What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Occupational therapy for chronic pain, which involves physical and mental exercises, typically has minimal side effects but may cause temporary increases in pain or discomfort as patients adapt to new activities. Virtual reality, used to distract from pain and enhance engagement, is generally safe but can sometimes lead to dizziness, nausea, or motion sickness. Both treatments avoid the side effects associated with pharmacologic interventions, such as gastrointestinal issues or dependency.

What prior FDA approvals exist?

The FDA has approved various treatments for chronic pain that align with the principles of occupational therapy and virtual reality. These include non-pharmacologic interventions such as spinal cord stimulation devices, which provide electrical impulses to the spinal cord to reduce pain perception, and transcutaneous electrical nerve stimulation (TENS) units, which use electrical currents to relieve pain. Additionally, the FDA has cleared several digital health technologies and mobile applications designed to support pain management through cognitive-behavioral therapy and other therapeutic exercises. While specific FDA approvals for virtual reality in pain management are still emerging, the growing body of evidence supports its potential as an adjunctive treatment for chronic pain.

What other types of research exist?

Promising, novel alternatives to Occupational Therapy and Virtual Reality for chronic pain patients include: 1) Mindfulness-Based Practices (e.g., meditation, mindfulness-based stress reduction) which help in managing pain by shifting cognitions and creating a desirable emotional state; 2) Music Therapy, which has been shown to improve psychological and physical outcomes; 3) Acupuncture/Acupressure, which can provide pain relief and improve overall well-being; 4) Cognitive Behavioral Therapy (CBT), which helps in altering pain perception and improving coping strategies; and 5) Integrative Movement Therapies (e.g., yoga, tai chi), which combine physical activity with mindfulness to reduce pain and improve function.

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Occupational Therapy + Virtual Reality for Chronic Pain

N/A

Waitlist Available

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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline vs 3 months

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 2Eligibility criteria met

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.