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
Phase 2
Recruiting
- Conditions
- Chronic low back pain10023213
- Registration Number
- NL-OMON53675
- Lead Sponsor
- Hogeschool Arnhem Nijmegen (HAN)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 120
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 >= 40)
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 supplementary health insurance
- no email-address and Wi-Fi
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Physical functioning (primary outcome), in addition to pain and a minimal set<br /><br>of other secondary clinical, adherence-related, psychological and economic<br /><br>measures, at baseline and 1, 3 and 12 months follow-up.</p><br>
- Secondary Outcome Measures
Name Time Method <p>See protocol 6.1.2</p><br>