Immersive Virtual Reality and Chronic Back Pain

NCT04307446 | Completed Results FDA Device

• 2 other identifiers: STUDY00000192UL1TR002544
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

In the proposed project the investigators will evaluate the feasibility of Immersive Virtual Reality (IVR) and assess the initial effects of IVR on symptoms, affect, and tolerance to cutaneous stimuli. In this single-arm trial, the investigators will recruit 20 adults with CBP. Prior to their IVR experience, subjects will complete multiday baseline assessments using ecological momentary assessment (EMA) methodology to establish typical levels of symptoms and affect. Afterward, in a single experimental session, they will participate in two counterbalanced IVR sessions: one 10-minute and one 20-minute. Immediately after each session the investigators will measure current symptoms and affect using valid and reliable self-report questionnaires, and we will measure changes in tolerance to cutaneous stimuli using quantitative sensory testing. We will measure symptoms and affect for 72 hours after the experimental session using EMA to determine if there is a carryover. At the completion of this study, we will continue to work with stakeholders to develop clinically relevant IVR interventions for people with CBP.

Conditions

Chronic Back Pain

Outcome Measures

Primary Outcomes (3)

• Pain Numerical Rating Scale

  Pain Intensity - Numerical rating scale 0 to 10 with lower score better score

  Change in Pain Intensity from before to immediately after intervention

• Mechanical Pressure Pain Thresholds (MPPTh)

  Sensitivity to pressure will be assessed using a digital pressure algometer on the right upper trapezius and right thumb MP joint. The measures from each site were averaged to obtain an overall mean pressure score for each participant. A lower score indicates a better outcome.

  Median Pre and post intervention sensitivity to pressure scores in kilograms

• Mechanical Temporal Summation of Pain (MTSP)

  Sensitivity to pinprick was assessed using weighted pinprick stimulators. We applied a train of 10 stimuli at the rate of 1 per second on the middle finger of the right hand, and subjects rated the painfulness of the first and tenth stimulus using a 1 to 100 pain intentsity rating scale. We calculated the difference from the 1st stimuus to the 10th stimulus to calculate the sensitivity. A lower change score is a better outcome

  Change in Sensitivity to pinprick from before to immediately after intervention

Secondary Outcomes (2)

• PANAS

  Change in affect form before immediately after intervention

• PROMIS Fatigue

  Change in fatigue from before to immediately after intervention

Study Arms (2)

10 Minutes/20 Minutes

EXPERIMENTAL

Subject takes part in 10 minute VR experience first and 20 minute VR experience second

Device: Immersive Virtual Reality

20 Minutes/10 Minutes

EXPERIMENTAL

Subject takes part in 20 minute VR experience first and 10 minute VR experience second

Device: Immersive Virtual Reality

Interventions

Immersive Virtual Reality DEVICE

Immersive Virtual Reality

10 Minutes/20 Minutes; 20 Minutes/10 Minutes

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 75 years old
• Any Back Pain (including neck pain) that has lasted greater than 3 months due to non-cancer related injury or illness.

You may not qualify if:

• People with back pain primarily due to rheumatic (e.g. rheumatoid arthritis or fibromyalgia)
• people with back pain due to central neurological disorders (e.g. stroke, multiple sclerosis, spinal cord injury)
• has contagious disorder on the face (such as pink eye) that could be transmitted via the VR head set or has open areas on the face that would come in contact with the headset
• had a seizure, loss of awareness, or other symptom linked to an epileptic condition
• insufficient vision to see IVR programs
• insufficient upper extremity coordination to operate IVR controls
• insufficient cognitive ability to answer questionnaires or learn to use the IVR
• unable to understand and respond to English
• Does not own a cell phone or tablet for baseline and follow-up EMA testing.

Sponsors & Collaborators

• Tufts University: lead

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Results Point of Contact

• Title: Nancy Baker
• Organization: Tufts University

nancy.baker@tufts.edu

617 627 5562

Study Officials

• Nancy Baker, ScD

  Tufts University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: March 10, 2020
• First Posted: March 13, 2020
• Study Start: May 1, 2021
• Primary Completion: July 6, 2022
• Study Completion: May 31, 2023
• Last Updated: August 15, 2023
• Results First Posted: August 15, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)