Clinical trial NCT05285462: Feasibility of Virtual Reality Delivery of Pain Neuroscience Education
Official title: Feasibility of Virtual Reality Delivery of Pain Neuroscience Education
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Belmont University
name: Benchmark Physical Therapy
First posted: 2022-03-17
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Rate of Recruitment
timeFrame: 6 weeks
measure: Adherence
timeFrame: 6 weeks
measure: Acceptability Measures
timeFrame: 6 weeks
Secondary outcomes:
measure: Oswestry Disability Index (ODI
timeFrame: 6 weeks
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: 6 weeks
measure: Pain Self-Efficacy Questionnaire (PSEQ):
timeFrame: 6 weeks
measure: Pain Catastrophizing Scale (PCS)
timeFrame: 6 weeks
measure: Global Rating of Change (GROC
timeFrame: 6 weeks
measure: Neurophysiology of Pain Questionnaire (NPQ)
timeFrame: 6 weeks
measure: Fear Avoidance Beliefs Questionnaire (FABQ)
timeFrame: 6 weeks
measure: Brief Resiliency Scale (BRS):
timeFrame: 6 weeks
measure: Back Beliefs Questionnaire (BBQ):
timeFrame: 6 weeks
measure: Working Alliance Inventory (WAI):
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Belmont University
state: Tennessee
Study officials:
References: