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

NCT04225884 | Completed

• 1 other identifier: 3129002
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Low Back Pain

Outcome Measures

Primary Outcomes (9)

• Self-report of disability, Oswestry

  Oswestry Disability Index (subjects with a score of ≤22 will be considered as responders), index 0%-100% (0=no disability, 100=maximum disability possible).

  From randomisation upto 6-8 weeks

• Self-report of disability; Pain Interference

  The Patient Reported Outcomes Information System (PROMIS) 6b - Pain Interference Scale, score 6-30 (6=pain not at all interfering patient's life, 30=maximum interfering to patient's life).

  From randomisation upto 6-8 weeks

• Objective report of disability, steps

  Average number of steps per day over one week, as assessed by wearable equipment, 0-maximum amount of steps (0=patient not taking steps at all, maximum disability; maximum number of steps=minimum disability).

  From randomisation upto 6-8 weeks

• Fear of movement and re-injury

  Tampa Scale of Kinesiophobia (TSK), score 17-68 (17=negligible or no kinesiophobia,68=extreme fear of pain with movement).

  From randomisation upto 6-8 weeks

• Pain Behaviour, pain intensity

  Numerical Rating Scale, PROMIS 3a - Pain Intensity Scale, score 3-15 (3=no pain,15=very severe pain).

  From randomisation upto 6-8 weeks

• Pain Behaviour, pain medications

  Any changes in pain medication during the study period are reported as outcome.

  From randomisation upto 6-8 weeks

• Quality of life, own experience

  EuroQol-5D-5L-scale: European Quality (EQ) of Life (l), 5-dimension-5-level-scale. a). Descriptive System, 5-dimension-5-level-scale, scores are converted to a value where 1 equals 'perfect health' and 0 equals 'dead'. b). Visual Analogue Score, score 0 to 100 where 100 is the best health you can imagine and 0 = the worst health you can imagine.

  From randomisation upto 6-8 weeks

• Quality of life, adverse events

  Adverse Event reporting, number of adverse events and their severity

  From randomisation upto 6-8 weeks

• Quality of life, change

  Patient Clinical Global Impression of Change (PGIC) results, score 1-7 (1=very much improved, 7=very much worse).

  From randomisation upto 6-8 weeks

Study Arms (3)

DTx for pain

ACTIVE COMPARATOR

Treatment A software

Other: DTx for pain software

Control

SHAM COMPARATOR

Treatment B software

Other: Control software

Standard care

OTHER

Pain medication

Other: Standard care

Interventions

DTx for pain software OTHER

Software with active intervention

DTx for pain

Control software OTHER

Software without active intervention

Control

Standard care OTHER

Pain medication

Standard care

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Orion Corporation, Orion Pharma: lead

Study Sites (1)

CPU Orion Pharma

Espoo, Finland

Location

Related Publications (2)

• Liikkanen S, Makinen M, Huttunen T, Sarapohja T, Stenfors C, Eccleston C. Body movement as a biomarker for use in chronic pain rehabilitation: An embedded analysis of an RCT of a virtual reality solution for adults with chronic pain. Front Pain Res (Lausanne). 2022 Dec 20;3:1085791. doi: 10.3389/fpain.2022.1085791. eCollection 2022.

  PMID: 36606032 DERIVED

• Eccleston C, Fisher E, Liikkanen S, Sarapohja T, Stenfors C, Jaaskelainen SK, Rice ASC, Mattila L, Blom T, Bratty JR. A prospective, double-blind, pilot, randomized, controlled trial of an "embodied" virtual reality intervention for adults with low back pain. Pain. 2022 Sep 1;163(9):1700-1715. doi: 10.1097/j.pain.0000000000002617. Epub 2022 Mar 25.

  PMID: 35324507 DERIVED

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Orion Pharma Clinical Study Director

  Orion Corporation, Orion Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2019
• First Posted: January 13, 2020
• Study Start: February 4, 2020
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: November 8, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)