Digital Therapeutics (DTx) for Pain: Pilot Study of a Virtual Reality Software for Chronic Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-04

Study Completion Date

2023-10-31

Brief Summary

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Prospective, randomised, double-blind, 3-arm parallel group comparison of 2 different virtual reality softwares and standard care.

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Detailed Description

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Prospective, randomised, double-blind, 3-arm parallel group comparison of DTx for pain (treatment A), control (treatment B) and an open standard care arm, over 6-8 weeks. An optional adaptive, multi-objective, multi-purpose, extension is included. Study devices will be delivered to the patient's home with instructions for use; patients will receive remote technical support.

Conditions

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Chronic Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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DTx for pain

Treatment A software

Group Type ACTIVE_COMPARATOR

DTx for pain software

Intervention Type OTHER

Software with active intervention

Control

Treatment B software

Group Type SHAM_COMPARATOR

Control software

Intervention Type OTHER

Software without active intervention

Standard care

Pain medication

Group Type OTHER

Standard care

Intervention Type OTHER

Pain medication

Interventions

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DTx for pain software

Software with active intervention

Intervention Type OTHER

Control software

Software without active intervention

Intervention Type OTHER

Standard care

Pain medication

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Competent male or female adults (age ≥ 18 years).
* Chronic low back pain
* Written informed consent
* Finnish speaking
* having a clear, flat surface of at least 2 x 2 m of size to interact with DTx for pain
* Can stoop without severe pain

Exclusion Criteria

* History of epilepsy, migraine, vertigo or psychosis
* Confirmed diagnosis of cancer
* Prone to strong motion sickness requiring treatment
* Pregnancy
* Physiotherapy based interventions contraindicated
* Severe or acute structural pathologies (e.g. spondylitis, epidural abscess, spondylolisthesis, acute herniated or ruptured disc, traumatic injury, or severe spinal stenosis) that could be worsened by the intervention as assessed by the principal investigator
* Has received (in last 2 years) or is receiving formal psychotherapy from a psychologist for pain or allied health care professional at the screening stage
* Any other condition that would affect posture or balance, and
* Prior participation in DTx for pain feasibility study or in any part of the current study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No