Status:
COMPLETED
The Efficacy, Acceptability, Tolerability and Feasibility of a Therapeutic Virtual Reality Application
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
Rijnstate Hospital
Conditions:
Back Pain Lower Back Chronic
Quality of Life
Eligibility:
All Genders
18-110 years
Phase:
NA
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. T...
Detailed Description
Rationale: 21,2% of the Dutch population is suffering from chronic low-back pain. 90% of these patients suffers from chronic low-back pain not attributable to a recognisable, specific pathology (non-...
Eligibility Criteria
Inclusion
- 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).
- Patient reports a pain score related to chronic low-back pain ≥4.
- Patient is placed on the waiting list to receive intervention and receives no treatment yet, apart from medication or physiotherapy.
- At the day of recruitment, the estimated length of the waiting list for intervention is at least six weeks.
- Patient did not receive any invasive treatment for his chronic non-specific low-back pain in the last year.
- Patient is willing and able to comply with the trial protocol.
- Patient is at least 18 years old on the day the oral informed consent will be given.
- Patient can read and understand the Dutch language.
Exclusion
- Patient is included in another trial to evaluate new ways of treating pain.
- Patients suffers from severe anxiety or depression (HADS≥16).
- Patient has difficulties to handle virtual reality:
- Patient suffers from delirium or acute confusional state.
- Patient has (a history of) dementia, seizure, or epilepsy.
- Patient has severe hearing/visual impairment not corrected.
- The skin of the patient's head or face is not intact (for example head wounds, psoriasis, eczema).
Key Trial Info
Start Date :
December 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 15 2021
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT04042090
Start Date
December 10 2019
End Date
June 15 2021
Last Update
September 29 2021
Active Locations (1)
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1
Rijnstate
Velp, Gelderland, Netherlands, 6883AZ