Clinical trial NCT05254509: Virtual Reality, Debriefing and Chronic Pain
Official title: The Effects of Virtual Reality With Debriefing on Patients With Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: chronic pain
virtual reality
Occupational therapy
debriefing
self-efficacy
fear of movement
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2022-02-24
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes from Baseline in average rating of chronic pain at 3 months using Numeric Pain Rating Scale
timeFrame: Baseline vs 3 months
Secondary outcomes:
measure: Change from Baseline self-efficacy using Pain Self Efficacy Questionnaire (PSEQ).
timeFrame: Baseline vs 3 months
measure: Change from Baseline fear of movement using the Tampa Scale of Kinesiophobia (TSK).
timeFrame: Baseline vs 3 months
measure: Change from Baseline Pain Intensity at 3 months using PROMIS-29
timeFrame: Baseline vs 3 months
measure: Change from Baseline participation and scaling at 3 months using Goal Attainment Scale (GAS)
timeFrame: Baseline vs 3 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Centers for Rehab Services Centre Commons
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Ajay Wasan, MD,MSc
role: PRINCIPAL_INVESTIGATOR
References: