Virtual Reality, Debriefing and Chronic Pain

Chronic Pain Clinical Trial

Official title:

The Effects of Virtual Reality With Debriefing on Patients With Chronic Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05254509
• Other study ID #: STUDY21110066
• Status: Recruiting
• Phase: N/A
• Start date: April 18, 2022
• Est. completion date: August 31, 2024

Study information

• Verified date: December 2023
• Source: University of Pittsburgh
• Contact: Kunal Lohana
• Phone: 4126652903
• Email: KUL31[@]pitt.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Other:
• Occupational Therapy
Occupational therapy helps individuals with chronic pain to participate in daily activities in an adaptive way. The subjects will be provided with customized plans and objectives to address their self-care, vocational, and leisure goals. This includes education, home exercises, stress management, home safety, energy conservation, and work simplification - all of which promote a safe return to daily activities.
• Occupational Therapy +Virtual Reality
The occupational therapy +VR utilizes the regular therapy sessions along with providing a Virtual reality headset to relieve pain. After each VR session, there will be a debriefing from the therapist.

Locations

Country	Name	City	State
United States	UPMC Centers for Rehab Services Centre Commons	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes from Baseline in average rating of chronic pain at 3 months using Numeric Pain Rating Scale	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.	Baseline vs 3 months
Secondary	Change from Baseline self-efficacy using Pain Self Efficacy Questionnaire (PSEQ).	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".	Baseline vs 3 months
Secondary	Change from Baseline fear of movement using the Tampa Scale of Kinesiophobia (TSK).	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.	Baseline vs 3 months
Secondary	Change from Baseline Pain Intensity at 3 months using PROMIS-29	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.	Baseline vs 3 months
Secondary	Change from Baseline participation and scaling at 3 months using Goal Attainment Scale (GAS)	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.	Baseline vs 3 months