODI
Description
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).
Time Frame
6 weeks
Title
Numeric Pain Rating Scale (NPRS)
Description
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).
Time Frame
6 weeks
Title
Pain Self-Efficacy Questionnaire (PSEQ):
Description
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).
Time Frame
6 weeks
Title
Pain Catastrophizing Scale (PCS)
Description
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.
Time Frame
6 weeks
Title
Global Rating of Change (GROC
Description
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.
Time Frame
6 weeks
Title
Neurophysiology of Pain Questionnaire (NPQ)
Description
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.
Time Frame
6 weeks
Title
Fear Avoidance Beliefs Questionnaire (FABQ)
Description
is used to assess fear and avoidance beliefs related to physical activity (FABQ-PA) and work activity (FABQ-W).
Time Frame
6 weeks
Title
Brief Resiliency Scale (BRS):
Description
a measure of a person's ability to bounce back or recover from stress.
Time Frame
6 weeks
Title
Back Beliefs Questionnaire (BBQ):
Description
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)
Time Frame
6 weeks
Title
Working Alliance Inventory (WAI):
Description
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)
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Belmont University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Feasibility of Virtual Reality Delivery of Pain Neuroscience Education

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