Virtual Reality Vased Exercises and Hyperlordosis in Low Back Pain

Not Applicable

Not yet recruiting

• Conditions: Hyperlordosis

• Registration Number: NCT06868329
• Lead Sponsor: University of Hail

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.

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-07
• Study First Submitted QC: 2025-03-07
• Last Update Submitted: 2025-03-07
• Study First Posted: 2025-03-10
• Last Update Posted: 2025-03-10
• Study Start: 2025-05-01
• Primary Completion: 2025-11-30
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Intensity of low back Pain	at base line and after 8 weeks of tretment	Pain intensity will be assessed using NPRS. This scale consists of a horizontal 10cm line numbered from 0 to 10. The higher numbers indicate higher pain intensity while lower numbers indicate lower pain intensity. The validity and reliability of this scale for measuring musculoskeletal pain were approved in previous work. Participants were asked to select the number that represents their current pain level.
Active ROM of the lumbar spine	at base line and after 8 weeks of tretment	Active Lumbar flexion and extension were assessed using the Back range of motion (BROM) device. This device was designed to assess the ROM of the lumbosacral region. It consisted of a set of inclinometers - attached to two plastic frames - arranged in vertical and horizontal fashions to assess the sagittal, frontal, and rotational movement of the lower back. BROM is a valid and reliable device for measuring lumbar ROM. The current study used BROM (Performance Attainment Associates, Roseville, Minnesota) to assess active flexion and extension of the lumbar spine. Measurements were taken according to the guidelines described previously.; The AROM was determined by calculating the difference between the angle recorded in the starting position and the angle recorded at the end position of either flexion or extension.
Lumbar lordotic angle (LLA)	at base line and after 8 weeks of tretment	LLA will be measured using a Flexi curve ruler. A flexi ruler is utilized as a non-invasive tool to assess lumbar curvature. This 60 cm ruler is constructed from special steel and coated with plastic, allowing it to be bent to match the lumbar curve and maintain its shape. Its reliability and validity have been previously confirmed. The assessment will be conducted by an assessor who will be unaware of the patient's intervention allocations. To measure the lumbar curve, patients will stand with their knees extended and feet about shoulder-width apart, while the lordosis was measured between the L1 and S2 prominences. The angle between L1 and S2, referred to as the Ө angle, will be calculated using the formula: Ө = 4\[Arc tan (2H/L)\], where L is the line connecting the two ends of the curve, and H is the maximum distance between L and the curve. The normal lordosis angle is 30 degrees, while angles exceeding 40 degrees are classified as hyper
Functional level	at base line and after 8 weeks of tretment	The Oswestry Disability Index (ODI) was used to assess functional disability levels. It consists of 10 sections covering the discomfort of the back and the activities conducted every day. Each item has six answers with a score range from 0-5 according to the arrangement of the statement as 1st refers to 0 and the 2nd takes 1, etc. Then the scores were added to reach the total score ranging from 0 - 50. This score can be used as raw data or it can be used to calculate a percentage. In either case, lower values indicate better function and higher values indicate more disability. In the current study, the raw data was used to conduct the analysis, as it was considered more sensitive to show minor changes compared to ratio values. The validity and reliability of the ODI have been studied and shown to have a high level , where the ICC for the reliability range (0.96-0.88).

Secondary Outcome Measures

Name	Time	Method
Satisfaction level	after 8 weeks of tretment	This outcome was measured using a 1-10 scale which resembles the NPRS. However, the 0 point indicated no satisfaction while the number 10 indicated maximum satisfaction. The patient was asked to answer the following question, "To what extent can you rate your satisfaction with the introduced physical therapy program?". The patient then chose any number from 0 to 10 that represented the current level of satisfaction
Commitment to exercise sessions	after 8 weeks of tretment	This outcome was assessed by calculating the percentage (%) of the successful sessions that were attended by the patients and subdivided by 420 (the total number of sessions) and then multiplied by 100