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HyperlordosisNCT06868329

Virtual Reality Vased Exercises and Hyperlordosis in Low Back Pain

A study testing Superficial moist heat, Hamstring and back muscles stretching and posterior pelvic tilting exercises regular procedures in people with Hyperlordosis, run by University of Hail at 1 site in Saudi Arabia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 44 years
Conditions the study is for
Hyperlordosis
What is being tested?
Superficial moist heat, Hamstring and back muscles stretching and posterior pelvic tilting exercises regular procedures
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteSaudi Arabia
Study dates
6 Mar 2025to 15 Aug 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 44 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Saudi Arabia1 site
  • University of Hail

    Ha'il, Ha'il Region, 3994

Other trials in Saudi Arabia

About this study

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

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.

Conditions
Hyperlordosis
Being tested
Superficial moist heat, Hamstring and back muscles stretching, posterior pelvic tilting exercises regular procedures, Postural correction with lumbar stabilization using TBed
Keywords
lordosis, low back pain, lumbar curve, virtual reality, TBed
Medical subject headings
Swayback, Lordosis, Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Superficial moist heatOther

    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 stretchingOther

    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 proceduresOther

    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.

  • Postural correction with lumbar stabilization using TBedOther

    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.

Study groups in NCT06868329
Study groupRoleWhat they receive
VR TBed groupExperimentalthis arm will receive superficial moist heat, hamstring and low back stretching plus posterior pelvic tilting exercises applied using TBed virtual reality gaming system,
Receives: Other: Superficial moist heat; Other: Hamstring and back muscles stretching; Other: Postural correction with lumbar stabilization using TBed
Control groupActive comparatorthis arm will receive superficial moist heat, hamstring and low back stretching plus posterior pelvic tilting exercises applied using the traditional technique from supine position
Receives: Other: Superficial moist heat; Other: Hamstring and back muscles stretching; Other: posterior pelvic tilting exercises regular procedures

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 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

    Measured: 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).

    Measured: at base line and after 8 weeks of tretment

Secondary outcomes (2)
  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

    Measured: 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

    Measured: after 8 weeks of tretment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2025
  2. Study start6 Mar 2025
  3. Primary completion15 Aug 2025
  4. Study completion15 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06868329
Sponsor's protocol ID
H-2025-675
Status last verified
Mar 2025
First submitted
7 Mar 2025
Last updated
3 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: data will be used in future studies

Questions about this trial

What is this clinical trial studying?

A study testing Superficial moist heat, Hamstring and back muscles stretching and posterior pelvic tilting exercises regular procedures in people with Hyperlordosis, run by University of Hail at 1 site in Saudi Arabia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intensity of low back Pain (time frame: at base line and after 8 weeks of tretment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.

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