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Effect Virtual Reality Fully Immersive Based Exercise Game on Reducing Fear of Movement in People With CLBP

Exploring the Difference in Using Virtual Reality Fully Immersive Based Exercise Game or Usual Care on Physical and Psychosocial Factors in People With Chronic Non-specific Low Back Pain

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05267756
Enrollment
28
Registered
2022-03-04
Start date
2021-10-10
Completion date
2022-07-30
Last updated
2022-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CLBP - Chronic Low Back Pain

Keywords

CLBP, VR, Fear of movement, Disability, Video Game, Adherence

Brief summary

Low back pain is one of the most common problems among adults and a leading cause of disability worldwide including in Saudi Arabia (Buchbinder et al., 2018) (Awaji, 2016) . Studies have shown that 80% of adults would experience low back pain at least once in their lifetime (Awaji, 2016). Research has shown that physical exercises are the most effective rehabilitation method. However, some CLBP patients have fear of movement and fear of increasing the pain (Alamam et al., 2019b), which will lead to inactivity and more disability. Moreover, low adherence to the prescribed exercise program is very common, which could be due to complexity of the program, boredom or lack of supervision and follow up(Elbur, 2015). VR fully-immersive -based exercise game can be used to enhance CLBP rehabilitation by keeping the patients engaged in the virtual environment distracting them from pain and stopping the cycle of fear of movement. Based on the previous problem our research questions are: * Will the VR fully immersive based exercise game improve patient outcomes (fear, pain, reduce disability and improves physical function and adherence)? Aims of the Study. * To assess the effectiveness of the VR fully immersive-based exercise game in the rehabilitation program for patients with CNSLBP with kinesiophobia, in reducing fear of movement, pain-related to disability, and improving physical function. To assess the adherence of the VR-based exercise, which has entertainment aspect is better than adherence to the conventional paper-based exercise.

Detailed description

Significance of the Study. Based on the Fear-Avoidance model, the fear comes from the pain perception which increases level of disability (Leeuw et al., 2007). Thus, to break the fear cycle, we need first to reduce the pain intensity. This can be done by a virtual environment into a Head Mounted Displays (HMDs) that provides a fully immersive experience to engage the patients in a virtual environment and distract them from the pain while performing their exercises. Moreover, based on recent clinical guidelines for LBP rehabilitation, exercises are one of the most effective treatments for LBP. Therefore, we believe that a fully immersive based exercise game integrated with physical exercises that include a series of trunk movements such as moving forward, backward, sideways, and rotation. This solution will enhance the rehabilitation outcome since the patients who are suffering from CLBP with fear of movement and high level of disability can use the system at their home and train more for long period of time using a low-cost virtual reality device.

Interventions

DEVICE(kurki-application),VR glasses

it is virtual reality immersive based-exercise game

Sponsors

King Saud University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

1. Consented adult patients, male and female, aged 18 or older. 2. patient diagnosed with chronic non-specific low back pain (symptoms duration more than 3 month). 3. patient reported no health condition that would restrict movement or prevent safe participation 4. patient able to use smart phone.

Exclusion criteria

1. patients age more than 60 years. (As patient has high risk of morbidity could affect balance and movement) 2. Patients with spine surgery, hip arthroplasty, or spinal deformity like scoliosis. 3. Patient with red flags (e.g., active cancer, report recent or unexplained loss weight, infection, inflammation, or fracture) 4. Clinical neurological features like lumbar radiculopathy. 5. vestibular system dysfunction like vertigo or imbalance by using Head impulse test(Furman & Barton, 2015). 6. pregnancy.

Design outcomes

Primary

MeasureTime frameDescription
Fear-avoidance Belief Questionnaire (FABQ)The change after 2 weeks of interventionConsists of 16 items a self-report questionnaire based on evaluation on the Fear-avoidance model.The maximum score is 96, that representing higher levels of fear-avoidance beliefs. The FABQ has two subscales: the work subscale (FABQw),and the physical activity subscale (FABQpa)

Secondary

MeasureTime frameDescription
Numeric Pain Rating Scale (NPRS)The change after 2 weeks of interventionTo measure pain intensity, The patients rated their pain level on an 11-point scale ranging from 0 to 10, which 0 indicates no pain and the highest score 10 indicates the worst possible pain

Other

MeasureTime frameDescription
The Oswestry disability index (ODI)The change after 2 weeks of interventionThis scale is self-assess questionnaire, which is designed to assess level of function and (disability) in activities of daily living in individual with LBP.It consists of ten everyday activities .A total score is calculated, percentage of disability (score obtained divided by 50 and multiplied by 100)
The Back Belief Questionnaire (BBQ)The change after 2 weeks of interventionThis is a specific self-report questionnaire consists of 14 items beliefs score help to Measuring back beliefs are associated with pain chronicity and disability in people with LBP.Score Range from 9 to 45 the higher the patients scores mean, the less he\\she displays fear and false beliefs
physical performance test .The change after 2 weeks of interventionsix-minutes walking test , Repeated times sit to stand ,Repeated trunk flexion
Adherence to home exercise programThe patient commits to the intervention within 2 weeksdiary to record every time they exercised

Countries

Saudi Arabia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026