Back Pain Lower Back ChronicPijnVRijNCT04042090
The Efficacy, Acceptability, Tolerability and Feasibility of a Therapeutic Virtual Reality Application
A study testing Reducept, virtual reality in people with Back Pain Lower Back Chronic and Quality of Life, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Back Pain Lower Back Chronic, Quality of Life
- What is being tested?
- Reducept, virtual reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteNetherlands
- Study dates
- 10 Dec 2019to 15 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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-specific low-back pain). 30-40% of all patients suffering from chronic pain visit their GP for treatment. Treatment includes mostly analgesics, in particular NSAIDs and opioids.
Adequate treatment of chronic pain is important as chronic pain negatively impacts, amongst others, quality of life, activities of daily living and feelings of helplessness. A systematic review by Bala et al. however shows that chronic pain treatment is often inadequate. Moreover, each different type of analgesic has its own associated side effects. NSAIDs increase the risk of cardiovascular and gastrointestinal complications. Common side effects of opioid analgesics include sedation, dizziness, nausea, vomiting, constipation, physical dependence, and even cases of hyperalgesia.
Recently, more attention has been given to psychological interventions for relieving chronic pain. A systematic review by Castelnuovo et al. shows the efficacy of a range of psychological interventions, including acceptance and commitment therapy (ACT), mindfulness-based interventions, hypnotherapy, eye movement and desensitization and reprocessing (EMDR) therapies and virtual reality based interventions. All of these psychological interventions focus on changing people's attitudes, feelings and behaviors on chronic pain, to improve their quality of life.
The first psychological intervention is the commonly used acceptance and commitment therapy (ACT). ACT is a cognitive behavioral therapy for treating chronic pain that uses exposure-based and experiential methods aiming at improving patients' abilities to cope with their chronic pain. Several systematic reviews indicate that ACT is effective in improving health outcomes of chronic pain patients. Mindfulness-based interventions seem to work as well for chronic pain relief. This set of interventions aims at learning strategies for pain awareness and acceptance. Furthermore, hypnotherapy is a mind-body based intervention that uses hypnoses to learn patients to cope with their pain. It focuses attention away from pain, thereby blocking its experience. Hypnotherapy seems effective in reducing pain experience. Then, eye movement desensitization and reprocessing (EMDR) is another psychotherapeutic approach in treating chronic pain. EMDR has already shown to be effective in treating posttraumatic stress disorder, and has recently as well been introduced as a treatment for chronic pain. Early research findings indicate EMDR to be effective in treating chronic pain.
Finally, one of the most recent fields of inquiry in treating chronic pain by means of psychological interventions is Virtual Reality. VR consists of a Head Mounted Device (HMD) and a sound system which immerses the user in a three-dimensional (3D) virtual world. There are multiple mechanisms behind the efficacy of VR in treating chronic pain. The most commonly studied mechanism is distraction. VR seems to be effective in reducing pain via distraction as it diverts attention away from pain. As both the VR application and the pain require attention and the brain has only limited attentional capacity, less attention is available for pain processing. In this manner, it reduces current feelings of pain, anxiety and stress. Though, the distraction mechanism only diverts attention away from pain shortly. To actually treat chronic pain by means of VR, it seems that other strategies, apart from distraction, are required.
Several studies aimed to find alternative mechanisms behind pain reduction by VR. The use of psychological interventions in VR, such as ACT or hypnosis, appears to be effective. Although the context of VR is different from traditional psychotherapy, the idea of how change occurs is not. Moreover, the immersiveness of VR provides opportunities to even better influence cognitions and emotions of patients suffering from chronic pain. Multiple virtual reality interventions have been designed with this knowledge in mind. A proof-of-concept study by Gromala et al., for example, looked into the application Virtual Meditative Walk (VMW). VNW focuses on mindfulness-based stress reduction via VR. The user study shows VNW's efficacy compared to non-VR interventions. Likewise, Guarino et al. proved that using virtual mindfulness therapy eight times over a period of a month is effective in chronic pain reduction. Therapeutic hypnosis has as well been tested in several case report studies. All conclude that virtual reality hypnosis seems to be effective in dealing with chronic pain.
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.
- Education: Reducept provides its players with information about the biological mechanisms underlying chronic pain. Learning about chronic pain helps to cope with it in daily life.
- Control: Reducept's first game has been based on the mechanisms of hypnotherapy. The patient should shoot away painful stimuli in the nervous system. By visualizing their pain, they learn to control and cope with it.
- Relaxation: the second game within Reducept is a mindfulness-based intervention. It takes place in the spinal cord. Players should collect positive neurotransmitters and focus on their respiration rate.
- Processing: game three has been based on the mechanisms of ACT and EMDR. It asks players to recover negative patterns in the brain. Players have to switch attention between the pain and the game, helping them to decrease their experience of pain.
This study aims to gain a first understanding in the ability of the therapeutic VR intervention Reducept to treat chronic low-back pain. It will define a wide range of outcome measures, including quality of life indicators, pain, stress and anxiety measures and measures on ability to execute daily activities. What outcome measures does it affect? What outcome measures will be left unaffected? Moreover, tolerability, feasibility and acceptability of Reducept in relation to different patient characteristics (age, gender, Motivaction profiling) will be measured to understand which patients might benefit most from virtual reality based psychological interventions. The study focuses on patients with non-specific chronic low-back pain as this group represents a large part of all chronic pain patients. This explorative study is necessary as an input for future studies on the actual effects of therapeutic virtual reality interventions on quality of life of patients.
Objective:
To investigate whether a therapeutic virtual reality application can improve the quality of life of people suffering from non-specific chronic low-back pain, compared to a control condition.
Study design:
This explorative study uses a randomised controlled parallel design (1:1). Participants will be randomly assigned to either the control group or the intervention group. In the control group, participants are placed on the waiting list to receive the common treatment to handle their chronic pain. As they are placed on the waiting list, they will receive no therapeutic treatment yet (apart from the during intake prescribed physiotherapy and medication). Participants placed in the intervention group, who are also placed on the waiting list and only receive, when prescribed, physiotherapy and medication, will use the therapeutic virtual reality intervention meanwhile at home during a period of 28 days for at least ten minutes each day and in addition the education module at least during day 1 (which lasts 25 minutes). The randomisation is not blinded: both researchers and participants know which participants are part of the intervention and control group.
Study population:
Adult patients, males and females, suffering from daily non-specific chronic low-back pain are eligible for this study. Patients' pain should have last for at least three months. Patients should report a pain score of ≥4 during the intake questionnaires filled in before intake at the Rijnstate Pijncentrum.
Intervention (if applicable):
Participants will be randomly assigned to either the intervention group or the control group. Participants assigned to the intervention group will receive virtual reality glasses with the Reducept application. They are asked to use the therapeutic virtual reality intervention at home over a period of 28 days starting the day after collecting the virtual reality goggles. Participants are asked to use the therapeutic virtual reality intervention at least once a day for ten minutes. In addition, they should, on the first day, and preferably during more days, watch the whole education program which lasts 25 minutes. Participants can decide themselves to use the application more often. Participants assigned to the control group will receive no intervention, they are, just as the intervention group, placed on the waiting list to receive normal treatment.
Unfortunately, it is not possible to provide all patients with the opportunity to use the virtual reality application, as the design requires a control group that does not use it over the study period.
The investigators will study the possibility of continuing the virtual reality treatment for all participants want-ing to after finishing this study. At least they will be able to buy themselves the virtual reality glasses for using the therapeutic virtual reality.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
There is no risk involved in exposure to the therapeutic virtual reality application. Participants can leave the study at any time for any reason if they wish to do so without any consequences. As mentioned before, the burden for participants associated with this study is mainly related to measurements of endpoints, which will take approximately 30-45 minutes three times over a period of five months. The intervention group will spend at least ten minutes a day on the therapeutic virtual reality application and in addition on day 1 25 minutes.. As explained in the rationale, no or only minimal adverse effects from this intervention are expected.
- Conditions
- Back Pain Lower Back Chronic, Quality of Life
- Being tested
- Reducept, virtual reality
- Keywords
- Virtual reality, Quality of life, Back pain
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reducept, virtual realityDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0, day 28, day 148
Secondary outcomes (10)
Change in positive health questionnaire
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.
Measured: Day 0, day 28, day 148
Change in pain via numeric rating score
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.
Measured: Day 0, day 28, day 148
Change in BPI: brief pain inventory, numeric rating score
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.
Measured: Day 0, day 28, day 148
Change in PCS: Pain Catastrophizing Scale
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.
Measured: Day 0, day 28, day 148
Change in PCCL: Pain Coping and Cognition list
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.
Measured: Day 0, day 28, day 148
Change in HADS: Hospital Anxiety and Depression Scale
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.
Measured: Day 0, day 28, day 148
Change in OLBPDQ: Oswestry Low Back Pain Disability Questionnaire
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.
Measured: Day 0, day 28, day 148
Change in ADL: Activities of Daily Life
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.
Measured: Day 0, day 28, day 148
Change in pain questionnaire via numeric pain rating scale
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).
Measured: Questionnaires will be filled in at the end of each intervention day during the intervention period of 28 days
Medication use questionnaire
Use of medication during the intervention period.
Measured: Questionnaires will be filled in at the end of each intervention day during the intervention period of 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2019
- Study start10 Dec 2019
- Primary completion15 Jan 2021
- Study completion15 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back Pain Lower Back ChronicStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Rijnstate Hospital
- Responsible party
- Sponsor
- Investigators
- Harry van Goor, MD, PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04042090
- Sponsor's protocol ID
- NL70042.091.19
- Other IDs
- 2019-5441, 2019-5441
- Acronym
- PijnVRij
- Status last verified
- Jul 2020
- First submitted
- 5 Jul 2019
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only upon asking.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04042090
- Acronym / sponsor ID
- PijnVRij / NL70042.091.19
- Conditions
- Back Pain Lower Back Chronic, Quality of Life
- Keywords
- Virtual reality, Quality of life, Back pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Rijnstate Hospital
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 1 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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-specific low-back pain). 30-40% of all patients suffering from chronic pain visit their GP for treatment. Treatment includes mostly analgesics, in particular NSAIDs and opioids.
Adequate treatment of chronic pain is important as chronic pain negatively impacts, amongst others, quality of life, activities of daily living and feelings of helplessness. A systematic review by Bala et al. however shows that chronic pain treatment is often inadequate. Moreover, each different type of analgesic has its own associated side effects. NSAIDs increase the risk of cardiovascular and gastrointestinal complications. Common side effects of opioid analgesics include sedation, dizziness, nausea, vomiting, constipation, physical dependence, and even cases of hyperalgesia.
Recently, more attention has been given to psychological interventions for relieving chronic pain. A systematic review by Castelnuovo et al. shows the efficacy of a range of psychological interventions, including acceptance and commitment therapy (ACT), mindfulness-based interventions, hypnotherapy, eye movement and desensitization and reprocessing (EMDR) therapies and virtual reality based interventions. All of these psychological interventions focus on changing people's attitudes, feelings and behaviors on chronic pain, to improve their quality of life.
The first psychological intervention is the commonly used acceptance and commitment therapy (ACT). ACT is a cognitive behavioral therapy for treating chronic pain that uses exposure-based and experiential methods aiming at improving patients' abilities to cope with their chronic pain. Several systematic reviews indicate that ACT is effective in improving health outcomes of chronic pain patients. Mindfulness-based interventions seem to work as well for chronic pain relief. This set of interventions aims at learning strategies for pain awareness and acceptance. Furthermore, hypnotherapy is a mind-body based intervention that uses hypnoses to learn patients to cope with their pain. It focuses attention away from pain, thereby blocking its experience. Hypnotherapy seems effective in reducing pain experience. Then, eye movement desensitization and reprocessing (EMDR) is another psychotherapeutic approach in treating chronic pain. EMDR has already shown to be effective in treating posttraumatic stress disorder, and has recently as well been introduced as a treatment for chronic pain. Early research findings indicate EMDR to be effective in treating chronic pain.
Finally, one of the most recent fields of inquiry in treating chronic pain by means of psychological interventions is Virtual Reality. VR consists of a Head Mounted Device (HMD) and a sound system which immerses the user in a three-dimensional (3D) virtual world. There are multiple mechanisms behind the efficacy of VR in treating chronic pain. The most commonly studied mechanism is distraction. VR seems to be effective in reducing pain via distraction as it diverts attention away from pain. As both the VR application and the pain require attention and the brain has only limited attentional capacity, less attention is available for pain processing. In this manner, it reduces current feelings of pain, anxiety and stress. Though, the distraction mechanism only diverts attention away from pain shortly. To actually treat chronic pain by means of VR, it seems that other strategies, apart from distraction, are required.
Several studies aimed to find alternative mechanisms behind pain reduction by VR. The use of psychological interventions in VR, such as ACT or hypnosis, appears to be effective. Although the context of VR is different from traditional psychotherapy, the idea of how change occurs is not. Moreover, the immersiveness of VR provides opportunities to even better influence cognitions and emotions of patients suffering from chronic pain. Multiple virtual reality interventions have been designed with this knowledge in mind. A proof-of-concept study by Gromala et al., for example, looked into the application Virtual Meditative Walk (VMW). VNW focuses on mindfulness-based stress reduction via VR. The user study shows VNW's efficacy compared to non-VR interventions. Likewise, Guarino et al. proved that using virtual mindfulness therapy eight times over a period of a month is effective in chronic pain reduction. Therapeutic hypnosis has as well been tested in several case report studies. All conclude that virtual reality hypnosis seems to be effective in dealing with chronic pain.
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.
- Education: Reducept provides its players with information about the biological mechanisms underlying chronic pain. Learning about chronic pain helps to cope with it in daily life.
- Control: Reducept's first game has been based on the mechanisms of hypnotherapy. The patient should shoot away painful stimuli in the nervous system. By visualizing their pain, they learn to control and cope with it.
- Relaxation: the second game within Reducept is a mindfulness-based intervention. It takes place in the spinal cord. Players should collect positive neurotransmitters and focus on their respiration rate.
- Processing: game three has been based on the mechanisms of ACT and EMDR. It asks players to recover negative patterns in the brain. Players have to switch attention between the pain and the game, helping them to decrease their experience of pain.
This study aims to gain a first understanding in the ability of the therapeutic VR intervention Reducept to treat chronic low-back pain. It will define a wide range of outcome measures, including quality of life indicators, pain, stress and anxiety measures and measures on ability to execute daily activities. What outcome measures does it affect? What outcome measures will be left unaffected? Moreover, tolerability, feasibility and acceptability of Reducept in relation to different patient characteristics (age, gender, Motivaction profiling) will be measured to understand which patients might benefit most from virtual reality based psychological interventions. The study focuses on patients with non-specific chronic low-back pain as this group represents a large part of all chronic pain patients. This explorative study is necessary as an input for future studies on the actual effects of therapeutic virtual reality interventions on quality of life of patients.
Objective:
To investigate whether a therapeutic virtual reality application can improve the quality of life of people suffering from non-specific chronic low-back pain, compared to a control condition.
Study design:
This explorative study uses a randomised controlled parallel design (1:1). Participants will be randomly assigned to either the control group or the intervention group. In the control group, participants are placed on the waiting list to receive the common treatment to handle their chronic pain. As they are placed on the waiting list, they will receive no therapeutic treatment yet (apart from the during intake prescribed physiotherapy and medication). Participants placed in the intervention group, who are also placed on the waiting list and only receive, when prescribed, physiotherapy and medication, will use the therapeutic virtual reality intervention meanwhile at home during a period of 28 days for at least ten minutes each day and in addition the education module at least during day 1 (which lasts 25 minutes). The randomisation is not blinded: both researchers and participants know which participants are part of the intervention and control group.
Study population:
Adult patients, males and females, suffering from daily non-specific chronic low-back pain are eligible for this study. Patients' pain should have last for at least three months. Patients should report a pain score of ≥4 during the intake questionnaires filled in before intake at the Rijnstate Pijncentrum.
Intervention (if applicable):
Participants will be randomly assigned to either the intervention group or the control group. Participants assigned to the intervention group will receive virtual reality glasses with the Reducept application. They are asked to use the therapeutic virtual reality intervention at home over a period of 28 days starting the day after collecting the virtual reality goggles. Participants are asked to use the therapeutic virtual reality intervention at least once a day for ten minutes. In addition, they should, on the first day, and preferably during more days, watch the whole education program which lasts 25 minutes. Participants can decide themselves to use the application more often. Participants assigned to the control group will receive no intervention, they are, just as the intervention group, placed on the waiting list to receive normal treatment.
Unfortunately, it is not possible to provide all patients with the opportunity to use the virtual reality application, as the design requires a control group that does not use it over the study period.
The investigators will study the possibility of continuing the virtual reality treatment for all participants want-ing to after finishing this study. At least they will be able to buy themselves the virtual reality glasses for using the therapeutic virtual reality.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
There is no risk involved in exposure to the therapeutic virtual reality application. Participants can leave the study at any time for any reason if they wish to do so without any consequences. As mentioned before, the burden for participants associated with this study is mainly related to measurements of endpoints, which will take approximately 30-45 minutes three times over a period of five months. The intervention group will spend at least ten minutes a day on the therapeutic virtual reality application and in addition on day 1 25 minutes.. As explained in the rationale, no or only minimal adverse effects from this intervention are expected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group: use of therapeutic virtual reality | Experimental | Device: Reducept, virtual realityIntervention 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. |
| Control group: no use of therapeutic virtual reality | No intervention | –Control group: no intervention, patient is waiting to receive normal chronic pain treatment. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (7 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reducept, virtual realityThe 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. | Device | Intervention group: use of therapeutic virtual reality |
Primary outcome
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.
10 secondary outcomes
Change in positive health questionnaire
Time frame: Day 0, day 28, day 148
Change in pain via numeric rating score
Time frame: Day 0, day 28, day 148
Change in BPI: brief pain inventory, numeric rating score
Time frame: Day 0, day 28, day 148
Change in PCS: Pain Catastrophizing Scale
Time frame: Day 0, day 28, day 148
Change in PCCL: Pain Coping and Cognition list
Time frame: Day 0, day 28, day 148
Change in HADS: Hospital Anxiety and Depression Scale
Time frame: Day 0, day 28, day 148
Change in OLBPDQ: Oswestry Low Back Pain Disability Questionnaire
Time frame: Day 0, day 28, day 148
Change in ADL: Activities of Daily Life
Time frame: Day 0, day 28, day 148
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
Medication use questionnaire
Time frame: Questionnaires will be filled in at the end of each intervention day during the intervention period of 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Individual participant dataSharing planned: No. Only upon asking.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harry van Goor, MD, PhD principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reducept, virtual reality in people with Back Pain Lower Back Chronic and Quality of Life, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in SF12: short form health survey (time frame: Day 0, day 28, day 148). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2021.