Chronic Low-back PainVARIETYNCT05701891
Virtual Reality Integrated Within Physiotherapy for Patients With Complex Chronic Low Back Pain
A study testing Physiotherapy with integrated Virtual Reality in people with Chronic Low-back Pain, run by HAN University of Applied Sciences at 1 site in Netherlands.
Trial summary
This study examines the effect of a 12-week intervention of physiotherapy with integrated Virtual Reality (VR) on 120 patients with complex chronic low back pain. Patients in the intervention group will receive physiotherapy with integrated VR, while patients in the control group will receive physiotherapy as usual. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- Physiotherapy with integrated Virtual Reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Mar 2023to Mar 2025
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- LBP > 3 months as reason to visit physiotherapist
- absence of 'red flags' or signs of specific LBP
- combination of severe disability (Oswestry Disability Index (ODI) score ≥ 30) and severe pain (numeric rating score (NRS) ≥ 5)
- age 18-80 years
- provides informed consent.
Who cannot join
- severe (physical or mental) comorbidity that will substantially hinder the physiotherapy
- planned diagnostic or invasive therapeutic procedure (e.g. injection, nerve block or operation) for LBP in next three months
- no comprehension of Dutch language
- inability to use VR (e.g. epilepsy, open wounds on face or severe visual impairment)
- no email-address and Wi-Fi
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
HAN University of Applied Sciences
Nijmegen, 6525EN
About this study
Official title: The (Cost-)Effectiveness of an Innovative, Personalised Intervention of Therapeutic VirtuAl Reality IntEgrated Within physioTherapY for a Subgroup of Complex Chronic Low Back Pain Patients
This study examines the effect of a 12-week intervention of physiotherapy with integrated Virtual Reality (VR) on 120 patients with complex chronic low back pain. Patients in the intervention group will receive physiotherapy with integrated VR, while patients in the control group will receive physiotherapy as usual. The (cost-)effectiveness of this intervention will be investigated at 3 months and 12 months follow-up.
Read the detailed description
Rationale: Physiotherapy, mainly consisting of exercise therapy and patient education, is a first-choice primary care treatment for patients with chronic low back pain (LBP), but unfortunately, especially patients with severe disability and pain demonstrate poor outcomes. Therapeutic VR is considered a potential breakthrough for LBP patients in general and for our complex group of patients with severe disability and pain in particular, as it specifically targets the identified limitations of usual physiotherapy. Therefore, a personalised, VR-integrated physiotherapy intervention, tailored to specific patient characteristics, is expected to result in larger improvements in physical functioning and pain, and more favourable cost-effectiveness, compared to usual physiotherapy.
Objective: The primary objective is to investigate whether a personalised, physiotherapy intervention with integrated therapeutic virtual reality (VR) is (cost-)effective at 3 months and 12 months follow-up, compared to usual physiotherapy, in a subgroup of patients with complex chronic low back pain (LBP) and severe disability and pain.
Study design: Cluster randomised controlled trial.
Study population: 120 chronic LBP patients with combination of severe disability and severe pain, consulting a physiotherapist in primary care.
Intervention: The experimental intervention will be a 12-week personalised, VR-integrated physiotherapy intervention in which a selection of existing VR modules developed by research partners (i.e. Reducept and SyncVR) will be integrated into physiotherapy based on the recommendations of the LBP guidelines. The control intervention will be physiotherapy as usual.
Main study parameters/endpoints: Physical functioning (primary outcome), in addition to pain and a minimal set of other secondary clinical, adherence-related, psychological and economic measures, at baseline and 1, 3 and 12 months follow-up.
- Conditions
- Chronic Low-back Pain
- Being tested
- Physiotherapy with integrated Virtual Reality, Physiotherapy (usual care)
- Keywords
- Chronic low back pain, Chronic pain
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapy with integrated Virtual RealityCombination product
Also called Reducept, SyncVR Relax & Distract, SyncVR Fit
A 12-week personalised, VR-integrated physiotherapy intervention.
Physiotherapy (usual care)Other
A 12-week usual physiotherapy care intervention.
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapy with integrated VR | Experimental | Our intervention will be a 12-week personalised, VR-integrated physiotherapy intervention in which a selection of existing VR modules developed by our partners (i.e. Reducept and SyncVR) will be integrated into physiotherapy treatment. The following VR modules will be used: education (Reducept), relaxation and distraction (SyncVR Relax \& Distract), activation (SyncVR Fit). Patients will use the Pico Neo 3 VR headset at the physiotherapy practice and at home 5 days a week for 10-30 minutes. In addition, physiotherapists will help patients transition from movements performed in a VR context to daily activities without VR. Receives: Combination Product: Physiotherapy with integrated Virtual Reality |
| Physiotherapy (usual care) | Active comparator | The control condition is usual physiotherapy care for 12 weeks. Receives: Other: Physiotherapy (usual care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in physical functioning measured using the Oswestry Disability Index (ODI)
This questionnaire on physical functioning scores from 0 (best possible score) to 100 (worst possible score).
Measured: baseline, 1, 3 and 12 months
Secondary outcomes (8)
Change in pain intensity measured using the Numeric Pain Rating Scale (NPRS)
This questionnaire on pain intensity scores from 0 (best possible score) to 10 (worst possible score).
Measured: baseline, 1, 3 and 12 months
Change in pain-related fears measured using the Fear-Avoidance Beliefs Questionnaire - Physical Activity (FABQ-PA)
The FABQ scores from 0 (best possible score) to 30 (worst possible score).
Measured: baseline, 1, 3 and 12 months
Change in pain-related fears measured using the Pain Catastrophizing Scale (PCS)
The PCS scores from 0 (best possible score) to 52 (worst possible score).
Measured: baseline, 1, 3 and 12 months
Change in physical activity on self-reported moderate physical activity (i.e. minutes of performed physical activity in past week)
This questionnaire scores from 0 minutes (worst possible score) to 1680 minutes (best possible score, based on a maximum of 4 hours of possible moderate physical activity per day).
Measured: baseline, 1, 3 and 12 months
Change in general effect measured using the Global Perceived Effect (GPE)
This questionnaire scores from 0 (worst possible score) to 14 (best possible score).
Measured: baseline, 1, 3 and 12 months
Change in problems with activities measured using the Patient Specific Complaints (PSK)
This questionnaire scores from 0 (best possible score) to 10 (worst possible score) per activity.
Measured: baseline and 3 months
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, 1, 3 and 12 months
Change in cost-effectiveness measured using the EuroQol - 5 Dimensions - 5 Level (EQ-5D-5L)
The questionnaire consists of two components: the EQ-5D descriptive system and the EQ Visual Analogue Scale (EQ-VAS).The first part consists of five subjects, from which for each subject a single EQ-5D index score can be calculated ranging from 0 (worst possible score) to 1 (best possible score). The EQ-VAS scores from 0 (worst possible score) to 100 (best possible score).
Measured: baseline, 1, 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start1 Mar 2023
- Primary completionMar 2024 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Low-back 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
- Model description
- This study is a two-arm cluster-randomized controlled trial. Twenty physiotherapists with expertise in chronic LBP treatment will be recruited and equally randomised (10 in each arm) on the level of physiotherapy practice using allocation concealment. This clustered design means that eligible patients consulting a participating physiotherapist will be automatically allocated to the study arm (experimental or control arm) to which the physiotherapy practice was allocated.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HAN University of Applied Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bart Staal, HAN University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05701891
- Sponsor's protocol ID
- 10270032021502
- Acronym
- VARIETY
- Status last verified
- Apr 2023
- First submitted
- 2 Dec 2022
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Slatman S, van Goor H, Koke A, van Lankveld W, Maas E, Ostelo R, Poolman E, Tabak M, de Vries M, Staal JB, Knoop J. Physiotherapy with integrated virtual reality for patients with severe chronic low back pain: cluster-randomized controlled trial (VARIETY). BMC Musculoskelet Disord. 2026 May 1;27(1):530. doi: 10.1186/s12891-026-09873-z.
PubMed 42067884Slatman S, Ostelo R, van Goor H, Staal JB, Knoop J. Physiotherapy with integrated virtual reality for patients with complex chronic low back pain: protocol for a pragmatic cluster randomized controlled trial (VARIETY study). BMC Musculoskelet Disord. 2023 Feb 20;24(1):132. doi: 10.1186/s12891-023-06232-0.
PubMed 36803315
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The (Cost-)Effectiveness of an Innovative, Personalised Intervention of Therapeutic VirtuAl Reality IntEgrated Within physioTherapY for a Subgroup of Complex Chronic Low Back Pain Patients
- ClinicalTrials.gov ID
- NCT05701891
- Acronym / sponsor ID
- VARIETY / 10270032021502
- Conditions
- Chronic Low-back Pain
- Keywords
- Chronic low back pain, Chronic pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- HAN University of Applied SciencesUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 27 Jan 2023 (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 examines the effect of a 12-week intervention of physiotherapy with integrated Virtual Reality (VR) on 120 patients with complex chronic low back pain. Patients in the intervention group will receive physiotherapy with integrated VR, while patients in the control group will receive physiotherapy as usual. The (cost-)effectiveness of this intervention will be investigated at 3 months and 12 months follow-up.
Detailed description
Rationale: Physiotherapy, mainly consisting of exercise therapy and patient education, is a first-choice primary care treatment for patients with chronic low back pain (LBP), but unfortunately, especially patients with severe disability and pain demonstrate poor outcomes. Therapeutic VR is considered a potential breakthrough for LBP patients in general and for our complex group of patients with severe disability and pain in particular, as it specifically targets the identified limitations of usual physiotherapy. Therefore, a personalised, VR-integrated physiotherapy intervention, tailored to specific patient characteristics, is expected to result in larger improvements in physical functioning and pain, and more favourable cost-effectiveness, compared to usual physiotherapy.
Objective: The primary objective is to investigate whether a personalised, physiotherapy intervention with integrated therapeutic virtual reality (VR) is (cost-)effective at 3 months and 12 months follow-up, compared to usual physiotherapy, in a subgroup of patients with complex chronic low back pain (LBP) and severe disability and pain.
Study design: Cluster randomised controlled trial.
Study population: 120 chronic LBP patients with combination of severe disability and severe pain, consulting a physiotherapist in primary care.
Intervention: The experimental intervention will be a 12-week personalised, VR-integrated physiotherapy intervention in which a selection of existing VR modules developed by research partners (i.e. Reducept and SyncVR) will be integrated into physiotherapy based on the recommendations of the LBP guidelines. The control intervention will be physiotherapy as usual.
Main study parameters/endpoints: Physical functioning (primary outcome), in addition to pain and a minimal set of other secondary clinical, adherence-related, psychological and economic measures, at baseline and 1, 3 and 12 months follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is a two-arm cluster-randomized controlled trial. Twenty physiotherapists with expertise in chronic LBP treatment will be recruited and equally randomised (10 in each arm) on the level of physiotherapy practice using allocation concealment. This clustered design means that eligible patients consulting a participating physiotherapist will be automatically allocated to the study arm (experimental or control arm) to which the physiotherapy practice was allocated.
| Arm | Type | Receives |
|---|---|---|
| Physiotherapy with integrated VR | Experimental | Combination Product: Physiotherapy with integrated Virtual RealityOur intervention will be a 12-week personalised, VR-integrated physiotherapy intervention in which a selection of existing VR modules developed by our partners (i.e. Reducept and SyncVR) will be integrated into physiotherapy treatment. The following VR modules will be used: education (Reducept), relaxation and distraction (SyncVR Relax \& Distract), activation (SyncVR Fit). Patients will use the Pico Neo 3 VR headset at the physiotherapy practice and at home 5 days a week for 10-30 minutes. In addition, physiotherapists will help patients transition from movements performed in a VR context to daily activities without VR. |
| Physiotherapy (usual care) | Active comparator | Other: Physiotherapy (usual care)The control condition is usual physiotherapy care for 12 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- LBP > 3 months as reason to visit physiotherapist
- absence of 'red flags' or signs of specific LBP
- combination of severe disability (Oswestry Disability Index (ODI) score ≥ 30) and severe pain (numeric rating score (NRS) ≥ 5)
- age 18-80 years
- provides informed consent.
Key exclusion criteria (5 listed)
- severe (physical or mental) comorbidity that will substantially hinder the physiotherapy
- planned diagnostic or invasive therapeutic procedure (e.g. injection, nerve block or operation) for LBP in next three months
- no comprehension of Dutch language
- inability to use VR (e.g. epilepsy, open wounds on face or severe visual impairment)
- no email-address and Wi-Fi
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 |
|---|---|---|
| Physiotherapy with integrated Virtual RealityAlso: Reducept, SyncVR Relax & Distract, SyncVR FitA 12-week personalised, VR-integrated physiotherapy intervention. | Combination product | Physiotherapy with integrated VR |
| Physiotherapy (usual care)A 12-week usual physiotherapy care intervention. | Other | Physiotherapy (usual care) |
Primary outcome
Change in physical functioning measured using the Oswestry Disability Index (ODI)
Time frame: baseline, 1, 3 and 12 months
This questionnaire on physical functioning scores from 0 (best possible score) to 100 (worst possible score).
8 secondary outcomes
Change in pain intensity measured using the Numeric Pain Rating Scale (NPRS)
Time frame: baseline, 1, 3 and 12 months
Change in pain-related fears measured using the Fear-Avoidance Beliefs Questionnaire - Physical Activity (FABQ-PA)
Time frame: baseline, 1, 3 and 12 months
Change in pain-related fears measured using the Pain Catastrophizing Scale (PCS)
Time frame: baseline, 1, 3 and 12 months
Change in physical activity on self-reported moderate physical activity (i.e. minutes of performed physical activity in past week)
Time frame: baseline, 1, 3 and 12 months
Change in general effect measured using the Global Perceived Effect (GPE)
Time frame: baseline, 1, 3 and 12 months
Change in problems with activities measured using the Patient Specific Complaints (PSK)
Time frame: baseline and 3 months
Change in pain self-efficacy measured using the Pain Self-Efficacy Questionnaire (PSEQ)
Time frame: baseline, 1, 3 and 12 months
Change in cost-effectiveness measured using the EuroQol - 5 Dimensions - 5 Level (EQ-5D-5L)
Time frame: baseline, 1, 3, 6 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
- Derived from this study: PubMed 42067884Slatman S, van Goor H, Koke A, van Lankveld W, Maas E, Ostelo R, Poolman E, Tabak M, de Vries M, Staal JB, Knoop J. Physiotherapy with integrated virtual reality for patients with severe chronic low back pain: cluster-randomized controlled trial (VARIETY). BMC Musculoskelet Disord. 2026 May 1;27(1):530. doi: 10.1186/s12891-026-09873-z.
- Derived from this study: PubMed 36803315Slatman S, Ostelo R, van Goor H, Staal JB, Knoop J. Physiotherapy with integrated virtual reality for patients with complex chronic low back pain: protocol for a pragmatic cluster randomized controlled trial (VARIETY study). BMC Musculoskelet Disord. 2023 Feb 20;24(1):132. doi: 10.1186/s12891-023-06232-0.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy with integrated Virtual Reality in people with Chronic Low-back Pain, run by HAN University of Applied Sciences 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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 14 Apr 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bart Staal, PhD (06-55 24 06 98, bart.staal@han.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in physical functioning measured using the Oswestry Disability Index (ODI) (time frame: baseline, 1, 3 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05701891, which also lists 2 linked publications.
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 14 Apr 2023.