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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline vs 3 months

Awards & highlights

Study Summary

This trial will compare occupational therapy, a common treatment for chronic low back pain, to a combination of occupational therapy and virtual reality.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Changes from Baseline in average rating of chronic pain at 3 months using Numeric Pain Rating Scale

Secondary outcome measures

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of PittsburghLead Sponsor

1,722 Previous Clinical Trials

16,342,836 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any remaining opportunities to participate in this research trial?

"Yes, the clinicaltrials.gov website has information affirming that this trial is recruiting participants at present. It was first listed on April 18th 2022 and updated most recently on the same date. The study seeks 50 individuals from a single medical location."

Answered by AI

How many participants have been admitted to this clinical trial?

"Affirmative. The clinicaltrials.gov page indicates that this investigation is still recruiting participants, having been first listed on April 18th 2022 and most recently updated on the same date. This medical trial seeks to enlist 50 individuals from a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Virtual Reality, Debriefing and Chronic Pain

Ajay Wasan, MD, Msc 2022. "Virtual Reality, Debriefing and Chronic Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05254509.

All > American Chronic Pain > Chronic Pain