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Completed

NCT Number: NCT05254509

Virtual Reality, Debriefing and Chronic Pain

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UPMC Centers for Rehab Services Centre Commons

Pittsburgh, Pennsylvania, 15206, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: 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.

Other names: OT+VR

Primary outcomes

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

    Time frame: Baseline vs 3 months

    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.

Secondary outcomes

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

    Time frame: Baseline vs 3 months

    Change from Baseline Pain Self Efficacy at 3 months using Pain Self Efficacy Questionnaire (PSEQ). The questionnaire will assess how confident a person feels despite the pain with 10 questions ranked on a 7-point scale, from "0 = not at all confident" to "6 = Completely confident".

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

    Time frame: Baseline vs 3 months

    The Tampa Scale of Kinesiophobia (TSK) questionnaire will assess fear of movement with 17 questions ranked on a 1-4 scale, from "1 = Strongly disagree" to the "4 = Strongly agree." Lower scores suggest lower fear of movement.

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

    Time frame: Baseline vs 3 months

    The PROMIS Numeric Rating Scale v2.0 questionnaire will assess how much a person hurts with a question ranked on a 11-point scale, from "0 = no pain" to "10 = worst imaginable pain." The minimum raw summed score is 0 and the maximum score is 10. Lower raw response scores suggest lower pain intensity and better outcomes.

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

    Time frame: Baseline vs 3 months

    The Goal Attainment Scale will assess the response to participation based on a 5 point scale ranging from "+2 = MUCH more than expected" to "-2 = MUCH less than expected".HIgher scores suggest higher response to participation.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Official study title

The Effects of Virtual Reality With Debriefing on Patients With Chronic Pain

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 24, 2022
Registry last updated
Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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