Virtual Reality, Debriefing and Chronic Pain

NCT ID: NCT05254509

Last Updated: 2025-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-18
• Study Completion Date: 2023-09-13

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.

Conditions

Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Occupational Therapy (OT)

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.

Group Type: ACTIVE_COMPARATOR

Occupational Therapy

Intervention Type: OTHER

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 (OT+VR)

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.

Group Type: EXPERIMENTAL

Occupational Therapy +Virtual Reality

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Other Intervention Names

OT; OT+VR

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Ajay Wasan, MD, Msc

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ajay Wasan, MD,MSc

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

UPMC Centers for Rehab Services Centre Commons

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

STUDY21110066

Identifier Type: -

Identifier Source: org_study_id