Chronic low back pain Musculoskeletal Diseases Low back pain
Conditions
Interventions
The study will be done in two phases. In the first phase, fully immersive VR using a head-mounted display will be delivered to the 30 participants, and their feedback will be collected using questionn
Sponsors
University of Nottingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The inclusion criteria for patients are as follows: 1. Adults with CLBP for more than 12 consecutive weeks 2. Attending physiotherapy clinic for their CLBP 3. Be able to read, write, communicate in Arabic or English, and give consent The inclusion criteria for HCPs are as follows: 1. Qualified physiotherapists with a minimum of 2 years of experience 2. Worked with patients with CLBP for the past 12 months 3. Be able to communicate in Arabic or English and give consent
Exclusion criteria
Exclusion criteria: The exclusion criteria for patients are as follows: 1. Evidence of severe pathological conditions, including neurological, cardiovascular, or musculoskeletal disorders, such as cauda equina, tumours, fractures, and spondyloarthropathies 2. Health conditions that prevent safe participation include but are not limited to seizures, vertigo, blindness, and disorders affecting balance 3. History of spinal or hip surgery 4. Pregnancy 5. Wearing medical devices containing magnets or components emitting radio waves, such as cardiac pacemakers, hearing aids, and defibrillators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 19/09/2023: 1. The recruitment rate is recorded as the rate at which participants will be recruited to participate in 12 weeks 2. The retention rate is assessed by the rate at which participants will complete the outcome assessment within 14 weeks 3. The dropout rate is assessed as the rate for participants who do not follow up resulting in an inability to record outcome measures by 14 weeks 4. Completeness of questionnaire data is recorded as the completion rate of secondary outcomes data up to 14 weeks 5. Treatment compliance is assessed as the rate of participants completing treatment by 13 weeks 6. Treatment fidelity is assessed as the rate for sessions adhered to the fitting standard operating procedure designed for this study by 13 weeks 7. Adverse events are recorded as the participants will be asked to report any adverse events throughout the study 8. The acceptability will be explored with qualitative interviews 9. The facilitators and barriers to implementing fully immersive VR will be explored with qualitative interviews _____ Previous primary outcome measure: 1. The recruitment rate is recorded as the rate at which participants will be recruited to participate in 10 weeks 2. The retention rate is assessed by the rate at which participants will complete the outcome assessment within 10 weeks 3. The dropout rate is assessed as the rate for participants who do not follow up resulting in an inability to record outcome measures by 10 weeks 4. Completeness of questionnaire data is recorded as the completion rate of secondary outcomes data up to 11 weeks 5. Treatment compliance is assessed as the rate of participants completing treatment by 10 weeks 6. Treatment fidelity is assessed as the rate for sessions adhered to the fitting standard operating procedure designed for this study by 10 weeks 7. Adverse events are recorded as the participants will be asked to report any adverse events throughout the study 8. The accep | — |
Secondary
| Measure | Time frame |
|---|---|
| The questionnaire completion rate will be tested if they are feasible to be collected, which are as follows: 1. Pain measured using the Numerical Pain Rating Scale (11-NPRS) at baseline and 3-5 days post-intervention 2. Disability measured using the Oswestry Disability Index (ODI) at baseline and 3-5 days post-intervention 3. Kinesiophobia measured using the 17-item Tampa Scale of Kinesiophobia (17-item TSK) at baseline and 3-5 days post-intervention 4. Quality of life measured using the 36-item Short Form Health Survey (SF-36) at baseline and 3-5 days post-intervention | — |
Countries
Saudi Arabia
Outcome results
None listed