Chronic PainNCT05254509
Virtual Reality, Debriefing and Chronic Pain
A study testing Occupational Therapy and Occupational Therapy +Virtual Reality in people with Chronic Pain, run by University of Pittsburgh at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Occupational Therapy and Occupational Therapy +Virtual Reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2022to 13 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 18 and older
- Referred for chronic pain occupational therapy services at the UPMC Centers for Rehab Services Centre Commons site.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Centers for Rehab Services Centre Commons
Pittsburgh, Pennsylvania, 15206
About this study
Official title: The Effects of Virtual Reality With Debriefing on Patients With Chronic Pain
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.
Read the 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.
- Conditions
- Chronic Pain
- Being tested
- Occupational Therapy, Occupational Therapy +Virtual Reality
- Keywords
- chronic pain, virtual reality, Occupational therapy, debriefing, self-efficacy, fear of movement
- Medical subject headings
- Chronic Pain, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occupational TherapyOther
Also called OT
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 RealityOther
Also called OT+VR
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.
| Study group | Role | What they receive |
|---|---|---|
| Occupational Therapy (OT) | Active comparator | 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. Receives: Other: Occupational Therapy |
| Occupational Therapy + Virtual Reality (OT+VR) | Experimental | 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. Receives: Other: Occupational Therapy +Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline vs 3 months
Secondary outcomes (4)
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".
Measured: Baseline vs 3 months
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.
Measured: Baseline vs 3 months
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.
Measured: Baseline vs 3 months
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.
Measured: Baseline vs 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start18 Apr 2022
- Primary completion13 Sep 2023
- Study completion13 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ajay Wasan, MD, Msc, University of Pittsburgh
- Investigators
- Ajay Wasan, MD,MSc, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05254509
- Sponsor's protocol ID
- STUDY21110066
- Status last verified
- Feb 2025
- First submitted
- 23 Feb 2022
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Virtual Reality With Debriefing on Patients With Chronic Pain
- ClinicalTrials.gov ID
- NCT05254509
- Acronym / sponsor ID
- STUDY21110066
- Conditions
- Chronic Pain
- Keywords
- chronic pain, virtual reality, Occupational therapy, debriefing, self-efficacy, fear of movement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 18 Apr 2022 (actual)
- Primary completion
- 13 Sep 2023 (actual)
- Study completion
- 13 Sep 2023 (actual)
- First posted
- 24 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Occupational Therapy (OT) | Active comparator | Other: Occupational TherapySubjects 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. |
| Occupational Therapy + Virtual Reality (OT+VR) | Experimental | Other: Occupational Therapy +Virtual RealitySubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ages 18 and older
- Referred for chronic pain occupational therapy services at the UPMC Centers for Rehab Services Centre Commons site.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Occupational TherapyAlso: OTOccupational 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. | Other | Occupational Therapy (OT) |
| Occupational Therapy +Virtual RealityAlso: OT+VRThe 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. | Other | Occupational Therapy + Virtual Reality (OT+VR) |
Primary outcome
Changes from Baseline in average rating of chronic pain at 3 months using Numeric Pain Rating Scale
Time frame: 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.
4 secondary outcomes
Change from Baseline self-efficacy using Pain Self Efficacy Questionnaire (PSEQ).
Time frame: Baseline vs 3 months
Change from Baseline fear of movement using the Tampa Scale of Kinesiophobia (TSK).
Time frame: Baseline vs 3 months
Change from Baseline Pain Intensity at 3 months using PROMIS-29
Time frame: Baseline vs 3 months
Change from Baseline participation and scaling at 3 months using Goal Attainment Scale (GAS)
Time frame: Baseline vs 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ajay Wasan, MD,MSc principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Occupational Therapy and Occupational Therapy +Virtual Reality in people with Chronic Pain, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from Baseline in average rating of chronic pain at 3 months using Numeric Pain Rating Scale (time frame: Baseline vs 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2025; AzTrials last refreshed its copy on 31 Oct 2026.