Virtual Reality, Debriefing and Chronic Pain

NCT05254509 | Completed

• 1 other identifier: STUDY21110066
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Keywords

chronic pain; virtual reality; Occupational therapy; debriefing; self-efficacy; fear of movement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change from Baseline self-efficacy using Pain Self Efficacy Questionnaire (PSEQ).

  Baseline vs 3 months

• Change from Baseline fear of movement using the Tampa Scale of Kinesiophobia (TSK).

  Baseline vs 3 months

• Change from Baseline Pain Intensity at 3 months using PROMIS-29

  Baseline vs 3 months

• Change from Baseline participation and scaling at 3 months using Goal Attainment Scale (GAS)

  Baseline vs 3 months

Study Arms (2)

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.

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.

Other: Occupational Therapy +Virtual Reality

Interventions

Occupational Therapy 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.

Also known as: OT

Occupational Therapy (OT)

Occupational Therapy +Virtual Reality 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.

Also known as: OT+VR

Occupational Therapy + Virtual Reality (OT+VR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 18 and older
• Referred for chronic pain occupational therapy services at the UPMC Centers for Rehab Services Centre Commons site.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

UPMC Centers for Rehab Services Centre Commons

Pittsburgh, Pennsylvania, 15206, United States

Location

MeSH Terms

Conditions

Chronic Pain; Kinesiophobia

Interventions

Occupational Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Phobic Disorders; Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Ajay Wasan, MD,MSc

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: February 24, 2022
• Study Start: April 18, 2022
• Primary Completion: September 13, 2023
• Study Completion: September 13, 2023
• Last Updated: February 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)