Clinical trial NCT06868329: Virtual Reality Vased Exercises and Hyperlordosis in Low Back Pain
Official title: Effect of Using VR Game-based Training to Correct Lumbar Lordosis in Patients with Chronic Low Back Pain and Lumbar Hyperlordosis: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hyperlordosis
Keywords: lordosis
low back pain
lumbar curve
virtual reality
TBed
Lead sponsor: University of Hail
Sponsor class: OTHER
First posted: 2025-03-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: this study aimed to evaluate the impact of incorporating postural correction exercises through VR video gaming on lumbar lordotic angle (LLA), pain, range of motion (ROM), and function in patients with chronic non-specific low back pain (CNLBP). Furthermore, the study sought to assess satisfaction and commitment levels when VR was integrated into the exercise regimen

Detailed description: Low back pain is referred to as the most common musculoskeletal dysfunction. Almost every person is at risk of experiencing a low back pain attack at least once in life. Due to its high prevalence rate, low back pain can be attributed to high rates of work absenteeism, long-term functional disability and compromised quality of life. A huge economic burden has been linked to the management of this condition, especially in low-income countries.

The mechanism of development of low back pain could be quite variable. Some cases develop low back pain after accidents or trauma to the lower spine or pelvis. In other occasions, bad postural alignment, such as anterior pelvic tilting, leg length discrepancy, could be the primary source of the lesion. Other patients could experience low back pain secondary to discogenic lesion in the lumbar spine, which is usually associated with referred pain to the lower extremities (sciatica). Interestingly, the majority of the cases have no obvious mechanism of origin. Hence, were referred to as nonspecific low back pain.

According to previous literature, some researchers argue that the lumbar spine lordotic curvature (LLC) is the origin of low back pain. This curve was developed in the early infancy when the infant starts to assume an upright posture. The presence of the LLC allows the center of mass of the trunk to be located superior to the hips and provides biomechanical advantages to the soft tissue in neutralizing shear loads and allows better locomotion on the lower extremity. However, this comes with the cost of increased susceptibility for the development of low back pain.

The value of the LLC is usually influenced by the surrounding muscles situated in the abdomen, low back, anterior and posterior hip region, and hamstrings. Imbalance between the sagittal plane muscles, such as tight low back muscle and anterior hip muscle along with weak or elongated abdominal muscles can result in anterior pelvic tilt and an increase in the LLC. Conversely, other patients might demonstrate a decrease in the LLC value secondary to muscle imbalance.

qLLC can be assessed accurately using plain X-ray of the spine. Several angles can be measured to reflect the LLC. However, the lumbar lordotic angle (LLA) is considered the most accurate one. LLA can be calculated using a lateral view X-ray film where the intersection angle between two lines was calculated. The first line was drawn from the upper surface of the first lumbar vertebra and the second line was drawn from the lower surface of the last lumbar vertebral body.

Due to the diverse mechanisms of low back pain, there are also variations of treatment strategies, exercise therapy, manual therapy, physical therapy modalities, as well as medications and surgery, which can be all used according to the characteristics of each patient.

Exercises consisting of pelvic rocking (anterior and posterior) are considered cornerstone in any exercise therapy because they improve mobility of the lower trunk muscles and regain balance between anterior and posterior muscle groups to regain the normal.

TBed is a fully sensorized treatment bed divided into four sections. It features a network of sensors capable of detecting any pressure applied by the patient's body, which is then displayed in real-time on an attached computer screen. This allows patients to play various games by using their neck, upper, and lower back muscles, making it an excellent option for video game-based rehabilitation of spinal conditions.

Numerous studies have explored the effectiveness of gaming and VR in treating low back pain (LBP), yet there remains debate about their short-term impact. Moreover, satisfaction and adherence to exercise sessions have not been thoroughly examined.

Eligibility criteria: Inclusion Criteria:

* males or females,
* 18 - 44 years of age,
* unilateral, bilateral, or central (midline) pain in the low back,
* demonstrate lumbar hyper lordosis of the lumbar spine (lumbar lordotic angle more than 40°, measured using flexi ruler and spinal mouse) (Tack 2021),
* pain persists for 3 months or more,
* pain intensity between 2 -6 on numeric pain rating scale (NPRS).

Exclusion Criteria:

* acute low back pain (less than 3 months),
* specific pain due to well diagnosed pathology such as trauma, surgery, dick lesion, tumor, adhesions.
* Low back pain associated with sciatica, patients who cannot stop using analgesic drugs during the period of the study.

Primary outcomes:
measure: Intensity of low back Pain
timeFrame: at base line and after 8 weeks of tretment
measure: Active ROM of the lumbar spine
timeFrame: at base line and after 8 weeks of tretment
measure: Lumbar lordotic angle (LLA)
timeFrame: at base line and after 8 weeks of tretment
measure: Functional level
timeFrame: at base line and after 8 weeks of tretment
Secondary outcomes:
measure: Satisfaction level
timeFrame: after 8 weeks of tretment
measure: Commitment to exercise sessions
timeFrame: after 8 weeks of tretment
Other outcomes:
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