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Occupational Therapy + Virtual Reality for Chronic Pain

N/A
Recruiting
Led By Ajay Wasan, MD,MSc
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ages 18 and older
Be older than 18 years old
Must not have
Had a seizure, loss of awareness, or other symptom linked to an epileptic condition
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline vs 3 months
Awards & highlights

Summary

This trial is testing whether traditional occupational therapy or a combination of occupational therapy and virtual reality is better for treating chronic low back pain. Occupational therapy helps patients manage daily activities and improve physical function. Virtual reality uses a headset to immerse patients in a 3D world, which can distract them from their pain and help them move more normally. The study aims to see if virtual reality can provide lasting pain relief. Virtual reality has been shown to help reduce pain intensity, minimize fall risk, and improve quality of life in elderly women with chronic low back pain.

Who is the study for?
This trial is for adults over 18 with chronic low back pain who are referred for occupational therapy at UPMC Centre Commons. It's not suitable for those with epilepsy, recent VR intervention, sensory impairments, facial skin infections, pacemakers/defibrillators, poor arm coordination or cognitive ability to use VR as assessed by the investigator, or if they have ASD or can't understand/respond in English.
What is being tested?
The study aims to compare two treatments: standard occupational therapy and a combination of occupational therapy with virtual reality (VR), to see which is more effective in managing chronic low back pain.
What are the potential side effects?
Potential side effects may include discomfort from wearing the VR headset, motion sickness from the virtual environment, eye strain or headache. The risks associated with standard occupational therapy are minimal but could include muscle soreness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have experienced seizures or loss of awareness due to epilepsy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline vs 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline vs 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Changes from Baseline in average rating of chronic pain at 3 months using Numeric Pain Rating Scale
Secondary study objectives
Change from Baseline Pain Intensity at 3 months using PROMIS-29
Change from Baseline fear of movement using the Tampa Scale of Kinesiophobia (TSK).
Change from Baseline participation and scaling at 3 months using Goal Attainment Scale (GAS)
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Occupational Therapy + Virtual Reality (OT+VR)Experimental Treatment1 Intervention
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 II: Occupational Therapy (OT)Active Control1 Intervention
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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for chronic pain include psychological interventions, exercise therapy, and integrative/complementary therapies. Psychological interventions, such as cognitive behavioral therapy, work by altering pain perception and improving coping strategies. Exercise therapy helps by improving physical function and reducing pain through movement and strengthening exercises. Integrative therapies, like mindfulness and acupuncture, aim to reduce pain by promoting relaxation and altering pain pathways. Occupational therapy focuses on improving daily functioning and reducing pain through tailored physical and mental exercises. Virtual reality (VR) provides immersive experiences that distract from pain and enhance engagement in therapeutic activities. These treatments are crucial for chronic pain patients as they offer non-pharmacological options that can improve quality of life, reduce reliance on medications, and address both physical and psychological aspects of pain.
Virtual reality hand therapy: A new tool for nonopioid analgesia for acute procedural pain, hand rehabilitation, and VR embodiment therapy for phantom limb pain.[Use of Virtual Reality as a Component of Acute and Chronic Pain Treatment].Virtual Reality interventions for acute and chronic pain management.

Find a Location

Who is running the clinical trial?

University of PittsburghLead Sponsor
1,762 Previous Clinical Trials
16,347,903 Total Patients Enrolled
16 Trials studying Chronic Pain
128,916 Patients Enrolled for Chronic Pain
Ajay Wasan, MD,MScPrincipal InvestigatorUniversity of Pittsburgh
Megan DriscollPrincipal InvestigatorUPMC Centers for Rehab Services

Media Library

Occupational Therapy Clinical Trial Eligibility Overview. Trial Name: NCT05254509 — N/A
~29 spots leftby Sep 2025
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