Chronic PainNCT06312735
VR for Patients With Chronic Pain (Wait & Work)
A study testing VR (Reducept) in people with Chronic Pain, run by University of Twente at 4 sites in Netherlands.
Trial summary
This cluster-RCT evaluates the effect of therapeutic virtual reality (VR) on patients with chronic musculoskeletal pain (CMP) who are on a waiting list to receive pain treatment. The used VR application, Reducept, offers pain education and pain management techniques. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- VR (Reducept)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 4 sitesNetherlands
- Study dates
- 1 Oct 2023to 30 Nov 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 18 years or older
- suffering from primary or secondary CMP
- finished with biomedical diagnostics and treatment
- open to biopsychosocial treatment
- willing and capable of complying with study procedures.
Who cannot join
- not able to finish the VR intervention due to physical (e.g. visual impairment), mental (e.g. severe sensitivity to stimuli) or practical problems (e.g. insufficient tech-literacy)
- unable to finish Dutch questionnaires.
Trial locations and contacts
4 sites in 1 country.
Netherlands4 sites
Deventer Ziekenhuis
Deventer, Overijssel, 7416SE
Revalidatie Friesland
Emmeloord, Provincie Friesland, 8303BX
Roessingh rehabilitation center
Enschede, Overijssel, 7522AH
Nocepta
Hengelo, Overijssel, 7555DL
About this study
Official title: Cluster-randomized Controlled Trial of Virtual Reality for Patients With Chronic Musculoskeletal Pain (Wait & Work)
This cluster-RCT evaluates the effect of therapeutic virtual reality (VR) on patients with chronic musculoskeletal pain (CMP) who are on a waiting list to receive pain treatment. The used VR application, Reducept, offers pain education and pain management techniques. This home-based, stand-alone, immersive VR intervention was used daily for four weeks in the intervention group. The control group received standard care (no treatment). Primary outcome measure for this study was health-related quality of life, secondary outcome measures included various pain-related variables (e.g. pain self-efficacy and acceptance. Outcome variables will be measured after four weeks and follow-up after six months.
- Conditions
- Chronic Pain
- Being tested
- VR (Reducept)
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR (Reducept)Device
Reducept is a novel VR intervention that consists of a combination of pain neuroscience education (PNE) and pain management techniques. It includes different psychological therapy modalities (e.g. acceptance and commitment therapy (ACT), cognitive behavioral therapy (CBT) and hypnotherapy) into a single application.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Four-week, at-home VR intervention with a recommended daily use of 10-30 minutes Receives: Device: VR (Reducept) |
| Control group | No intervention | No intervention, patient is a waiting-list control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in quality of life measured using the short-form 12 (SF-12)
This questionnaire on quality of life scores from 12 (worst possible score) to 56 (best possible score)
Measured: Baseline, directly after the intervention, and at six months follow-up
Secondary outcomes (7)
Change in pain intensity measured using the numeric pain rating scale (NPRS)
This questionnaire on pain intensity scores from 0 (best possible score) to 100 (worst possible score)
Measured: Baseline, directly after the intervention, and at six months follow-up
Change in pain catastrophizing measured using the pain catastrophizing scale (PCS)
This questionnaire on pain catastrophizing scores from 0 (best possible score) to 52 (worst possible score).
Measured: Baseline, directly after the intervention, and at six months follow-up
Change in pain self-efficacy measured using the pain self-efficacy questionnaire (PSEQ)
This questionnaire scores from 0 (worst possible score) to 60 (best possible score).
Measured: Baseline, directly after the intervention, and at six months follow-up
Change in pain acceptance measured using the chronic pain acceptance questionnaire (CPAQ-8)
This questionnaire scores from 0 (worst possible score) to 48 (best possible score).
Measured: Baseline, directly after the intervention, and at six months follow-up
Change in feelings of anxiety and depression measured using the hospital anxiety and depression scale (HADS)
This questionnaire scores from 0 (worst possible score) to 42 (best possible score).
Measured: Baseline, directly after the intervention, and at six months follow-up
Change in quality of care measured using the client satisfaction questionnaire (CSQ-8)
This questionnaire scores from 8 (worst possible score) to 32 (best possible score).
Measured: Baseline, directly after the intervention, and at six months follow-up
Change in medication use measured using an open-ended question
This question inquires about current medication use
Measured: Baseline, directly after the intervention, and at six months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start1 Oct 2023
- Primary completion30 Apr 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Twente
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Monique Tabak, University of Twente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06312735
- Sponsor's protocol ID
- 230405
- Status last verified
- Apr 2025
- First submitted
- 8 Mar 2024
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cluster-randomized Controlled Trial of Virtual Reality for Patients With Chronic Musculoskeletal Pain (Wait & Work)
- ClinicalTrials.gov ID
- NCT06312735
- Acronym / sponsor ID
- 230405
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of TwenteUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 15 Mar 2024 (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 cluster-RCT evaluates the effect of therapeutic virtual reality (VR) on patients with chronic musculoskeletal pain (CMP) who are on a waiting list to receive pain treatment. The used VR application, Reducept, offers pain education and pain management techniques. This home-based, stand-alone, immersive VR intervention was used daily for four weeks in the intervention group. The control group received standard care (no treatment). Primary outcome measure for this study was health-related quality of life, secondary outcome measures included various pain-related variables (e.g. pain self-efficacy and acceptance. Outcome variables will be measured after four weeks and follow-up after six months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: VR (Reducept)Four-week, at-home VR intervention with a recommended daily use of 10-30 minutes |
| Control group | No intervention | –No intervention, patient is a waiting-list control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- aged 18 years or older
- suffering from primary or secondary CMP
- finished with biomedical diagnostics and treatment
- open to biopsychosocial treatment
- willing and capable of complying with study procedures.
Key exclusion criteria (2 listed)
- not able to finish the VR intervention due to physical (e.g. visual impairment), mental (e.g. severe sensitivity to stimuli) or practical problems (e.g. insufficient tech-literacy)
- unable to finish Dutch questionnaires.
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 |
|---|---|---|
| VR (Reducept)Reducept is a novel VR intervention that consists of a combination of pain neuroscience education (PNE) and pain management techniques. It includes different psychological therapy modalities (e.g. acceptance and commitment therapy (ACT), cognitive behavioral therapy (CBT) and hypnotherapy) into a single application. | Device | Intervention group |
Primary outcome
Change in quality of life measured using the short-form 12 (SF-12)
Time frame: Baseline, directly after the intervention, and at six months follow-up
This questionnaire on quality of life scores from 12 (worst possible score) to 56 (best possible score)
7 secondary outcomes
Change in pain intensity measured using the numeric pain rating scale (NPRS)
Time frame: Baseline, directly after the intervention, and at six months follow-up
Change in pain catastrophizing measured using the pain catastrophizing scale (PCS)
Time frame: Baseline, directly after the intervention, and at six months follow-up
Change in pain self-efficacy measured using the pain self-efficacy questionnaire (PSEQ)
Time frame: Baseline, directly after the intervention, and at six months follow-up
Change in pain acceptance measured using the chronic pain acceptance questionnaire (CPAQ-8)
Time frame: Baseline, directly after the intervention, and at six months follow-up
Change in feelings of anxiety and depression measured using the hospital anxiety and depression scale (HADS)
Time frame: Baseline, directly after the intervention, and at six months follow-up
Change in quality of care measured using the client satisfaction questionnaire (CSQ-8)
Time frame: Baseline, directly after the intervention, and at six months follow-up
Change in medication use measured using an open-ended question
Time frame: Baseline, directly after the intervention, and at six months follow-up
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 11 Apr 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR (Reducept) in people with Chronic Pain, run by University of Twente at 4 sites 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 5 inclusion and 2 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 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 quality of life measured using the short-form 12 (SF-12) (time frame: Baseline, directly after the intervention, and at six months follow-up). 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 11 Apr 2025.