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

NCT04042090 | Completed

• 2 other identifiers: NL70042.091.192019-5441
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Back Pain Lower Back Chronic; Quality of Life

Keywords

Virtual reality; Quality of life; Back pain

Outcome Measures

Primary Outcomes (1)

• Change in SF12: short form health survey

  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.

  Day 0, day 28, day 148

Secondary Outcomes (10)

• Change in positive health questionnaire

  Day 0, day 28, day 148

• Change in pain via numeric rating score

  Day 0, day 28, day 148

• Change in BPI: brief pain inventory, numeric rating score

  Day 0, day 28, day 148

• Change in PCS: Pain Catastrophizing Scale

  Day 0, day 28, day 148

• Change in PCCL: Pain Coping and Cognition list

  Day 0, day 28, day 148

Other Outcomes (4)

• Patient characteristics related to use of VR

  Baseline (Questionnaire will be filled in once before the start of the intervention period.)

• Feasibility of therapeutic virtual reality via semi structured interview

  Semi-structured interviews with intervention group at intervention day 7,14 and 28

• Acceptability of therapeutic virtual reality via semi structured interview

  Semi-structured interviews with intervention group at intervention day 7,14 and 28

Study Arms (2)

Intervention group: use of therapeutic virtual reality

EXPERIMENTAL

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

Control group: no use of therapeutic virtual reality

NO INTERVENTION

Control group: no intervention, patient is waiting to receive normal chronic pain treatment.

Interventions

Reducept, virtual reality DEVICE

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 a VR goggles. It consists of an education module and three games.

Intervention group: use of therapeutic virtual reality

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Rijnstate Hospital: collaborator

Study Sites (1)

Rijnstate

Velp, Gelderland, 6883AZ, Netherlands

Location

MeSH Terms

Conditions

Back Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Harry van Goor, MD, PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 5, 2019
• First Posted: August 1, 2019
• Study Start: December 10, 2019
• Primary Completion: January 15, 2021
• Study Completion: June 15, 2021
• Last Updated: September 29, 2021

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)