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

King Saud University

Status: Active, not recruiting

Conditions: CLBP - Chronic Low Back Pain

Treatments: Device: (kurki-application),VR glasses

Study type: Interventional

Funder types: Other

Identifiers

NCT05267756

VR with LBP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

28 participants in 2 patient groups

intervention Group

Experimental group

Description:

Patient will be receive . 1. usual care that included the education patients(e.g., information, and behavior modification advice techniques) based on the latest clinical practice guidelines (Qaseem et al., 2017 ; Delitto et al., 2012). Also, Patients understood their back problem by reassurance that the condition is not a serious disease and information about the nature of the disorder and prognosis and course of recovery. And what should be done to reduce worry (e.g., stay active and returning to normal activities as soon as possible, avoid worry, coping with having a sore back, and positive attitudes towards back pain are important). The given pamphlets produced by the Saudi Spine Society. 2. The intervention group will have in addition to the usual care, virtual reality immersive based-exercise game, the participants will download (kurki-application), and will given VR glasses

Treatment:

Device: (kurki-application),VR glasses

Control Group

No Intervention group

Description:

Patient will be receive . 1. usual care that included the education patients(e.g., information, and behavior modification advice techniques) based on the latest clinical practice guidelines (Qaseem et al., 2017 ; Delitto et al., 2012). Also, Patients understood their back problem by reassurance that the condition is not a serious disease and information about the nature of the disorder and prognosis and course of recovery. And what should be done to reduce worry (e.g., stay active and returning to normal activities as soon as possible, avoid worry, coping with having a sore back, and positive attitudes towards back pain are important). The given pamphlets produced by the Saudi Spine Society. 2. The control group will have in addition to usual care that included the education patients, a Brochure for LBP therapeutic exercises