ClinicalTrials.gg
CompletedNCT06868329Updated Oct 3, 2025

Virtual Reality Vased Exercises and Hyperlordosis in Low Back Pain

An interventional study of Superficial moist heat and Hamstring and back muscles stretching in Hyperlordosis, sponsored by University of Hail. Completed at 1 site in Saudi Arabia. Open to participants aged 18 Years to 44 Years. Per ClinicalTrials.gov, last updated 2025-10-03.

Sponsored by University of Hail · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 44 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Hyperlordosis

Keywords

  • lordosis
  • low back pain
  • lumbar curve
  • virtual reality
  • TBed
03

In context

Swayback

10 studies on the registry are indexed under Swayback; 2 are open to participants now.

Browse Swayback studies →

Lead sponsor

University of Hail is the lead sponsor of 24 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 44 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    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,

    Other: Superficial moist heat · Other: Hamstring and back muscles stretching · Other: Postural correction with lumbar stabilization using TBed

  • Active comparator
    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

    Other: Superficial moist heat · Other: Hamstring and back muscles stretching · Other: posterior pelvic tilting exercises regular procedures

Interventions

  • OtherSuperficial 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

  • OtherHamstring 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.

  • Otherposterior 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.

  • OtherPostural 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.

06

What researchers measure

Primary outcomes

  1. Intensity of low back Pain

    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.

    Time frame: at base line and after 8 weeks of tretment

  2. Active ROM of the lumbar spine

    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.

    Time frame: at base line and after 8 weeks of tretment

  3. Lumbar lordotic angle (LLA)

    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

    Time frame: at base line and after 8 weeks of tretment

  4. Functional level

    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).

    Time frame: at base line and after 8 weeks of tretment

Secondary outcomes

  1. Satisfaction level

    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

    Time frame: after 8 weeks of tretment

  2. Commitment to exercise sessions

    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

    Time frame: after 8 weeks of tretment

07

Study locations

1 site
  • University of Hail
    Ha'il, Ha'il Region 3994, Saudi Arabia
08

References and documents

Individual participant data

Plan to share: No — data will be used in future studies

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2025 to primary completion in Aug 2025, 5 months.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 7, 2025
First posted
Mar 10, 2025
StartActual
Mar 6, 2025
Primary completionActual
Aug 15, 2025
CompletionActual
Aug 15, 2025
Last update
Oct 3, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06868329
Lead sponsor
University of Hail
Responsible party
Hisham Mohamed Hussein (Associate Professor, University of Hail) — Principal investigator
First posted
Mar 10, 2025
Start date
Mar 6, 2025
Primary completion
Aug 15, 2025
Completion
Aug 15, 2025
Last update
Oct 3, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion