Virtual Reality Vased Exercises and Hyperlordosis in Low Back Pain

NCT ID: NCT06868329

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-06
• Study Completion Date: 2025-08-15

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.

Conditions

Hyperlordosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

VR TBed group

this arm will receive superficial moist heat, hamstring and low back stretching plus posterior pelvic tilting exercises applied using TBed virtual reality gaming system,

Group Type: EXPERIMENTAL

Superficial moist heat

Intervention Type: OTHER

Twenty minutes of automatic moist hot pack (Besmed© BE-267, Taiwan) of suitable size was used to apply superficial heat. The heat level was adjusted to the medium level. While the moist environment was assured by placing a moist sponge layer between the pack and its cotton outer coverage. The duration was calculated after 8 minutes of warming up (when the temperature reaches its maximum level). The patient-reported sensation should be moderate warmth. A thermal sensation test using two test tubes was performed before applying heat therapy to avoid any adverse effects

Hamstring and back muscles stretching

Intervention Type: OTHER

Patients received manual passive stretch for the hamstring and lower back muscles. Three repetitions per session with every repetition sustained for 30 s. The patient assumed a long sitting position with both knees in full extension and feet together. The patient was then asked to bend forward from the hips to reach the furthest point towards the feet. The therapist applied over pressure by pressing hands on the patient's upper back and pushing forward.

Postural correction with lumbar stabilization using TBed

Intervention Type: OTHER

These exercises consisted of pelvic rocking, and activation of the upper back and interscapular muscles. TBed from Techno body©, Italy was used to assist the patient to perform these exercises through VR video gaming interface. The patients in the experimental group will be asked to contract the targeted muscles and push down on the surface of the TBed. Patient's pressure will activate the sensors inserted inside the TBed, which will be reflected on the game as triggering of the gun that targets flying fruits. The game consists of three levels, easy, medium, and hard. The patient will be asked to play the game for the lower back where pushing the lower back against the bed (posterior pelvic tilting) triggered the gun and for the upper back where pushing the scapula against the bed was the triggering action.

Control group

this arm will receive superficial moist heat, hamstring and low back stretching plus posterior pelvic tilting exercises applied using the traditional technique from supine position

Group Type: ACTIVE_COMPARATOR

Superficial moist heat

Intervention Type: OTHER

Twenty minutes of automatic moist hot pack (Besmed© BE-267, Taiwan) of suitable size was used to apply superficial heat. The heat level was adjusted to the medium level. While the moist environment was assured by placing a moist sponge layer between the pack and its cotton outer coverage. The duration was calculated after 8 minutes of warming up (when the temperature reaches its maximum level). The patient-reported sensation should be moderate warmth. A thermal sensation test using two test tubes was performed before applying heat therapy to avoid any adverse effects

Hamstring and back muscles stretching

Intervention Type: OTHER

Patients received manual passive stretch for the hamstring and lower back muscles. Three repetitions per session with every repetition sustained for 30 s. The patient assumed a long sitting position with both knees in full extension and feet together. The patient was then asked to bend forward from the hips to reach the furthest point towards the feet. The therapist applied over pressure by pressing hands on the patient's upper back and pushing forward.

posterior pelvic tilting exercises regular procedures

Intervention Type: OTHER

Patients will be asked to assume the supine position with both knees semi-flexed. A small billow will be placed under the low back, another billow will be placed under the flexed knees for comfort. The patient will be asked to tuck the abdominal muscles inward and press with the low back on the underlying billow and hold for six seconds, then relax. after a few seconds of rest, the patient should repeat this procedure for 3 sets X 10 repetitions per session during the first 2 weeks. the number of sets will be increased according to the adaptation of each patient and his/her fatigue threshold.

Interventions

Superficial moist heat

Twenty minutes of automatic moist hot pack (Besmed© BE-267, Taiwan) of suitable size was used to apply superficial heat. The heat level was adjusted to the medium level. While the moist environment was assured by placing a moist sponge layer between the pack and its cotton outer coverage. The duration was calculated after 8 minutes of warming up (when the temperature reaches its maximum level). The patient-reported sensation should be moderate warmth. A thermal sensation test using two test tubes was performed before applying heat therapy to avoid any adverse effects

Intervention Type: OTHER

Hamstring and back muscles stretching

Patients received manual passive stretch for the hamstring and lower back muscles. Three repetitions per session with every repetition sustained for 30 s. The patient assumed a long sitting position with both knees in full extension and feet together. The patient was then asked to bend forward from the hips to reach the furthest point towards the feet. The therapist applied over pressure by pressing hands on the patient's upper back and pushing forward.

Intervention Type: OTHER

posterior pelvic tilting exercises regular procedures

Patients will be asked to assume the supine position with both knees semi-flexed. A small billow will be placed under the low back, another billow will be placed under the flexed knees for comfort. The patient will be asked to tuck the abdominal muscles inward and press with the low back on the underlying billow and hold for six seconds, then relax. after a few seconds of rest, the patient should repeat this procedure for 3 sets X 10 repetitions per session during the first 2 weeks. the number of sets will be increased according to the adaptation of each patient and his/her fatigue threshold.

Intervention Type: OTHER

Postural correction with lumbar stabilization using TBed

These exercises consisted of pelvic rocking, and activation of the upper back and interscapular muscles. TBed from Techno body©, Italy was used to assist the patient to perform these exercises through VR video gaming interface. The patients in the experimental group will be asked to contract the targeted muscles and push down on the surface of the TBed. Patient's pressure will activate the sensors inserted inside the TBed, which will be reflected on the game as triggering of the gun that targets flying fruits. The game consists of three levels, easy, medium, and hard. The patient will be asked to play the game for the lower back where pushing the lower back against the bed (posterior pelvic tilting) triggered the gun and for the upper back where pushing the scapula against the bed was the triggering action.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Hail

OTHER

Sponsor Role: lead

Responsible Party

Hisham Mohamed Hussein

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Hail

Hail, Ha'il Region, Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

H-2025-675

Identifier Type: -

Identifier Source: org_study_id