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Completed

NCT Number: NCT05285462

Feasibility of Virtual Reality Delivery of Pain Neuroscience Education

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Belmont University

Nashville, Tennessee, 37212, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VR Pain Education

Behavioral

pain education delivered via VR headset, up to 12 sessions

Usual Care Physical Therapy

Behavioral

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

Primary outcomes

  1. 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.

  2. Adherence

    Time frame: 6 weeks

    Number of visits completed, number of VR modules completed.

  3. Acceptability Measures

    Time frame: 6 weeks

    Patient satisfaction and acceptability of VR-delivered PNE.

Secondary outcomes

  1. Oswestry Disability Index (ODI

    Time frame: 6 weeks

    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).

  2. Numeric Pain Rating Scale (NPRS)

    Time frame: 6 weeks

    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).

  3. Pain Self-Efficacy Questionnaire (PSEQ):

    Time frame: 6 weeks

    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).

  4. Pain Catastrophizing Scale (PCS)

    Time frame: 6 weeks

    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.

  5. Global Rating of Change (GROC

    Time frame: 6 weeks

    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.

  6. Neurophysiology of Pain Questionnaire (NPQ)

    Time frame: 6 weeks

    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.

  7. Fear Avoidance Beliefs Questionnaire (FABQ)

    Time frame: 6 weeks

    is used to assess fear and avoidance beliefs related to physical activity (FABQ-PA) and work activity (FABQ-W).

  8. Brief Resiliency Scale (BRS):

    Time frame: 6 weeks

    a measure of a person's ability to bounce back or recover from stress.

  9. Back Beliefs Questionnaire (BBQ):

    Time frame: 6 weeks

    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)

  10. Working Alliance Inventory (WAI):

    Time frame: 6 weeks

    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)

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • Belmont University
  • Benchmark Physical Therapy

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 17, 2022
Registry last updated
Feb 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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