Feasibility of Virtual Reality Delivery of Pain Neuroscience Education

University of Utah52 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Low Back Pain

Interventions

VR Pain EducationBEHAVIORAL

pain education delivered via VR headset, up to 12 sessions

Usual Care Physical TherapyBEHAVIORAL

Normal course of PT without influence by study team on frequency or duration

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Belmont University

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

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.

Time frame: 6 weeks

Adherence

Number of visits completed, number of VR modules completed.

Time frame: 6 weeks

Acceptability Measures

Patient satisfaction and acceptability of VR-delivered PNE.

Time frame: 6 weeks

Secondary Outcomes

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).

Time frame: 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).

Time frame: 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).

Time frame: 6 weeks

Data from ClinicalTrials.gov

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