Feasibility of Virtual Reality Delivery of Pain Neuroscience Education

Low Back Pain Clinical Trial

Official title:

Feasibility of Virtual Reality Delivery of Pain Neuroscience Education

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05285462
• Other study ID #: IRB_00145358
• Status: Completed
• Phase: N/A
• Start date: March 9, 2022
• Est. completion date: September 9, 2022

Study information

• Verified date: February 2023
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: September 9, 2022
• Est. primary completion date: September 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Low Back Pain

Intervention

Behavioral:
• VR Pain Education
pain education delivered via VR headset, up to 12 sessions
• Usual Care Physical Therapy
Normal course of PT without influence by study team on frequency or duration

Locations

Country	Name	City	State
United States	Belmont University	Nashville	Tennessee

Sponsors (3)

Lead Sponsor	Collaborator
University of Utah	Belmont University, Benchmark Physical Therapy

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Adherence	Number of visits completed, number of VR modules completed.	6 weeks
Primary	Acceptability Measures	Patient satisfaction and acceptability of VR-delivered PNE.	6 weeks
Secondary	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 (a=0.85). Discrimination of all the items is high to perfect (1.08-2.01).	6 weeks
Secondary	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).	6 weeks
Secondary	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).	6 weeks
Secondary	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.	6 weeks
Secondary	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.	6 weeks
Secondary	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.	6 weeks
Secondary	Fear Avoidance Beliefs Questionnaire (FABQ)	is used to assess fear and avoidance beliefs related to physical activity (FABQ-PA) and work activity (FABQ-W).	6 weeks
Secondary	Brief Resiliency Scale (BRS):	a measure of a person's ability to bounce back or recover from stress.	6 weeks
Secondary	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)	6 weeks
Secondary	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)	6 weeks