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

CompletedNot applicableNCT04042090
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

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
Interventions
  • Device: Reducept, virtual reality
Sponsor
Radboud University Medical Center
Collaborators
Rijnstate Hospital
Start date
2019-12-10
Primary completion
2021-01-15
Sex
All
Age range
from 18 Years to 110 Years
Results posted
No results posted in this snapshot
Countries
Netherlands
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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).

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04042090