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The Efficacy, Acceptability, Tolerability and Feasibility of a Therapeutic Virtual Reality Application (PijnVRij)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04042090
Recruitment Status : Recruiting
First Posted : August 1, 2019
Last Update Posted : August 4, 2020
Sponsor:
Collaborator:
Rijnstate Hospital
Information provided by (Responsible Party):
Radboud University

Brief Summary:
This study evaluates the effect of therapeutic Virtual Reality (VR) on quality of life of 60 patients with non-specific chronic low-back pain. 30 patients will be included in the intervention group. These patients will use Reducept, a therapeutic virtual reality application based on diverse cognitive therapies (ACT, mindfulness, EMDR, hypnotherapy), at home over a period of 28 days, for at least 10 minutes each day. This will be an add-on intervention next to standard care, while the patient is waiting to receive actual treatment for chronic pain. 30 patients in the control group will only receive standard care, whilst waiting to receive actual treatment for their chronic pain. Intervention and control group will be compared on a number of outcome measures related to quality of life before using VR, during VR use, just after use and 4 months after final use. This explorative study is necessary to get first insights as a basis for a confirmative study.

Condition or disease Intervention/treatment Phase
Back Pain Lower Back Chronic Quality of Life Device: Reducept, virtual reality (Oculus Go) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomly assigned (1:1) to either the intervention group or the control group. Both intervention and control group are placed on the waiting list (approximate time of waiting is 6 weeks) to receive treatment. Meanwhile, our study will be executed. Intervention group: use of virtual reality intervention at home over a period of 28 days (with a maximum of 35 days) at least ten minutes a day (excluding day 1, in which the participants should do the entire education module of 25 minutes) and in addition, when participants feel the need. The control group: no intervention, patient is waiting to receive normal chronic pain treatment. Randomisation is not blinded: both researchers and participants know which participants are part of the intervention and control group. Randomisation will take place using a computerised randomisation list with variably sized blocks, directly after providing oral informed consent.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study on the Efficacy, Acceptability, Tolerability and Feasibility of a Therapeutic Virtual Reality Application on Improving the Quality of Life in Non-specific Chronic Low-back Pain Patients
Actual Study Start Date : December 10, 2019
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: Intervention group: use of therapeutic virtual reality
Intervention group: use of virtual reality intervention at home over a period of 28 days (with a maximum of 35 days) at least ten minutes a day (excluding day 1, in which the participants should do the entire education module of 25 minutes) and in addition, when participants feel the need. Meanwhile, participant is placed on the waiting list to receive normal chronic pain treatment.
Device: Reducept, virtual reality (Oculus Go)
The VR serious game Reducept is a novel psychological VR intervention for treating chronic pain. It incorporates several psychological therapies into one application: hypnotherapy, mindfulness, ACT and EMDR. Reducept has been made in co-creation with patients, researchers, psychologists and developers and can be installed and played on the VR goggles Oculus Go. It consists of an education module and three games.

No Intervention: Control group: no use of therapeutic virtual reality
Control group: no intervention, patient is waiting to receive normal chronic pain treatment.



Primary Outcome Measures :
  1. Change in SF12: short form health survey [ Time Frame: Day 0, day 28, day 148 ]
    Measurement of changes in quality of life of patient before intervention, just after intervention period and 4 months after intervention period. SF12 measures via different scaled questions eight concepts: physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health. The first four items together form the physical health scale. The latter four items form the mental health scale. The higher the scores, the better the physical and mental health. Highest possible score: 56. Lowest possible score: 12.


Secondary Outcome Measures :
  1. Change in positive health questionnaire [ Time Frame: Day 0, day 28, day 148 ]
    Measurement of changes in the positive health framework (a questionnaire and conversation tool for understanding health in a larger context) before intervention period, just after the intervention period and four months after the intervention period. Positive health consists out of 42 statements separated in 6 categories: bodily functioning, mental functioning, spiritual dimension, quality of life, social participation, daily functioning. Each question should be rated with a 0 (worst) to a 10 (best). The higher the scores, the better the quality of life.

  2. Change in pain via numeric rating score [ Time Frame: Day 0, day 28, day 148 ]
    Measurement of changes in pain scores of patient before intervention period, just after intervention period and 4 months after intervention period. Pain scores are measured via a numeric rating score from 0 (no pain at all)-10 (worst pain ever). Questionnaire consists out of 4 questions, with a maximum score of 40.

  3. Change in BPI: brief pain inventory, numeric rating score [ Time Frame: Day 0, day 28, day 148 ]
    Measurement of changes in pain inventory of patient before intervention period, just after intervention period and 4 months after intervention period. Questionnaire consists out of 7 questions to be answered with 0 (no obstruction) to 10 (full obstruction). A total of 70 points is the maximum score.

  4. Change in PCS: Pain Catastrophizing Scale [ Time Frame: Day 0, day 28, day 148 ]
    Measurement of changes in pain catastrophizing of patient before intervention period, just after intervention period and 4 months after intervention period. Questionnaire consists out of 13 questions to be answered with 0 (not at all) to 4 (always). Questionnaire has 3 subscales (rumination, magnification, helplessness) and a total score of maximum 52.

  5. Change in PCCL: Pain Coping and Cognition list [ Time Frame: Day 0, day 28, day 148 ]
    Measurement of changes in pain coping strategies (PCCL) of patient before intervention, just after intervention period and 4 months after intervention period. Questionnaire consists out of 42 questions to be answered with 0 (don't agree) to 5 (totally agree). 4 subscales: catastrophizing, pain coping, internal pain control, external pain control. Per subscale is the total sum calculated and divided by the number of questions. A score of 1-6 is assigned per subscale.

  6. Change in HADS: Hospital Anxiety and Depression Scale [ Time Frame: Day 0, day 28, day 148 ]
    Measurement of changes in anxiety (HADS) of patient before intervention period, just after intervention period and 4 months after intervention period. Questionnaire consists out of 14 questions with answers ranging from 0 (often) to 3 (almost never). All questions are summed up to a total of 42 points.

  7. Change in OLBPDQ: Oswestry Low Back Pain Disability Questionnaire [ Time Frame: Day 0, day 28, day 148 ]
    Measurement of changes in activities of daily life as a consequence of experienced pain of patient before intervention period, just after intervention period and 4 months after intervention period. Questionnaire consists out of 10 questions to be answered with 0 (no disability) to 6 (full disability). All questions are to be summed up to a total of 60 points.

  8. Change in ADL: Activities of Daily Life [ Time Frame: Day 0, day 28, day 148 ]
    Measurement of changes in activities of daily life (ADL) of patient before intervention, just after intervention period and 4 months after intervention period. Questionnaire consists of 22 questions ranging from 0 (not at all) to 3 (easily autonomous). Maximum score is 63.

  9. Change in pain questionnaire via numeric pain rating scale [ Time Frame: Questionnaires will be filled in at the end of each intervention day during the intervention period of 28 days ]
    Changes in pain intensity during the intervention period measured via 4 questions on scales ranging from 0 (pain doesn't influence me) to 10 (pain hinders me a lot). And two visual analogue scales of 10 centimeters (I don't have pain at all - I am in full pain).

  10. Medication use questionnaire [ Time Frame: Questionnaires will be filled in at the end of each intervention day during the intervention period of 28 days ]
    Use of medication during the intervention period.


Other Outcome Measures:
  1. Patient characteristics related to use of VR [ Time Frame: Baseline (Questionnaire will be filled in once before the start of the intervention period.) ]
    Age, gender, education, employment, lifestyle, experience with technology - qualitative measures.

  2. Feasibility of therapeutic virtual reality via semi structured interview [ Time Frame: Semi-structured interviews with intervention group at intervention day 7,14 and 28 ]

    Dosing and frequency of treatment, time of use, type of game. This will be monitored by the therapeutic virtual reality application itself.

    Reasons for use. Patient will be interviewed about issues during use of therapeutic virtual reality software/hardware.


  3. Acceptability of therapeutic virtual reality via semi structured interview [ Time Frame: Semi-structured interviews with intervention group at intervention day 7,14 and 28 ]
    Patient will be interviewed about his or her opinion on therapeutic virtual reality hardware and software, patients' opinion on the effectiveness of therapeutic virtual reality, reasons to withdraw.

  4. Tolerability of therapeutic virtual reality via semi structured interview [ Time Frame: Semi-structured interviews with intervention group at intervention day 7,14 and 28 ]
    Patient will be interviewed and asked about experienced adverse events, discomfort, inconveniences.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 110 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient suffers from chronic non-specific low-back pain (LBP) not attributable to a recognisable, known specific pathology (e.g. infection, tumour, osteoporosis, lumbar spine fracture, structural deformity, inflammatory disorder, radicular syndrome, or cauda equina syndrome).
  2. Patient reports a pain score related to chronic low-back pain ≥4.
  3. Patient is placed on the waiting list to receive intervention and receives no treatment yet, apart from medication or physiotherapy.
  4. At the day of recruitment, the estimated length of the waiting list for intervention is at least six weeks.
  5. Patient did not receive any invasive treatment for his chronic non-specific low-back pain in the last year.
  6. Patient is willing and able to comply with the trial protocol.
  7. Patient is at least 18 years old on the day the oral informed consent will be given.
  8. Patient can read and understand the Dutch language.

Exclusion Criteria:

  1. Patient is included in another trial to evaluate new ways of treating pain.
  2. Patients suffers from severe anxiety or depression (HADS≥16).
  3. Patient has difficulties to handle virtual reality:

    1. Patient suffers from delirium or acute confusional state.
    2. Patient has (a history of) dementia, seizure, or epilepsy.
    3. Patient has severe hearing/visual impairment not corrected.
    4. The skin of the patient's head or face is not intact (for example head wounds, psoriasis, eczema).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04042090


Contacts
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Contact: Merlijn Smits, Msc (+31) 024-36 17612 merlijn.smits@radboudumc.nl
Contact: Marjan de Vries, PhD (+31) 024-36 10903 Marjan.devries@radboudumc.nl

Locations
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Netherlands
Rijnstate Recruiting
Velp, Gelderland, Netherlands, 6883AZ
Contact: Jan-Willem Kallewaard, MD, PhD         
Sponsors and Collaborators
Radboud University
Rijnstate Hospital
Investigators
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Principal Investigator: Harry van Goor, MD, PhD Radboud University
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Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT04042090    
Other Study ID Numbers: NL70042.091.19
2019-5441 ( Registry Identifier: CMO )
2019-5441 ( Other Identifier: Radboudumc valorisation )
First Posted: August 1, 2019    Key Record Dates
Last Update Posted: August 4, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Only upon asking.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Radboud University:
Virtual reality
Quality of life
Back pain
Additional relevant MeSH terms:
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Back Pain
Pain
Neurologic Manifestations