Thinking of joining a study?

Register your interest

NCT05701891 | Recruiting | Chronic Low-back Pain


Virtual Reality Integrated Within Physiotherapy for Patients With Complex Chronic Low Back Pain
Sponsor:

HAN University of Applied Sciences

Information provided by (Responsible Party):

Bart Steel

Brief 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. The (cost-)effectiveness of this intervention will be investigated at 3 months and 12 months follow-up.

Condition or disease

Chronic Low-back Pain

Intervention/treatment

Physiotherapy with integrated Virtual Reality

Physiotherapy (usual care)

Phase

Not Applicable

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 Type : Interventional
Estimated Enrollment : 120 participants
Masking : None (Open Label)
Primary Purpose : Treatment
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
Actual Study Start Date : March 1, 2023
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : March 2025
Arm Intervention/treatment

Experimental: Physiotherapy with integrated VR

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.

Combination Product: Physiotherapy with integrated Virtual Reality

Active Comparator: Physiotherapy (usual care)

The control condition is usual physiotherapy care for 12 weeks.

Other: Physiotherapy (usual care)

Ages Eligible for Study: 18 Years to 80 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • 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.
Exclusion Criteria
  • 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

Virtual Reality Integrated Within Physiotherapy for Patients With Complex Chronic Low Back Pain

Location Details


Please Choose a site



Virtual Reality Integrated Within Physiotherapy for Patients With Complex Chronic Low Back Pain

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Recruiting

Netherlands,

HAN University of Applied Sciences

Nijmegen, Netherlands, Okay

Loading...