Virtual Reality, Debriefing and Chronic Pain

Not Applicable

Completed

• Conditions: Chronic Pain

• Registration Number: NCT05254509
• Lead Sponsor: University of Pittsburgh

Brief Summary

This study will determine if occupational therapy or the combination of occupational therapy and virtual reality is the better treatment for chronic low back pain (CLBP)patients.

Detailed Description

Chronic musculoskeletal pain is defined as persistent or recurrent pain lasting more than 3 months. Chronic pain is a complex and disabling physiological and psychosocial disorder that does not provide an adaptive or protective purpose. In chronic pain, the precipitating event (e.g., fracture, sprain, trauma) is healed, and yet excessive pain remains. In Immersive Virtual Reality (IVR) people experience a three-dimensional, computer-generated environment via a computer headset. IVR has been used to treat acute pain, but there have been few focused studies on the effects of IVR on chronic pain. When people with chronic pain are in IVR, they become unaware of their body and tend to move normally. We would like to test to see if IVR has a lasting effect in this study. Thus, IVR has strong potential as an additional tool in an arsenal of treatments for chronic pain. This study will examine if IVR can reduce pain and other symptoms in people with chronic pain.

Study Timeline

• Study First Submitted: 2022-02-23
• Study First Submitted QC: 2022-02-23
• Study First Posted: 2022-02-24
• Study Start: 2022-04-18
• Primary Completion: 2023-09-13
• Study Completion: 2023-09-13
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-09
• Last Update Posted: 2025-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Ages 18 and older
• Referred for chronic pain occupational therapy services at the UPMC Centers for Rehab Services Centre Commons site.

Exclusion Criteria

• Had a seizure, loss of awareness, or other symptom linked to an epileptic condition
• Had virtual reality intervention within the last 3 months
• Has sensory insensitivity such as hearing loss or low vision, as assessed by the PI
• Has contagious disorder on the face, such as pink eye, that could be transmitted via the VR headset or has open areas on the face that would come in contact with the headset
• Has a pacemaker or defibrillator
• Insufficient upper extremity coordination to operate IVR controls, as assessed by the PI
• Insufficient cognitive ability to answer questionnaires or learn to use the IVR, as assessed by the PI
• Have a diagnosis of ASD (Autism Spectrum Disorder) or unable to understand and/or respond in English

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes from Baseline in average rating of chronic pain at 3 months using Numeric Pain Rating Scale	Baseline vs 3 months	Numeric Pain Rating questionnaire will assess how much a person hurts with a question ranked on a 11-point scale, from "0 = no pain" to "10 = worst pain imaginable." The minimum raw summed score is 0 and the maximum score is 10. Lower raw response scores suggest lower pain intensity and better outcomes.

Secondary Outcome Measures

Name	Time	Method
Change from Baseline Pain Intensity at 3 months using PROMIS-29	Baseline vs 3 months	The PROMIS Numeric Rating Scale v2.0 questionnaire will assess how much a person hurts with a question ranked on a 11-point scale, from "0 = no pain" to "10 = worst imaginable pain." The minimum raw summed score is 0 and the maximum score is 10. Lower raw response scores suggest lower pain intensity and better outcomes.
Change from Baseline participation and scaling at 3 months using Goal Attainment Scale (GAS)	Baseline vs 3 months	The Goal Attainment Scale will assess the response to participation based on a 5 point scale ranging from "+2 = MUCH more than expected" to "-2 = MUCH less than expected".HIgher scores suggest higher response to participation.
Change from Baseline self-efficacy using Pain Self Efficacy Questionnaire (PSEQ).	Baseline vs 3 months	Change from Baseline Pain Self Efficacy at 3 months using Pain Self Efficacy Questionnaire (PSEQ). The questionnaire will assess how confident a person feels despite the pain with 10 questions ranked on a 7-point scale, from "0 = not at all confident" to "6 = Completely confident".
Change from Baseline fear of movement using the Tampa Scale of Kinesiophobia (TSK).	Baseline vs 3 months	The Tampa Scale of Kinesiophobia (TSK) questionnaire will assess fear of movement with 17 questions ranked on a 1-4 scale, from "1 = Strongly disagree" to the "4 = Strongly agree." Lower scores suggest lower fear of movement.

Trial Locations

Locations (1)

UPMC Centers for Rehab Services Centre Commons; 🇺🇸 Pittsburgh, Pennsylvania, United States