Feasibility of Virtual Reality Delivery of Pain Neuroscience Education

NCT05285462 | Completed

• 1 other identifier: IRB_00145358
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (3)

• 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.

  6 weeks

• Adherence

  Number of visits completed, number of VR modules completed.

  6 weeks

• Acceptability Measures

  Patient satisfaction and acceptability of VR-delivered PNE.

  6 weeks

Secondary Outcomes (10)

• Oswestry Disability Index (ODI

  6 weeks

• Numeric Pain Rating Scale (NPRS)

  6 weeks

• Pain Self-Efficacy Questionnaire (PSEQ):

  6 weeks

• Pain Catastrophizing Scale (PCS)

  6 weeks

• Global Rating of Change (GROC

  6 weeks

Study Arms (2)

Usual Care PT

ACTIVE COMPARATOR

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

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

Behavioral: VR Pain Education; Behavioral: Usual Care Physical Therapy

Interventions

VR Pain Education BEHAVIORAL

pain education delivered via VR headset, up to 12 sessions

Usual Care PT + VR Pain Education

Usual Care Physical Therapy BEHAVIORAL

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

Usual Care PT; Usual Care PT + VR Pain Education

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead
• Belmont University: collaborator
• Benchmark Physical Therapy: collaborator

Study Sites (1)

Belmont University

Nashville, Tennessee, 37212, United States

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Investigator

Study Record Dates

• First Submitted: March 8, 2022
• First Posted: March 17, 2022
• Study Start: March 9, 2022
• Primary Completion: September 9, 2022
• Study Completion: September 9, 2022
• Last Updated: February 2, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)