Virtual reality for chronic low back pain: a mixed-methods feasibility study in the Kingdom of Saudi Arabia

ISRCTN	ISRCTN14434517
DOI	https://doi.org/10.1186/ISRCTN14434517
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	Nil known
Sponsor	University of Nottingham
Funder	Taif University through the Saudi Arabian Cultural Bureau in London

Submission date: 09/05/2023
Registration date: 11/05/2023
Last edited: 19/08/2025

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Chronic low back pain (CLBP) is persistent pain in the lower back that lasts more than 12 weeks and has been the leading cause of functional disability for over three decades. Recently, there is growing interest in managing pain using fully immersive virtual reality (VR) technology. The study aims to assess the possibility of delivering fully immersive VR to patients with CLBP, measure its outcomes, investigate its safety, and gather opinions of patients and staff regarding the intervention.

Who can participate?
People with CLBP and healthcare providers

What does the study involve?
The study will be done in two phases. In the first phase, fully immersive VR will be delivered to the participants, and their feedback will be collected using questionnaires. The second phase will involve follow-up interviews with patients and physiotherapists to understand their thoughts on the fully immersive VR treatment. The interviews will be recorded, transcribed, and analyzed using computer software.

What are the possible benefits and risks of participating?
The possible benefits of participating include reducing pain, disability and fear of movement and improving the quality of life resulting from the fully immersive VR treatment. There is minimal risk of experiencing discomfort from wearing the VR goggles or participating in the study, but all necessary precautions will be taken to ensure participant safety.

Where is the study run from?
King Abdulaziz Specialist Hospital (Saudi Arabia)

When is the study starting, and how long is it expected to run for?
October 2021 to September 2023

Who is funding the study?
Taif University (Saudi Arabia)

Who is the main contact?
Fahad Alotibi, fsotibi@tu.edu.sa

Contact information

Mr Fahad Alotibi
Principal investigator

Derby Road
Queen’s Medical Centre
Faculty of Medicine and Health Sciences
Room B320
Nottingham
NG7 2HA
United Kingdom

Phone	+44 (0)750 866 5801
Email	fsotibi@tu.edu.sa

Dr Paul Hendrick
Scientific

Derby Road
Queen’s Medical Centre
Faculty of Medicine and Health Sciences
Room B317
Nottingham
NG7 2HA
United Kingdom

Phone	+44 (0)115 823 1827
Email	paul.hendrick@nottingham.ac.uk

Dr Fiona Moffatt
Scientific

Derby Road
Queen’s Medical Centre
Faculty of Medicine and Health Sciences
Room B219c
Nottingham
NG7 2HA
United Kingdom

Phone	+44 (0)115 823 1788
Email	fiona.moffatt@nottingham.ac.uk

Study information

Primary study design	Interventional
Study design	Mixed-methods explanatory sequential design in a multi-centre uncontrolled pre-intervention post-intervention feasibility trial
Secondary study design	Non randomised study
Study type	Participant information sheet
Scientific title	Delivering fully immersive virtual reality as a rehabilitation tool to adult patients with chronic low back pain in the context of the Kingdom of Saudi Arabia: a mixed-methods feasibility study
Study objectives	This research aims to investigate the feasibility, safety, and acceptability of using fully immersive virtual reality (VR) as a rehabilitation intervention for adult patients with chronic low back pain (CLBP), in the Kingdom of Saudi Arabia (KSA). The objectives are to evaluate the feasibility of delivering fully immersive VR interventions to CLBP patients in the KSA context as follows, assess recruitment, retention, and dropout rates, assess treatment compliance and fidelity, assess the completeness of questionnaire data, evaluate the tolerability of fully immersive VR, evaluate the acceptability of delivering fully immersive VR interventions in a population with CLBP and healthcare providers (HCPs) in the KSA context, and identify facilitators and barriers to delivering fully immersive VR intervention.
Ethics approval(s)	1. Approved 28/04/2023, Research Ethics Committee at the Faculty of Medicine and Health Sciences at University of Nottingham (Faculty of Medicine & Health Sciences, Research Ethics Committee c/o Faculty Hub E41, E Floor (nr School of Life Sciences Reception), Medical School, QMC Campus, Nottingham University Hospitals, NG7 2UH, UK; +44 (0)115 951 5559; fmhs-researchethics@nottingham.ac.uk), ref: FMHS 2310-0323 2. Approved 15/03/2023, Local Research and Studies Department at the Directorate of Health Affairs Taif (Al Khalediah, Qurwa, Taif 26521, KSA; +966 (0)12 736 6200; rs-taif@moh.gov.sa), ref: 801
Health condition(s) or problem(s) studied	Chronic low back pain
Intervention	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 questionnaires. The second phase will involve 12 follow-up interviews with nine patients and three physiotherapists to understand their thoughts on the fully immersive VR treatment. The interviews will be recorded, transcribed, and analyzed using computer software. Fully Immersive Virtual reality via head-mounted display equipment (Meta Quest 2) with two connected touch controllers (Oculus, Facebook Technologies, LCC, Menlo Park, USA) will be used in this study. The intervention will involve games that may encourage patients with chronic low back pain to perform exercises and stay active. The intervention will be delivered over three 6-minute sessions over 1 week.
Intervention type	Other
Primary outcome measure(s)	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 acceptability will be explored with qualitative interviews on weeks 11-12 9. The facilitators and barriers to implementing fully immersive VR will be explored with qualitative interviews in weeks 11-12
Key secondary outcome measure(s)	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
Completion date	22/09/2023

Eligibility

Participant type(s)	Patient, Health professional
Age group	Adult
Sex	All
Target sample size at registration	33
Total final enrolment	36
Key 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
Key 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
Date of first enrolment	29/05/2023
Date of final enrolment	28/08/2023

Locations

Countries of recruitment

Saudi Arabia

Study participating centres

King Abdulaziz Specialist Hospital

Qurwa
Taif
26521
Saudi Arabia

King Faisal Medical Complex

Shihar road
Alhadaek
Taif
26514
Saudi Arabia

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Stored in non-publicly available repository, Available on request, Published as a supplement to the results publication
IPD sharing plan	The datasets generated during and/or analysed during the current study will be stored in a non-publicly available repository. The de-anonymised data will be available upon reasonable request from Fahad Alotibi (fahad.alotibi@nottingham.ac.uk). Consent will be obtained from participants for data sharing. The data will be shared 12 months after the PhD thesis submission and will be available for 7 years after the award date of the degree. Data requestors need to sign a data access agreement to access data. Upon publication, the datasets generated and/or analysed during the current study will be published as a supplement to the results publication.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

19/08/2025: Contact details updated.
11/06/2024: The following changes were made to the study record:
1. The public title was changed from 'Virtual reality for chronic low back pain: a feasibility study in the Kingdom of Saudi Arabia' to 'Virtual reality for chronic low back pain: a mixed-methods feasibility study in the Kingdom of Saudi Arabia'.
2. The study design was changed from 'Mixed-methods explanatory sequential design in a single-centre one-group pre-intervention post-intervention feasibility trial' to 'Mixed-methods explanatory sequential design in a multi-centre uncontrolled pre-intervention post-intervention feasibility trial'.
3. The overall study end date was changed from 18/08/2023 to 22/09/2023.
4. The intention to publish date was changed from 01/06/2024 to 01/06/2025.
5. Total final enrolment added.
19/09/2023: The primary outcome measure was changed.
23/08/2023: The following changes were made to the trial record:
1. The recruitment start date was changed from 21/05/2023 to 29/05/2023.
2. The recruitment end date was changed from 18/08/2023 to 28/08/2023.
3. The study participating centre
12/05/2023: Internal review.
11/05/2023: Study's existence confirmed by the University of Nottingham.