Immersive Virtual Reality and Central Sensitization in People With Chronic Pain

NCT04609787 | Withdrawn FDA Device

• 1 other identifier: 2016P000725
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with chronic low back pain from Dr. Robert Edwards' study at the Brigham \& Women's Pain Institute that examines sensory and pain perceptions in patients with chronic pain who use opioids will complete quantitative sensory testing (QST) and current pain levels will be obtained. Subsequently, 20-minutes of Immersive Virtual Reality (IVR) will be completed and then QST testing will be completed again post-IVR.

Conditions

Chronic Pain

Keywords

Immersive Virtual Reality

Outcome Measures

Primary Outcomes (8)

• Quantitative sensory testing (QST): Mechanical Pressure Pain Thresholds (MPPTh)

  Test for threshold of detection: Measure the amount of pressure needed at the shoulder and thumb (body sites that routinely do not have pain in people with low back pain) to elicit a pain report from participants

  Completed immediately prior to IVR intervention: Approximately 5 minutes

• Quantitative sensory testing (QST): Mechanical Pressure Pain Thresholds (MPPTh)

  Test for threshold of detection: Measure the amount of pressure needed at the shoulder and thumb (body sites that routinely do not have pain in people with low back pain) to elicit a pain report from participants

  Completed immediately after IVR intervention: Approximately 5 minutes

• Quantitative sensory testing (QST): Mechanical Temporal Summation of Pain (MTSP)

  Test for temporal summation: Apply a train of 10 stimuli (light pinprick) at the rate of 1 per second on the middle finger and have participants rate the painfulness of the first, fifth, and tenth stimulus.

  Completed immediately prior to IVR intervention: Approximately 5 minutes

• Quantitative sensory testing (QST): Mechanical Temporal Summation of Pain (MTSP)

  Test for temporal summation: Apply a train of 10 stimuli (light pinprick) at the rate of 1 per second on the middle finger and have participants rate the painfulness of the first, fifth, and tenth stimulus.

  Completed immediately after IVR intervention: Approximately 5 minutes

• PANAS

  Two scales one for Positive and one for Negative Affect - Score for each scale 10 to 50 with a lower score indicating less of that affect

  Completed immediately prior to IVR intervention

• PANAS

  Two scales one for Positive and one for Negative Affect - Score for each scale 10 to 50 with a lower score indicating less of that affect

  Completed immediately after IVR intervention

• Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2)

  Scale examining quality of pain with 22 possible pain related symptoms - Score for each scale 0 - 10; 0 as "none", 10 as "worst possible"

  Completed immediately prior to IVR intervention

• Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2)

  Scale examining quality of pain with 22 possible pain related symptoms - Score for each scale 0 - 10; 0 as "none", 10 as "worst possible"

  Completed immediately after IVR intervention

Secondary Outcomes (2)

• Simulator Sickness Questionnaire

  Completed immediately after IVR experience

• IGroup Presence Questionnaire

  Completed immediately after IVR experience

Study Arms (1)

All participants

EXPERIMENTAL

Quantitative sensory testing will be completed and current pain levels obtained. 20-minutes of immersive virtual reality will be completed, and then complete quantitative sensory testing again. We will compare pre-IVR quantitative sensory testing with post IVR levels.

Device: Immersive Virtual Reality

Interventions

Immersive Virtual Reality DEVICE

Participants are placed in three-dimensional, life-sized computer-generated environments via a computer headset shows potential as a treatment for chronic pain and central sensitization.

All participants

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 25-65
• CLBP lasting for more than 6 months as the primary complaint
• Typical pain ratings ≥ 4/10 on a visual analogue scale
• Currently prescribed oral opioid therapy and under consideration for dose reduction by the prescribing clinician.
• able to speak and understand English

You may not qualify if:

• Evidence of delirium, dementia, psychosis, or other cognitive impairment preventing completion of study procedures
• current (i.e., active) substance use disorder (SUD).
• history of myocardial infarction or other serious cardiovascular condition.
• current peripheral neuropathy.
• current pregnancy, or intention to become pregnant during the study.
• current intrathecal pump
• history of seizures
• history severe motion sickness

Sponsors & Collaborators

• Tufts University: lead
• Brigham and Women's Hospital: collaborator

Study Sites (1)

Brigham and Women's Hospital

Chestnut Hill, Massachusetts, 02467, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nancy A Baker

  Tufts University

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Pre-IVR MPPTh and MTSP with post IVR levels will be compared.

Study Record Dates

• First Submitted: October 23, 2020
• First Posted: October 30, 2020
• Study Start: January 5, 2021
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: November 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)