Back to resultsVirtual Reality, Debriefing and Chronic Pain
Primary Purpose
Chronic Pain
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Occupational Therapy
Occupational Therapy +Virtual Reality
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring chronic pain, virtual reality, Occupational therapy, debriefing, self-efficacy, fear of movement
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
Sites / Locations
- UPMC Centers for Rehab Services Centre CommonsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Occupational Therapy (OT)
Occupational Therapy + Virtual Reality (OT+VR)
Arm Description
Subjects in this treatment group will receive outpatient occupational therapy geared towards people with chronic pain conditions. After obtaining consent, an occupational therapist will meet with the participant to begin their occupational therapy sessions targeted for those who have chronic pain. Additionally, subjects will complete online surveys administered by the therapist before and after each therapy session. There is a total of six 1-hour visits during the 3-month study duration involving occupational therapy. They will also receive online surveys every two weeks and will be asked to complete them at home.
Subjects in this treatment group will receive outpatient occupational therapy intervention geared towards people with chronic pain conditions followed by active, immersive virtual reality sessions. Participants in this treatment group will have 10-30minutes of usual care while receiving 10-30 minutes of virtual reality (e.g. exercises, games, and activities in the virtual world) during each study visit. Subjects will complete online surveys before and after each virtual reality session, along with debriefing from a therapist after each VR session to review what happened and why. Debriefing will include questions to obtain thoughts and narrative information about the participant's experience, as well as overall take-aways from the session. The therapist and subject will also watch a video recording of the subject's VR experience as a method to provide them feedback on their performance. Subjects will receive online surveys every two weeks and will be asked to complete them at home.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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".
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.
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.
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.
Full Information
NCT ID
NCT05254509
First Posted
February 23, 2022
Last Updated
March 22, 2023
Sponsor
University of Pittsburgh
1. Study Identification
Unique Protocol Identification Number
NCT05254509
Brief Title
Virtual Reality, Debriefing and Chronic Pain
Official Title
The Effects of Virtual Reality With Debriefing on Patients With Chronic Pain
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 18, 2022 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
chronic pain, virtual reality, Occupational therapy, debriefing, self-efficacy, fear of movement
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Occupational Therapy (OT)
Arm Type
Active Comparator
Arm Description
Subjects in this treatment group will receive outpatient occupational therapy geared towards people with chronic pain conditions. After obtaining consent, an occupational therapist will meet with the participant to begin their occupational therapy sessions targeted for those who have chronic pain. Additionally, subjects will complete online surveys administered by the therapist before and after each therapy session. There is a total of six 1-hour visits during the 3-month study duration involving occupational therapy. They will also receive online surveys every two weeks and will be asked to complete them at home.
Arm Title
Occupational Therapy + Virtual Reality (OT+VR)
Arm Type
Experimental
Arm Description
Subjects in this treatment group will receive outpatient occupational therapy intervention geared towards people with chronic pain conditions followed by active, immersive virtual reality sessions. Participants in this treatment group will have 10-30minutes of usual care while receiving 10-30 minutes of virtual reality (e.g. exercises, games, and activities in the virtual world) during each study visit. Subjects will complete online surveys before and after each virtual reality session, along with debriefing from a therapist after each VR session to review what happened and why. Debriefing will include questions to obtain thoughts and narrative information about the participant's experience, as well as overall take-aways from the session. The therapist and subject will also watch a video recording of the subject's VR experience as a method to provide them feedback on their performance. Subjects will receive online surveys every two weeks and will be asked to complete them at home.
Intervention Type
Other
Intervention Name(s)
Occupational Therapy
Other Intervention Name(s)
OT
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Occupational Therapy +Virtual Reality
Other Intervention Name(s)
OT+VR
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes from Baseline in average rating of chronic pain at 3 months using Numeric Pain Rating Scale
Description
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.
Time Frame
Baseline vs 3 months
Secondary Outcome Measure Information:
Title
Change from Baseline self-efficacy using Pain Self Efficacy Questionnaire (PSEQ).
Description
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".
Time Frame
Baseline vs 3 months
Title
Change from Baseline fear of movement using the Tampa Scale of Kinesiophobia (TSK).
Description
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.
Time Frame
Baseline vs 3 months
Title
Change from Baseline Pain Intensity at 3 months using PROMIS-29
Description
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.
Time Frame
Baseline vs 3 months
Title
Change from Baseline participation and scaling at 3 months using Goal Attainment Scale (GAS)
Description
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.
Time Frame
Baseline vs 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Caitlin Mickles
Phone
4126652903
Email
cem218@pitt.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Megan Driscoll
Phone
4126658035
Email
driscollme@upmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ajay Wasan, MD,MSc
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
UPMC Centers for Rehab Services Centre Commons
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15206
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Megan Driscoll
Phone
412-665-8035
Email
driscollme@upmc.edu
First Name & Middle Initial & Last Name & Degree
Caitlin Mickles
Phone
4126652903
Email
cem218@pitt.edu
First Name & Middle Initial & Last Name & Degree
Ajay Wasan, MD, MSc
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Virtual Reality, Debriefing and Chronic Pain
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